Faculty members in science, technology, engineering, and mathematics (STEM) disciplines are typically expected to pursue grant funding and publish to support their research or teaching agendas. Providing effective professional development programs on grant preparation and management and on research publications is crucial. This study shares the design and implementation of such a program for Native STEM faculty (NAF-STEM) from two tribal colleges and one public, non-tribal, Ph.D. granting institution during a 3-year period. The overall development and implementation of the program is centered on the six R’s Indigenous framework – Respect, Relationship, Representation, Relevance, Responsibility, and Reciprocity. The role of NAF-STEM and their interactions with the program, as members of the community formed by their participation, impacted the program. Their practices and the program co-emerged over time, each providing structure and meaning for the other. Through such reciprocity, NAF-STEM and the program research team continually refined the program through their mutual engagement. They took on the shared responsibility of the program while they participated in and shaped its practices. The process and results of formative and summative assessment and the impact of COVID-19 on the program are reported. Results of the program offer lessons on the implementation of six R’s framework in professional development at institutions of higher education. The need for a culturally responsive and effective professional development (PD) program to support Native American Faculty in Science, Technology, Engineering, and Mathematics (NAF-STEM) was identified through research into the experiences of Native American students in the field of natural resources and the critical contributions of Native American faculty to the success of Native American students e.g., . A team The research team consists of 20 researchers. Ten of the team members are enrolled members of seven Tribal Nations; two are Asian and eight are non-Native. Four members of the team led the development and implementation of the Research Publication and Grant Preparation (RPGP) Program and are the first authors of this article. Three are Native, one is Asian. Between the two coauthors, one is Native, the other is White. The personal and professional lived experiences of the Native American team members contributed an additional layer of richness and perspective to the Willow project.One of the project founders is a member of the Hidatsa tribe, who are also known as People of the Willows because historically, they lived along the river where willows were abundant. As the project was conceptualized, the vision of NAF-STEM as being similar to willows developed: a group of people who are thriving and play a critical role in their ecosystem. Willows represent flexibility and adaptation – not only to survive, but to thrive in some of the most challenging conditions and environments. The branches symbolize structure and a sense of responsibility. The roots symbolize being grounded and nurturing. The leaves symbolize nature and growth. Native Americans also use willows as a traditional medicine and willows are widely utilized in natural resources restoration for stream stabilization. The vision of the project was to create a model that supports NAF-STEM to become like the willows: abundant, contributing to a more diverse and enriched ecosystem, and a medicine for our people.The research team developed a Willow model with three interconnected components to support NAF-STEM: Indigenous mentoring program (branches), institutional support program (roots), and research publication and grant preparation program . The creation process of the model was Native American-led and was guided by specific tenets of Indigenous research methodologies (IRM), drawing upon Respect, Relationship, Representation, Relevance, Responsibility, and Reciprocity, our six R’s framework. In this article, we share the work on the RPGP component of the Willow model.The definition of American Indian and Alaska Native varies across United States federal agencies and at different times in history. In this article, we use Native American, American Indian, American Indian and Alaska Native, Native, and Indigenous interchangeably. We are aware of the variation among the 500+ tribal nations in the United States and respect the differences in their traditions, cultures, languages, and worldviews. Here, we seek to look at Native American faculty broadly, focusing on commonalities among these groups.The first Tribal College was established by the Navajo Nation in 1969 to provide culturally sensitive, place-based higher education to Native Americans. As of the Tribal Colleges and Universities are classified separately from other institutions of higher education, which fall under several familiar categories, such as Doctoral Universities and Baccalaureate Colleges . AccordiIn 2018, in higher education institutions nationwide, less than 1% of faculty were Native American . Among TA 2008 AIHEC report indicates that many faculty members at TCUs commit a high level of effort to student support services and few faculty receive release time, which means they have less time to develop research products .give back to their community , but TCU faculty, especially American Indian faculty, have a strong sense of obligation and commitment to Native communities . Furtherommunity . In a 20ommunity . Many Naommunity . This seommunity .Pursuing grant funding is a common expectation of faculty in STEM disciplines. Providing effective PD programs on grant preparation and management can help advance their careers. However, institutional contexts and culture are important factors that support or constrain faculty research activities . In thisThe overall design of the RPGP is centered on the six R’s framework for Indigenous research: Respect, Relationship, Representation, Relevance, Responsibility, and Reciprocity. The ideology behind the six R’s has been put into practice in Indigenous communities and elsewhere for generations. They came into the practice fairly recently and not all at the same time.Three decades ago, Verna J. Kirkness and Ray Barnhardt laid the groundwork stressing the need to incorporate into higher education systems, The Four R’s: Respect, Relevance, Reciprocity, and Responsibility (1991). The authors presented American Indian students’ perspectives that differed from mainstream institutions and characterized ways programming transforms education . Over tiIndigenizing Online Learning,” examining how a Canadian First Nations course for school principals was centered around the Five R’s. Representation was the sixth R to be included. Representation of Indigenous communities has been a struggle since colonization, and the ability to “represent ourselves” is seen as a fundamental right . Their home institutions are in the Northern Great Plains. Four participants are from two different TCUs and four participants are from one state-funded 4-year PWI.represented at the center of our continued journey.merely tolerating Indigenous knowledge(s) “to one where Indigenous knowledge(s) are embraced as part of the institutional fabric”  and Collaborative Writing and Support (CWS). The GWS offered four, 90-min sessions to collaboratively explore different aspects of writing grant proposals. All sessions were in person and online. The CWS was based on a best practice in grant writing, i.e., to have periodic reserved writing time with peers for accountability and support . ParticiComponent 2: A research publication program. The expected outcome was that the participant would complete a submit-ready, peer-reviewed journal article, conference proceeding, or book chapter with the participant serving as a major contributor . NAF-STEM who chose this option participated in at least two of the four GWS sessions in option 1. Each individual worked with the research team to determine the time for regular Collaborative Writing and Support (CWS) based on availability, location, and format. The research team worked with individual participants at the frequency they wanted.Component 3: A collaborative writing program (CWP) among participants on their experiences as Native faculty and researchers. The expected outcome was a submit-ready manuscript co-authored by participants for a journal or alternative destination determined by authors. The Willow team facilitated regular CWS meetings for participants who chose to work on the manuscript.The five elements from Relationships were fostered through face-to-face interactions at group sessions, one-on-one correspondence , and through an open-door policy. Ongoing interactions helped our team to further understand participants’ individual contexts in relation to proposal writing and grant management.Tribal Colleges and University context and participants’ needs differ from public state-funded institutions. TCUs tend to be very student-focused and encourage their faculty to embody this in their day-to-day work. At many public state-funded institutions, faculty are expected to perform research and are sometimes afforded resources  to accommodate this. This difference means that the number and types of proposals that a faculty member submits depends upon their institutional context.Participants had various degrees of grant writing and management experience. Those with more experience became peer mentors for others. This informed our decision to adapt the program to engage the senior faculty in discussions during the GWS sessions.Other “intersectional” traits for participants included tribal cultures and traditions, family composition and status , individual professional status, and environmental factors such as a global pandemic.The understanding of individual context led us to realize that some participants prefer to publish their scholarly work, rather than securing grants due to institutional and individual factors. Many faculty in our program opted to focus on publishing their work to strengthen their research agenda. This resulted in further adaptation of our PD program by adding Component 2 – Research Publications.Through our reciprocal relationships and respectful listening, we learned that several participants desired to share their lived experiences as Native faculty in TCU and non-TCU settings to (a) support Native communities to inspire more students into STEM fields and become faculty and (b) help the broader audience in higher education to better understand the strengths/challenges for Native STEM faculty and provide suggestions on support. This resulted in adding Component 3 – the Collaborative Writing Program.Over the period of the project, we revised the initial grant writing and management program to better meet the needs of our participants. We implemented our professional development plan, gathered data, and made adjustments (as described above). This process resulted in the final program, where participants were allowed to choose the component(s) that best suited their personal and professional goals: Component 1: Grant Writing Series; Component 2: Research Publications; Component 3: Collaborative Writing Program.The program effectiveness was assessed through formative and summative assessments. The formative assessments included: participation rates in the program and conversations between external evaluators and participants at biannual gatherings and summer retreats for feedback.Summative assessments include: (a) final outcomes from the RPGP, that is, number of proposals submitted and awarded for Component 1; number of publications submitted and accepted for publication for Component 2; number of publications or presentations for Component 3; (b) findings from informal focus group with participants at the end of the program.In this section we present the formative and summative assessment results of the RPGP. We then share the results on the program effectiveness from our participants’ perspective. We also address how the COVID-19 pandemic impacted the RPGP and our response to it.Results from Component 1 GWS: Among the eight NAF-STEM, the numbers of participants in GWS sessions 1–4 are 3, 8, 8, and 5 (note that participants only need to attend two of the four GWS sessions). One of the TCU NAF-STEM participants chose to further develop and submit a proposal in collaboration with a faculty member at the state institution to start a new graduate program at the TCU. The proposal was selected for funding.Results from Component 2 Research Publication: Two NAF-STEM chose to participate in this component working at their own pace. Based on one participant’s writing log, he used 15 writing sessions, ranging from 1 to 5 h long, to work on a manuscript. The manuscript has been published in a refereed journal in his field. The other participant published one book chapter.Results from Component 3 CWP: Five participants collaborated with three research team members on this component. This component was extended from a 1-year program to a 20-month period due to the COVID-19 pandemic. The group had a total of 38 1-h gatherings to work on the writing project. The participants gave a presentation followed by question-and-answers with about 50 participants at a national conference for Native American and Chicano/Hispanic students. A manuscript authored by the four participants and three team members on how Native American faculty navigate academia is currently being revised for its second submission to a peer review journal.Regarding the effectiveness of the program, we learned that participants appreciated the opportunity to get to know one another and share their stories. They felt that the work in RPGP was meaningful and gave them the ability to reclaim knowledge in an Indigenous context. These conversations also allowed Indigenous knowledge to expand beyond the TCUs and into other institutions, where the conversation on cultural change was brought to a wider audience. Others felt that the program could have been improved by offering a less time-consuming option. Some participants with ample grant writing, management, and research publication experiences indicated that they did not learn new skills through the program, and the RPGP could have benefited from an even deeper contextual understanding of where participants are, both in terms of career trajectory and institution type.We also asked participants to posit what a similar program might look like if it were implemented solely at a TCU or solely at a PWI. One participant indicated that many TCUs do not ask that their faculty write proposals, but rather hire grant writers to support institutional-level proposals. There is no pressure from the institution for the NAF-STEM to pursue individual research funding. Taking this comment into account, we might avoid proposal writing for PD at TCUs altogether, potentially replacing it with advice for seeking or working with a professional grant writer . Because NAF tend to have a self-transcendent approach to their work, broadening the definition of knowledge production beyond research publications and into creative scholarship would be beneficial. Including creative dissemination products  would be useful in a classroom and in the community, therefore reciprocating the NAF’s impact beyond their own research and career and into their community.The COVID-19 pandemic challenged the implementation of the RPGP by limiting interaction among participants. The collaborative writing sessions and annual workshops were shifted from in-person to abbreviated remote formats, limiting interactions and reducing opportunities that could potentially lead to publication.Additionally, Native American (NA) communities experienced the pandemic in especially devastating ways. In the United States the COVID-19 mortality rate was 2.5 times higher among NA than it was among non-Hispanic whites . These hWe responded with flexible timelines to complete the RPGP and added a weekly “wellness check-in” for our team and NAF-STEM to provide support to each other. We purchased technology and provided financial support to alleviate some of the added pressure on participants.In this section, we discuss the findings of the study through the conceptual lens of six R’s. We conclude with reflections on lessons learned and recommendations for researchers and administrators in institutions of higher education.remain grounded in the Indigenous six R’s framework. Using the six R’s framework also provided the Willow team with a system of accountability aligned with Indigenous practices.Incorporating the six R’s  into the RPGP served two purposes. When working in systems that value non-Indigenous processes, it was important for the Willow team to Many of the ways the six R’s guided the process were complex and integrated. In this section, we discuss the development and implementation of the RPGP and the holistic strengths of the six R’s, which are congruent with Indigenous Research Methodologies (IRM).Representation. Representation existed at the beginning, with its development by several Native American team members leading the RPGP and elevating Native perspectives. NAF shared narratives throughout, contributing to important national conversations on using IRM in science communities with their shared work. Having a shared identity with NAF-STEM, Willow team members as a whole carried a sense of Responsibility with Reciprocity in RPGP development. This sense of Responsibility is represented by Willow team leader’s responsiveness to NAF-STEM needs, while simultaneously NAF-STEM reciprocated responsiveness to the needs of their campus community. The responsiveness of the modifications are connected to Relationship, Respect, and Reciprocity.The connections and overlapping of the six R’s is important. Highlighting how they are represented and connected to each other in the Willow project is integral to understanding the process. The first of the six R’s recognized in this process is Relationships with NAF-STEM using a Respectful Reciprocal approach. As participants began to express needs and interests to modify the structure of the RPGP, the Willow team Respected their requests to make modifications. Because of the Respect given to NAF-STEM, they were open to Reciprocate and express what their hopes were for the program.The Willow team facilitators entered into As a result, a new option, the Collaborative Writing Project (CWP), was developed and took on a different, less hierarchical structure. All participants, whether they were Willow team or NAF-STEM, held equal influence. In this collective approach, as NAF-STEM felt compelled to direct the conversations, Willow rotated leadership of meetings and sections.Relevant needs at each of their institutions. They were given opportunities to tell their stories – stories about themselves, their students, their experiences, and their communities. This meaningful and sustainable engagement with the Indigenous community is Relevance  guided the RPGP team to emphasize Native perspectives, respond to participants’ needs and contexts, and support participants’ desires to give back to their communities. Native communities have had the experiences of western researchers and large institutions conducting research on Native communities with unethical approaches and without truly building long-lasting, reciprocal relationships or understanding the contexts of Indigenous cultures, traditions, needs, and ideologies. We hope this example of adaptive program development helps researchers better understand the importance of learning and applying the six R’s Indigenous framework when working with tribal communities and Native peoples.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.The studies involving human participants were reviewed and approved by the IRB at University of Montana, Salish Kootenai College, and Sitting Bull College. The patients/participants provided their written informed consent to participate in this study.All authors listed have made a substantial, direct, and intellectual contribution to the work, and approved it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Developing a diverse informatics workforce broadens the research agenda and ensures the growth of innovative solutions that enable equity-centered care. The American Medical Informatics Association (AMIA) established the AMIA First Look Program in 2017 to address workforce disparities among women, including those from marginalized communities. The program exposes women to informatics, furnishes mentors, and provides career resources. In 4 years, the program has introduced 87 undergraduate women, 41% members of marginalized communities, to informatics. Participants from the 2019 and 2020 cohorts reported interest in pursuing a career in informatics increased from 57% to 86% after participation, and 86% of both years’ attendees responded that they would recommend the program to others. A June 2021 LinkedIn profile review found 50% of participants working in computer science or informatics, 4% pursuing informatics graduate degrees, and 32% having completed informatics internships, suggesting AMIA First Look has the potential to increase informatics diversity. The National Science Foundation U.S. Science and Engineering 2020 Report data showed that women accounted for about 52% of the college-educated workforce between 2013 and 2017, but only 29% of the science and engineering workforce.,Given the increasing influence, demand, and reliance on health information technology, it is critical to diversify the biomedical informatics workforce. Biomedical informaticians use biomedical data, information, and knowledge for scientific inquiry, problem-solving, and decision-making to improve human health.The American Medical Informatics Association (AMIA) observed that the workforce disparities in STEM were also present throughout its organization.Over the course of developing this volunteer program, its goals have evolved to encompass the following: (1) expose women, with emphasis on those from historically marginalized communities to the field of biomedical informatics, (2) facilitate connections with women mentors in the field, and (3) equip students with resources for internship and postgraduation career “next-steps” in informatics.AMIA First Look was launched under the umbrella of the WIA Initiative,Each program year, Pathways subcommittee members identified public and private undergraduate colleges and universities local to the AMIA Annual Symposium . Deliberate attention was given to include Historically Black Colleges and Universities, Tribal Colleges and Universities, and Hispanic-Serving Institutions. Subcommittee members reviewed websites for all local STEM, pre-med, pre-nursing, nursing, and allied health programs to identify a point of contact. Each program was then invited by e-mail with the AMIA First Look announcement and link to the application form. A total of 301 programs were contacted over the years with increased social media messages in 2020 with intent to increase the outreach. This invitation provided information about AMIA, program details, and participant benefits, which included complimentary conference registration, lunch for the AMIA Symposium Opening Day (2017–2019), and travel allowance ($25 for years 2017–2019). The application form required that students submit: (1) demographics, (2) undergraduate institution, and (3) informatics exposure. These recruitment activities commenced 6 months before the conference and student outreach 4 months before the conference. Since a virtual conference was held in 2020, lunch and travel allowances were omitted. However, this allowed opening the registration to programs across the nation.Exposure to biomedical informatics was achieved by curating AMIA First Look participant access to several activities. First, participants received complimentary conference registration to the entire conference, with tailored sessions highlighted. Onsite mentors greeted participants during registration and recommended sessions, such as the Opening Plenary Session, which sought to highlight the breadth of informatics, display student research and prowess via the Student Paper Competition, or to stimulate participant curiosity about a particular topic. In 2019, subcommittee members created an Introduction to Informatics panel that included an open discussion featuring WIA members. Additionally, mentors joined the AMIA First Look Lunch, provided interactive discussions about biomedical informatics careers, gave short research talks, and accompanied participants to tutorials and scientific sessions. In 2020, AMIA First Look included a unique, game night, bonding experience with the participants called, “Informatics After Dark.” Second, participants received complimentary student membership to AMIA for 3 years with access to all online content. Lastly, participants received access to the AMIA online communities, including one created for AMIA First Look participants.The AMIA First Look Program used different approaches to seed connections and build community for participants. First, women members of AMIA volunteered to serve as program mentors. Mentor application forms required: (1) name and organization, (2) availability for mentoring, and (3) career stage and areas of expertise. Mentors were then paired with participants ∼1 month before the conference. Second, participants were added to the AMIA First Look Connect Community,Each year, participants were asked to complete an anonymous survey developed by the subcommittee after attending the program. Since survey questions evolved each year in response to participant feedback, data for some questions were not available for every year. Additionally, web searches from LinkedIn were performed in June 2021 to examine participants’ continued engagement with informatics from 2017 to 2020. Two authors independently reviewed each LinkedIn profile and recorded data in spreadsheet form. Data captured included graduation year, current position and organization, and internship organization. LinkedIn and survey data were analyzed across the 4 years using summary statistics including response percentages, response counts, and open-ended responses in Microsoft Excel and the result analyzer in Survey Monkey software.n = 36; 12 in 2017, 4 in 2018, 10 in 2019, 10 in 2020) were members of marginalized identity groups, Black, Indigenous, and People of Color participants, as defined by the National Institutes of Health.n = 77), juniors , or sophomores ; majors included computer science or information technology , health sciences , basic sciences , biomedical or health informatics , and engineering  (n = 95), Black or African American , Hispanic/Latinx , American Indian , and Native Hawaiian  communities  and 87 attended ; 41% ( n = 20)  and 2. Bmunities . Gender All participants in the 2019 cohort indicated that the AMIA First Look lunch allowed them to connect with women in the field, and 90% reported that the orientation and introduction to informatics sessions were welcoming, engaging, and informational. In the Exhibition Hall, mentors guided participants around the booths, facilitating introductions to representatives while making informal introductions along the way. Importantly, several mentors and mentees reported maintaining engagement postprogram about internships and graduate school applications. In the AMIA First Look Connect Community, mentors and staff have posted resources about internship opportunities, seminars, and jobs relevant to participants. Participants expressed that meeting women experts in their desired area will continue to be most helpful. Survey of participants revealed that advice and information about careers, graduate school, scholarships, and suitable programs were unmet participant needs. Networking receptions during the symposium and connections to academic partners and industry sponsors gave participants exposure to career opportunities in the field.n = 13) or informatics field (n = 7). Forty-one percent (30/73) were continuing their undergraduate studies; 4% (3/73) were pursuing informatics graduate degrees . Thirty-four percent (25/73) had completed or initiated at least one internship, 32% (8/25) of which were applied informatics training programs.The LinkedIn profile review found that 55% (40/73) of AMIA First Look participants completed their undergraduate degree program; 50% (20/40) of those were working in the computer science and data sciences  to evaluation limits the iterative design of the program for a better fit. This will be addressed by soliciting assessments right at end of program day instead of emailing evaluation link few days later. Based on the STEM focused outreach, AMIA First Look attracted undergraduates who were in computer science programs (33%) and conscious efforts will be made to recruit students from other fields to draw new talent into informatics. In incorporating any of these components into their approach, other programs should note key lessons from our experience. First, administrative processes require considerable program management resources. Dedicated volunteers have led AMIA First Look to this point, but significant resources are nonetheless required to execute the program, especially when it comes to engaging participants. Second, securing financial resources for a workforce diversity program is critical. AMIA has supported this program since 2017, but sponsorships are solicited annually. Procuring additional funding would further aid program sustainability by overcoming obstacles such as travel costs—the number one reason that prevented participation. Based on continued success, AMIA First Look is scheduled to be offered in 2021. The WIA is also adopting this model to increase the number of women in the clinical informatics subspeciality.,,Women and Black or African American, Indigenous, and Hispanic/Latinx students are earning STEM degrees, but they are not represented in the biomedical informatics workforce proportionate to their overall presence in the workforce and population. AMIA First Look integrates strategies for supporting women and especially women from marginalized communities such as building an inclusive community and providing access to women mentors, both which can be significant to helping develop a sense of belonging in STEM majors and careers, overcome barriers, and persist in the STEM field.The authors have not received direct funding to support the program and volunteer their time. The First Look Program receives support from AMIA, industry and academic partners for program logistics and operational costs.TJB conceptualized the First Look Program and led the launch in 2017 as part of the AMIA Annual Symposium; she also led the authoring and incorporated feedback from the coauthors. ABM and KSW are current Co-Chairs of the AMIA Pathways Committee and in charge of the First Look Program. ABM led the data analysis. All authors have read and approved the final manuscript.Journal of the American Medical Informatics Association online.ocab246_Supplementary_DataClick here for additional data file.


Psychosocial, self-guided, internet-based programs are effective in treating depression and anxiety. However, the community uptake of these programs is poor. Recent approaches to increasing engagement (defined as both uptake and adherence) in internet-based programs include brief engagement facilitation interventions (EFIs). However, these programs require evaluation to assess their efficacy.myCompass 2) in improving engagement (uptake and adherence) with that program (primary aim), assess the relative efficacy of the myCompass 2 program, and determine whether greater engagement was associated with improved efficacy (greater reduction in depression or anxiety symptoms) relative to the control (secondary aim).The aims of this hybrid implementation effectiveness trial are to examine the effects of a brief internet-based EFI presented before an internet-based cognitive behavioral therapy self-help program , tailored audio-visual content on a series of click-through linear webpages.A 3-arm randomized controlled trial  assessed the independent efficacy of the EFI and myCompass 2 condition  and the myCompass 2 alone condition  was not significant . In addition, there was no significant difference in the proportion of participants who started any number of modules (1-14 modules) versus those who started none between the EFI + myCompass 2  and the myCompass 2 alone  conditions . Finally, there was no significant difference between the EFI + myCompass 2 and the myCompass 2 alone conditions in the number of modules started  or completed . The myCompass 2 program was not found to be efficacious over time for symptoms of depression  or anxiety . However, planned contrasts suggested that myCompass 2 may have been effective for participants with elevated generalized anxiety disorder symptoms .Uptake was high in all groups; 82.8% (703/849) of participants clicked through the intervention following the pretest survey. However, the difference in uptake between the EFI + This brief internet-based EFI did not increase the uptake of or adherence to an existing internet-based program for depression and anxiety. Individuals’ motivation to initiate and complete internet-based self-guided interventions is complex and remains a significant challenge for self-guided interventions.Australian New Zealand Clinical Trials Registry ACTRN12618001565235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375839 Implementation science focuses primarily on implementing novel evidence-based interventions in existing health care systems . HoweverConsiderable evidence has demonstrated that self-guided internet-based programs are effective in preventing and treating symptoms of common mental health problems such as depression ,11. DespThere are many reported barriers to the uptake of E–MH programs . These iMany of these attitudinal barriers are modifiable and might be offset by benefits such as increased privacy , high fiFurther research is clearly needed to evaluate AFIs, or more broadly, interventions that target engagement with internet-based psychosocial programs, which we label engagement facilitation interventions (EFIs). This study adopts a model of engagement ,32 that Enhancing Engagement with Psychosocial Interventions (EEPI) trial, assessed the independent efficacy of the EFI and myCompass 2 by comparing the conditions of (1) myCompass 2 + EFI, (2) myCompass 2 , and (3) an attention control condition.A 3-arm RCT, called the The ethical aspects of this research were approved by The Australian National University Human Research Ethics Committee (protocol number 2018/257).+ myCompass 2) on a series of click-through linear webpages. The participants in this condition viewed the EFI after they were randomized and before commencing the E–MH program for depression and anxiety (myCompass 2). The EFI was delivered on an internet-based platform that also housed the surveys and control group content. myCompass 2 program to create a seamless flow of the EFI intervention into myCompass 2.The EFI comprised brief, tailored, written, and audio-visual content (approximately 5 minutes) presented to participants in the EFI condition  and a written description of the benefits of participating in E–MH programs, tailored to symptom levels.Written information about the efficacy of the E–MH program, its content, the time commitment involved, and its data security.Two testimonials (presented in a single 1-minute video) outlining the benefits of E–MH programs to provide information and normalize participation in internet-based, self-guided therapy interventions.myCompass program that we named for this study as myCompass 2. myCompass has previously been demonstrated to reduce symptoms of depression and anxiety in two community samples  [myCompass 2 program is a fully automated and interactive self-help program that is free to the end user and was designed for people with mild-to-moderate symptoms of stress, anxiety, and depression. It is delivered without therapist assistance and can be accessed privately, at any time, on a variety of platforms, including mobile phones, tablets, and computers.The E–MH program used was an updated version of the ; n=720) ,38. The myCompass 2 program is similar to its predecessor and contains 14 modules derived primarily from cognitive behavioral therapy, problem-solving therapy, interpersonal psychotherapy, and positive psychology. The program was delivered over 7 weeks to enable sufficient time to complete the 14 modules. The user is expected to complete two modules per week. However, symptom reduction may occur with the completion of fewer modules [myCompass [myCompass 2 was designed to be tailored to the user’s needs. The program screens the user and then directs them to modules that are likely to be suitable for them. The clinical approaches of the original myCompass and myCompass 2 programs were identical. However, the manner in which the content is delivered, the design of the program, and the user experience were all upgraded for myCompass 2, focusing on personalization and ease of use. This process was influenced by input from clinicians, consumers, and information technology specialists, resulting in the following key differences: (1) faster and easier sign up for users, (2) a more comprehensive user dashboard with more options for personalization, (3) modules that are more clearly displayed and easier to navigate, and finally (4) more comprehensive symptom trackers that are easier to personalize for the user.The  modules ,39. EachyCompass , myCompaHealthWatch) has previously been shown to have high credibility [myCompass 2 program for the time taken to complete and comprised 14 brief modules of written information offered over 7 weeks. The information was taken from public domain health and lifestyle information and was deliberately unrelated to mental health. Module topics included Keeping bones strong and healthy, Your microbes and you, and The power of your pancreas. At the end of the 6-month trial period, after the follow-up data were collected, the control group was sent information about how to access the myCompass 2 program if they wished.The attention control condition , was met within 2 months. All follow-up data were collected in November 2019. Facebook was used to ensure that a broad cross-section of the community could be reached and to maintain ecological validity, as internet-based interventions are often marketed on the web directly to consumers. We set up a Facebook page to describe the study and used paid Facebook advertisements using nature imagery  that asked, “Want to learn more about your mental health? Complete a survey and 7-week online program now” along with the ethics approval information listed earlier. We also ran a concurrent advertisement targeting male Facebook users only and using typical masculine-targeted imagery . This was to increase male participants and address the commonly higher ratio of female to male participants in internet-based mental health trial research [sign up were directed to the information and consent page, where they were provided the key details of the study and asked to provide their consent to participate on the web.Participants were recruited from the general community via a social network, Facebook, from January to March 2019. As outlined in the study protocol , the recresearch . To incrmyCompass web-based program, (2) were not currently receiving psychological therapy, (3) had not made a suicide plan in the past month, (4) had not been diagnosed with psychosis or bipolar disorder, (5) were aged 18 years or older, and (6) were currently living in Australia. The second part of the screening process involved completing the Generalized Anxiety Disorder 7-item (GAD-7) [Participants were invited to read the information sheet and consent to participate before completing the screening measures. After consenting, participants were screened using a two-stage screening process. First, they read a list of eligibility criteria that they had to endorse to be eligible for the trial. These were as follows: (1) had not previously used the  (GAD-7)  and Pati (GAD-7)  instrume (GAD-7) , potentiPrefer not to answer and other were categorized as the group expected to be smaller . This was completed using a computerized randomization algorithm embedded in the trial portal. Those who were assigned to the myCompass 2 conditions (conditions 1 and 2) were required to log in again when automatically redirected to the myCompass 2 program.We delivered the trial using the digital infrastructure portal of the Black Dog Institute, Sydney, Australia. The portal allowed for computer-generated random allocation, automatic assessments, intervention materials, and reminders to be delivered seamlessly to the participants. The portal collected web use data automatically for all conditions, allowing us to assess participants’ uptake and usage (adherence) of their assigned program. After completing the two-stage screening process, participants provided an email address and selected a password they could use to log in to access their assigned treatment. Participants were then randomized to one of the three conditions, using computer-based randomization stratified by general psychological distress symptom severity  or the attention control websites (condition 3). Participants were also sent emails to complete the 7-week posttest and 6-month follow-up surveys. Participants were sent reminder emails to complete if they had not completed the questionnaire after 1 and 2 weeks. Individual participant access to surveys was closed 4 weeks after the initial email was sent to each participant.The intervention period ran for 7 weeks. By using their email and password, participants were able to access their assigned programs as much or as little as they preferred. Through the automated system, weekly reminder emails were sent to participants to encourage them to engage with the We emailed participants with small incentives in the form of e-gift cards for the completion of each internet-based assessment across all conditions , regardless of their level of engagement with the intervention. These incentives were considered a token of appreciation for the participants’ time and effort for each survey.myCompass 2), (2) education about internet-based interventions plus program (EFI + myCompass 2), or (3) general health and lifestyle information (attention control). They were not provided with information about which of these interventions was expected to be the most effective. Assessments were also blinded, as they were self-report. The statistician performing the analyses was also blinded to the conditions.The trial was double-blinded. The participants were blinded to whether they received active or attention control interventions. They were informed that they would be randomized to receive one of three programs: (1) strategies for challenging unhelpful thoughts and behaviors . We also expected greater adherence to be observed  in the EFI + myCompass 2 condition relative to the myCompass 2 alone condition (H2).We hypothesized that uptake (initiation of at least one module) would be higher in the EFI + myCompass 2 intervention conditions than the HealthWatch attention control condition at posttest and 6-month follow-up (H3). Finally, we also expected that efficacy would be higher in the EFI + myCompass 2 condition than in the myCompass 2 alone condition at posttest and follow-up, and this difference would be mediated by adherence to the program (H4).We expected that efficacy (reduction in symptoms of depression and anxiety) would be higher in the two active myCompass 2, followed by myCompass 2 alone, which would also outperform the attention control condition (H6).We expected that uptake (H1), adherence (H2), and efficacy (H3) would be moderated by a range of sociodemographic and psychological characteristics, including gender, age, cultural and linguistic background, education, social support, symptoms of depression and anxiety, acceptability of psychosocial internet-based programs, attitudes toward professional psychological treatment, familiarity and use of technology, personality, stigma, and mental health literacy (H5). We also predicted that secondary indices of efficacy  would be greatest in the EFI + f=0.19 . We allowed up to 30% attrition from the posttest assessments. Thus, a minimum sample size of 158 per condition was required. We aimed to recruit a sample of n=693, which was based on the largest estimate of N required (n=231 per condition). This study achieved an adequate sample size (N=849) to meet the power requirements.To detect a significant difference in uptake (H1) from 50% to 65% (a conservative baseline based on previous research ), with cresearch ) betweenot et al ) betweenThe following demographic characteristics were assessed: gender, age category, language spoken at home, level of education , employment status , and region or area of residence . Other assessments including previous psychological treatment, mental health literacy, and stigma were also measured as per the protocol  but wereThe PHQ-9  was usedWe used the GAD-7 to assess anxiety symptoms. The GAD-7 scale comprises seven items that correspond to the DSM-IV and DSM-V criteria for generalized anxiety disorder . ParticiWe used the DQ5  to measutotally disagree to totally agree. For example, one item is as follows:The acceptability of internet-based programs was assessed using items developed and compiled by Ebert et al , based oIf I was suffering from psychological strain such as enduring lowered mood, loss of interest and lowered energy, sleeping problems, rumination, loss of joy in life...I could imagine trying out an internet-based intervention for mental health problems.performance expectancy ; higher scores indicate higher acceptability of internet-based programs. This scale has acceptable internal consistency . Out of  Lankton  and Scho Lankton , exampleon et al  and Schoon et al , examplert et al , exampleWe used five suicide-specific items from the Psychiatric Symptom Frequency scale  to measuDisability and the days out of role were measured by two items. The first assessed the number of days out of role: “In the last 30 days, how many days were you totally unable to work, study, or manage your day-to-day activities because of emotional problems (such as feeling depressed or anxious)?” The second assessed days of disability: “Aside from those days, in the last 30 days, how many days were you able to work, study, or manage your day-to-day activities but had to cut back on what you did or did not get as much done as usual because of emotional problems?”We used the European Health Interview Survey Quality of Life 8-item index (EUROHIS-QOL)  to measuWe also asked participants at the end of the posttest survey to complete a measure of self-reported adherence by asking, “Did you complete all of the program?” For those that responded “No,” we asked, “What were some of the reasons you didn’t complete the program?”myCompass 2 program. Uptake (H1) was assessed as the number of individuals who accessed at least one therapeutic module of the program. We compared the rate of uptake in EFI + myCompass 2 to that in the myCompass 2 alone condition using a chi-square test. Adherence (H2) was assessed using a Mann-Whitney U test to compare the number of modules that started and completed myCompass 2 during the intervention period of 7 weeks. We selected modules completed as they captured the dosage of the therapeutic content received. We also examined qualitative data on self-reported reasons for nonadherence using thematic analysis.The primary outcomes were uptake and adherence to the Efficacy (H3 and H4) was assessed on the basis of reduced symptoms of depression (PHQ-9 ) and GADThe MMRM processes described above were also used to examine the effects of the interventions on secondary efficacy outcomes (H6). The exploratory logistic regression and negative binomial regression models, and growth mixture model analyses (planned for H5)  did not A total of 858 participants met the eligibility criteria, agreed to participate in the trial, and completed the baseline assessment. Nine participants withdrew over the course of the study, and these were evenly spread across the three conditions. 22=19.3; P<.001), and 6-month follow-up assessments . Examination of the standardized residuals indicated that there were fewer participants missing from the control group, and a greater number of participants were missing from the EFI + myCompass 2 condition at both the posttest and follow-up.A chi-square test indicated a significant difference between conditions in completion of posttest assessments . However, the difference in uptake between the EFI + myCompass 2  and the myCompass 2 alone  conditions was not significant . There was also no significant difference in the proportion of participants who did and did not start a module in the myCompass 2 program between the EFI + myCompass 2  and the myCompass 2 alone  conditions .myCompass 2 program was low. Most participants  across the two intervention conditions failed to complete a single module of the program. Some participants  completed at least part of the program, with only 1.8% (10/565) completing all 14 modules of the program. A Mann-Whitney U test indicated no significant difference in the number of modules started between the EFI + myCompass 2 (mean rank=284.91) and the myCompass 2 alone (mean rank=281.13) conditions . There were no differences in the number of modules completed between the EFI + myCompass 2 (mean rank=284.45) and the myCompass 2 alone (mean rank=281.58) conditions . The overall adherence to the F4,349.97=1.16; P=.33) or anxiety  based on MMRM analyses. Planned contrasts demonstrated no significant interactions between time and conditions on symptoms of depression or anxiety at posttest or follow-up. As the intervention was not significantly effective overall, we restricted our planned moderation analyses of these outcomes to examine module completion, symptom levels, and basic demographics (age and gender) only. First, we examined those who completed a greater number of modules in the myCompass 2 program. In MMRM analyses testing the effect of module completion (0 vs 1-14 modules) on mental health outcomes, the three-way interaction between module completion, time, and condition was not significant , indicating no differential effects of the intervention for those who were more engaged. F4,332.80=3.50; P=.01). Finally, the three-way interaction between time, condition, and age  and time, condition, and gender  was not significant.There were no significant overall interactions between conditions and measurement occasions for depression , performance expectancy , effort expectancy , or concerns regarding data security . Similarly, there were no significant effects on general psychological distress , disability , the days out of role , or overall quality of life . Suicidal ideation also did not differ between the pretest and 6-month follow-up groups . MMRM analyses showed that there were no significant overall interactions between conditions and over time for any of the factors related to the acceptability of internet-based psychosocial interventions based on acceptance  and EFI + myCompass 2 (n=52) conditions reported time as an important barrier that prevented them from completing the myCompass 2 program. Other major barriers included technical issues, simply forgetting to use the program, experiencing difficulties with concentration, or fatigue.A total of 47.1% (128/271) of 271 participants who responded to this question reported that they did not complete their assigned program at posttest. This self-reported rate was similar to those who were automatically recorded to have not started  or completed  a single module of their program . Table 4This study describes the outcomes of the EEPI trial, which involved an RCT of an EFI designed to increase uptake and adherence to a self-guided internet-based mental health program. The EFI was not found to be efficacious in improving the uptake of or adherence to E–MH intervention in this study. These findings are somewhat consistent with those of Lin et al , who foumyCompass 2 program was not found to be efficacious in improving depression or anxiety in this sample. In contrast, several previous RCTs have demonstrated improvements in depression and anxiety in community-based samples for the original myCompass program [myCompass 2 program for this study, the characteristics of the sample (moderate depression or anxiety symptoms), the fully web-based nature of the trial (and consequent high attrition), or a combination of these factors. Our planned contrasts indicated that the program may be more beneficial for those with moderate anxiety symptoms. However, this result should be interpreted with caution given that the overall model for efficacy was not significant; we acknowledge that this test was post hoc and could be by chance. Further investigation is warranted to test the conditions under which this program may be effective. There is a possibility that a poor fit between the program and the needs of the participants may have had a negative impact on adherence. Additionally, the broad lack of adherence may have affected our ability to detect efficacy in this study. Nevertheless, module completion did not improve the program’s efficacy, and it was not found to be effective at scale in this real-world community-based trial.In addition, the  program ,38. It iDespite the null effects of the trial, the implications of these findings remain important. There was no evidence that the implementation strategy of educating participants about their need for intervention (feedback on symptoms), benefits, perceived barriers to use, and norms of engaging with psychosocial interventions was effective in increasing engagement (uptake and adherence) with a subsequent E–MH program. Further research might evaluate whether specific components of this EFI may be able to influence the engagement of specific groups of people using factorial experiments or additional qualitative methods. It may also be the case that uptake and adherence are more challenging in the context of potentially complex mental health needs but may be more amenable to intervention in the context of other health problems ,29.forgetting as a barrier to using the program. Blending human support with a self-guided program may also be beneficial for increasing the uptake of internet interventions [At the outset of the study, it was clear that adherence to psychosocial interventions is a complex and dynamic behavior ,20. Peopventions , althougventions , as it rImportantly, the quality of the therapeutic alliance can influence treatment outcomes , regardlAlthough this was one of the first studies to rigorously evaluate an implementation strategy to increase engagement with a self-guided psychosocial intervention, there were some limitations of both the EFI and this study that should be noted.First, as noted above, the EFI may have been too brief or insufficiently tailored to the needs of users. Although our development approach involved considerable collaboration with people who had lived experience of depression or anxiety, it is possible that the intensity of the EFI was insufficient or that it did not meet the diverse needs of users in the trial. We also did not assess participants’ engagement with the EFI . Attrition was the greatest in the EFI condition. It is possible that there was greater disengagement in the study in this condition, which may have occurred if the information from the EFI had a demotivating effect . When educating potential users about psychosocial interventions, there remains a risk of either overwhelming users with information or inadvertently reducing their motivation to engage.myCompass 2 program and were required to sign up for the intervention as a separate process, which may have led to reductions in uptake for both active conditions and raised the slight possibility of dual accounts that we may not have been able trace . The lack of efficacy of the myCompass 2 program in this study suggests that the intervention may be better suited to participants with different symptom profiles or that further work is needed to refine the intervention based on the low adherence rates. Nevertheless, the lack of evidence for efficacy did not limit our ability to compare the levels of uptake or adherence within the RCT design of the study.Overall, the attrition from the study was considerable. Although the study remained well-powered to detect hypothesized effects on uptake and adherence, it was slightly underpowered to examine efficacy outcomes, as the final samples in the active conditions were less than the targets (n=111). Attrition may have also led to biases in the analyses, although rigorous MMRM models were used to account for all available data. Incentives were used to minimize attrition but clearly provided insufficient motivation for most participants. Attrition from fully internet-based trials remains a challenge, which indicates that some form of human contact in a research trial is likely to be necessary to maintain samples over extended periods. Moreover, there were some technical challenges in the delivery of the trial. Participants could not be automatically logged into the The use of Facebook or certain imagery in advertisements may have attracted a certain type of user; however, we believe this is not a significant limitation as it reflects a similar process for real-world marketing of internet-based interventions and typical users of internet-based programs, and the promotion of the trial was identical across the three arms of the trial. Participants in the trial may have been aware of their allocation based on the content, despite interventions not being explicitly labeled as active or control. Finally, the composition of the sample was biased toward female participants. Although this imbalance reflects the usage of E–MH programs in the community, it may have limited the generalizability of the results for males.Although there is considerable scope for self-guided psychosocial programs to reduce health burdens, the uptake and adherence to these programs in the general population is limited. EFIs have been proposed as a specific strategy to overcome the implementation gap in psychosocial programs. However, this study indicates that the strategy was not effective in the context of an internet-based mental health program based on cognitive behavioral therapy for people with mild-to-moderate symptoms of depression or anxiety. Further research is required to identify implementation strategies that consider the dynamic and complex nature of intervention adherence and minimize the engagement barriers associated with internet-based programs.


The program aims to support staff at non-profit community-based organizations by ensuring policy development, training, practice overdose response exercises, and post-overdose debriefing opportunities are established and implemented.The BC Centre for Disease Control implemented the Facility Overdose Response Box (FORB) program December 1st, 2016 to December 31st, 2019 were analyzed using descriptive statistics. A Cochran-Armitage test was used to assess trends over time in naloxone administration event characteristics. Site coordinator survey results are reported to supplement findings from administrative data.Three data sources were used in this descriptive cross-sectional study: FORB site registration data; naloxone administration forms; and a survey that was distributed to FORB sites in February 2019. FORB program site and naloxone administration data from December 1st, 2019, FORB was implemented at 613 sites across BC and 1,758 naloxone administration events were reported. The majority  were indicated as overdose reversals. At registration, 43.6% of sites provided housing services, 26.3% offered harm reduction supplies, and 18.6% provided Take Home Naloxone. Refusal to be transported to hospital following overdose events when emergency services were called showed an increasing trend over time. Most respondents (81.3%) reported feeling confident in their ability to respond to the overdose and 59.6% were offered staff debrief. Based on the 89 site survey responses, supports most commonly made available following an overdose were debrief with a fellow staff member (91.0%), debrief with a supervisor (89.9%), and/or counselling services (84.3%).As of December 31The uptake of the FORB program has contributed to hundreds of overdose reversals in community settings in BC. Findings suggest that the FORB program supports developing staff preparedness and confidence in overdose response in community-based settings. Overdose fatalities now constitute the leading cause of unnatural deaths in BC and life expectancy at birth has declined [Rates of mortality and morbidity associated with opioid overdose continue to increase in North America as a result of a contaminated and unpredictable illicit drug supply , 2. On Adeclined , 4. In Jdeclined .Naloxone, an opioid antagonist, is a cost-effective medication that can rapidly reverse an opioid overdose . In Canast, 2016 in order to train and support non-healthcare service providers who may witness an overdose during the course of their work and ensure sufficient naloxone and other response supplies are available through centralized ordering processes [The BC THN program, which launched in 2012, was rapidly expanded in response to increasing overdose fatalities in 2016 –13. Althrocesses , 15. TheThe launch of FORB followed a successful pilot project involving two BC Health Authority Regions and a community-based organization in the Vancouver Mainland . An evalTo our knowledge, the FORB program is the first of its kind that directly aims to support non-healthcare service providers in settings where overdoses are likely to occur, including staff at housing services (e.g. emergency shelter and/or supportive or subsidized housing). The program addresses a limitation of existing provincial community-based naloxone programs where THN kits may not be suitable for use by staff in the workplace. Little evidence is available in the literature about programs such as FORB and the resources and supports needed by staff to feel prepared to respond to an overdose in non-healthcare settings.The objective of this cross-sectional study is to describe the FORB program and its role in preparing community sites and non-healthcare service providers for overdose recognition and response. Specifically, we describe services provided by registered sites, characteristics of staff naloxone administration events, and staff preparedness for overdose response. The findings of this study can inform the implementation of staff naloxone programs for community-based sites in other jurisdictions both nationally and internationally.BCHRS works closely with Regional Health Authority Harm Reduction Coordinators who identify eligible organizations or sites and provide support in registration and initial staff training. Sites that are eligible to participate in the FORB program are non-profit and community-based organizations across BC that work with individuals at risk of experiencing an opioid overdose. Non-eligible sites include: government agencies, medical clinics and health authority sites, as well as private or for-profit businesses.www.towardtheheart.com) [BCHRS operates the FORB program and is responsible for enrolling FORB sites, supplying overdose response boxes, naloxone, and replacement or training supplies to be kept at the site. BCHRS also develops training and program resources which are available on the program’s web-platform, Toward the Heart (art.com) .Prior to receiving overdose response boxes, sites are required to develop an overdose response policy and protocol for their organization and create a training plan for staff. Sites are responsible for training their staff to administer naloxone, providing support and debriefing to staff following an overdose response, and providing ongoing training and practice drills to maintain staff competency , 15.Three data sources were used in this descriptive cross-sectional study including: site registration data, naloxone administration forms, and a site coordinator survey.For the primary analysis, we reviewed FORB program administrative data from December 1, 2016 to December 31, 2019. This includes site registration data and naloxone administration forms from 613 sites across BC. Naloxone administration forms, which are completed by staff responding to overdose events at FORB sites, collect demographic and overdose response information; responses without a date were excluded. For the secondary analysis, we used data from a survey that was distributed by e-mail to FORB site coordinators (e.g. an executive director or program coordinator) between February 7 to 22, 2019. The survey was piloted with BCHRS team members to assess face validity of questions.All descriptive statistics were computed in Microsoft Excel and trend analyses were conducted in R version 3.6.3. For the site survey, ethics approval was obtained from the University of British Columbia Review Board (H12-02557) and consent to participate not applicable as data was analyzed anonymously.Using FORB program administrative data, we executed a descriptive analysis using counts and proportions to outline the services offered at FORB sites, characteristics of naloxone administration events reported, and staff preparedness. We used site registration data to outline services offered by FORB sites.Variables related to naloxone administration events included: location of overdose, how overdose was recognized, first responder attendance, and if the client was transported to the hospital. We also assessed variables on reported staff confidence in overdose response, participation in debrief following overdose event, and number of overdoses responded to prior to the event in question.Questions where participants did not respond were classified as missing and are provided for each variable. Additionally, a two-sided Cochran-Armitage test was used to assess if there were any trends over time in staff confidence in overdose response, overdose debrief, calling emergency services, naloxone administration by first responders, and transport to hospital after an overdose. Missing responses were excluded from trend analyses.From the site coordinator survey, responses to questions on supports and training provided to staff were summarized and are shown in As of December 31, 2019, 613 sites across BC were registered in the FORB program. A total of 1,795 naloxone administration forms were received between December 1, 2016 to December 31, 2019. Thirty-seven respondents submitted forms without a precise date of naloxone administration and were excluded from the analysis, providing a final sample of 1,758. There were 89 respondents for the site coordinator survey.Of the 613 sites registered, 471 (76.8%) of these sites were registered in the first 13 months  of the program; while 87 (14.2%) and 55 (9.0%) sites joined in 2018 and 2019 respectively. Of the 1,758 completed forms, 465 (26.5%) were completed in 2017, 595 (33.8%) in 2018 and 696 (39.6%) in 2019 . The majAmong the 1,758 overdose reversals reported by FORB sites, the vast majority of respondents (81.3%) reported feeling confident in their ability to respond to the overdose . Table 3The online survey was completed by 89 of 330 site coordinators from active FORB sites contacted, representing a response rate of 27%. Table in There was a rapid uptake of the FORB program in BC, almost three-quarters of sites enrolled within the first year of program launch. FORB was introduced during a sudden and unprecedented increase in overdose deaths and coincided with the ramp up with the THN program and ministerial order for development of OPS sites in BC , 10, 20.16 Staff at FORB sites are trained to follow SAVE ME  protocols for overdose prevention, recognition, and response, which is consistent with training offered through the BC Take Home Naloxone program [Previous program evaluation highlighted that the FORB program is easy to implement and sustain at all levels of the program and changes were implemented to help distinguish between the intended purpose of the BCHRS naloxone programs, as well as to improve application and supply management processes. program , 21, 22. program . Having The number of naloxone administration forms received each year has increased over time. This is consistent with increasing site numbers and overdose events but may also reflect completion of administration forms becoming a standard process. The vast majority of reported naloxone administration events were indicated as an overdose reversal. About half of the fatalities occurred in a private room and in one quarter, staff were called to respond to an event occurring off-site. It is plausible that the person was using drugs alone and/or that naloxone was not administered in time. This highlights the importance of messaging and initiatives around not using drugs alone and making access to observed consumption more readily available. For instance in 2020, initiatives including the downloadable Lifeguard Application and BeSafe Application were launched in BC to support connecting to emergency health services for individuals using drugs alone if an overdose occurred , 24. In An increase in refusing transport to hospital was observed between 2017 and 2019. This is consistent with findings that have observed a notable decrease in transport across all regions in BC based on paramedic-attended overdose events . IndividAlthough site staff most often call 911 (81.8%), the majority of overdoses responded to by staff who report do not require additional naloxone administration by emergency health services while on site which may demonstrate timely overdose response by staff. Adherence to calling 911 is likely the result of embedding alerting 911 into the overdose response protocols at FORB sites. Frontline staff continue to have a critical role as first responders for overdose interventions. This has been demonstrated in settings such as OPS/SCS which provide observed consumption , 27, as In light of the ongoing dual public health emergency with COVID-19, individuals may be at increased risk of overdose as the toxicity of the illicit drug supply is heightened . FurtherA program like FORB prompts community agencies to examine the policies and supports in place and ultimately the safety and well-being of their clients and staff. FORB site staff continue to report being offered debrief after response to an overdose. This is important as we learn more about the impacts of repeat overdose response for individuals who work at the frontline of the overdose crisis such as burnout, grief, stress and trauma –34. At mOur study has some limitations. Data regarding staff naloxone administration events depends on staff at FORB sites returning forms. Therefore, overdose events and reversals may be underreported as forms are not always submitted; this is minimised through the registration process which includes an agreement to send naloxone administration forms and is expected in order to receive replacement supplies. Although there is no follow-up with sites after forms are received, only 2% of forms were excluded due to a missing date. Data collection is intended to be low-barrier, however site names are indicated; there is potential for under-reporting of overdose events with adverse outcomes. As these forms are completed by individuals, self-reported data is susceptible to response bias.The anonymous online survey had a response rate of 27%, thus results cannot be generalised to all regions and types of FORB sites in BC; however, respondents identified their sites provided a wide range of services. Survey respondents may be more engaged with BCHRS. The findings are based on site coordinators responses which may differ from the perceptions of frontline staff and may be subject to response bias.The BC FORB program is one of many innovative responses to the illicit drug crisis in BC and has contributed to hundreds of overdose reversals in community settings. Our findings suggest that FORB supports non-healthcare service providers in being confident and competent in recognizing and responding to an overdose on site and prompts sites to have a variety of debrief supports available. Implementation of programs similar to FORB that support staff at community-based and non-profit sites where overdoses are likely to occur should be considered in other jurisdictions nationally and internationally. Additional research is needed to explore considerations around staff debriefing, perceptions of clients at participating FORB sites, as well as variations in uptake and management of the program in rural and remote areas.S1 File(DOCX)Click here for additional data file.S1 Appendix(DOCX)Click here for additional data file.S2 Appendix(DOCX)Click here for additional data file.


Schizophrenia is a severe mental illness associated with a heavy symptom burden and high relapse rates. Digital interventions are increasingly suggested as means to facilitate continuity of care, relapse prevention, and long-term disease management for schizophrenia spectrum disorders. In order to investigate the feasibility of a mobile and internet-based aftercare program, a 2-arm randomized controlled pilot study was conducted. The program could be used by patients for six months after inpatient treatment and included psychoeducation, an individual crisis plan, optional counseling via internet chat or phone and a supportive monitoring module. Due to the slow pace of enrollment, recruitment was stopped before the planned sample size was achieved. Reasons for the high exclusion rate during recruitment were analyzed as well as attitudes, satisfaction, and utilization of the program by study participants. The data of 25 randomized patients suggest overall positive attitudes towards the program, high user satisfaction and good adherence to the monitoring module. Overall, the results indicate that the digital program might be suitable to provide support following discharge from intensive care. In addition, the study provides insights into specific barriers to recruitment which may inform future research in the field of digital interventions for severe mental illness. Schizophrenia is a severe psychiatric illness affecting approximately 0.3–0.7% of the population throughout their lifespan. The disorder is characterized by positive and negative symptoms covering a heterogenous range of dysfunctions in behavior, thoughts, perception and affect . SchizopN = 1139 participants, Välimäki et al. )When it comes to the analyses of intervention effects, it must be clearly stated that the present study was not designed to evaluate the efficacy of the program. Moreover, the small sample size also did not allow a preliminary estimation of intervention effects. Overall, the mean PANSS scores at baseline in our study correspond to previous reports on the symptom status of patients with schizophrenia spectrum disorders at discharge e.g. ,39) and  and 39])The present RCT provides important insights and may inform other researchers about potential challenges in conducting such a study, and helps to minimize publication bias ,41, even


It is crucial to provide care based on individual needs. Swedish health care is obliged to give care on equal conditions for the entire population. The person with the greatest need should be given the most care, and the health care system should strive to be cost-efficient. Medical and technical advances have been significant during the last decades and the recent Covid-19 pandemic has caused a shift in health care, from in-person visits to virtual visits. The majority of pregnant women with a low risk assessment have an uncomplicated antenatal course without adverse events. These women probably receive excessive and unnecessary antenatal care. This study will investigate if an antenatal care program for healthy pregnant women with a low risk for adverse outcomes could be safely monitored with fewer in-person visits to a midwife, and with some of them replaced by virtual visits.This is a non-inferiority trial where a stepped wedge cluster randomized controlled design will be used. Data collection includes register data and questionnaires that concern antenatal, obstetric and neonatal outcomes, patient- and caregiver-reported experiences, healthcare-economy, and implementation aspects. The modified antenatal care (MAC) study is performed in parts of the southeast of Sweden, which has approximately 8200 childbirths annually. At the start of the study, all antenatal care centers included in the study will use the same standard antenatal care (SAC) program. In the MAC program the in-person visits to a midwife will be reduced to four instead of eight, with two additional virtual meetings compared with the SAC program.This presented study protocol is informed by research knowledge. The protocol is expected to provide a good structure for future studies on changed antenatal care programs that introduce virtual visits for healthy pregnant women with a low risk for adverse outcomes, without risking quality, safety, and increased costs.ISRCTN14422582, retrospectively registered.The study is registered the 21th of April 2021 in the ISRCTN registry with trial ID: The online version contains supplementary material available at 10.1186/s12884-022-04406-7. Historically, antenatal care programs were mainly developed to detect preeclampsia and gestational diabetes mellitus. Medical and technical advances in the last decades and new tests to detect complications e.g. the oral glucose tolerance test and screening for the risk of preeclampsia have been included in the antenatal care. There is a lack of evidence on the effectiveness, frequency and timing of the scheduled antenatal care visits. Studies regarding antenatal care programs has looked at different models and concluded that a reduction in the number of antenatal care visits during pregnancy is safe regarding neonatal and obstetric outcomes . Also, nThe recent Covid-19 pandemic has caused a shift from in-person visits to virtual visits. Peahl et al. conducted a study in 2020 with a redesign of the antenatal care for pregnant women with a low risk, consisting of four in-person visits, one obstetric ultrasound and four virtual visits . E-healtThe current standard antenatal care (SAC) program was developed by the Swedish national reference group for maternal health care during the early 1990s and has undergone some minor revisions regarding frequency and timing of the scheduled midwife visits during the last decades. At the same time, the medical content has expanded, now including for example screening for anemia, thyroid disease, evaluation for thromboembolic risk and anti-Rhesus immunization during pregnancy.The SAC program in Sweden is free of charge with a high attendance rate of almost 100%. There is no longer a routine visit to an obstetrician for all pregnant women, but instead the midwife carries out a risk assessment based on national guidelines in early pregnancy. The risk assessment determines if the SAC program is sufficient or if extra visits are needed, i.e., for an ultrasound for fetal growth or an appointment with an obstetrician.According to the Swedish Health Care Act, publicly funded care is obliged to follow ethical principles for prioritization and resource allocation, namely the human dignity principle, the need-solidarity principles and the cost-effectiveness principle. That means that all people must be treated with respect for their dignity and considered as having equal value, those with the greatest need for health care should be given priority, and health care activities should be organized so that cost-effectiveness is promoted . The majThe proportion of women with a high risk for complications during pregnancy and childbirth is increasing due to e.g. obesity, advanced age or intercurrent diseases , 17. It Our hypothesis is that the modified antenatal care (MAC) program does not differ in regard to antenatal, obstetric and neonatal outcomes compared to the SAC program. We also hypothesize that the cost of the MAC program is lower than the cost of the SAC program. We also assume that selected implementation strategies will support a high level of adherence and sustainability for the MAC program.This study protocol will describe the guideline development of a MAC program. The study design and methods aimed to investigate if a reduction in-person visits to a midwife with some of those visits replaced with virtual visits is safe for healthy pregnant women with a low risk for adverse outcomes. The planned study will evaluate a MAC program in comparison to the SAC program for healthy pregnant women with a low risk for adverse outcomes, considering the following aspects: maternal- and neonatal outcomes, patient- and caregiver-reported experiences, healthcare economy, and will also evaluate the MAC program implementation.This is a stepped wedge cluster randomized controlled trial comparing two different programs: the standard antenatal care (SAC) program and the modified antenatal care (MAC) program in five antenatal care centers (ACC) where each participating ACC constitutes one cluster (A-E). All visits to both the SAC and MAC take place in an ACC in the South East region of Sweden. At the start of the study, all ACCs will use the same and current SAC program. The healthy pregnant women with a low risk for adverse outcomes, who are attending the current SAC program will constitute the control group. After the start of the MAC program, the corresponding women will constitute the index group.To scrutinize all aspects of antenatal care, we first assembled a research team consisting of senior consultants in maternity and obstetric care, midwives, a health economist, experts in implementation strategies, and in the later stages also statistics experts, hospital administration staff, health communicators, IT consultants and executives. We used systematic literature reviews and PubMed searches to investigate existing evidence in the fields of antenatal care and e-health. After having drawn up the recommended checks during pregnancy, they were divided into two categories: the ones who we assumed would need in-person visits i.e., ultrasounds, laboratory tests and physical examination, and the others that we assumed could be offered remotely through virtual meetings, mainly concerning information and reassurance. These controls were thereafter grouped, based on their recommended timing during pregnancy. With the introduction of the MAC program the in-person visits to a midwife will be reduced to four instead of eight, including the visit with the risk assessment, with two additional virtual meetings. Two obstetric ultrasounds are conducted in both the SAC and MAC, see Table The information given during pregnancy to the pregnant women is listed in Table An in-person visit in the MAC study is defined as an in-office visit between a pregnant woman and a midwife for assessing maternal or fetal well-being. Visits solely for e.g. blood sampling are not counted. For virtual meetings, the video-meeting solution adopted by the included ACCs will be used.If additional visits are called for during pregnancy, e.g. elevated blood pressure, signs of depression, deviating oral glucose tolerance test, follow-up is individualized. The additional visits could be either back to the midwife for closer surveillance, or booked appointments with other health care staff.Two sets of questionnaires have been developed to assess the pregnant women’s and midwives’ views on quality of care and work situation/condition respectively. The questionnaires are called Patient Reported Experience Measures (PREM 1 and 2) and Midwife Reported Experience Measures (MREM 1 and 2). These questionnaires are seen as Supplements Information about the upcoming change of the antenatal care program for healthy pregnant women with a low risk for adverse outcomes is developed and planned to be communicated to the general public with the help of the administration for health communication.The same unit also develops a communication tool for the midwife to use when communicating with the pregnant women about questions that concern the MAC program.Six ACCs in the South East region of Sweden with the same SAC program have been informed about the MAC study and five have agreed to participate. They are called ACC A-E in the study. The participating ACCs have approximately 8200 childbirths annually in total.A randomization will be performed for the order in which the ACCs will implement the MAC program. A stepped wedge cluster design was chosen to allow participating centers to serve as control and intervention groups respectively . The intIn order to achieve a successful implementation, the change to the MAC program in each ACC will follow an implementation plan consisting of a step-by step introduction, with a plan-do-study-act design that offers opportunities to evaluate the implementation and, if necessary, facilitate adherence to the program –23. ImplAll pregnant women will be assessed in the first trimester and classified according to risk, see Supplement Low risk assessment in four dimensions .Low risk in risk assessment for developing preeclampsia. The assessment for the risk of developing preeclampsia is carried out in the first trimester, based on the uterine pulsatility index, medical history, biochemical markers  and median blood pressure in both arms. The pregnant women are classified as either low or high risk for preeclampsia before gestational week 37 and 0 days according to this routine .Possibility for the pregnant woman to download an app for virtual meetings and use it.Fluent in Swedish or EnglishOn different dates, three of the five ACCs will switch to the MAC program for healthy pregnant women with a low risk for adverse outcomes; the other two will remain as control groups, see Fig. In this study the definition of healthy pregnant women with a low risk for adverse outcomes eligible for the MAC program is as follows  will be included as controls from study start. The two other ACCs (ACC D-E) will begin as control groups three months after the study start. ACC A will be starting with the MAC program four months after the study start followed by ACCs B and ACC C that will begin the MAC program six and seven months respectively after study start. ACCs D-E will remain as control groups. The first data collection will take place approximately 1.5–2 years after study start.© and Cosmic© databases as well as local databases.National registers in Sweden offer a possibility to assess the impact of the MAC program on antenatal, obstetric and neonatal outcomes. Healthy pregnant women with a low risk for adverse outcomes will be registered in the Swedish Pregnancy Register in the first trimester as planned to follow either the SAC or the MAC program. Data will also be extracted from medical records in the ObstetrixDuring the study period, the pregnant women will receive a web survey around gestational week 37–40, with emphasis on their experience of the given care. Healthy pregnant women with a low risk for adverse outcomes in the SAC program  , 26. ThiThe sample size was calculated with a stepped wedge sample size add-on program to Stata. The program can only detect minimum difference between two groups for superiority designs; therefore, the program was used to calculate the minimum difference that can be detected with a given sample size. It was estimated that a minimum of 1500 pregnant women a year will be possible for the MAC program. The average number of pregnancies per month in the clusters will be approximately 46 and was inserted in the program in ten steps, excluding the baseline. This study population will be enough for our primary outcome, the obstetric composite. The minimum detectable difference with a p-value of 5% and 80% power will be larger than what is estimated in the main non-inferiority hypothesis, resulting in the effect size of 4%. The analysis will be based on the principle of intention to treat.The answered questionnaires will be checked by research staff for errors and missing data. All cases of intrauterine death will go through an audit and will be monitored specifically by a senior consultant in obstetrics not involved in the study.The study follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. All data collected will be stored in the study database in a safe server.The MAC program will be thoroughly evaluated considering medical safety, but also patient and midwives’ experiences. The Swedish Ethical Review Authority Dr no 2020–03,801 has approved the evaluation of the MAC program.The pregnant women have the right according to Swedish Law to decline any aspect of care or to change to a different caregiver.All data that is collected will be coded and results published only on group level. Great efforts will be made to ensure that the women will be given sufficient information regarding the recommended antenatal care program according to their individual risk assessment.From a fairness perspective, it is crucial to provide care based on individual needs. Swedish health care is obliged to give care on equal conditions for the entire population, but that does not mean the exact same care to everyone. The person that has the greatest need should be given the most care, and the health care system must at the same time strive to be cost-efficient. Hopefully, this study could be useful in that endeavor.st of October 2020. The first ACC changing to the MAC program was the 1st of February 2021. The study is ongoing during the whole of 2021–2022 with the first data collection planned for the end of 2022.The study preparation period began in 2019 and the first recruitment to the control group started1Since publicly funded resources are limited, it is important to evaluate whether proper care is given, to ensure patient safety but also to investigate whether unnecessary care is provided or not.When introducing the MAC program the research team has chosen a high safety approach when defining “healthy pregnant women with a low risk for adverse outcome”. The MAC program could in the future provide a solid base to the antenatal care, and with minor additional services, for example psychological support, to women with fear of childbirth or psychosocial risk factors. This could probably be done virtually as well, but has to be studied more closely. The MAC program could probably also be combined with remote monitoring, e.g. of blood pressure if extra checkups are needed .The stepped wedge cluster design is practical when it is difficult to provide the intervention to all participants at the same time, in this study due to logistical and practical reasons. It is also appropriate for a cost-effectiveness analysis of an intervention on a population basis.A disadvantage of this study design is the difficulty in blinding the participants. It is also likely to lead to a longer trial duration than a traditional parallel design study. Stepped wedge trials can also be impacted by wider secular trends that could differ between the beginning and the end of the study period. During the preparation period of the MAC study, there was a national change in recommendations for the surveillance of prolonged pregnancy, meaning pregnancy beyond week 41, due to the SWEdish Post Induction Study . This chIdentifying intrauterine growth restriction (IUGR) is one of the most important tasks for midwives at ACCs since a fetus with IUGR has a higher risk of intrauterine fetal death and of being born small for gestational age (SGA). Most of the cases of IUGR are identified due to specific medical guidelines concerning pregnant women with elevated risk for adverse outcomes that recommends extra ultrasounds to assess the fetal growth. Pay et al. stated in their study that the Symphysis-fundus (SF) height can serve as a clinical indicator along with other clinical findings, current and previous medical history, and that it is important to be aware of the limitations of this test, since the SF height has high false negative rates . The risAdditional file 1. Risk assessment protocol for adverse pregnancy outcomes using four dimensions, in brief summary.Additional file 2. First questionnaire with Patient Reported Experience Measures.Additional file 3. Second questionnaire with Patient Reported Experience Measures.Additional file 4. First questionnaire with Midwife Reported Experience Measures, also called BREM 1. (midwife eng – barnmorska swe).Additional file 5. Second questionnaire with Midwife Reported Experience Measures, also called BREM 2.


Few studies have examined how the intersectionality of geographic context and race/ethnicity influences Alzheimer’s disease and related dementia (ADRD) caregiving. Our aims were to determine whether 1) caregiver experiences and health differed across urban and rural areas; and 2) these links were moderated by caregiver race/ethnicity. We used data from the 2017 National Health and Aging Trends Study and National Study of Caregiving. The sample included caregivers (n=808) of care recipients ages 65+ with ‘probable’ ADRD (n=482). Geographic context was defined as care recipient’s residence in metro (urban) or non-metro  counties. Outcomes included caregiving experiences  and health . Bivariate analyses indicated that non-metro ADRD caregivers were less racially/ethnically diverse (82.7% white) and more were spouses/partners (20.2%). Among racial/ethnic minority ADRD caregivers, non-metro context was associated with having more chronic conditions (p<.01), providing less care (p<.01), and not co-residing with care recipients (p<.001). Amid white ADRD caregivers, non-metro context was associated with not reporting caregiving was more than they could handle (p<.05) and finding financial assistance for caregiving (p<.05). Multivariate regression analyses demonstrated that non-metro minority ADRD caregivers had 3.09 times higher odds  of reporting anxiety in comparison to metro minority ADRD caregivers. Geographic context shapes ADRD caregiving experiences and caregiver health differently across racial/ethnic groups. Despite higher rates of ADRD and ADRD-related mortality in non-metro areas, findings suggest both positive and negative aspects of caregiving among White, Black, and Hispanic ADRD caregivers.