In Canada, there is widespread agreement about the need for integrated models of team-based care. However, there is less agreement on how to support the scale-up and spread of successful models, and there is limited empirical evidence to support this process in chronic disease management. We studied the supporting and mitigating factors required to successfully implement and scale-up an integrated model of team-based care in primary care.We conducted a collective case study using multiple methods of data collection including interviews, document analysis, living documents, and a focus group. Our study explored a team-based model of care for chronic obstructive pulmonary disease (COPD) known as Best Care COPD (BCC) that has been implemented in primary care settings across Southwestern Ontario. BCC is a quality improvement initiative that was developed to enhance the quality of care for patients with COPD. Participants included healthcare providers involved in the delivery of the BCC program.We identified several mechanisms influencing the scale-up and spread of BCC and categorized them as Foundational , Transformative , and Enabling Mechanisms . Based on these results, we developed a framework to inform the progressive implementation of integrated, team-based care for chronic disease management. Our framework builds off our empirical work and is framed by local contextual factors.This study explores the implementation and spread of integrated team-based care in a primary care setting. Despite the study’s focus on COPD, we believe the findings can be applied in other chronic disease contexts. We provide a framework to support the progressive implementation of integrated team-based care for chronic disease management. Integrated team-based models of care have emerged as a means to improve care delivery and promote system sustainability . CanadiaThe shift towards integrated team-based care can be observed in the management of chronic obstructive pulmonary disease (COPD) . GloballBroadly, implementation efforts have been supported through several frameworks including the Consolidated Framework for Implementation Research (CFIR) , the ProWe wanted to understand the progressive implementation of the BCC program across multiple primary care sites within the Southwestern region of Ontario, Canada. A previous phase of this research explored the initial spread of the program into one site . This cuWe conducted a collective case study exploring the progressive implementation of BCC within one geographic region over multiple years 2019–2021) . Each im–2021 . ESouthwestern Ontario is home to nearly 1 million residents; approximately 30% of residents live in rural regions, 3% identify as Aboriginal, and 30% live below the provincial low-income cut-off . ServiceBCC is a quality improvement initiative developed in 2009 by the Asthma Research Group Inc. (ARGI) to enhance the quality of care delivered to patients with COPD, within a primary care setting. One-on-one consultations with patients with COPD are conducted by a Respiratory Therapist (RT), RN, or other allied health provider. BCC providers hold an additional credential as a Certified Respiratory Educator (CRE). The program is designed to enable the educators to collaborate with the primary care site to proactively search to invite any patient at risk of COPD to the program. BCC providers work closely with the patient’s care team to develop an action plan, coordinate care, and educate patients about self-management.The BCC program started in one geographic region of Southwestern Ontario, Canada and providers believed that it contributed to remarkable improvements in clinical outcomes, reduced emergency department visits, and improved patient quality of life , 23. TheMultiple methods of data collection were used to develop an in-depth understanding of the progressive implementation of BCC. These included living documents (LDs), a focus group, interviews, and document analysis. The research team was an independent, objective party and possessed significant experience conducting semi-structured focus groups and interviews, and expertise in qualitative and mixed research methods. Participants were briefed on the purpose of the study and the data collection methodology in Consent Forms.LDs are a semi-structured journaling approach  for gathA focus group was conducted with the nine providers responsible for implementing and delivering the BCC program. Questions were guided by CFIR, and informed by data collected in the LD to explore experiences of the implementation process and provider experience. CFIR provided a strong guiding framework for the focus group as it is a meta-theoretical framework incorporating a combination of constructs from several implementation frameworks . This frInterviews were conducted over the phone with resident primary care providers (physicians and nurse practitioners) from BCC implementation sites, who work collaboratively with the BCC CRE at their site, but that were external to BCC prior to implementation. Interviews explored implementation, provider experience, and impacts on care provision. The focus group and interviews involved the use of guides, spanned 1–2 h in length, and were audio recorded then transcribed for analysis.Document analysis was used to advance the researchers’ knowledge of the BCC program’s implementation process through the contextual and background data. We collected existing team documents  to develop a rich understanding of the context that supported our analysis.Data analysis was iterative and continuous; the research team relied on a conceptual and theoretical coding approach to identify themes . Data wan = 9; response rate = 100%). One physician and one nurse practitioner participated in an interview . The response rates for the living documents (n = 8) ranged from 44% to 89%. In total, we collected 47 documents. Our results are informed by all data sources across all sites and include verbatim quotes to demonstrate the themes that emerged through analysis.In total, there were 11 participants. All invited RTs participated in the LD and focus group . The phases built on one another and were mutually reinforcing. The success of each implementation phase was dependent on several mechanisms, which were categorized as foundational, transformative, and enabling Table . MechaniParticipants acknowledged their pre-implementation decision to implement the BCC program was multi-faceted. Three elements were foundational in pre-implementation: (1) an evidence-based program, (2) readiness to implement, and (3) implementation support. Each mechanism built on and supported the others.“[this strategy was] not just [to reduce] emergency visits, you’ve got to look at the fact that we’ll decrease the amount of spirometry needed at the hospitals, the full pulmonary function if they only want spirometry. The [RTs] that are freed up - Freed up to deal with seeing sick patients.” – Participant 6, InterviewParticipants valued the increased access for their patients to COPD-specific care, within a primary care setting.“A significant barrier to healthcare is access – FHT/FHO/family physician offices are generally more accessible  than hospitals or specialized clinics. [The] BCC program benefits patients by offering easier access to another HCP [Health Care Provider] and tools previously unavailable.” – Participant 4, Living Document 1When asked about their motivation to implement BCC, participants described a need for increased support for patients and providers regarding COPD care. BCC provided patients with more time to both discuss and learn about their disease and treatment options. Providers felt this time was valuable for both themselves and their patients.“In my opinion, patients are looking for time with HCP’s to explain their concerns and receive education /feedback etc. Time is a luxury in healthcare, and I feel we do offer a lot of time and education to every patient.” – Participant 5, Living Document 1The quality of the program was often cited by participants as a key benefit of implementation. Participants explained that BCC standardizes the quality of care and ensures that all patients get access to the same care. Providers valued the self-management focus of BCC and described the program as an interactive and engaged relationship between providers and their patients. One participant shared that “[b]y placing a focus on the patient during every appointment. Ensuring that they understand all of the information being discussed, they have opportunity for questions, and that I look at their overall health and seek any opportunity to help” .Across sites, participants unanimously described BCC as being developed based on best practices and strong evidence. When creating the program, ARGI first identified existing programs and gaps within the care available to patients within their region. ARGI used this information to create evidence-based solutions to address patient and provider needs. Participants saw BCC as a multifaceted solution to manage care in a resource-strapped system.The decision to implement was also influenced by the support and guidance offered by BCC leadership and the implementation team. Participants noticed the interprofessional composition of the implementation team and how it facilitated peer-to-peer learning. From the beginning, healthcare professionals heard and learned from peers (of the same profession) about the goals, challenges, and successes of the program. The leadership team  were available throughout implementation, bolstering participants’ readiness to implement. Frontline providers  were integral to the implementation; almost all participants indicated that having an RT as a core member of the implementation team was vital to overall success. A participant discussed that the implementation team supported all clinicians, centralized the information, and ensured that the messaging  was consistent from the outset. Additionally, participants valued the “physician-to-physician” role and considered it to be integral to growing a common understanding and increasing commitment (and buy-in) to the BCC program.A key task of the peer-led implementation team was support in patient recruitment. Recruitment was initially led by the BCC implementation team in collaboration with providers at the implementation sites. BCC’s recruitment strategy involved the RTs “proactively searching [the electronic medical records] for patients who would benefit from the program” . This initiated provider empowerment as well as surfaced possible future barriers to delivery and evaluation. Participants appreciated the proactive approach to patient recruitment as opposed to waiting for referrals.The majority of the participants stated their readiness to implement was strengthened with the knowledge of the growing evidence of positive outcomes from the BCC program in other sites. As more sites implemented the BCC program, there was a feeling of not wanting to be left behind.Adaptive ProcessThree transformative mechanisms were key to supporting the successful implementation: (1) adaptive process, (2) provider empowerment, and (3) embedded evaluation. These three transformative mechanisms were buttressed by four enabling mechanisms: (1) provider training, (2) administrative support, (3) role clarity, and (4) patient outcomes.An adaptive process was key in supporting implementation. While the structure of the BCC program was largely prescribed, how the program was implemented was flexible and was often adapted to different practice settings. For example, BCC implementation was adapted based on the funding model of the clinic, clinic capacity, and space.“even the receptionist at one of my sites, she at first – patients would come up to the window to see social work and they’d be huffing and puffing, and she didn’t really acknowledge it. But before I left there she was saying, ‘Oh my God, are you OK? Do you need to see our RT? We have a RT.” – Participant 5, Focus GroupPrimary care providers acknowledged the program’s easy incorporation into the day-to-day workflow and credited the support from administration staff. In the early implementation, participants described having to spend more time with program elements. A few participants felt this occupied a considerable amount of time and was seen as a challenge to the early delivery and workflow of BCC.Program delivery needed to adapt to resources such as administrative capacity and space. The administrative staff were key to supporting implementation and embedding the program in usual care. These staff were well-positioned to increase awareness of the program among patients and adapt BCC delivery to improve efficiency based on current work practices.“Finding patients, then booking them (if they answer phone), then the initial appt. is 1.5 hours, which is completely necessary, and the consultation … chasing down doctors, waiting outside of their rooms to get approval or simply discuss appointment and finally charting which takes up quite a lot of time.” – Participant 9, Living Document 4BCC’s implementation was an evolving process as the program was adapted by the clinic for its unique context; clarity about roles and responsibilities grew as the clinic worked through the implementation process. This adaptive feature of the program meant that the program required an upfront investment of time and resources which was key in facilitating buy-in from different stakeholders as they progressively integrated the program into their routine activities. For example, administrative staff were key in securing role clarity and trust, through methods such as reminder calls (to patients with access to telephone) to minimize last-minute cancellations and no-shows.One participant expressed that during early implementation, BCC activities absorbed more time than any other resource:(2)Empowerment & CollaborationAs the implementation process progressed, the program was able to adapt to the processes of the site and integrate within the day-to-day practice to reduce this significant time commitment.Empowerment was embodied and discussed in several ways; namely, the empowerment of staff to deliver the services associated with the program, and the subsequent empowerment of patients and caregivers to better manage their COPD. Interprofessional collaboration was identified as a key strength of the program as it was an opportunity where staff were “working with the doctor rather than against the doctor, and ideally working with respirologists” . This was a function of time  and observing positive patient outcomes. A provider shared that “there’s a lot of … collaboration that didn’t happen before this [program]… [this has] increased our ability to do our jobs better too” . Document analysis confirmed this collaboration as a priority, and essential in establishing a self-management plan for the patient. One participant shared that “[t]here have been some challenges such as getting all team member[s] on the same page but over time the program has built trust and has proven its worth” . Lack of role clarity in early implementation was also described as a barrier. For example, participants felt a lack of communication with all clinic providers and staff gave rise to ambiguity about program roles and objectives; “certain health care professionals felt their toes were being stepped on by the BCC program” . Additionally, this initial lack of role clarity was perceived as a major challenge to the development of trust and professional relationships; “I feel that a major challenge exist[s] in the understanding of “just what we do”. All HCP’s have been supportive of my presence but not always supportive of talking about the patient right away” .Participants believed that achieving empowerment and collaboration could have occurred sooner with more up-front provider training related to clarification of roles and purpose of the program. As the BCC program was able to integrate into the site, the roles of BCC and primary care providers evolved. Participants explained how some physicians initially lacked understanding of the RT roles within the program; one participant felt this lack of understanding may lead to physicians being reluctant to refer patients or give RTs patient information. Multiple participants felt all clinic providers and administration should be trained on the program’s offerings early in implementation. Participants noted that there was an increase in engagement at the clinician and administrative level after the program had been operating for some time and they became more familiar with it. For example, physicians started adding patients to the RT’s schedule, making patient recruitment easier. Embedding the RT on-site, co-located with the primary care provider, helped to enhance role clarity during implementation through regular contact and communication.(3)Embedded EvaluationParticipants noticed as administrative staff developed a clearer understanding of their role and the function of the program, they provided increased support through reminder calls and managing appointments. Participants also noted that in early implementation, higher level of no-show and cancellation rates  was, in part, attributable to a lack of role clarity of support from administration and other clinicians. When administrative support was strengthened, there was better patient attendance. As the implementation process progressed and the program became aligned with the internal processes of the site, the program as able to utilize the support from staff to ease the delivery of the BCC program.Evaluation made providers aware of the value of the educational component of the program; “they’re understanding their disease, they’re understating why they’re in seeing us. And at first they’re hesitant sometimes at an hour-and-a-half appointment, but I’ve never had anybody upset that they came” . One participant noted that they typically see the benefits of the program within a year. Another participant noted that the impact of the program is demonstrated in decreased patient’s COPD Assessment Test (CAT) scores. The CAT score is a validated measure of disease-specific quality of life.Embedded evaluation meant patient outcomes were constantly and consistently reported. For most participants, the regular appointments allowed for both formal and informal evaluation. Participants were able to see, first-hand, positive improvements. One participant shared that they “measure [patient outcomes] from comparing their knowledge starting the program compared to today. The patients review their action plans and device technique at most follow ups which demonstrates knowledge and understanding of our program” .This was coupled with patients’ positive responses to their appointments. Participants described patients as being receptive to the education, recalling for example patients saying “nobody’s ever shown me this, nobody’s ever explained this to me” . Participants also believed that the program empowered patients by improving patients’ self-efficacy by equipping them with the skills, knowledge, and confidence to manage their COPD. One participant noted that BCC “give[s] patients the power and knowledge to understand their disease, symptoms, and management so they can take control of their own health” .There were metrics available such as patients’ CAT and the Modified Medical Research Council (mMRC) breathlessness scores (taken at every appointment), and healthcare services utilization data such as hospital admissions, emergency department visits, and consultations with physicians. One participant expressed that “people like data … even if they don’t truly understand it” . As the program was implemented across the region, there was an increase in the quantity and diversity of the data available, which, in turn, solidified the program in existing sites and further facilitated progressive implementation to new sites.BCC is understood to be a high-quality program with demonstrated improved patient outcomes and increased provider satisfaction. BCC was implemented in a primary care setting which is a reliable point of intervention for chronic disease management programs, and more specifically, COPD management programs . The proEnabling mechanisms  worked collectively across the transformative mechanisms . Our results suggest that implementation strategies must deviate from the traditional linear approach , 32. InsPost-implementation refers to the time when providers start to focus more on sustaining the program within the current site and program leaders focus on spreading into new clinics. The foundational, transformative, and enabling mechanisms at play during implementation remain active in post-implementation, although with less effort required. Demonstrated outcomes and word-of-mouth work to increase awareness of the program in other sites which, in turn, contributes to positive staff morale and staff buy-in when implementing in other sites , 36. AltAdaptive delivery and embedded evaluation both require a high investment of time and resources during the initial stages of implementation when the program is unfamiliar to staff and patients. A flexible approach to implementation has been shown to improve the likelihood of success in implementation . In our During implementation, cancellations and duration of the appointments presented challenges with some sites for program delivery. Participants felt this was especially relevant when working with patients who experience barriers in access to care due to a lack of stable housing, telephone, and/or internet . DespiteEmbedding evaluation required a significant amount of work during initial implementation however, this effort waned as implementation progressed. Collecting and sharing data from implementation sites is key not only in sustaining program success, but also in laying the foundation for future implementation success . In thisWith the BCC program, providers were able to enhance a patients’ self-management and improve access to appropriate care, resulting in overall improved patient care and improved provider satisfaction. This was accomplished with relative ease; participants were supported at each phase of implementation by a peer-led implementation team and continued support was maintained through peer-to-peer learning. Research shows that a program is more likely to be successfully implemented when there is adequate support coupled with relative ease of implementation , 41.Participants unanimously agreed that the BCC program was effective in improving the self-efficacy of the patients by supporting the development of their knowledge, skills and ultimately, confidence to manage their condition, and these findings are consistent with the literature –45. InteRole clarity also supported implementation. Clearly defined roles and each team member’s contribution to COPD care are essential to facilitating the collaboration needed for implementation . This maSupport from the administrative staff was a key resource in overcoming implementation barriers. In addition to facilitating communication (provider-patient and provider-provider), administrative staff understood the flow of resources – notably space, time, and personnel. As administrative staff became more aware of the program, its objectives, and their role within it, this allowed for efficient implementation, program delivery, and integrated workflow.Qualitative research poses unique challenges to the generalizability of findings and this study is no exception. The aim of this study is to share lessons from one example of progressive implementation as opposed to providing overarching recommendations. Accordingly, we believe the lessons learned are transferable to other settings and contexts.The primary limitation of this study relates to sample size and response rates, and we used a rigorous approach to our case study (multiple methods across multiple sites) to mitigate this limitation. More specifically, we acknowledge that our small sample size and variability in response rates may allow for potential biases to impact the data. For example, the study did not include results from patients and their caregivers, and this can pose the possibility of bias, especially in findings that report success based on perceived patient-centered outcomes. We would like to highlight that these groups were included in our larger research program which may serve to limit the influence of potential bias and its impact on the results.Among the participants that were included in this study, especially in the focus group, there is a potential for controversial or unpopular views to be suppressed which can give rise to false consensus . InclusiFinally, it would be remiss to not mention the impact of the COVID-19 pandemic on this work, however, it is difficult to fully assess its influence. Our data collection was concluding at the beginning of 2020, as the effects of the pandemic were beginning to impact the region. As a result, our study did not explore, nor do we believe it was impacted by the pandemic. The pandemic has shifted how healthcare operates; this may change the focus from co-location to collaboration in regards to integrated team-based care . FurtherThe rapidly increasing prevalence of chronic diseases, and COPD more specifically , emphasi


This study aimed to develop an Internet-based psychiatric nursing intervention, based on Swanson’s theory of caring, that could alleviate post-traumatic stress symptoms and improve the health functioning of adults who had experienced trauma. To evaluate the appropriateness and understanding of the program content, expert advice and content validity were examined using the content validity index. To analyze the participants’ responses and evaluate the appropriateness of conducting Internet-based programs, an online intervention program was implemented with five nurses between February and April 2020. The trauma recovery nursing intervention program was for adults who had experienced trauma and consisted of eight sessions, each lasting 30 min. It included a spoken audio track that was accompanied by visual prompts to provide knowledge on traumatic stress and introduce trauma recovery methods. Its online format made it convenient and widely accessible, and allowed for a low-intensity, cost-effective educational program. The program focused on providing self-help guidelines for clients to develop their mental and physical well-being. The results provide evidence that mental health nurses could develop and implement online programs to care for people who have experienced trauma. Such programs could provide trauma recovery for marginalized people unable to otherwise receive help. Psychological trauma refers to mental damage that occurs when one’s ability to overcome or integrate is exceeded as the result of a stress-inducing event . This isAmong the noninvasive social psychological treatments that are available for trauma patients, cognitive-behavioral therapy has been confirmed as the most effective intervention . HoweverIn various countries, professionals from health-care specialized fields are participating in the respective “Trauma Health” fields within their communities and are striving toward competency development ,9. In paIn Korea, mental health experts  are mobilized at the “Community Mental Health Welfare Center” . Mental Trauma recovery requires an integrated approach, from individual psychological and emotional problems to changes in social structure and environment . HoweverMany psychiatric nurses still struggle with deviating from the perspective of psychiatric hospital-oriented trauma treatment. Furthermore, decreased interest in the nursing field has led to a serious lack of nursing personnel who have received systematic trauma treatment training ,5. HowevPrevious studies have found that resilience and the ability to cope with stress buffer the negative symptoms associated with trauma experiences and contribute to improving mental health ,13. In aThis study used Swanson’s theory of caring , a middlPeople often do not receive early professional treatment following traumatic experiences because they are not aware of the negative impact that trauma can have on their mental health. Moreover, patients can present with a wide variety of symptoms, including physical symptoms and sleep disturbances . PatientWhen it comes to overcoming these limitations, Internet-based interventions are promising treatment options compared to face-to-face interventions. According to Lewis et al. , InterneThe aim of this study was to develop an Internet-based psychiatric nursing intervention that could alleviate post-traumatic stress symptoms and improve the health functioning of adults who have experienced trauma.This was a methodological research study that developed an Internet-based program based on Swanson’s theory of caring . The proApproval for this study was obtained from the institutional review board of Yonsei University (Y-2019-0083). The participants expressed their intention to voluntarily participate through the recruitment announcement and were provided with a description of the study. This material explained the study’s purpose, potential risks, and benefits. Participants were informed that participation was voluntary and they could withdraw from the study at any time.Swanson’s theory of caring is based on the experiences of women who had undergone abortions or given birth to a premature baby . The theThe concept of “maintaining belief” emphasizes the trust between the client and the nurse. To maintain hope and recovery, clients should help and respect themselves ,24. In tIn the “being with” stage, the nurse reports on the necessity behind recognizing the client’s feelings by allowing them space to share their feelings and experiences. One study reported that nurses should communicate clearly with clients and not feel burdened . In thisThe “knowing” stage aims to develop the client’s understanding of the meaning of the events that have occurred in their lives. From this perspective, the nurse and client try to create knowing and understanding around the human responses to recovery, rather than emphasizing or avoiding traumatic experiences ,17. In tThe “doing” stage is characterized by the nurse caring for the client. One study reported that nurses should help maintain client well-being by allowing the nurses to protect and care for clients and by allowing clients to set goals for themselves . In thisIn the “enabling” stage, nurses allow clients to change their daily routine and solve problems on their own as they encounter new events ,19. In tBased on the theoretical framework and literature review, the research team set the goals, theme, and main content of the intervention program, and determined the duration of the eight-session program. The qualification requirements for the researchers who conducted the program were identified.To confirm the content for each session, the content that we developed was reviewed, revised, and supplemented by experts on the program draft in paper documents. The experts comprised one trauma counselor at a counseling center and six mental health nurses at mental health services and mental health rehabilitation centers. Experts assessed the effectiveness of each session’s purpose and content using a four-point Likert scale, where 1 = completely inappropriate, 2 = not appropriate, 3 = appropriate, and 4 = very appropriate. The content validity index (CVI) was also calculated.To evaluate the appropriateness and understanding of the program content, expert advice and the CVI were checked.The suitability of the overall purpose of the program and the goals for each session were verified. The CVI was 3.2 points (86.1%), thus verifying the content validity of the program. Moreover, the program was modified and supplemented based on the expert advice.Through evaluation of the adequacy of the online program, we analyzed the participants’ responses to the Internet-based eight-session program. We confirmed the corrections and supplementations with the participants to establish their understanding of the composition and content of the program, the difficulty of the vocabulary, and the adequacy of the time provided. The final program was developed by applying the feedback that was received. We developed a trauma recovery nursing intervention program for adults who have experienced trauma. This Internet-based program consisted of eight 30 min sessions. The program included a spoken-audio track that was accompanied by visual prompts. It aimed to provide knowledge on traumatic stress and introduce methods to recover from trauma. We chose an online format to make it convenient and widely accessible, and to allow for a low-intensity, cost-effective educational program. The theoretical framework for this study was based on Swanson’s theory of caring  and a liFirst, before the start of the main program, the background and purpose were explained to participants and an overall introduction on how the program would be conducted was provided.Session 1 emphasized self-understanding and self-respect. Clients had time to understand themselves by remembering things that were either sad or happy and recording them. Clients were provided with information on PTSD, and we confirmed that the clients were not experiencing PTSD without support. In addition, clients were encouraged to determine their undiscovered strengths. They were also encouraged to consider how they could use their strengths in their lives. After Session 1, clients practiced abdominal breathing to calm their minds, which they may have been struggling with due to the task of recalling painful memories.Session 2 helped clients be more vulnerable than in the first session. Clients thought of people who had hurt them in their lives and faced the negative emotions they felt. To turn their negative emotions into positive ones, they were reminded of the aspects of their life for which they could be grateful. The clients were given information on flashbacks and how to cope with them if they experienced any. After Session 2, the clients practiced gradual muscle relaxation, a type of body stabilization. Body stabilization focuses on physical and emotional sensations, and on the present rather than the past.Session 3 focused on clients accepting and sharing trauma experiences on their own. Through self-exposure, clients were encouraged to understand and share how the difficult situations that were addressed in the second session affected their feelings, thoughts, and behavior. It helped evoke and discharge negative emotions and thoughts. In addition, clients were trained to control their emotions by turning negative thoughts into positive ones. After Session 3, clients practiced using their imagination. Imagination training calms emotions through the repeated, intermittent flashing of negative events or emotions on a computer screen.Session 4 highlighted the benefits of maintaining a rational viewpoint in stressful situations. Clients could look at their situation objectively and identified the benefits of rational thinking. Through examples of irrational thoughts , they recognized that they were often irrational themselves. Clients learned that, through a rational worldview and perspective, they could have positive emotions. After Session 4, body stabilization exercise was performed.Session 5 emphasized the management of the negative emotions felt by clients who experienced trauma. Clients checked the emotions they often felt to determine whether they experienced positive or negative emotions more frequently. Clients learned the benefits of positive emotions and were trained to distinguish between the thoughts and emotions experienced in certain situations through examples. They were also trained to change their emotions and behaviors by reminding themselves of stressful situations and transforming the emotions and thoughts that they were experiencing at that time into rational thinking. After completing the Session 5, the abdominal breathing exercises were repeated.Session 6 focused on developing effective communication skills. Clients learned the communication skills required to their express emotions and thoughts and change their behavior. After identifying their communication types and habits, clients shared their difficulties and conflicts related to communication with their therapists via response letters. They also learned to express negative emotions or deal with negative situations using “I-message” language. Through the use of examples of inefficient communication, clients became committed to avoiding inefficient communication. After Session 6, body stabilization exercise was repeated.Session 7 focused on managing stress and leading a healthy lifestyle. Clients were asked to learn four strategies that would assist with stress management: cognitive control, behavior control, physiological relaxation, and daily life management. Clients identified a situation and planned strategies to reduce stress. In addition, the application of a stress response strategy through identification of automatic thinking and adjustment to alternative and rational thinking was suggested. Finally, clients learned the “butterfly embrace” for physiological relaxation.In Session 8, clients were empowered to find meaning in their everyday lives. They recognized that they could enjoy a peaceful life by solidifying their strengths and that they could find happiness and meaning in their own lives. Through summarizing the information in Session 1–7, clients could confirm what had changed recently in their daily lives. They were provided with a perspective of gratitude and satisfaction in daily life. Through integration of the “knowing,” “doing for,” and “enabling” topics, clients who had difficult experiences could recover from trauma. At the end of the Session 8, the body stabilization exercise was repeated.During each of the aforementioned program sessions, the research team sent individual response letters to the clients. The response letter was created based on the evaluation feedback. To ensure mutual communication between the therapist and client, the therapist interacted with the client continuously and fulfilled the “maintaining belief” and “being with” domains for the client. Response letters were provided at the end of each session. Based on the content of the client’s responses throughout the program, we communicated with clients individually to provide support and hope through positive feedback. In addition, we motivated clients to continue participating in the program without giving up. The standardized response letter provided a framework for therapists and we expected that it would improve the service quality. In addition, we provided a guide in the responses to address each client’s individual circumstances or feelings.This study developed an Internet-based psychiatric nursing intervention for trauma recovery based on Swanson’s theory of caring , a middlThe participants were anonymous, and the researchers promised that their information would never be leaked in the study. In each session, the participants were asked several questions on the difficulties that they experienced. The researchers provided individual feedback on their answers using response letters. A previous study reported that nursing interventions that were provided based on the theory of caring for individuals who had experienced intimate partner violence had a therapeutic effect . As the For the “maintaining belief” and “being with” domains, response letters were sent to the clients individually after each session. The response letters were developed at the request of the participants during the evaluation. The participants proposed that interaction and support with the therapist would be effective. The response letter was created to facilitate interactive communication with the client and clients were provided feedback on their answers to the questions. The “being with” domain emphasizes the intimate relationship with the client as the center of care ; that isIn the Session 1 and 2, for the “knowing” dimension, clients were helped to understand their current state of mind, past traumatic experiences, moods, thoughts, and strengths. Specifically, clients were made aware of their strengths and ability to overcome the effects of trauma. It is imperative that nurses understand and respect clients from a holistic perspective. The patient can overcome a crisis by getting to know and respecting themselves through the process of knowing . The sesIn Sessions 3−5, the concept of “doing for” focused on enhancing the clients’ competencies. Clients in this program could accept and share their traumatic experiences through self-disclosure. To do this, clients were asked multiple questions through noninvasive techniques. Moreover, they were provided with a wealth of knowledge on trauma that enabled them to strengthen their own capabilities through constant training. The characteristics of competence included knowledge, ongoing adjustment to learning collective skills, and self-confidence ,31. ThisFor the “enabling” dimension, the client’s changes were identified, and clients were encouraged to continue to take care of themselves through intrinsic motivation in Sessions 6−8. “Enabling” emphasizes the need for continuous validation and confirms the appropriate results of caring ,26. EngaThis study was also significant because it was an online nursing intervention program. Although online treatment and intervention programs are provided in various clinical fields, there are few online nursing interventions in the mental health nursing field ,23,33. TOften in psychiatric counseling cases, patients avoid counseling due to the fear of stigma . The stiAlthough Internet-based therapies have posed technical difficulties ,33, the A limitation of the study is that it was not possible to evaluate the effectiveness of the program. Another limitation is the small number of participants.The trauma recovery program that was developed in this study was based on Swanson’s theory of caring . Caring


The Accreditation Council for Graduate Medical Education (ACGME) lists “educating patients, families, students, residents, and other health professionals” as a common core requirement for residency programs in every medical specialty.5A 2004 review of existing resident-as-teacher (RAT) curricula outside of emergency medicine (EM) found that they improve resident teaching confidence, teaching organization, and student evaluations, as well as resident motivation to teach and confidence in their teaching skills.12Our objective was to create a longitudinal, multimodal RAT curriculum for EM residents that would foster early development of clinician-educators and develop residents’ confidence in their teaching abilities.An elective curriculum, known as Resident Distinction in Education (RDE), was designed at our four-year residency using the six modules for creating an education curriculum described by Farrell et al: clinical teaching; bedside teaching; effective feedback; teaching procedures; teaching with high fidelity simulation; and leading effective lectures and discussions.14ABC of Learning and Teaching in MedicineTo create the curriculum, we used pre-existing RAT opportunities within our residency program and added two that have been successful at other institutions. These were subdivided into three domains: teaching; scholarship; and personal learning/development. We assigned a numerical credit to activities proportional to the amount of time a resident was expected to spend in preparation and execution. Historically, prior to the creation of the RDE curriculum our program’s graduates would complete the equivalent of 74 credits over four years simply by participating in residency activities. This was used as a basis to set additional requirements for the RDE certification at 225 credits . We estaThe RDE curriculum, introduced in 2018, is open for enrollment in the middle of the intern year as an elective. The directors meet with interested residents annually to track progress. Upon graduation, residents who fulfilled the RDE requirements received a certificate attesting to their dedication and recognizing their efforts and skills as an educator.Since its implementation, 28 residents have enrolled in the RDE program. Eight of the enrolled residents have completed residency, and six satisfied all requirements to receive the RDE certificate. The two residents who did not complete the program failed to satisfy the requirements set forth. All six graduates who received the RDE certificate are currently working at academic institutions.A survey that was deemed exempt by our institutional review board was sent to all graduates who completed the program; one graduate, a co-author of this study, was excluded (n = 5). We created the survey through our our university-based, web survey instrument . A link to the online survey was distributed via email to all residency graduates who had participated in the RDE program. No identifying information was collected from participants. The response rate was 100%. In evaluating the objective of fostering resident confidence in their teaching abilities, the survey results showed that all participants felt at least “somewhat confident” in their ability to contribute to education/ scholarship, quality of bedside teaching, and creating/ presenting lectures. All but one resident felt at least “somewhat confident” in giving feedback. “Extreme confidence” was reported by one resident in presenting lectures, and by another in bedside teaching. All respondents stated they would recommend participation in the program to future residents and that their involvement helped solidify their desire to actively incorporate medical education into their future careers .The RDE program is currently in its third year of implementation, and RDE participants represent about one-third of each residency class. The RDE curriculum was designed to be reproducible within other EM residency programs. The ease of incorporating a similar program would depend on the breadth of pre-existing RAT opportunities at a given residency. However, some components likely exist at other programs, and minimal additional burden should be needed to implement a similar framework. Based on the limited number of participants, the one aspect of the RDE program that many have found particularly challenging and that led to two residents failing to complete the program was the scholarly project criteria. As of now, the definition of what constitutes a “scholarly project” at our institution is being evaluated and may be broadened.We want to acknowledge several limitations. First, our program was implemented at a four-year residency with four months of elective time. This may limit reproducibility at programs with less elective time. One solution would be to decrease the total number of credits needed to attain the RDE at those programs. Another limitation is the lack of formal feedback or evaluation of participants’ bedside teaching and lecturing skills beyond self-assessment, which is prone to bias. The graduates rated themselves “average” or “somewhat competent” in their skills based on survey results. No self-evaluations were performed before participation in the program; thus, conclusions cannot be drawn as to the program’s effects on resident skills or level of comfort. The program affiliation with a medical school as well as a large university did provide our resident participants with many diverse teaching opportunities that could be difficult to replicate at programs that lack such affiliations.The small number of participants did not allow for statistically significant conclusions to be drawn. The “soft” outcomes  based on


The Australian Nurse Family Partnership Program (ANFPP) is an evidence-based, home visiting program that offers health education, guidance, social and emotional support to first-time mothers having Aboriginal and/or Torres Strait Islander (First Nations) babies. The community-controlled sector identified the need for specialised support for first time mothers due to the inequalities in birthing and early childhood outcomes between First Nations’ and other babies in Australia. The program is based on the United States’ Nurse Family Partnership program which has improved long-term health outcomes and life trajectories for mothers and children. International implementation of the Nurse Family Partnership program has identified interagency service integration as key to program recruitment, retention, and efficacy. How the ANFPP integrates with other services in an Australian urban setting and how to improve this is not yet known. Our research explores the barriers and enablers to interagency service integration for the Australian Nurse Family Partnership Program ANFPP in an urban setting.A qualitative study using individual and group interviews. Purposive and snowball sampling was used to recruit clients, staff , Elders and family members. Interviews were conducted using a culturally appropriate ‘yarning’ method with clients, families and Elders and semi-structured interview guide for staff. Interviews were audio-recorded and transcribed prior to reflexive thematic analysis.Seventy-six participants were interviewed: 26 clients, 47 staff and 3 Elders/family members. Three themes were identified as barriers and three as enablers. Barriers: 1) confusion around program scope, 2) duplication of care, and 3) tensions over ‘ownership’ of clients. Enablers : 1) knowledge and promotion of the program; 2) cultural safety; and 3) case coordination, co-location and partnership forums.Effective service integration is essential to maximise access and acceptability of the ANFPP; we provide practical recommendations to improve service integration in this context. Aboriginal and Torres Strait Islander (herein referred to as First Nations) families have strong, cohesive and nurturing cultural practices that contribute to healthy family functioning and child rearing . HoweverThe Nurse-Family Partnership (NFP) program was developed in the 1970s for first-time mothers from socially and economically disadvantaged communities in the United States (US) to improve the life trajectories of their children , 18. TheSince 1996, the NFP program has been implemented in the United Kingdom (UK) , NetherlThe ANFPP is only available to women pregnant with a First Nations baby, including non-Indigenous women carrying a First Nations baby. The ANFPP is currently offered in 15 communities across Australia, through 11 organisations, 10 Aboriginal Community Controlled Health Services (ACCHS) and one government agency . The ACCWhen women present for maternity care at primary care services or hospital based maternity care providers (whether through Midwifery Group Practice (MGP) or standard care), they can be referred to the ANFPP. However, a previous Australian evaluation identified that not all eligible women are aware of, or referred to, the ANFPP , 36. SimTo date, there have been three published studies on the ANFPP in Central Australia, which outline findings around acceptability, accessibility and effectiveness of the program in remote Aboriginal communities , 36, 37,This qualitative study is part of a larger mixed-methods study of the ANFPP in Brisbane, Australia. We conducted a reflexive thematic analysis, which is useful in applied health research as it enables flexible methods of generation, interpretation and analysis of themes . ReflexiTwo female researchers led the research – a non-Indigenous doctoral student (LM) and a First Nations community researcher (SM). Both researchers have experience conducting interviews with First Nations people in various research studies and worked closely together throughout this project in both data collection and analysis. The First Nations community researcher is also a mother who accessed the ANFPP previously at another site. Other research team members have significant clinical and research knowledge and experience of pregnancy, birthing, infant and child health services and programs in Australia and internationally, and include: two Directors of a research centre dedicated to First Nations maternal and infant health programs and evaluations, one of which is a First Nations Professor, and two Professors who are Midwives/Registered Nurses, a senior Clinical Director of an ACCHS, and a Postdoctoral Researcher with substantial experience with First Nations health services research in an urban setting. The research team met regularly to discuss and reflect on researcher assumptions, with First Nations mentorship provided by YR.The ANFPP setting for this study was a large urban ACCHS in Brisbane, Australia. The program was being offered in two sites: North (since 2016) and South (since 2017). Women enrolled in ANFPP were to give birth at one of several public hospitals that offer care though a specialised MGP for women carrying a First Nations baby; this means most women received continuity of midwifery care during pregnancy, birth and until the baby is six weeks old.Purposive sampling was used to identify participants who had information relevant to the topic and research question. This strategy was augmented by snowball sampling . EligiblEligible women were those who had declined enrolment, enrolled, dropped out of, or ‘graduated’ from ANFPP. Women were recruited in three ways. First, ANFPP staff or referring centres identified eligible women and invited them to participate in the study; interested women gave permission to be contacted by the research team. Second, research team members attended ANFPP drop in/community days and invited attendees to participate. Third, participants identified other women who may be interested in participating and gave them information about how to contact the research team.This study was approved by a primary Hospital Human Research Ethics Committee (HREC/18/MHS/59) and ratified by two University Human Research Ethics Committees. Participation was voluntary and participants could withdraw at any time without affecting their employment, their care, their relationship with staff, or the services they were accessing. Participants were assured all information they provided was de-identified and confidential and were asked to sign a participant information and consent form prior to the interviews. Informed consent was established in both individual and group interviews by starting with a summary of the purpose of the research and details about how participant data would be managed to protect confidentiality. Clients, family members and Elders were reimbursed with an AUD$30 gift voucher for their time and contribution.Interviews were conducted by LM and SM during September 2018 – April 2019. Semi-structured interviews were conducted with non-Indigenous health service staff, while ‘yarning’ interview methods were used with First Nations participants. Yarning recognises the data in the stories told, avoids imposing a preferred structure on data by interrupting stories, and increases the trustworthiness of data collected with First Nations’ participants , 49. YarInterviews were transcribed verbatim by research team members, de-identified and saved as password protected files on the researcher’s computer and organisation’s server. Audio files and transcripts have been stored in a password protected server. Each participant was ascribed a role title and number.Reflexive thematic analysis was conducted using Braun and Clarke’s , 50 six-n = 26) or individual interview (n = 50), are summarised in Fig. The characteristics of the 76 participants who took part in either a focus group . Where necessary for fluency, brevity or confidentiality, words have been deleted (indicated by ‘ … ’). In some instances, to improve clarity or protect confidentiality, words have been inserted which is indicated by [square brackets].Each theme includes illustrative quotations to validate them. Most quotations are from staff and service providers, due to the focus on interagency service integration for this paper. Although all client data was also considered in the analysis, we have included clients’/women’s quotes only where relevant to illustrate the themes presented. Acronyms used in this section include: NHV for Nurse Home Visitor, FPW for Family Partnership Worker, and MGP for Midwifery Group Practice. Quotations are presented in There’s a lot [of services] out there and it gets a little confusing as to which one is gonna be the best for which … women. … it’s a little overwhelming. One of my [MGP] pregnant ladies who I had referred to ANFPP did come back to me [at] the next appointment and she said “you’re still going to be my midwife aren’t you? That’s not my midwife now is it?” And [I said] ‘of course’, and she said, “oh because I don’t need another midwife, do I?” (MGP Midwife – FG5).Staff from referral agencies reported a lack of awareness of what the program offers, including the program scope and role of ANFPP staff. There was a perception that ANFPP was not necessarily offering something different to what was already being offered by various maternal, infant and child health programs, particularly maternity. This confusion resulted in some referrers and potential clients questioning the value of the ANFPP. The confusion stemmed mainly from sometimes having another midwife in the NHV role, which seemed to require clarification of the differences between services for clients and justification of the program for referring staff.Particularly in Australia where you’ve got Midwifery Group Practices visiting in the home, you’ve got Child Protection, you’ve got [Family] Wellbeing Services. We had one woman […], she had four visits in two days, and she didn’t know who they were. She just knew that four people came to her home in 48 h. And she had like a two-week old baby. So that’s a problem. (ACCHS staff member – S8).Confusion about the key staff roles and their scope of practice led to misunderstandings about who was providing what care for some respondents. Issues around the number of service providers visiting some women were also highlighted.Patients will be like “I didn’t answer your call [as] I didn’t need to see you because I’ve already got these people [ANFPP]” and we are like ‘no, no, no, … you don’t see them for your pregnancy, like they are just an extra thing. You have to see me. I do your foetal [checks] … They are just checking on ‘you’. (MGP Midwife - FG4).As a clinical MGP midwife explained, some clients thought having contact with the ANFPP staff was adequate for their antenatal care checks, which midwives often had to explain was not the case.[F] rom the second you mention [ANFPP], [women] they’re just like ‘no I don’t want another thing’. Because you were trying to catch them before 28 weeks, and there’s a lot to go over [at] booking-in, those first few appointments, … sometimes I think it’s just a bit overwhelming. And they’re a bit like, ‘I don’t want another thing’. I think it’s just a bit much. (MGP midwife – FG4).Some referring staff participants believed there was too much information to cover during antenatal booking-in visits, so referrals to ANFPP either did not happen, or just involved handing out the ANFPP brochure. Referring agencies questioned whether women needed additional support or offered other, more familiar programs (e.g. Young Mums and Family Wellbeing Program).I still think there are service providers that need... some more information around … what the criteria is, how to make the referral or who is appropriate. (NHV – S5).In addition, referring staff were at times unclear of the program’s eligibility criteria, for example if they could refer women who were not first-time mothers, or what gestation they had to be.Midwife 1: Just because that’s their client and our client, doesn’t mean we can share information.Midwife 2: Because they do, they’ll call us and be like ‘hey what’s happening with her, what’s this, we’ve been trying to get in contact with her. Where is she at?’ And it’s always been seen as a real collaboration from the staff point of view, but I was kind of like, where are we actually at, legally?Midwife 3: Yeah, you’ve got to be very careful. (MGP Midwives – FG4).Some service providers were unsure if sharing patient information breached privacy laws so were careful in how much information they could share with ANFPP staff. This proved a barrier to collaboration and communication between agencies at times, as some referring midwives said they tried to avoid these exchanges with the ANFPP.Due to service providers’ lack of understanding of the ANFPP’s scope as an educational, health promotion and parenting program , there was perceived service duplication and over-servicing which at times led to tension between the maternity care providers and ANFPP staff. This led to referring agency staff being hesitant to accept and work with another program in the maternal and infant health area.As [MGP] midwives, our job is to educate women about labour, about birth, and about what to expect ... [For] some women, that crossover [with the ANFPP] is just silly … I think it’s a waste of resources and … a waste of time. (MGP Midwife - S25).This was particularly apparent during pregnancy and immediately post-birth, as both MGPs and ANFPP delivered similar education to clients, which was regarded as an overlap in services. There was a need for clearer distinction between programs, to ensure referring staff members did not regard the ANFPP as duplicating their healthcare service provision.[The ANFPP staff says:] ‘Oh you want to formula feed your baby, yeah no problems with that. How about we get you some formula so you can take it to hospital’ ...and what she should actually be saying, ‘oh let’s talk to your midwife about what the formula requirements in hospital are’. And when the midwife finds out about that she says, ‘see I told you, they’re doing clinical work’.(ANFPP staff member - S8)Duplication was also seen when ANFPP staff offered answers and practical solutions to women’s health related questions, instead of referring to their clinical midwife. Non-ANFPP midwives felt ANFPP staff sometimes crossed that line from providing health education and support to giving clinical health advice. This was most evident when both the MGPs and ANFPP were closely monitoring women during pregnancy, birth and post-natal, as once the MGP care concluded at six weeks, the ANFPP worked closely with community and health care networks, such as early childhood health.I had ANFPP, I had [MGP], I had someone else, I had like four different people coming out and seeing me and I just like, well this is, this is a bit too much for me [laughs]! It wasn’t anything bad or anything like that, but yeah I think that was the only time I can remember that it was a bit full on because there was so many people wanting to come out and see me and then I was having like three different people a week coming out to see and I was like, whoa, this is too much.(Woman – W15)Some women reported feeling overwhelmed and over-serviced from the number of home visits or services involved in their care. Some women commented that at times they were unsure of who exactly was visiting them, and why.Some midwives love us, [but] some find it really challenging for them to hand over their clients. (ANFPP staff member - S23).The confusion between program scope and roles, and the perceived duplication of care, led to tensions or competition over ownership of clients for some participants. Some service providers seemed reluctant to promote ANFPP to their clients, at times adjudicating whether their client should join the program or not.I guess with the continuity program [of the MGP] you sort of, you grow to look after these women. They sort of do become your own. You get quite protective of them. (MGP midwife – S25).Midwives explained their relationship with clients was most important due to the building of trust, care and rapport, typically established with continuity of care midwifery models (such as MGPs), as they would accompany women at this most significant time of birthing.The actual program [ANFPP] in theory, you can see the benefit there but what’s actually happening loses that benefit because of, the lack of communication. You know the lack of feedback, the fact that certain things aren’t being told to people means that those benefits that are supposed to be there, don’t exist anymore.(MGP team member – FG2)Some participants reported that open communication and information exchange between service providers and ANFPP was infrequent, which also highlighted ownership over clients and their data. This resulted in tensions and lack of support for the ANFPP by some agencies also caring for women throughout the antenatal and post-natal time periods. Both staff and some client participants stated that programs for women and families during pregnancy and the early years needed to work together effectively, with clear communication channels established.I just see it as an adjunct service. They [ANFPP] can fulfil a role that a lot of things in our capacity [as midwives] we are unable to do... [and] don’t necessarily have the expertise to do. (MGP Midwife – FG6).Maternal and infant health service providers worked effectively with the ANFPP when they understood and promoted the benefits of the program to clients. Knowledge of the program included evidence supporting the biomedical benefits , as well as the social emotional benefits for women and families. Participants reported that ANFPP was unique in that it supports and empowers women through pregnancy and their first two years of motherhood by addressing the social and cultural determinants of health. Some referring midwives recognised this as one of the major strengths of the ANFPP, offering a holistic, women-centred service to first-time mothers and their babies.I see women throughout the pregnancy, up until the baby is six weeks old, and then you’re out of my scope. And women know that I’m not going to continue to see them when their baby is seven months old, so … it’s nice that you have someone who you’re continuing to see and continue to have this link in with. (Referring Midwife – FG1).One of the program’s key strengths and selling points was the program length over 24 months, particularly as it applied to the crucial developmental stages of the first 1000 days of pregnancy and early childhood. This program length went beyond what many other maternal and infant health services offer, providing continuity of care for women, babies and families for the best start to life.It was really good because they explained that they are going to stay with me until, bub’s like two years old … so I was really excited to have someone like that to go through this whole thing with. (Woman – W9).This program longevity enabled strong relationships for the women to develop with ANFPP staff (the NHV and FPW). For some women, this relationship was the only support they had.[ANFPP] is very good in helping support women to stay in those [other] services as well. … it’s just about encouraging them to still link in with services, especially when I can see the baby for two years [so have that continuity with the mother and baby], that’s just excellent.(NHV – S13)Participants reported that ANFPP staff worked to ensure referral pathways were well established, and services were adequate and receptive to their clients. When professional relationships with referral service providers were viewed positively by staff, a collaborative working relationship between agencies and ANFPP was considered possible.Some people [from referring services] have said that they can notice when they see clients that are on our program, the difference in them compared to some of the mums that haven’t been on the program. That their confidence and just the way they assert themselves in situations and the way they can access support and help has really been quite impressive. (NHV – S9).When stakeholders witnessed how the program helped to build women’s confidence as new mothers, they were more likely to promote it. Women’s increased confidence was seen to positively impact their health-seeking behaviour, including their willingness and ability to access services and advocate for themselves and their baby’s needs.To see the [women] from where they’ve come from, to see them graduate this year was amazing. One’s doing [university studies], … she stayed on the program for the whole two years. She was very low self-esteem, no confidence, to ‘being the best mum she could be’ and to be studying … it’s good to see. (FPW – S2).The program was seen to develop women’s self-belief to become the best version of themselves they can be, which is one of the five client-centred principles the ANFPP focuses on.I think as a single mother this is what keeps us going. Like today [community day] we woke up and I’m like “Yay! Favourite day of the week!” … I think this has changed me to be a better mum. Just look at her [my baby], she’s ‘deadly’ , she’s so chill, she doesn’t cry, she’s just easy for me. Walking, all of that, learnt here pretty much … (Woman – W4).It’s all about awareness, that we are trying to make it easier, because we can make it as easy as we want but if they are not aware of it then it’s not going to happen. (NHV - S11).The scope, intent and purpose of ANFPP needed to be clearly communicated and promoted to hospital and ACCHSs staff, potential clients and the First Nations community. It was suggested that promotional visits to meet and greet, and explain the ANFPP’s features to referring agency staff were needed regularly to clarify its educational, social support focus and strengths-based approach.Being with this organisation [ACCHS] … it’s like a ‘one stop shop’, with all the other medical centres, all the other services. (FPW – S7).Participants regarded the cultural components of the ANFPP as a benefit for women. One of these components was the location of the program within an ACCHS with First Nations governance. Not only did women feel more comfortable accessing services within the ACCHS, it also enabled access to many other community-based health and social services. This ensured culturally responsive, wrap-around care which included allied health services .Being an Aboriginal nurse, I find that just being in the house and showing women that … there is something you can do with [your] life, … you can step up for your kid and be better. I think that’s probably the biggest positive in the program. (NHV - S3).Receiving care from First Nations staff was highly valued by both staff and women and offered both strong role models and understanding of the unique context of First Nations family life.I come from a pretty dysfunctional family home, and the women [program staff] that have stood in as a role [model] …, they have been able to be a healthy woman figure in my life and a healthy option for me around my baby …. I really don’t know how I would’ve gone about it … I think I would’ve struggled a lot if I didn’t have the support service. (Woman – W3).They [ANFPP staff] understand. … a lot of them are Aboriginal and Torres Strait Islanders worker [s] too so they know first-hand … like the struggles and what the families are going through. … (MGP Referring First Nations staff member – FG6).They go to the special birthing site and that was awesome. … we went there last time and she [my baby] loved it like, we got to thank the ancestors and you got to realize all this stuff that I didn’t know because my family didn’t really get brought up in Aboriginal culture. So being introduced to all this stuff is amazing and knowing your own culture and bringing her up in her own culture is really awesome. I really enjoy it. (Woman – W6).For many women, the care they received through the ANFPP was culturally empowering, including for those women who were raised not knowing much about their First Nations heritage or culture.My husband is Torres Strait Islander and when he first moved down to Brisbane, he didn’t know anyone else who was Torres Strait. So, it’s been really good like cultural- wise as well for him to … get reconnected and to meet others in his culture. (Woman – W5).100% the friends you make from the drop-ins or even from the program they are the people that you can potentially see in your life [for] ever because you don’t just let anybody into your kid’s life. (Woman - W16).Another valued feature of the program was the ‘drop in’ or ‘community day’ which served as a social and cultural gathering for first-time mothers and their babies in the ANFPP. Participants felt these community days provided: emotional support, cultural connections and friendships, and access to Elders and ANFPP staff. Despite being a home visiting program, these community days, which sometimes included excursions to sacred First Nations sites, were considered a key strength and benefit for women and families.Because our program should be weekly for the first six weeks after bub’s born, so we might pull back a little bit and say ‘we’ll not overwhelm you with people we’ll sort of step back, let you get in what you need with those clinical services and then once that six week mark comes you know, let us know when you want a visit’. (ANFPP staff member – S21).Several participants suggested a case coordination approach would be useful, to manage the contact and support provided by different, integrated programs, with a view to facilitating the woman’s journey.We can do a home visit and be like ‘and this is the ANFPP … [their] workers can come with us and introduce you to this service and you can decide if you want to participate’. (MGP midwife – FG4).Conducting joint client visits was considered a potential strategy to establish more collaborative working relationships between agencies. Joint client visits between MGP midwives and ANFPP staff could also serve to introduce the program to clients, and potentially assist to distinguish between the different services on offer to women during pregnancy and beyond.I liked it when ANFP was [located] in [with MGP] because you saw a little bit more. You would have that corridor chat. You would say like ‘oh hey, I saw this woman. Have you seen her lately? No, I’ve had trouble getting in contact with her. Cool I’ll talk you up’. You know, ‘do you want to come out to visit with me?’ ‘Yeah. Great. Let’s go’. (MGP midwife - S26).Co-location of ANFPP and MGP teams had previously occurred but discontinued due to limited office space. Co-location was considered beneficial to foster service integration, improve communication and reduce duplication of care.I think communication, getting [ANFPP] out there and linking with the clinics, and exposure of people being aware of what the program can do, I guess … feedback, like some of the positives of what they’ve actually achieved, and sort of [sharing] some good stories. (Referring staff member – FG1).Regular visits and scheduled meetings between ANFPP and referring agency staff would help facilitate familiarisation with the program and rapport building among staff and shared clients.[T] here needs to be more formal forums that actually take place and happen and [they] have to be consistent and regular, for sure. I think that’s something that would really help … cross-sectoral forums where … we can talk about the different programs in our own community and make sure we build good relationships up. (ANFPP staff member – S23).Some participants recommended that a regular partnership forum for staff members would help develop a regional approach to service delivery.This study explored integration of ANFPP with the local maternal, infant and child health sector for First Nations families in an urban setting in Australia. While service integration is complex and varied, a clear purpose for integration and understanding what needs to be integrated is key . The resClient Information Sharing Protocol between agencies involved in the women’s care is recommended, to improve communication and information sharing across agencies while maintaining privacy and confidentiality across the client journey [Our findings were consistent with research that shows that poor communication between organisations, inadequate client referral pathways, and resistance to new staff working arrangements  are barriers to service integration –61. Hick journey . A summaIntegrated service delivery is an important mechanism for clients to access appropriate midwifery and nursing, medical, social, behavioural and community-wide environmental interventions , 12. A kChallenges to service integration are heightened when there are several programs addressing similar health and wellbeing needs of mothers and families . There wOther considerations to improve interagency collaboration include the sharing of client care information across agencies, which requires established communication protocols or systems which address client consent . IntroduWe used a culturally appropriate approach to conduct this research with First Nations’ people and organisations; this included a research team with strong First Nations representation, use of a First Nations yarning method of data collection, and privileging of First Nations voices during analysis. We recruited and interviewed a variety of participants including staff from key stakeholder agencies, family and ANFPP clients to collect a breadth of perspectives on the topic. We were not able to recruit women who were offered the program and declined joining the program, though did interview women who left the program. The divergent experiences of a small number of women who had dropped out of the program early due to reasons such as, changes in program staff and preference for First Nations NHVs, was considered in our analysis, although only included if relevant to our key findings. The nature of group interviews may have resulted in some participants not expressing their views as openly, if they differed from the majority opinion/view; efforts were made by interviewers to make participants comfortable, including prompting for diverse views. At the time of data collection, one of the ANFPP sites was newly operating, therefore some findings may elucidate barriers during initial implementation only. Finally, the unique urban context of the ANFPP sites in this study means the results may not be transferable to other settings, such as regional and remote locations.This study demonstrated the importance of service integration to maximise uptake and benefits of ANFPP for First Nations families in an urban setting and provided evidence-based recommendations to improve communication and collaboration between services. The ANFPP’s valuable contribution to the community-controlled sector should be made available to other First Nations communities across Australia, including other urban locations. The results of this research suggest that stakeholders of the ANFPP support its potential to significantly improve the life trajectories of First Nations families. For it to be fully effective, however, relies on improved integration with other service providers, particularly during pregnancy and early infancy where other relationship-based models exist. The program is currently available to 15 different communities across Australia. To inform the expansion of the program, additional research could focus on: the role of the ACCHS sector in delivering the program; the importance of cultural and peer-group connections; the unique role of the First Nations FPW; and determining program impact and identifying measures that capture the empowerment of women to be the best mothers they can be. Effective service integration has the potential to improve access and acceptability of maternal and infant health services, including evidence-based and well-resourced programs such as the ANFPP. Insights from this study can further inform improvements to the existing program; ways forward for similar interagency collaborations; and future policy and intervention approaches in Australia to continue to improve the social investment in First Nations people.


Owing to considerable differences observed in anatomy and physiology between paediatric subsets, it has been well established that children respond to drugs differently compared to adults. Furthermore, from a formulation perspective, there is a distinct challenge to develop a dosage form that is capable of safely, accurately, and reliably delivering the dose across the whole paediatric population. Orally disintegrating mini-tablets (ODMT) have widely been considered as an age-appropriate formulation option that possess the ability for adequate dose flexibility, avoids swallowing difficulties, and exhibits superior stability due to its solid state. Within this study, two strengths (0.5 mg and 2 mg) of carvedilol ODMT formulations were developed using an excipient composition and load that is appropriate for paediatric use. The formulations demonstrated adequate mechanical strength (>20 N) and fast disintegration times (<30 s). Dissolution profiles observed were robust and comparable to the marketed conventional tablet formulation across various parts of the gastrointestinal (GI) tract in both the fed and fasted state, signifying appropriate efficacy, quality, and performance. As such, the formulations developed in this study show potential to address the need of an ‘age-appropriate’ formulation of carvedilol, as highlighted by the European Medicines Agency (EMA) Inventory of the Needs for Paediatric Medicine. In Europe, a product licence (‘marketing authorisation’) is required to market a medicinal product that specifies the agreed terms of use, including medical indication, target age, dose, and route of administration . HoweverThe benefits and limitations of current paediatric formulation platforms have been evaluated, where innovative and flexible solid oral dosage forms have shown superior acceptability among paediatric subsets . Other tIn 2007, the paediatric regulation came into force and aimed to improve the health of children by facilitating the development and availability of medicines for children . The paeCarvedilol is a weakly basic biopharmaceutical class II model drug with a pKa value of 7.8 and aqueous solubility of 4.44 mg/L . It is aThe aim of the present work was to develop an age-appropriate formulation of carvedilol, with paediatric biopharmaceutical considerations for evaluation. Formulation selection was based on API properties, target dose banding, and the suitability of a delivery system for paediatric population needs. A systematic approach including excipient screening, formulation development, characterisation, dissolution studies, and stability evaluation were conducted to generate a holistic preclinical data set. The application of the ODMT technology with paediatric biopharmaceutical consideration for evaluation aims to safely and accurately facilitate the development of more age-appropriate formulations for this vulnerable patient group and serves as a potential candidate for PUMA application.Carvedilol was obtained by Acros Organics . Pharmaceutical grade D-Mannitol (≥98% purity) and magnesium stearate were obtained from Sigma-Aldrich , while MCC as Pharmacel 102 was obtained from DFE Pharma (Germany). Lastly, colloidal silicon dioxide (Aerosil 200) was obtained from Evonik Industries . Pepsin from porcine gastric mucosa (≥400 units/mg protein), sodium hydroxide pellets, sodium chloride, sodium acetate, and sodium monooleate were purchased from Sigma-Aldrich . Sodium taurocholate hydrate, 96%, acetic acid, maleic acid and Lecithin, 60%, eggs were obtained from Alfa Aesar . Glyceryl monooleate as Monomuls 90-O 18 PH was kindly gifted by BASF . Carvedilol tablets, 3.125 mg, were obtained from Bristol laboratories .For sample analysis, Acetonitrile and Methanol (HPLC-grade) were obtained from Fisher Scientific , whereas Trifluoroacetic acid (TFA), for HPLC (≥99.0%) was purchased from Sigma-Aldrich .v/v). TFA was used at a concentration of 0.1% (v/v). Flow rate was set at 1 mL/min and a wavelength of 240 nm was used for detection. A 7-point calibration curve in the range 0.19 to 12.5 mg/mL was prepared via serial dilution in methanol (1 in 2 dilution). All samples prepared for analysis were diluted so as to fall within the calibration range. Method validation was carried out following The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines (Q2(R1)) [All samples were analysed on an Agilent 1260 series , equipped with a reverse-phased Eclipse plus C18, 4.6 × 150 mm, 3.5 μm column  was used. Separation of carvedilol was achieved using an isocratic mobile phase compromising TFA: ACN (55:45 (Q2(R1)) .−1) using sealed flat-bottomed TZero aluminium pans and pierced lids (sample mass 1–2 mg) at a heating rate of 10 °C min−1 in the range of 50 to 400 °C. For samples containing both the drug and excipient, 1 mg of each was measured in a weighing boat and gently mixed with a spatula for one minute before being transferred into the sample pan. All studies were conducted in triplicate and data are presented as mean ± standard deviation.Excipient and drug compatibility were studied using a TA DSCQ200 apparatus  with TA Instruments Universal Analysis 2000 software. Data was collected under nitrogen atmosphere . A total of 1 g of sample was placed on the VIBRI/I feeder and fed through the RODOS disperser. Pressure was set at 2 bars and measuring range was set between 0–175 μm. Measurements were taken in triplicates and presented as ±SD. Volume mean diameter (VMD), X10, X50, and X90 were the values obtained. Both starting materials and final blends were analysed to give an indication of flow based on particle size and to ensure acceptable flow properties are prevalent for successful direct compression.Angle of repose was determined using the method outline in the U.S. Pharmacopeia monograph, <1174> . A knownMeasurements were carried out in triplicates and presented as mean ± standard deviation.Bulk (ρbulk) and tapped densities (ρtapped) were also used to assess powder flow. A Sotax tap density tester USP II  was used as outlined in the USP monograph, <616> . A 25-mLCarrs’s index and hausner ratios were calculated using the following equations:An Erweka AR403s Multi-Lab , equipped with a cube mixer attachment was used to mix a total of 50 g of powder that included mannitol, MCC, magnesium stearate, colloidal silicon dioxide, and carvedilol. Different speed rates, mixing times, and blending order were evaluated to analyse any consequent effects on content uniformity. In each case, magnesium stearate was added at the end and allowed to mix for a total of 1 min, whilst colloidal silicon dioxide (CSD) was added second to last and allowed to mix for a total of two minutes. A Sartorius LA220S balance  was used to accurately weigh out samples.Content uniformity was assessed using a random sampling technique, where 10 samples of 50 ± 1 mg were taken out from different parts of each powder blend. Each sample was dissolved with 50 mL of methanol in a volumetric flask and sonicated for 30 min. Post sonication, the samples were filtered through a 0.45-μm syringe filter and analysed via High Performance Liquid Chromatography (HPLC).w/w and a tablet mass of 50 mg were produced using a Specac semi-automatic hydraulic press  equipped with a 4-mm multi-tip (three) with concave faced punches at a compression force of 10 KN with quick release. After step wise fine-tuning of the formulation composition and tabletting parameters, two formulations for ODMT production were finalised  was used to measure the force required to break the tablets produced. Hardness values were measured in Newton’s. Measurements and carried out in triplicates and presented as mean ± standard deviation.Friability testing was carried out using a Sotax F2 Friabilitor  that measures the capacity of tablets to resist mechanical stress. Six tablets were carefully de-dusted using a soft brush and an initial weight was taken. Tablets were then placed in the rotating drum and rotated for 4 min at a speed of 25 rpm . The tablets were removed, dusted, and a final weight was taken. The percentage friability was calculated using the following equation:Disintegration testing was carried out as stated in the official USP disintegration monograph <701>. An Erweka ZT3  disintegration tester was used. A tablet was placed in one of the six vessels and allowed to oscillate at a rate of 30 cycles per minute. In this instance, a disk was not used in order to allow for a more direct comparison of the oral cavity environment. A total of 800 mL of distilled water was used as the disintegration medium that had a constant temperature of 37 °C. Measurements were achieved for a single tablet at a time to enhance accuracy. The disintegration time was noted until there was no more residue of tablet aggregates left on the upper side of the vessel mesh. Measurements were carried out in triplicates and presented as mean ± standard deviation.Adult simulated gastric and intestinal media , were prepared as presented by Jantratid et al.  and emplThe saturation solubility of carvedilol in simulated dissolution media was determined according to the reported method . BrieflySink value (S/C) was calculated as a ratio of solubility (S) to drug concentration (C) to determine whether sink conditions were achieved. A sink value greater than 3 indicates sink conditions . PercentMinimum dissolution volume was calculated using sink condition (Sc), determined by the ratio of solubility (S) to drug concentration (C), denoted by S/C. A value of greater than 3 is considered as sink condition . All disGraphPad Prism version 8  was used to carry out one-way analysis of variance (ANOVA) with a posthoc Tukey’s test to identify statistically significant differences in solubility between adult and paediatric biorelevant media. An alpha value of 0.05 was used.Although carvedilol has been approved since 1995 and its clinical need has been established, no attempt has been made to reformulate carvedilol into an age-appropriate formulation; the only licensed medicinal form that is available is a conventional tablet, while forms available from special-order manufacturers include oral suspension. In addition, the EMA Inventory of the Needs for Paediatric Medicine has also listed carvedilol in need of an ‘age-appropriate’ formulation. To address this formulation gap, the objective of the current work was to develop two strengths (0.5 mg and 2 mg) of an age-appropriate carvedilol formulation that possess increased dose flexibility, palatability, safety, quality, and efficacy. Carvedilol is a low dose potent compound with low aqueous solubility. It is gastric stable and does not exhibit any taste concerns. For such reasons and with an aim to minimise the total number of excipients within the formulation, the selection of an ODMT was most suitable. The dose of carvedilol is based on child weight and is usually titrated when initiated. The availability of multiple strengths ensures to cover a wide range of therapeutic doses and therefore, the novel ODMT formulation is aimed at birth up to the age of 12 years.In order to limit the total number of excipients within the formulation, one of the objectives of this study was to exploit excipient characteristics that provided multiple functions including palatability, compressibility, and disintegrating properties.Drug and excipient compatibility is an important part of pre-formulation study, where concomitant use of excipient and active pharmaceutical ingredients (API) are assessed. Commonly used excipients in ODT formulation were scanned alongside carvedilol to determine compatibility. However, for the purpose of this study, carvedilol:excipeint compatibility is displayed for excipients that were included in the final formulation only.Carvedilol displayed a sharp endothermic peak at 117.33 °C, indicating its melting point and crystalline structure . The phaThe sharp melting peak of carvedilol remained consistent when combined with magnesium stearate, suggesting compatibility between the two components . Howeverw/w), the success of direct compression is dictated by the excipients to ensure content uniformity, flow, and compressibility [For low concentration drugs, as in the case of carvedilol  indicated carvedilol to possess poor flow (46.47°) , which iAccording to Carr’s index and Hausner ratio, mannitol exhibited very poor flow (33.33% and 1.5) whereas MCC shows passable flow (23.08% and 1.3) . These rMixing of particulate solids is an important process step in achieving homogenous blends and key to assuring that each resulting unit dose possesses the specified amount of drug to achieve effective therapeutic levels. For low concentration drugs, as in the case of carvedilol, the success of direct compression is dictated by the excipients which are incorporated into the powder blend, with an aim to optimise flow and compressibility. It is essential for the powder to flow evenly, ensuring that the right amount of homogeneous powder enters the tableting die, ensuring consistent tablet weight and content uniformity .It was expected that longer mixing time would provide better content uniformity, since the API particles would have more contact time with other particles, increasing the chances of collision and resulting in improved homogeneity ,40. HoweBoth formulations produced a balance between mechanical strength and fast disintegration times . FriabilCarvedilol is a weakly basic compound with a pKa value of 7.8, exhibiting the distinctive pH-dependent solubility profile of a weak base, with low solubility in dissolution media of high pH values and high solubility in media of low pH values due to changes in ionisation  and as sAll adult and paediatric biorelevant media prepared for dissolution testing are categorised as level II media (biorelevant) that mimic various parts of the GI tract in regards to adjusted osmolality, pH, buffer capacity, bile components, and phospholipid concentration, and therefore, are superior to conventional USP/BP dissolution methods as they better reflect the solubilisation capacity of adult and paediatric GI fluids both during the fed and fasted state .p value > 0.05). It was expected that the dissolution rate to decrease in adult and paediatric FeSSGF due to the higher pH values of 5 and 5.7. This was true as the percentage release of carvedilol was only about 30–40% after the first 10 min. Nonetheless, no significant difference between adult and paediatric biorelevant media was observed.The initial rate of release of carvedilol from the novel ODMTs in a pre-prandial state was immediate, with the carvedilol percentage release exceeding 80% after the first 10 min . The absAlthough the fasted state of the gastric media is ideal for rapid and complete dissolution, it has been advised that heart failure patients take their medication with food to avoid a sharp increase in plasma concentration and limit the risk of orthostatic hypotension . Due to On the other hand, a clinically relevant dissolution profile between FeSSIF-V2 and paediatric FeSSIF was observed, where both ODMT formulations displayed a faster dissolution rate and an overall greater extent of percentage carvedilol release in FeSSIF-V2. This may be owing to the larger concentration of bile salt (sodium taurocholate) and lipid (lecithin) in FeSSIF-V2. Lecithin enhances the solubility of drugs through complexation, whilst sodium taurocholate holds the ability to produce micelles. Other than micellar solubilisation, bile salts may alter drug polarity and therefore solubility through ion pairing, when interacting with drug molecules . Based up > 0.05) differences observed. The choice of excipients and concentrations utilised, alongside fine-tuned production parameters for the manufactured carvedilol ODMT, ensured a robust dissolution profile, comparable to the marketed formulation without including dedicated functional disintegrants. Tablet disintegration is a prerequisite for dissolution, where orodispersible formulations must disintegrate rapidly however, the use of superdisintegrants in and as a model formulation constituent is not preferred, since many are incompatible with various drugs compounds, moisture sensitive (leading to instability), and lack toxicity data in both adults and paediatrics [diatrics . Upon coTwo strengths of carvedilol ODMT formulations were developed using an excipient composition and load that is appropriate for paediatric use. The novel ODMTs displayed all relevant features of an age-appropriate formulation, including enhanced dose flexibility, palatability, excipient safety, and concordance to development and ability for safe administration. Dissolution profiles observed were robust and comparable to the marketed formulation across various part of the GI tract in both the fed and fasted state, signifying appropriate efficacy, quality, and performance. No significant difference in dissolution profiles between adult and paediatric biorelevant media were established. The systematic selection of drug candidates listed within the EMA inventory of paediatric therapeutic needs, alongside paediatric specific formulation approach, provides an encouraging starting point that ultimately aims to increase the availability of more age-appropriate formulations for children through PUMA applications.