TM) delivered under real-world conditions. The program was delivered to 430 adults living across rural South Australia. Participants of the program attended weekly 2 h healthy lifestyle education and exercise group-based sessions for 8 weeks. A total of 47 programs were delivered in over 15 communities. In total, 548 referrals were received, resulting in 430 participants receiving the intervention (78% uptake). At baseline, 74.6% of participants were female, the mean age of participants was 53.7 years and 11.1% of participants identified as Aboriginal and/or Torres Strait Islander. Follow-up assessments were obtained for 265 participants. Significant improvements were observed for walking, planned physical activity, incidental physical activity, total physical activity, 30 s chair stand, 30 s arm curl, 6 min walk, fruit consumption and vegetable consumption, sitting time and diastolic blood pressure. Positive satisfaction and favourable feedback were reported. The healthy lifestyle program achieved excellent real-world uptake and effectiveness, reasonable intervention attendance and strong program acceptability amongst rural and vulnerable communities.Whilst there is considerable evidence to support the efficacy of physical activity and dietary interventions in disease and death prevention, translation of knowledge into practice remains inadequate. We aimed to examine the uptake, retention, acceptability and effectiveness on physical activity, physical function, sitting time, diet and health outcomes of a Healthy Eating Activity and Lifestyle program (HEAL Poor diet and insufficient physical activity are leading modifiable causes of death and disease . They inInternational evidence consistently shows that physical inactivity and poor dietary patterns disproportionately affect people residing in rural areas, and those who are socioeconomically disadvantaged ,6,7,8. PThere is a great deal of evidence supporting the efficacy of physical activity and dietary interventions among adults in the scientific literature ,14,15. ETM) program. A systematic review of 28 real-world studies of lifestyle programs modelled on the Diabetes Prevention Program, on average, led to 4 percent weight loss [Real-world trials are needed to help close this gap. Two evidence-based programs that have been evaluated under real-world conditions and reported in the peer-reviewed literature are studies based on the US Diabetes Prevention Program and the Australian Healthy Eating Activity and Lifestyle  across 67 local government areas suggested the program leads to measurable improvements in physical activity, sitting time, fruit and vegetable consumption, anthropometry, and physical function [t-tests) and did not consider or account for differences in program effectiveness based on sex, age, ethnicity, and it is also unclear which settings the program was tested in .In Australia, the HEALfunction . HoweverTM program delivered under real-world conditions in rural and Indigenous settings such as Aboriginal Controlled Community Health Organisations (ACCHOs). In particular, we aimed to: (1) describe the program’s uptake, retention and engagement; (2) examine the effectiveness of the program for improving physical activity, sedentary behaviour, diet, health outcomes and physical function; and (3) describe participants’ and health professionals’ views on program acceptability and satisfaction. Understanding how healthy lifestyle programs work in real-world settings and with rural and vulnerable communities is essential to address chronic disease risk and management.This study helps to address these gaps in the literature, offering an analysis of the HEALTM program—a group-focused lifestyle program implemented in a ‘real world’ primary health care setting. The HEALTM program is an evidence-based program, developed by South Western Sydney Primary Health Network and supported by Exercise & Sport Science Australia (ESSA) [TM program across rural South Australia. A project officer employed by Sonder was responsible for the implementation of the program. This included undertaking regular promotion and engagement activities with local General Practitioners (GPs) and practice nurses to encourage and support referrals into the program. The project officer recruited local allied health professionals who were subsequently trained and certified to deliver the HEALTM program as facilitators through ESSA. Local facilitators also engaged with local GPs to support referrals and local community engagement. Intervention and data collection took place between 1 July 2018 and 30 September 2019. Participants provided written consent to partake in the program and for their data to be used for program evaluation purposes. This retrospective analysis of quality assurance data was deemed to be exempt from ethics approval by the University of South Australia’s Human Research Ethics Committee (application no. 204196).This study uses a mixed quantitative and qualitative methods, pre–post design comprising of the delivery of the HEALa (ESSA) . Sonder To be eligible, participants were required to be referred by a GP or Nurse Practitioner located in one of the following South Australia regions: Gawler, Barossa, Lower North, Mid North, Yorke Peninsula, Far West, Flinders and Port Augusta, Lower Eyre and Upper Eyre. Participants were eligible for referral if they met one of the following criteria: CVD or 2+ CVD risk factors, were diagnosed with Type 2 diabetes, were pre-diabetic, or had a body mass index (BMI) ≥30. Further eligibility criteria assessed upon receipt of the referral included aged 18 years or over and completion of pre-exercise screening  with appTM facilitator located in their region of residence. Facilitators contacted participants via phone to enrol them into the next available program. Participant anthropometry, blood pressure, and physical function assessments were conducted by facilitators in-person prior to the participants’ commencement in the program and immediately following program completion (8 weeks). Participants completed a paper survey assessing their physical activity, sitting time, and diet at baseline and 8 weeks and were invited to complete an online or paper-based satisfaction survey following the completion of the program. Participant referrals were sent from the general practice to Sonder, where they were processed and allocated to a HEALn = 30) to complete an online survey to provide feedback about the program in June 2019.Stakeholders, including program facilitators, referrers and practice/service managers, were invited  . Socioecsr = 0.56–0.64) and validity (sr = 0.52) [Physical activity questions were based on the Active Australia Survey  and incl = 0.52) ,29 compaSitting time was captured by a single item measuring the average number of hours per day in the previous week spent in sedentary activities .Daily fruit and vegetable consumption was assessed by two questions: one which asked the number of servings of fruit per day and another which asked the number of servings of vegetables per day. Each question provided examples and serving size equivalents. These questions were taken from the valid and reliable Fat and Fibre Barometer questionnaire .Height (cm), weight (kg), waist circumference (cm), hip circumference (cm), and blood pressure (mm/Hg) were measured objectively. Stadiometers were used to measure height; digital scales were used to measure weight; and waist/hip circumference were measured using tape measures. Blood pressure was measured once with the participant seated using a clinical grade sphygmomanometer. The brand and model of instruments varied based on facilitators’ access to equipment; however, participants’ baseline and follow-up assessments were collected using the same instrument. Physical function measures included the 6 min walk test, 30 s arm curl, and 30 s chair rise ,33.Weekly program attendance was recorded by the facilitator. The participant program satisfaction survey was delivered in paper form and consisted of 13 items with a mix of Likert scale and open-ended questions . The staz-test pairwise comparisons. Analyses were conducted in SPSS 25 .Baseline participants’ characteristics were analysed descriptively. Differences between those who accepted and did not accept their referral, and differences between those who completed and did not complete the 8-week follow-up assessments, were assessed using one-way analysis of variance and chi-square with post hoc Bonferroni-corrected To account for repeated measures and the hierarchical data structure (participants nested within program sites), linear mixed models with restricted maximum likelihood (REML) estimation were used to examine the effectiveness of the program. Random effects were specified to account for the hierarchical structure of the data and time was specified as a fixed effect. Consistent with the principle of intention-to-treat , REML alDescriptive statistics for program satisfaction and stakeholder feedback was reflected as percentages of participants responding across the Likert scale items. Open-ended questions were analysed thematically using Microsoft Word.Forty-seven programs were delivered across more than 15 communities, including the regions of Lower/Mid North, Lower Eyre, Yorke Peninsula, Gawler/Barossa, ACCHOs and Remote/Royal Flying Doctor communities.p = 0.02). Additionally, a greater proportion of those without a healthcare card (90.9%) compared to those with a healthcare card (81.9%) accepted the referral (p = 0.01). Acceptance also differed based on remoteness (p = 0.01); rates of acceptance in major cities (57.9%) was similar to inner regional (81.6%), outer regional (73.8%), and remote SA (81.0%), but lower than very remote SA (100.0%). There were no significant differences for age, socioeconomic status, or Aboriginal and/or Torres Strait Islander status for uptake in referrals.A comparison was undertaken of those who accepted vs. those who declined the referral . A greatFour hundred and fourteen participants completed baseline assessments. At baseline, 74.6% of the participants were female, the mean age of participants was 53.7 and average weight was 99.3 kg. Additionally, 11.1% of the sample identified as Aboriginal and/or Torres Strait Islander. Most participants lived in inner regional (30.8%) and outer regional (36.8%) areas and were in the lowest two socioeconomic status categories (63.4%). Participants completed an average of six of eight weekly sessions.p = 0.02), had a lower weight , smaller waist circumference , more 30 s chair stands , and completed more weekly sessions . Completion differed by remoteness (p = 0.003); rates of completion in major cities (100.0%) were similar to inner regional (57.7%), outer regional (68.0%), and remote SA (70.8%) but higher than very remote SA (33.3%). Completion also differed by socioeconomic status (p = 0.02); rates of completion in deciles 5–6 (55.1%) were lower than in deciles 3–4 (74.0%), while deciles 1–2 (59.8%), 3–4 (74.0%), 7–8 (73.5%), and 9–10 (57.1%) were similar. There were no differences in completion based on gender, Aboriginal and/or Torres Strait Islander status, health care card status, systolic blood pressure, diastolic blood pressure, walking, planned physical activity, incidental physical activity, total physical activity, sitting time, servings of fruit, servings of vegetables, 6 min walk test, or 30 s arm curl.Eight-week follow-up assessments were obtained for 265 participants (64%). A comparison was undertaken of those who completed vs. those who did not complete the follow-up assessment . CompareAt 8 weeks, statistically significant increases were shown in walking, planned physical activity, incidental physical activity, total physical activity, 30 s chair stand, 30 s arm curl, 6 min walk, fruit consumption and vegetable consumption. Statistically significant reductions were seen in sitting time, weight, waist circumference, and diastolic blood pressure. There were no changes in systolic blood pressure. Overall, 126 program participants  completed the satisfaction survey One hundred percent reported that they would recommend the program to family and friends and that the program was run at a convenient place. Most participants reported that the program was run at a convenient time (98%), that the quality of presentation was ‘excellent’ , and that they were ‘confident’ or ‘very confident’ that they were able to make changes to their lifestyle as a result of the program (98%). Participants reported that the program raised their awareness of the health benefits of healthy eating and physical activity ‘a lot’ (90%), ‘a little’ (7%), or ‘not much’ (3%). Most participants reported that the program increased their healthy eating and physical activity skills by ‘a lot’ (71%) or ‘a little’ (26%) and many reported that the program prompted them to want to change their eating and physical activity habits ‘a lot’ (73%) or ‘a little’ (25%).n = 13), 85% reported they received adequate training to deliver HEALTM and 77% reported that the resources provided were ‘extremely’ or ‘very effective’, with the remaining reporting that they were ‘somewhat effective’ (23%).A total of 22 of the 30 stakeholders invited (73%) provided feedback; this included 10 program facilitators, 9 referrers and 3 practice/service managers. A minimum of one stakeholder from each region of delivery responded to the survey. One hundred percent of stakeholders reported that they were ‘very satisfied’ or ‘satisfied’ with the program and that they were ‘very likely’ or ‘likely’ to recommend the program to potential participants and colleagues/other health professionals. All respondents either ‘strongly agreed’ or ‘agreed’ that the program both met the needs of participants and was beneficial for people with chronic disease. Most (90%) reported the program is effective and appropriate for chronic disease management. The majority (82%) ‘strongly agreed’ or ‘agreed’ that the referral process was simple and easy, with the remaining ‘neither agreeing nor disagreeing’ (5%) or ‘disagreeing’ (14%). 95% ‘strongly agreed’ or ‘agreed’ that the program aligned with existing prevention and management programs within their organisation. A total of 60% reported  that 2 h weekly group sessions for 8 weeks is sufficient for promoting positive behaviour change, with 40% reporting  that this was sufficient for improving self-management of chronic disease risk factors. Ratings were lower regarding receiving adequate communication, with 40% of respondents reporting that they received adequate communication and updates on the progress of people they had referred. Among facilitators   and SEIFThe key strength of this study was that it evaluated a community-based physical activity and healthy eating program delivered under real-world conditions. Not only did the intervention reach a large number of underserved participants, but it was embedded within the existing health care system, with participants referred through other local health service providers. The reporting of the program’s results in the peer-reviewed literature demonstrates a clinician-instigated collaboration between health service providers and health researchers. Such collaborations are vital to support the reporting of real-world outcome data in the peer-reviewed literature . At presLimitations must also be acknowledged. As is common for real-world intervention evaluations, a pre–post design was used with no control group. In addition, data relating to reasons for declining participation and attrition and drop-out were not captured Furthermore, physical activity and dietary outcomes were self-reported using simple instruments suited to a clinical setting, with modest validity relative to gold standard research measures. However, the changes in objectively measured health outcomes suggest that behaviour change was achieved. A further limitation was that blood pressure was measured using clinical-grade sphygmomanometers available at each site, but the brand and model were not recorded. However, given that the same sphygmomanometer was used for pre and post measures within participants, this should not have influenced the results, which focused on changes in blood pressure over time. Whilst these limitations might be considered major weaknesses for a traditional efficacy study, the health benefits of physical activity and healthy eating are well established, so the primary contribution of this study relates to implementation outcomes . A key limitation was that the program was delivered and evaluated over a relatively short period due to funding constraints. Thus, the longer-term impacts are unknown. Ideally, real-world lifestyle programs should embed long-term follow-up assessment procedures to capture long-term impacts.TM program was successfully delivered into these underserved rural communities, with strong uptake, reasonable intervention attendance, and excellent program acceptability. In the future, longer-term evidence and cost-effectiveness data would be valuable to support funding for ongoing programming and scale-up. Further work is needed to improve referral of, and program uptake, amongst men, who were under-represented in this study, and are characteristically reticent to partake in preventive health programs. The program may be improved by building in a communication mechanism by which participants’ progress is reported back to their referring health care providers.Overall, results suggest the HEALIn conclusion, this study evaluated the real-world uptake, retention, effectiveness and acceptability of a group-based healthy lifestyle intervention delivered in rural and underserved communities. The program achieved strong referral from clinicians, and uptake from participants. Around half of participants completed the 8-week program and follow-up assessments, with measurable improvements in behavioural and physiological outcomes. Future collaborative research between health service providers and researchers is warranted to establish the cost-effectiveness of the program and improve participation amongst men.


ABSTRACT IMPACT: Development and implementation of a parent navigator program to help parents of justice-involved youth could assist parents in navigating the justice system, improve engagement with court and probation, and ultimately improve outcomes for youth involved in the juvenile justice system OBJECTIVES/GOALS: The goals of the study are to (1) develop a parent-peer navigator program utilizing community-based participatory design; and (2) implement and assess the feasibility of a parent peer navigator program in an urban juvenile justice system. METHODS/STUDY POPULATION: The EPIS framework will guide development and implementation of the navigator program as well as measurement of the implementation process, including measurements of feasibility and acceptability. In the Exploration phase, qualitative interviews with juvenile justice staff, parents of justice-involved youth, and members of the local family advisory board will inform program needs. In the preparation stage, I will work closely with the family advisory board to develop the actual parent navigator program protocol, including a training plan for navigators and their specific roles. I will conduct an open trial in the implementation phase, measuring program feasibility and acceptability among parents, navigators, juvenile justice staff, parents, and youth utilizing mixed methods. RESULTS/ANTICIPATED RESULTS: Results will inform feasibility of implementing the program as well as acceptability of the program based on mixed methods data from parents of justice-involved youth, juvenile justice staff, family advisory board members, and other community stakeholders. Results will potentially inform conduct of a larger scale pilot hybrid implementation-effectiveness study. DISCUSSION/SIGNIFICANCE OF FINDINGS: Development and implementation of a parent navigator program to help parents of justice-involved youth could assist parents in navigating the justice system, improve engagement with court and probation, and ultimately improve outcomes for youth involved in the juvenile justice system.


Access to cutting-edge technologies is essential for investigators to advance translational research. The Indiana Clinical and Translational Sciences Institute (CTSI) spans three major and preeminent universities, four large academic campuses across the state of Indiana, and is mandate to provide best practices to a whole state.To address the need to facilitate the availability of innovative technologies to its investigators, the Indiana CTSI implemented the Access Technology Program (ATP). The activities of the ATP, or any program of the Indiana CTSI, are challenged to connect technologies and investigators on the multiple Indiana CTSI campuses by the geographical distances between campuses (1–4 hr driving time).Herein, we describe the initiatives developed by the ATP to increase the availability of state-of-the-art technologies to its investigators on all Indiana CTSI campuses, and the methods developed by the ATP to bridge the distance between campuses, technologies, and investigators for the advancement of clinical translational research.The methods and practices described in this publication may inform other approaches to enhance translational research, dissemination, and usage of innovative technologies by translational investigators, especially when distance or multi-campus cultural differences are factors to efficient application. The Indiana Clinical and Translational Sciences Institute (CTSI) is uniquely conceived in that it serves the state’s research centers. The Indiana CTSI is a partnership among Indiana University, Purdue University, and the University of Notre Dame, combining the expertise of three large and preeminent research universities on four large research campuses. The Indiana CTSI is designed to bring together the state’s brightest minds to solve Indiana’s most pressing health challenges through research, education, and workforce development. The Indiana CTSI achieves its mission through its various programs, one of which is the Access Technology Program (ATP), the focus of this communication.The overall goal of the ATP is to improve the impact and competitiveness of investigator research by integrating innovative technologies into research studies. The ATP encourages investigators to incorporate novel technologies into their research program and to assist those already using these technologies by improving the quality of core services. While the benefits of combining the expertise of three large research universities with four large research campuses across the state may seem obvious, the challenges presented are not easily overcome. In this paper, we share some insights we have gained to overcome these hurdles and consistently deliver access to cutting-edge technology across the state in order to conduct high-quality research for the benefit of Indiana’s citizens, the nation, and beyond. Challenges and solutions are presented in their respective sections.The mission of the ATP was formulated with three related but distinct programs, as shown in Fig. Core Pilot program, which is a competitive, investigator-initiated program that provides up to $10,000 for core services at any Indiana CTSI-Designated core. The program was initially started as a yearly competition, funding approximately 25 awards per year. In 2011, review sessions were increased to semi-annually at the suggestion of investigators. Selection of awards is based on a multi-institutional review committee that fosters interactions among the campuses. In addition to the scientific merit of the proposal, Core Pilot funding is awarded based on the following criteria: (i) obtaining critical preliminary data for grant applications; (ii) developing a new reagent or resource; (iii) testing a new idea or new line of research; or (iv) assisting in the development of intellectual property. The potential impact on future grant applications and intellectual property are key review criteria. Core Pilot grants are not intended to independently support the development of new core technologies; however, if that is part of the needs of investigators, development projects can be included in the Core Pilot applications.While novel technologies can enhance the significance of a research program, the Indiana CTSI recognized the challenge that investigators may lack the funds to generate sufficient preliminary data for grant applications. Responding to requests for additional data for submitted grants can also pose specialized research technology challenges. Our solution to these challenges was to develop the The Core Pilot competition became highly popular and competitive, and the semi-annual review now evaluates between 60 and 90 applications per cycle. As part of the application, the applicant must include a signed letter by the core director(s) attesting to the work discussion, the ability of the core to perform the work, and the accuracy of the budget. This assures feasibility of the project and promotes interactions with the core experts and helps to raise awareness for the cores on each campus. The 2-page applications are reviewed in a National Institutes of Health (NIH)-style review by reviewers (two per application) recruited from across the three Indiana CTSI institutions based on the expertise needed for evaluating the applications. Awardees and non-awardees alike receive extensive feedback from the reviews that serves as a guide not only for any resubmissions, but also for the external funding submission following the project completion. Investigators receiving awards must provide progress reports, including information of publications and grant applications while conducting the project and for 5 years following the completion of the funding. Progress reports from the Core Pilots funded between 2009 and 2019 indicated that these projects contributed to the publication of 220 peer-reviewed publications and 225 funded grants totaling over $248 million. Table Core Oversight program). Given the large number of core facilities within the 4 large university campuses (currently more than 60), the Core Pilot program facilitates Indiana CTSI support of cores through a mechanism that is investigator driven and vetted for scientific merit.Funds awarded through the Core Pilot program can only be utilized in Indiana CTSI-Designated core facilities. To be an Indiana CTSI-Designated core requires the facility to meet benchmarks on services, user satisfaction, and transparency on cost and authorship issues .Peer review of applications also provides an important training ground for young investigators, addressing the education mission of the Indiana CTSI. In this initiative, first-time reviewers are paired with more senior reviewers to help provide balanced reviews. New reviewers frequently end up submitting applications the following round. The program also recently added an educational and service opportunity for outstanding postdoctoral fellows to serve as reviewers  School of Medicine. This program aims to further maximize the impact of our cores by providing funding to purchase equipment that will either establish a new scientific capability, expand access to more investigators, or replace existing outdated or unreliable instruments. Cores must be Indiana CTSI-Designated cores (see Core Oversight program) to be eligible for Core Equipment Grants. To date, the IU School of Medicine is the only campus that has allocated funds to this program.In addition to providing funding via the Core Pilot program, the CTSI manages a CCore Equipment program provides an opportunity for the IU School of Medicine Indiana CTSI-Designated core directors to request support for the purchase of equipment and/or software. The goal is to enhance the research environment and contribute to the research mission of the school and the Indiana CTSI by expanding existing services, or providing for new technology and services. Each year, one cycle of funding is offered with a total institutional investment of $100,000. This mechanism is for equipment that costs between $5000 and $100,000. The cores can request up to the total amount offered each year. Equipment with higher costs are allowable if they can secure the funding to cover the balance of the item’s cost. This funding can be used for any combination of core applications. Since 2010, approximately 30 equipment requests have been awarded. Annual progress reports for Core Equipment awardees include a list of investigators who have used the new service/equipment, grant submissions and publications arising from data obtained from the new service/equipment, and a list of the publications that cited the core.The To enhance the research infrastructure on the Bloomington campus, the Indiana CTSI and the IU Bloomington Office of the Vice Provost for Research have coordinated to offer the Research Equipment Fund (REF). The aim of this funding mechanism is to support the purchase of critical equipment that increases the ability of researchers to secure extramural funding. To qualify, an applicant must be faculty on the IU Bloomington campus, but may include co-investigators at Indiana CTSI partner institutions. Up to $200,000 is available for two rounds per year . To leverage departmental resources, there is a 50% match requirement from participating units.The infrastructure enabled by the ATP program of the Indiana CTSI also allows for the creation of joint multi-university high-end cores and equipment to further facilitate access to cutting-edge technologies. As an example, six major life science entities – Purdue University, IU School of Medicine, IU Bloomington, the University of Illinois at Urbana-Champaign, Eli Lilly and Co., and the Indiana Biosciences Research Institute – strategically formed a consortium to deepen our regional strength in structural biology and have acquired a second Krios Cryo-Transmission Electron Microscope for Cryo-electron microscopy (Cryo-EM) applications. The new microscope will be located in the Cryo-EM Facility (a CTSI-Designated facility) on the Purdue University campus in West Lafayette, where there is a nucleus of expertise in structural biology. The facility is also an NIH-designated site for the Midwest Consortium for High-Resolution Cryoelectron Microscopy. Together with the CryoEM expertise and capabilities at Indiana University, the consortium has already been making biomedical breakthroughs from Alzheimer’s tau protein-aberrant structures to resolving the structure of the Zika virus. This partnership also acquired a Talos Artica single-particle CryoEM for the IU Bloomington campus to broaden access to the technology throughout the region. Cryo-EM technology is a “revolutionary technique for determining the 3D shape of proteins”, according to a recent editorial in Nature , which bPostdoctoral Challenge is a program intended to provide postdoctoral researchers with the opportunity to gain proposal development and peer review experience. Launched in October 2014, the program is designed to prepare postdoctoral investigators to be more effective translational researchers through the preparation of proposals that request they articulate a translational strategy for their project through a competitive granting mechanism. In the Postdoctoral Challenge, investigators prepare proposals for $5000 to use the services of Indiana CTSI-Designated core facilities (see Core Oversight program).The Indiana CTSI This review process was very helpful for me to understand the limitation of my own project proposal that I did not realize while writing my proposal.” Exemplary postdocs that demonstrate an aptitude as reviewers are recommended to the Indiana CTSI administration to participate as reviewers for the Core Pilot program competition (see Core Pilot Program for details on this program) along with faculty reviewers. This provides the young investigators the opportunity to participate in a larger, NIH-type study section and meet new colleagues from across the Indiana CTSI campuses. It also helps them develop their grant writing expertise and learn to provide feedback on other applications.The Postdoctoral Challenge also addresses the Indiana CTSI’s education and workforce development mission by providing valuable training in grant writing and reviewing for postdoctoral investigators. In the Postdoctoral Challenge program, postdocs are also encouraged to participate as reviewers of these applications in review sessions with other peers, faculty, and Indiana CTSI staff from the participating Indiana CTSI institutions. The purpose is to give postdocs first-hand experience of a typical review session using NIH guidelines, scoring, and review criteria. Several months prior to the application submission deadline, postdocs have the opportunity to attend workshops focused on “Effective Grant Writing Techniques”, “Writing Translational Research Proposals”, and an “Overview of an NIH Review Session”. The workshops help postdoctoral investigators with proposal preparation and best practices, as well as covering the preparation of NIH biosketches, project budget, and reviewer guidelines. For most postdocs, this is their first opportunity to participate in a peer review session that provides them with an invaluable perspective of the review process and can help them improve the development of future proposals. As one participant noted: “Investigational Agent Acquisition (IAA) program, which assists investigators with the acquisition of investigational agents  and with regulatory submission. Members of the ATP along with the Regulatory Knowledge and Support (RKS) program and the Participant and Clinical Interactions Resources (PCIR) programs within the Indiana CTSI, combined efforts to identify suitable vendors, assist in negotiations, and even provide guidance if manufacturing was required. The IAA program has since been relocated within the Indiana CTSI to the Molecular Therapeutics program.The fourth approach to facilitating research by the ATP was through the Pan-Indiana CTSI Contracting program. This program approached multiple technology vendors for preferred rates by combining the buying power of the three Indiana CTSI institutions. Key areas for saving included bioinformatics tool licenses and large-volume sequencing outsourcing. The ATP’s most popular pan-licenses to date have been for bioinformatics tools, namely Thomson Reuters’ MetaCore and QIAGEN’s Ingenuity Pathway Analysis (IPA) licenses. Both of these products enable an analysis of large omics datasets but are expensive, with the license costs prohibitive for most investigators. Given that investigators use these tools intermittently, Pan-Indiana CTSI licenses have saved investigators thousands of dollars annually in licensing costs, and facilitated interpretation of experimental results and publication of data.The fifth means by which the ATP facilitates the availability of research tools across the state of Indiana is through the To implement this program, the Indiana CTSI negotiates a license for the products based on the expected number of users, then charges investigators for sub-licenses based on the number of subscribers. MetaCore was the first software with an Indiana CTSI-wide license and investigators were charged based on total annual usage. However, this model was cumbersome and not sustainable. With QIAGEN’s IPA, two smaller licenses were combined from Purdue and IU School of Medicine, which were both previously charging a flat rate for the annual license. This model for the CSTI-wide IPA license has worked so well, it has now been extended to MetaCore. In both cases, the companies involved allow the Indiana CTSI to handle the creation and deletion of user accounts including trial licenses. The usage of MetaCore has waned over the years, but the IPA usage has continually risen to the current level of approximately 70 active users per quarter from 15 original users. In addition, users from Notre Dame and Indiana University Bloomington have now joined the IPA pan-license.For both MetaCore and IPA, the sharing of software has resulted in lower costs with more access. For example, each original IPA license allowed only one concurrent user, leading to frustration when the software was unavailable. Through the purchase of several multisite licenses, users from Indiana CTSI partner institutions now have greater access to IPA, increasing user satisfaction. The Indiana CTSI also arranges free annual training sessions at three different locations to introduce new users to the IPA software. Training occurs about 6 weeks before the new licensing period, allowing potential users the opportunity to evaluate the software more thoroughly before committing to the purchase of a 1-year sublicense. It also allows labs with existing licenses to train new employees. The cost and frustration resulting from limited licenses has been eased for investigators through implementation of the Indiana CTSI-wide licenses.Specimen Storage Facility  currently occupies 5858 net square feet of space at the IU School of Medicine Indianapolis campus. The initial facility included a 1702 square foot room specifically designed with dedicated heating, ventilation, and air conditioning (HVAC) and a comprehensive alarm system to support 54 ultra-low-temperature freezers and a second 978 square foot liquid nitrogen room with an initial cryogenic (LN2) freezer capacity of 295,100 vials. This high usage facility houses a number of national and local biobanks allowing sample ownership and management to remain with the biobank managers.The ATP also identified two key facilities that were of size or importance to warrant central management. The Indiana CTSI Today, the SSF continues to assist clinical investigators across multiple departments and throughout the Indiana CTSI partner institutions and includes investigators with large efforts such as the Indiana Biobank, IU Simon Cancer Center Tissue Bank, Komen Tissue Bank, Michael J. Fox Foundation, the NIH National Cell Repository for Alzheimer’s Disease, the National Heart, Lung, and Blood Institute (NHLBI) National Gene Vector Biorepository, Vector Production Facility, and the Cell and Gene Therapy Manufacturing Group. Most recently, the facility is banking COVID-19 research samples for genomics and cytokine analyses via a joint venture between the Indiana CTSI and the IU Grand Challenge Precision Health Initiative, which will make data available to any investigator conducting COVID-19 research. The facility is Standard Operating Procedure (SOP)-driven with an active quality oversight program in place that adheres to the International Society for Biological and Environmental Repositories (ISBER)  compreheAlthough investigators were initially hesitant to pay for services that prior to the formation of the SSF were held within Principle Investigator (PI) labs, once they recognized the value the SSF was providing, the program became popular and continues to grow and expand today. The SSF has addressed the challenges of increased demand with creative solutions. Two expansion projects added 2300 square feet to the facility, increasing capacity to 110 ultra-low-temperature freezers and 17 liquid nitrogen freezers. Efforts are ongoing to improve inventory management strategies, develop standard practices and services for purchasing, and to implement a change of the SSF model to allow monitoring and maintaining freezers in all labs on the IU School of Medicine Indianapolis campus. Enhancements over the years have included a secondary/redundant alarm system that added continuous temperature monitoring and increased sample safety, continuous improvements to operating procedures to meet evolving regulations and challenges, as well as a comprehensive freezer maintenance program, all with the goal to ensure the facility is utilized to its maximum potential. In addition, a Six Sigma process was recently initiated with the goal to optimize operations of the IU Bio-Repositories by providing oversight for the use, management, and integrity of biobank samples and data across their lifecycle, with a focus on supporting the IU School of Medicine mission and goals, providing value, minimizing risk, and complying with applicable regulations.Clinical and Translational Support Laboratory (CTSL), located at the IU School of Medicine Indianapolis campus in the Clinical Research Center of the Riley Hospital for Children at IU Health. The CTSL processes samples for many clinical trials conducted in the Indiana CTSI Clinical Research Center and throughout the campus. The CTSL developed a quality program with SOPs for laboratory management, equipment maintenance, sample processing, storage, and shipping in compliance with appropriate regulatory guidance. The ATP began processing samples in 2010 and processed 4755 samples that year and 6806 in 2011. The CTSL has grown and evolved over the past 10 years. While the original focus was to support clinical trials that were conducted in the Clinical Research Center located in IU Hospital, support now is extended to nearly every department within the IU School of Medicine. In 2018, the CTSL provided support to 188 clinical trials that included industry and PI-initiated research conducted in IU Health University Hospital, Riley Hospital for Children, Eskenazi Health, Veteran Health Indiana, and IU Health Methodist Hospital, and Purdue University in addition to collaborating facilities and other CTSI institutions around the nation.The ATP also manages the Tens of thousands of individual specimens are accessioned, processed, and shipped by the CTSL each year. Individualized support, such as specimen collection/processing guidance, specimen label creation, assistance with monitor audits, site initiation visits, and documentation requests, is provided by the CTSL so that research coordinators and PIs can concentrate on other priorities. Utilization of standardized practices, while remaining flexible enough to meet protocol-specific requirements, enables the CTSL to provide quality and consistency for every protocol that passes through the lab.As protocol requirements evolved over time, the CTSL added services to meet the growing needs. Shipping services were added in 2014, peripheral blood mononuclear cell (PBMC) processing was added in 2016, and DNA extraction from whole blood was added as a new service in early 2019. Future projects include implementing a process for electronic data capture of critical processing and storage information, lab manual templates for Investigator-Initiated Trials, and enhanced quality control.Core Oversight program, a voluntary accreditation process whereby cores on any Indiana CTSI campus that meet rigorous quality standards for scientific quality, pricing, operations, advisory committees, policies governing publication, payment and dispute resolution, user satisfaction, and reporting are granted “Indiana CTSI-Designated core” status. This designation lets researchers know that this core has policies, rates, an advisory committee, and survey results that have been reviewed by a committee representing all the Indiana CTSI partners, and gives researchers confidence that the operations and processes of the core are assessed and appropriate. The number of Indiana CTSI-Designated cores has grown by 30% since implementation of the program in 2010 (46 cores in 2010) to 60 Indiana CTSI-Designated cores in 2019. As mentioned earlier in this communication, Indiana CTSI-Designated cores are eligible for the Core Pilot and Core Equipment programs.Similar to other initiatives around the country –8, it waStaying connected” section below) from all Indiana CTSI campuses, the Core Oversight program also provides the ATP with information on capabilities of the cores on the various campuses, which can be passed onto investigators at their home institutions. The core oversight and approval process also ensures uniformity of standards across multiple campuses. The core website (which is undergoing reconstruction for improved utility) allows researchers to choose from facilities across the campuses, giving them more options with lower costs rather than paying higher prices for services outside their institution. User surveys are examined for user satisfaction and any issues addressed as needed.Since the cores are collectively reviewed by ATP liaisons  management program to manage ordering, invoicing, and track core services. The ATP was charged with assisting the various core facilities in implementing the software program. Agilent Technologies Inc. has recently acquired Vanderbilt CORES, which is being phased out and replaced by iLab Operations software. Purdue University uses iLab and the other three Indiana CTSI campuses are transitioning to iLab as well, which will provide new opportunities for cross-use of core facilities when all campuses are on the same system. Agilent will install the iLab system and provide web-based training for users.The ATP initiated an SOP-driven quality management program to monitor services, identify deficiencies, and implement corrective action when needed for the SSF and CTSL. This QA program reviews SOP-driven activities and conducts periodic QA audits. The ATP is also responsible for responding to findings during external audits. The ATP assigns tasks to the QA specialist, but to allow independence, the QA specialist is directed to report significant findings to the IU Office of Compliance.Adenosine triphosphate (ATP) is a complex organic chemical that provides energy to drive many processes in living cells, e.g., muscle contraction, nerve impulse propagation, and chemical synthesis. Found in all forms of life, ATP is often referred to as the “molecular unit of currency” of intracellular energy transfer. It is the high-energy molecule that stores the energy we need to do just about everything we do. Just as biologists view ATP as vital and being key to all we do, so is the ATP of the Indiana CTSI. Core facilities and other research resources play a large part in supporting and seeding research across the Indiana CTSI research partners.ATP liaison, the ATP representative from each campus. There are currently six liaisons and one program coordinator for the ATP. The liaisons are contact points for both investigators and Indiana CTSI-Designated core directors, and also serve on the Indiana CTSI Project Development Teams with the specific charge to identify projects which would be enhanced by incorporating new technologies, further fostering core use. Many of the liaisons have been in the role since the inception of the grant (2008), allowing continuity that has fostered close relationships among the campus representatives, which in turn fosters support of the needs of the grant and each other’s research community. This long-standing partnership has fostered a rapport among the liaisons. They reach out to each other for all things core-related, big or small. Communication is key. This group works very well together, all for the benefit of the Indiana CTSI. The ATP liaisons meet monthly via teleconference to discuss ongoing and new initiatives, brainstorm new ways to support access to technology, gain approval from the CTSI Executive committee when necessary, and then work with their home campuses to put ideas into action.To maximize usage of the Indiana CTSI ATP, the program leaders have developed innovative strategies to connect minds and talent on all four campuses. Key to this connectivity is the Help Desk to assist investigators in need of core services, identifying options within the Indiana CTSI, other CTSIs, and other academic institutions or commercial vendors. The Indiana CTSI website provides information on 60 core programs throughout the Indiana CTSI. In the first full year of use, the Indiana CTSI website (www.indianactsi.org) was accessed 1226 times by 524 unique users. In 2018, Services Cores pages on the Indiana CTSI website were accessed 6780 times. The Postdoctoral Challenge program has training programs on all campuses, and allows the interaction of postdocs from all of the campuses in the joint review process. The Indiana CTSI-Designated Core program is another example of the liaisons working together through a joint review of the cores and discussions at monthly meetings, allowing the liaisons to gain knowledge of technologies available on partner campuses that can be passed onto investigators at their home institutions. The Core Pilot program fosters collaboration across campuses through joint reviews and access to previously unattainable technologies in the Indiana CTSI-Designated cores. This competition allows researchers access to first-class facilities and vital instrumentation on partner campuses that may not otherwise be available on their local campuses. This access further facilitates collaboration across partner institutions. This can be especially helpful for the regional campuses of the IU School of Medicine. As an example, several Core Pilot awards have been awarded to the IU School of Medicine South Bend faculty members for use of Notre Dame cores.The many initiatives of the ATP also help to connect campuses and facilitate interactions. The ATP maintains a web-based The impact that the Core Pilot program has had on investigator productivity cannot be underestimated. Fig. In summary, this paper describes our experience in developing an effective program to deliver access to new and innovative technologies to translational research investigators spanning three institutions and four major campuses in the state of Indiana. Pilot grant programs incentivize use of cores and support acquisition of new equipment, leading to more robust cores with a broader clientele base. Pan-Indiana CTSI contracts provide investigators access to informatics programs at a fraction of the cost of single-user contracts. Support of key cores deemed essential to the success of clinical trials (SSF and CTSL) has resulted in growth and increased utilization of these cores, contributing to their vitality. Finally, applying quality oversight measures to the cores has strengthened them, increased user confidence in the cores, and aided core directors with operational procedures. These model systems developed by the ATP of the Indiana CTSI may be useful to other CTSIs or institutional administrative personnel in the development of more effective programs to advance translational research and enhance the interaction and collaborative activities of researchers spread across multiple campuses. The majority of these systems put in place 12 years ago with the initiation of the Indiana CTSI have not only stood the test of time but have grown to address increasing demand and innovations in research technology to support CTR. We believe this provides a potential model to other academic institutions and CTSAs with geographically dispersed partners to maximize access to and utilization of novel technologies.


Immediately following the March 13, 2020 declaration of COVID-19 as a national emergency  Pharmacies+ Testing, through a federal government collaboration with commercial partners, including retail pharmacies and other contract service providers; and 3) Surge Testing, for rapid surveillance of at-risk communities through increased testing capacity in support of state, tribal, local, and territorial health agencies. Individual testing sites provided predominantly nucleic acid amplification tests and were established with varying dates and durations of operation to meet the needs of the specific communities served.The CBTS program was created by a White House Joint Task Force, co-led by HHS and FEMA in March 2020  were assessed for the Drive-Through Testing, Pharmacies+ Testing, and Surge Testing programs. The age, race and ethnicity, and symptom status of persons tested through these programs was also assessed. Because of variations in reporting across states, aggregate data on these variables were unavailable for persons tested in the CBTS Drive-Through Testing program; thus, these data were not included in analyses. Data for this analysis came from COVIDResponder,During March 19, 2020–April 11, 2021, the CBTS program conducted 11,661,923 SARS-CoV-2 tests at 8,319 locations across the United States and its territories. The program included 402,223 (3.5%) tests administered through Drive-Through Testing, 10,129,142 (86.9%) through Pharmacies+ Testing, and 1,130,558 (9.7%) through Surge Testing. Tests administered through all CBTS programs yielded 1,176,959 (10.1%) positive results, 10,430,749 (89.4%) negative results, and 54,215 (0.5%) indeterminate results, including 59,195 (14.7%) positive results, 337,255 (83.9%) negative results, and 5,773 (1.4%) indeterminate results from the CBTS Drive-Through Testing program.Among persons tested through the Pharmacies+ Testing and Surge Testing programs, 67.8% were adults aged 20–54 years, and 42.3% were symptomatic . Among 9https://stacks.cdc.gov/view/cdc/111229).Among symptomatic and asymptomatic community members seeking testing, 17.1% and 5.1%, respectively, received a positive result . Among aDuring March 19, 2020–April 11, 2021, the CBTS program conducted 11,661,923 no-charge SARS-CoV-2 tests  at 8,319 locations across the United States and its territories, providing a model for geographically diverse, national, community-centered testing facilities in response to an infectious disease outbreak. Analyses suggest that both symptomatic and asymptomatic persons across a broad distribution of age, race and ethnicity, and sex categories accessed testing through the CBTS program. Results were consistent with other reports showing higher percentages of positive test results among Black, Hispanic, and American Indian or Alaska Native populations  program conducted 11,661,923 SARS-CoV-2 tests at 8,319 locations across the United States and its territories, including 3% administered through Drive-Through Testing, 87% through Pharmacies+ Testing, and 10% through Surge Testing.The CBTS program demonstrated the value of successful partnerships and collaboration for providing testing services that are responsive to local community needs. These lessons can guide current community-based screening, surveillance, and disease control programs and responses to future public health emergencies.


The purpose of this communication is to describe the Brighter Bites produce voucher program, and its implementation and utilization across Brighter Bites families in four cities in the U.S., during the COVID-19 pandemic. The voucher program was implemented over nine weeks starting April 2020, with up to four USD 25 store-specific produce coupons sent bi-weekly to the homes of each participating Brighter Bites family . Measures included type of produce purchased, amount of voucher that was used, number of vouchers distributed and redeemed by families, and a post-program participant satisfaction survey. Descriptive statistics, including count, frequency, and percent, were computed, both overall and stratified by city. During this time, Brighter Bites distributed a total of over 43,982 vouchers to 12,482 low-income families, with a redemption rate of 60% (at least one voucher redeemed) across all cities. During times of crisis, non-profit–for-profit partnerships, such as the one between Brighter Bites and the grocery retail industry, are feasible, and successful in providing produce to families in need. SARS COV-2 COVID-19) was declared a pandemic by the World Health Organization on 11 March 2020 9 was dec,4,5. In According to the United States Department of Agriculture (USDA), food security is defined as access by all people at all times to enough food for an active, healthy life . Food inIn the United States, the three largest food assistance programs include the Supplemental Nutrition Assistance Program (SNAP), the National School Lunch Program, and Women, Infants, and Children (WIC). In 2019, SNAP provided benefits to 35.7 million people in the United States , with an average benefit of USD 130 per person per month . The NatDuring the COVID-19 pandemic, relief packages included a 15 percent increase in SNAP’s maximum benefit, amounting to about USD 28 more in SNAP benefits per person per month, or just over USD 100 per month in food assistance for a family of four, with participation increasing between March and April of 2020 by 10 percent (3.6 million) [Although food assistance programs are useful for addressing food insecurity, in 2019 only 43.2 percent of food insecure households received SNAP benefits, only 27.6 percent received free or reduced-price school lunches, and 8.4 percent received WIC food vouchers . Other sBrighter Bites is a non-profit organization that implements an evidence-based school-based health promotion program in six cities  in the U.S. . During The Brighter Bites produce voucher program : SubsequBrighter Bites initially rolled out the produce voucher initiative in April 2020 with the Texas grocery retailer H-E-B, in Houston and Austin, Texas, and soon followed in Southwest Florida with Southeastern Grocers, the parent company of Winn-Dixie Stores. Brighter Bites also secured partnerships with a large national chain grocery store in Washington D.C. and 99 Cents Only Stores in Dallas, Texas. Implementation: The Brighter Bites voucher program was implemented over nine weeks starting April 2020 with up to four coupons of USD 25 sent to the homes of each participating Brighter Bites family bi-weekly over a nine week period. The vouchers were sent to families by mail. The H-E-B, Winn-Dixie, and 99 Cents Only Stores required the vouchers to be redeemed with a printed coupon due to their technology capabilities. Therefore, Brighter Bites teams reached out to all enrolled families in the participating locations to obtain accurate home addresses to mail the printed coupons. In Houston, Austin, and Southwest Florida (SWFL), vouchers were printed and each of the four coupons were mailed individually. The large national chain grocery store sent vouchers, such that they could be shared electronically via email. To redeem the vouchers, families presented them at the participating grocery store at checkout. Vouchers expired 6 weeks after the final voucher was distributed. The voucher program was established such that Brighter Bites paid the grocery retail partner for the cost of the produce subsequent to the voucher redemption. Additionally, each of the grocery retail partners provided a discount on the voucher. The discounts varied by each retail partner. Discount data from H-E-B was unavailable. H-E-B paid for the printing of each voucher and Brighter Bites paid for the postage. Brighter Bites received a 12% discount per voucher at the Winn-Dixie stores in Florida. Winn-Dixie paid for the printing and postage of each voucher. At the 99 Cents Only Stores in Dallas, Brighter Bites received a 20% discount per voucher. The 99 Cents Only Stores paid for printing and postage of each voucher. At the large national chain grocery store in D.C., families received a 25% discount per voucher. There were no printing or postage costs associated with these vouchers because they were sent electronically. However, Brighter Bites paid the large national chain grocery store an initial setup fee of USD 1000 plus USD 0.30 per card. Evaluation: Voucher and produce redemption data, including type of produce purchased and amount of money spent on produce, were collected on an ongoing basis by the grocery retail partners and de-identified data was shared with Brighter Bites, and subsequently with UTHealth School of Public Health, for analysis. Brighter Bites has a data use agreement with UTHealth School of Public Health to support program evaluation efforts. The budget impact of the program to Brighter Bites was computed. Participant surveys were conducted by Brighter Bites at the end of the nine week voucher administration period to assess participant utilization and satisfaction of the Brighter Bites voucher program. Voucher redemption: At the end of the four redemption periods, the overall number of vouchers redeemed at the city level was provided by the grocery retail partners to Brighter Bites for analysis. Produce purchased: Grocery retail partners provided city level data on the type and total amount of produce redeemed at their grocery stores at the end of the voucher redemption period.Participant Surveys: Survey questions were added to the existing end-of-year Brighter Bites participant process survey to assess voucher access, utilization, ease of use, and usefulness in improving family fruit and vegetable consumption; one open-ended question gauged overall impressions of the voucher program. The self-report process survey was administered electronically in both English and Spanish using Formsite  or paper format, depending on participant preference, to Brighter Bites households who were enrolled by week two of programming in the 2019–2020 school year. Survey completion was voluntary and informed consent was obtained from all participants completing the surveys. One parent/adult family member per household was provided with the survey for evaluation. All data were collected in June–July 2020 by the Brighter Bites non-profit organization as part of their yearly program evaluation efforts. The UTHealth Committee for Protection of Human Subjects Institutional Review Board approved the study protocol and all participants provided written informed consent.All data were analyzed using Microsoft Excel and STATA 15.0 . Descriptive statistics, including means, standard deviation, range, frequency, and percent, were computed to determine type of produce purchased, amount of money spent on produce, budget impact of the program, and number of vouchers distributed and redeemed by families, overall and stratified by city.Over the course of the nine week program, Brighter Bites distributed a total of over 43,000 vouchers to 12,482 families (52% of Brighter Bites families that responded and provided their addresses). The redemption rate was 60% (at least one voucher redeemed) across all cities. A descriptive analysis of the usage of the voucher program is presented in The purpose of the current paper is to describe the implementation and utilization of a novel produce voucher program in which Brighter Bites, a non-profit organization, partnered with multiple large grocery retail partners across five US cities to provide ongoing access to produce during the period of the COVID-19 pandemic when the residents of all five cities were required to shelter-in-place, i.e., April–June 2020. The COVID-19 pandemic has increased the number of families experiencing food insecurity and has worsened conditions for families that had already been food insecure ,7,26. ReDuring times of crisis, non-profit–for-profit partnerships, such as the one between Brighter Bites and the grocery retail industry, are feasible and helpful in meeting the needs of the most vulnerable populations, who may not be able to purchase healthy food during these times due to their financial hardship. Providing monetary incentives, such as produce vouchers, is potentially an effective means to improve produce consumption and reduce food insecurity ,20. ThesHealthy food incentive programs, such as the USDA Healthy Incentives Program and the Gus Schumacher Nutrition Incentive Program (GusNIP), have been shown to increase fruit and vegetable expenditure and intake ,12,13, rSimilar to that seen in our study, there are other models of such partnerships in the literature. For example, the Utah Double Up Food Bucks program was a partnership between farmer’s markets, the Utah Department of Public Health, and the non-profits Utahns Against Hunger and Urban Food Connections of Utah. They provided families with USD 10 in the form of tokens as an incentive for purchasing fruits and vegetables at farmers’ markets . ResultsStrengths of the study include the partnerships across multiple large local and national retail chains, which can potentially allow for rapid scalability of such programs. Furthermore, the data sharing between the retail partners and Brighter Bites allowed for assessment of program feasibility and success of implementation. Limitations include the lack of a stringent study design, including the lack of a comparison group or individual-level dietary intake data, which does not allow for assessment of the impact of the program on child or family produce consumption outcomes. Rather, the current study was an assessment of a natural experiment conducted during the acute phase of the pandemic. Furthermore, analytic approaches, such as social network analysis, may be considered to understand factors that inform the adoption and implementation success of produce voucher programs such as the one implemented here. Other limitations include the availability of data, which varied across the retail partners. In addition, the data was de-identified, which allowed only aggregated findings.Another limitation is that only about 52% of those enrolled in Brighter Bites received the produce vouchers. This was because only 52% of the Brighter Bites families provided addresses to mail the coupon, despite multiple outreach strategies to families from Brighter Bites staff. Finally, produce vouchers were provided only for four redemptions, totaling USD 100, which may not be sufficient to sustainably address food insecurity. However, Brighter Bites was able to resume programming, including produce distributions, in the summer, using produce boxes distributed to the families.The Brighter Bites produce voucher program was widely supported by participating families, easy to use, and valuable in addressing the needs of vulnerable populations who may have been unable to purchase healthy foods during the pandemic due to their financial hardship. This type of partnership has the potential to address critical needs of low-income families by leveraging existing infrastructure across non-profit grassroots efforts such as Brighter Bites, and for-profit grocery retail companies. As a result, these families can be provided with healthy food, particularly during times of crisis, such as the COVID-19 pandemic, when nutrition security is important to maintain health. The produce voucher program had significant social implications for low-income families, including incentivizing the purchase of produce and providing targeted assistance in the form of vouchers to alleviate the food insecurity and financial distress imposed by the pandemic.Although our study shows promise in the feasibility and acceptability of a produce voucher program, future research is needed to understand the effectiveness of such programs on improving parent and child dietary outcomes, and food insecurity over a longer time period, using a more stringent, experimental study design with a comparison group.


IntroductionThe purpose of this study was to identify themes and concepts derived from responses of physical therapy clinical leaders related to implementing a prevention-focused, home-based older-adult program known as HOP-UP-PT  into their clinical operations.MethodsFollowing Institutional Review Board approval, a retrospective qualitative analysis of transcribed interviews obtained by six undergraduate students participating in the Oakland University Ideas to Business Program (I2B) was conducted. Students interviewed nine local physical therapy clinical managers throughout Michigan using 12 questions developed by content experts. Questions aimed to ascertain the perceived opportunities and barriers to implementing HOP-UP-PT into each respondent's practice setting, clinic demographics, and suggested price point of a prevention-focused continuing education. Interview data was analyzed using the constant comparative method to identify themes and concepts.ResultsSixty-seven percent of respondents (n=6) reported practicing in an outpatient setting; 56% of respondents (n=5) indicated 50% or more of their clients were 65 years and older; and 67% of respondents (n=6) suggested a price point of $200-$500 for an eight-hour HOP-UP-PT training course. Three concepts  and eight themes  were identified.ConclusionPhysical therapy clinical managers identified a willingness to expand current rehabilitation models and incorporate prevention-focused care delivery into the existing care delivery approach. However, barriers and opportunities must be addressed in advance of a program roll-out to achieve optimal outcomes and cost savings within the healthcare system. The growing costs of falls and institutionalization associated with advancing age and frailty have brought about an opportunity for cost-savings within the health system for upstreaming prevention-focused programs . UpstreaPositive improvements in fall risk, health, and the built environment after participating in a six-month PT-directed program have been reported by Arena et al. ,4. FurthThe program and its associated outcomes highlight distinctive opportunities for PTs to provide prevention-focused programming in an individual’s home environment as compared to a clinic-based setting, even for a patient who does not meet homebound criteria. These opportunities included the ability to recognize various social, personal, and environmental determinants of health that may be affecting an individual’s quality of life outside of the clinic setting . In relaAlthough there is a growing body of evidence for upstream, preventative care models, they are still not implemented widely or consistently operationalized . SpecifiIn order to ascertain the clinical facilities’ willingness to change and garner insight into existing paradigms of care, an analysis of these perceptions related to potential barriers was necessary to better understand the root of potential concerns of healthcare professionals and to best operationalize programs of this type. The purpose of this study was to identify themes and concepts derived from responses of physical therapy clinical leaders related to the implementation of a prevention-focused, home-based older-adult programming into their clinical operations.Clinical relevanceBy analyzing the perceptions of physical therapy clinical managers using data collected from primary-source interview responses during Oakland University’s (OU) Ideas to Business (I2B) program in Fall 2019, the evaluation of professional notions related to prevention-focused care models would assist in identifying opportunities and barriers. This understanding will be instrumental to navigate future integration of home-based programming with a preventative aim delivered by rehabilitation professionals.Research design A retrospective qualitative analysis was completed via a review of written responses of telephone interviews from a market analysis completed as a component of the I2B program at OU . In the Fall of 2019, phone interviews were conducted by OU undergraduate health science and business students using a sample of convenience of physical therapy rehabilitation clinical managers in Michigan as a component of the I2B program design. After completion of the I2B program, these interview results were qualitatively reviewed in order to gain insight into the current environment surrounding contemporary models of rehabilitation care and the willingness and capacity of these managers to move beyond existing healthcare models to accommodate emerging initiatives. To ensure the rights and privacy of the I2B respondents were protected, Institutional Review Board (IRB) approval from OU was secured prior to beginning the retrospective analysis.Background on Data SourceOakland University's I2B program is a collaboration between undergraduate students and local business leaders to assist with market analysis and provide consultative advice aimed at strategic business implementation and commercialization. During the I2B program, six undergraduate students (three business majors and three pre-PT majors) partnered with the co-principals of the HOP-UP-PT program. After the HOP-UP-PT co-principals provided an introduction to the scientific background and clinical applicability of the program Figure , the sixDuring this market analysis, telephone interviews with physical therapy rehabilitation clinical managers were conducted to gain market insight on the perceptions of a prevention-focused physical therapy program in the homes of older adults. An informational script and interview questions were developed by the students and the principals of HOP-UP-PT describing programmatic components  and were utilized during telephone interviews administered by the six students. Participants were notified that their responses would be disseminated publicly and would be used to develop a business plan and final presentation for the I2B program; however, respondents' names and other identifying information would not be included in the dissemination. Participants were also informed that their responses would be utilized in providing a framework to complete the I2B program aims and to assist health science and business students in their future career development.Respondent descriptionNine individuals  were interviewed. The interviews were conducted by the aforementioned six student I2B participants. As the I2B program was not prospective research, no prior written informed consent was obtained. Inclusion and Exclusion CriteriaAs criteria of the I2B project, individuals participating in interviews were involved in the field of physical therapy or rehabilitation, either as medical professionals or clinical leaders. Exclusion criteria of the I2B program included a respondent self-reporting they did not have an influence on business or operational decisions at their respective facility; however, no participants were excluded for this reason. No additional inclusion or exclusion criteria were applied given the retrospective nature of this study.Data collectionDescription of Phone Interview ScriptAfter composing a list of 12 questions for the planned phone interviews  described his/her practice setting as a private or freestanding outpatient setting, 11% (n=1) described his/her practice setting as a hospital-based outpatient setting, and 22% (n=2) did not provide this information. Furthermore, five respondents reported the percentage of clients over the age of 65 were as follows: less than 25% (n=1), 26-50% (n=1), 51-75% (n=4) and 76-100% (n=1). Responses were not available for the other two inquiries. Financial inquiriesOf the respondents, 67% felt that an appropriate price point for certification in a prevention-focused, home-based program, such as HOP-UP-PT, would range between $200 and $500 for eight hours of training. Further information regarding program certification is listed in Table Concepts and themesAfter completing the analysis, three concepts and eight themes were identified based on the supporting data. Each is summarized in Table Community Involvement and PartnershipThe first concept identified was Community Involvement and Partnerships with the supporting themes of Community Altruism, Referral Source Expansion, and Integrated Community Relationships. Respondents voiced that Community Altruism was important to their public service intentions. Specifically, the altruistic intention was summarized in the comment “We always try to get involved in the community. Sometimes they just need a check-in, who knows how much turn out you’ll actually get though” - Participant 9. Additionally, one respondent stated that “There is benefit in prevention care prior to injury and helping healthcare costs and chronic disease prevention” - Participant 3.Referral Source Expansion was a second theme identified within the concept of Community Involvement and Partnerships. Responses included “[Finding] someone at risk and sending [PTs] to them is a very realistic entry point to the healthcare system” - Participant 5 and “We’ve done senior expos before with community centers - it’s a definite resource to get your name out there, and I like the 10-mile radius for the community aspect of it as well” - Participant 2. This demonstrated that some respondents and their organizations have previously identified this as an opportunity for new referrals, and that concrete steps had been taken, and yet further opportunities were warranted.Finally, Integrated Community Relationships was the third theme identified within the concept of Community Involvement and Partnerships. Supporting data included responses such as, “People want to meet PTs and form that relationship, even if they don’t need care” - Participant 2 and “Sometimes I have people who don’t have anything wrong and just want to be ‘checked out’ by me for the reassurance after they’ve met me. Just the presence of someone else seeing you and word of mouth is great. The PT going to the actual facility is a benefit” - Participant 2. This supporting data provides evidence that PTs already have a role as a valuable healthcare provider in the community and are sought out for professional advice; however, a limited overall consistency or organization within these circumstantial relationships may also be present.Administrative Barriers to an Innovative Delivery ModelA second concept identified was the presence of Administrative Barriers to an Innovative Delivery Model with the theme of Current Payment Methodology Challenges. Furthermore, it was found that this approach would have Favorability of Clinic Setting and Type when providing a prevention-focused innovative delivery model. The theme of Current Payment Methodology Challenges was supported by respondents’ quotes including “This would be tough to have the reimbursement of Medicare part B cover your visit due to additional travel time” - Participant 2 and “We would not be able to bill for time traveled” - Participant 3. One respondent additionally stated “Drive time and everything? There would typically be a drive time allowance on top of the reimbursement” - Participant 8, also highlighting a potential cost burden unaddressed in current rehabilitation outpatient payment models.Furthermore, as respondents indicated that this type of program may have Favorability of Clinic Setting and Type, comments included, “Clinics that are looking to increase patient population would definitely want to utilize this program” - Participant 2, “Smaller clinics have a lot more availability to go ahead with programs as such, whereas chain business may have a harder time getting involved in programs” - Participant 9 and “....in outpatient and homecare, [the program] would be very important”- Participant 6. Supporting data also provided insight into the types of practice settings that would be of most benefit. For example, respondents noted that a program like HOP-UP-PT would be of most use in clinics “...specifically with geriatric PTs” - Participant 5 and that among the population of older adults remaining active in their communities but also at risk for decline due to home-based factors,“...it would be good to get [involved]” - Participant 1.New Approach Using Foundational PT SkillsInvestigators identified a third concept, presented within similar programs to HOP-UP-PT, a New Approach using Foundational PT Skills, which represented themes of Minimal Additional Training Required, a Willingness to Pay for Certification Training, and the need for providers to have a Prevention-focused or Upstream Mindset.Regarding the theme of Minimal Additional Training Required, one respondent stated, “For a PT to do this prevention, it doesn’t require a license to do prevention. All PTs should be certified to do prevention” - Participant 4. For the theme of Willingness to Pay for Certification Training, respondents stated, “Maybe $250 to get the certification to be distinguished. You’d need to do a lot of testing to see what kind of certification you would be providing to PTs, because all PT’s should be certified and should know how to do fall-prevention” - Participant 4 and “There’s so much con-ed out there. Anywhere between $75-80 an hour. $100-150 an hour for online” - Participant 1. Another respondent discussed options for online training and suggested, “PT is a hands-on profession; therefore, it is essential for live training... Lots of online seminars are popular nowadays” - Participant 6. Finally, the theme of a Prevention-focused or Upstream Mindset of these clinical managers was supported by the statement, “There is benefit in preventing care prior to injury and help healthcare cost and chronic disease prevention” - Participant 3.The purpose of this study was to identify themes and concepts derived from responses of physical therapy rehabilitation clinical leaders related to the implementation of a prevention-focused, home-based older-adult program into their clinical operations. These responses were centered around the need for primary prevention in relation to the traditional rehabilitative practice models of PT care. Figure A broad-reaching need to have older adults remain safe in their homes and communities with the added benefit of healthcare cost savings stands at the core of a targeted population health program, including the HOP-UP-PT program; however, the clinical and financial sustainability of these programs must be considered . This stThe findings of this study are in congruence with prior related investigations. Kiami et al. reported that the primary barrier to participating in fall prevention programs was participants’ perceptions that their fall risk was not high enough to warrant action . AdditioIdentifying and describing various pre-existing perceptions of implementing a preventative care program into the current care system offered insight into the integration of future innovations in healthcare, leading to a reduction in falls and empowerment of older adults to remain safe and active in their own homes with associated cost-savings likely to follow. Each interview respondent demonstrated a willingness to provide quality health services, diversify referral sources, and to increase community outreach for their respective facilities. In addition, as interview respondents reported serving patients in home care, outpatient, and private and hospital-based practice settings, the findings may be applicable to different clinical settings and operations. Addressing barriers regarding travel time reimbursements, ideal practice settings for implementation, and an upstream mindset is important for the implementation of novel initiatives like HOP-UP-PT in order to positively impact older adults, their local communities, and healthcare facilities.Initiating novel models with an upstream, prevention focus aligns with the American Physical Therapy Association’s (APTA) Council on Prevention, Health Promotion, and Wellness in Physical Therapy mission to “develop and disseminate best practices in prevention, health promotion, and wellness for all individuals and populations" . The APTStudy limitations Limitations to this study included using a retrospective sample of convenience, which may have introduced bias into the results. In addition, there may have been a limited accuracy of quotes as the interviews were not audio recorded. As all respondents were from the lower peninsula of Michigan, USA, generalizability to other regions may be limited. Additionally, the small sample size is a limitation. It is noted these interviews were conducted prior to the massive societal shift to a virtual educational content delivery and healthcare service disruption from the COVID-19 pandemic; therefore, it is unclear if respondents’ views would be affected by these new circumstances. Due to the retrospective nature of this study, a lack of test-retest reliability could have affected study outcomes. Specifying sex, gender, age, or other demographic information was not the primary purpose of I2B research and thus was not collected. Future researchFuture research aiming to increase diversity among clinic manager demographics in terms of geographical location and practice setting may strengthen generalizability among rehabilitation clinic leaders. Additionally, a study analyzing a larger sample size for interview responses would be beneficial in identifying potential perceptions of rehabilitation clinic leaders not yet addressed. Physical therapy clinic managers identified a willingness to expand current rehabilitation models and incorporate prevention-focused care delivery into the existing care delivery approach. They identified that this approach would improve the functioning and health of the older adult population and that PTs were well suited to provide these services clinically. Respondents identified 1) a desire to have community involvement and partnership, 2) administrative barriers to this innovative delivery model, and 3) that this new approach to care would utilize foundational PT skills. In order to achieve the goal of prevention-focused, holistic services administered by PTs for at-risk older adults, these barriers and opportunities must be addressed in advance of a program roll-out to achieve optimal outcomes and cost savings within the healthcare system.


Vocational peer support (VPS) services are recovery-oriented interventions in modern psychiatric care for persons with schizophrenia. However, few VPS services are found in Taiwan. Hence, a pilot program of peer co-delivered vocational rehabilitation to support persons with schizophrenia in Taiwan was proposed and evaluated.Six peers were trained and were willing to co-lead and assist workplace problem-solving groups and care skills training in an extended vocational rehabilitation program from August 2017 to December 2018. The social support, mental health, psychiatric symptoms, and functioning of service users were assessed before and after peer co-delivered services, and the assessments were based on the following: Social Support Scale (SSS), Chinese Health Questionnaire-12 (CHQ-12), Brief Psychiatric Rating Scale (BPRS), Global Assessment of Function (GAF), and the Chinese version of the Social Functioning Scale (C-SFS).df = 41, t = 2.70, p = 0.01) and subscale of friend-peer dimension . The objective  and subjective social functional scores  both significantly increased. The weekly wage elevated significantly  and the BPRS-18 score decreased significantly, too .The recruited 46 service users were mostly middle-aged (49.1 ± 9.8), with 27 being male (58.7%). After interventions, 42 service users who completed the program had a significantly increased SSS score (149.1 ± 31.8 vs. 161.2 ± 35.0, Peer co-delivered vocational rehabilitation services may enhance the social support received by persons with schizophrenia and improve their occupational outcomes. The pilot program proposed can thus be a model for non-Western countries with limited resources allocated by governments to support persons with schizophrenia. Trial registration: ClinicalTrials NCT04767204, retrospectively registered on Feb 23, 2021. Persons with schizophrenia may see their social and/or occupational functions deteriorate during the course of their illness , 2, due To overcome these challenges, recovery-oriented services have been integrated into mental health care systems for decades to support persons with schizophrenia . Peer-deGiven the proven effectiveness of supported employment , 13, peeIn Taiwan, mental health services are primarily provided through hospital-based treatment but they have shifted to community care gradually in recent decades. In 2017, a total of 23,404 beds for psychiatric treatment in hospitals were provided for the general population in Taiwan, with a ratio of 99.4/100,000 persons . In contTherefore, we designed a 2-phase pilot program: Phase I includes the training of peers to become service providers of peer support services through the completion of a curriculum designed by the professionals in community rehabilitation center, and phase II includes the measurement of effectiveness among service users under peer co-delivered services Table . The invThe pilot program was held from April 2017 to December 2018 at the Taipei Veterans General Hospital Yuli Branch (TVGH-YL). The hospital provides treatment and community care for patients with mental illness who reside in the rural area of eastern Taiwan. The TVGH-YL administers a half-way house, a community rehabilitation center, and a supported housing program. The hospital also provides sheltered and supported employment as part of its community care services for persons with mental illness . In the The inclusion criteria for both phases of the program were: (i) Having disability certification with diagnoses of schizophrenia in the social welfare system, or catastrophic illness of schizophrenia in the health insurance system; (ii) living in half-way houses or receiving services from the supported housing program; (iii) participating in a sheltered or supported employment program; and (iv) showing interest in the job of care attendant. The exclusion criteria were: (i) Comorbidity of severe physical illnesses which could lead to hospitalization; (ii) acute exacerbation of psychosis; and (iii) a reading ability below the age of 6 years. For Phase I, there was one additional inclusion criterion which required experience of caring for elderly persons in the community for at least 1 year.Initially, there were seven professionals who had at least 5 years of experience in community facilities discussing the framework and content of the training curriculum for peer support workers in the focus groups Table . These sThe Phase II program was held twice, in August of 2017 and June of 2018 (Table P < 0.001) in factor analysis confirm the construct validity of the scale. Internal consistency is also confirmed by the Cronbach’s α of 0.86 [We used the Social Support Scale (SSS)—initially designed by Liu and later modified by Sung and Yeh —to measu of 0.86 . Three dThe Chinese Health Questionnaire-12 (CHQ-12) was employed to measure the mental health of service users. The value of the area under the Relative Operating Characteristic curve is 0.85, and the cutoff value is 3/4 . The senr = 0.87) is also deemed satisfactory [We also measured the psychiatric symptoms of the service users by using the Brief Psychiatric Rating Scale-18 (BPRS-18). According to Bell et al., the α values, which measure internal consistency for positive, negative, and general symptoms in the BPRS, are 0.69, 0.68, and 0.46, respectively, which are deemed satisfactory to acceptable . The intsfactory .We measured the social functions of service users objectively by using the Global Assessment of Functioning (GAF) and subjectively by using the Chinese version of the Social Functioning Scale (C-SFS). Jones et al. reported a reliability coefficient of 0.72 and a significant negative association between the GAF score and patients’ medication/support needs .The Chinese version of the Social Functioning Scale (C-SFS) was adapted by Song  from theThe weekly wages of service users from sheltered or supported employment were collected from users’ records on file for the 3 months before and after the intervention of vocational rehabilitation. The average weekly income and working hours during the 3 months were used as the measure of occupational outcome.The pre- and post-intervention self-report questionnaires were completed with assistance from the occupational therapist (MPK). The BPRS-18 and GAF scales were measured by a board psychiatrist (KYC) who had experience in the multiple-center clinical trial. The assistant and investigator both belonged to the intervention group, because there was no control group or blind procedure in the study design.t-test to compare the measurements before and after the intervention. IBM SPSS Statistics 16.0 was employed for statistical analysis.As all indicators examined in this study were continuous variables, we used the paired Among the 187 persons with severe mental illness under community care in the study site, 8 peers were trained to be peer support workers during phase I of the program. All the 8 peers passed the training curriculum Table . Howevern = 11, 23.9%) and manpower dispatch   among all service users and poorest self-reported mental health (CHQ = 6) when enrolling in the program. One user gained knowledge and skills caring for her disabled elderly mother at home. The other two failed to reach the attendance rate threshold of 80% (Table 8 = 45 amp < 0.001), and contributes directly to the higher post-intervention score of social support as a whole . The post-intervention score of psychiatric symptoms (BPRS-18) is significantly lower than the pre-intervention score , although the scores of mental health (CHQ-12) do not vary significantly before and after the intervention . The scores of social function as measured by the GAF  and the C-SFS  increase significantly after the intervention. The weekly wages earned from sheltered or supported employment also increased significantly after the rehabilitation program . Weekly working hours did not significantly change after the intervention . The increase of income among the service users primarily came from two participants with supported employment originally obtaining competitive employment of care attendant in daycare center and eight shifting the sheltered work to supported employment, housekeeping for the elderly persons.As shown in Table In this pilot study, the trained peers could cooperate with therapists in the extended work training course to enhance the social and occupational functions of service users with schizophrenia through the integration of peer support services into the current community settings for mental health in Taiwan. The correlation between social support and occupation has been reported in previous studies , 26. In Contrariwise, a significant improvement in weekly wage was found in the current study after persons with schizophrenia received vocational rehabilitation support co-delivered by peers Table . Two facIt is worth noting that the weekly wage earned by the 42 service users in the pilot program grew by 16.7% after the intervention. This increase contrasted with a growth of merely 5% (43.3 USD to 45.5 USD) among the 156 persons with mental illness participating in the supported employment program from 2017 to 2018 at the community rehabilitation center in Yuli. Hence, the peer co-delivered rehabilitation intervention proposed in this study appears to improve the occupational function of persons with mental illness more than the regular rehabilitation program.Our study also revealed positive effects on social functions of persons with schizophrenia after they received peer co-delivered interventions, as measured both subjectively (C-SFS) and objectively (GAF) Table . This fiImprovements in psychiatric symptoms and reduced rehospitalization have been reported in studies of persons with mental illness who received peer-delivered services as part of case management , 28. OurAlthough there was no significant change to mental health in the service users after peer co-delivered intervention Table , the parThere are a number of limitations in this study. First, there was no control group or blind procedure, so possible confounding factors were not excluded, such as the improvement of the vocational rehabilitation system as a whole in the society and changes of wage in the overall labor market during the study period. Second, whether the benefits observed during the current study can be sustained over a longer period of time remains unknown, given the lack of long-term follow-up. The positive effects demonstrated could be the result of focused attention paid during the relatively short timeframe, or the design and implementation of the program by participating professionals trained in various medical disciplines.Peer co-delivered services, when integrated into an extended vocational rehabilitation program, can enhance the social support received by persons with schizophrenia and improve their occupational function. The pilot program proposed in the current study can be a model for non-Western countries where only limited resources are allocated from the government to support persons with schizophrenia. The pilot program can also serve as the basis for building a more advanced vocational rehabilitation system jointly supported by peer support workers and trained professionals. The results of this pilot study should be confirmed by further randomized controlled trials to further understand the benefits and risks of peer co-delivered services in the settings of supported employment, especially occupational outcomes and changes in mental illness courses.