Evaluating the mobile Mantram Repetition Program for veterans with PTSD: A multimethod randomized feasibility trial of self-directed versus text support delivery.

OBJECTIVE: While mobile delivery can help increase access to evidence-based treatment for veterans with posttraumatic stress disorder (PTSD), feasibility and acceptability are of concern with the potential for high attrition rates and limited participation. The Mantram Repetition Program (MRP), a meditation-focused approach with documented efficacy for reducing symptoms of PTSD and insomnia, was adapted as a brief, mobile-delivered MRP (mMRP) training. This study assessed implementation indicators of mMRP and compared self-directed users of mMRP versus users who received additional text message support. METHOD: Thirty-six veterans with clinically significant PTSD symptoms (Mage = 50.50 years; 83.3% male; 72.2% White; 88.9% heterosexual) completed four weekly training video modules. Participants completed questions related to program satisfaction, mantram repetition use, clinical measures, and a 30-min individual interview. RESULTS: Participants reported using their mantram between 4 and 5 days per week. Participants indicated that mMRP was generally acceptable, appropriate, and feasible across quantitative and qualitative data. On clinical measures, change from pre- to postintervention was significant for the brief symptom screen, PTSD symptoms, and Personal Health Inventory but not for depression or insomnia symptoms. No significant differences were found between the self-directed and supported conditions; however, data suggest that participants primarily engaged with the support for administrative needs. Qualitative data highlighted suggestions for mMRP improvement, including alternative methods for receiving support and more content on how to use the skills taught. CONCLUSIONS: Findings suggest that mMRP can be delivered in a brief format, with veterans learning and using mantram repetition. Developing additional ways of individualizing the mMRP and further testing are warranted. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Tracking implementation strategies in real-world settings: VA Office of Rural Health enterprise-wide initiative portfolio.

OBJECTIVE: To use a practical approach to examining the use of Expert Recommendations for Implementing Change (ERIC) strategies by Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) dimensions for rural health innovations using annual reports on a diverse array of initiatives. DATA SOURCES AND STUDY SETTING: The Veterans Affairs (VA) Office of Rural Health (ORH) funds initiatives designed to support the implementation and spread of innovations and evidence-based programs and practices to improve the health of rural Veterans. This study draws on the annual evaluation reports submitted for fiscal years 2020-2022 from 30 of these enterprise-wide initiatives (EWIs). STUDY DESIGN: Content analysis was guided by the RE-AIM framework conducted by the Center for the Evaluation of Enterprise-Wide Initiatives (CEEWI), a Quality Enhancement Research Initiative (QUERI)-ORH partnered evaluation initiative. DATA COLLECTION AND EXTRACTION METHODS: CEEWI analysts conducted a content analysis of EWI annual evaluation reports submitted to ORH. Analysis included cataloguing reported implementation strategies by Reach, Adoption, Implementation, and Maintenance (RE-AIM) dimensions (i.e., identifying strategies that were used to support each dimension) and labeling strategies using ERIC taxonomy. Descriptive statistics were conducted to summarize data. PRINCIPAL FINDINGS: A total of 875 implementation strategies were catalogued in 73 reports. Across these strategies, 66 unique ERIC strategies were reported. EWIs applied an average of 12 implementation strategies (range 3-22). The top three ERIC clusters across all 3 years were Develop stakeholder relationships (21%), Use evaluative/iterative strategies (20%), and Train/educate stakeholders (19%). Most strategies were reported within the Implementation dimension. Strategy use among EWIs meeting the rurality benchmark were also compared. CONCLUSIONS: Combining the dimensions from the RE-AIM framework and the ERIC strategies allows for understanding the use of implementation strategies across each RE-AIM dimension. This analysis will support ORH efforts to spread and sustain rural health innovations and evidence-based programs and practices through targeted implementation strategies.

Usability Testing of a Web Tool for Dissemination and Implementation Science Models.

Dissemination and Implementation science is dedicated to increasing the speed of evidence-based research translated into practice as guided by one or multiple D&I theories, models, and frameworks. The Dissemination and Implementation Models in Health Research and Practice web tool guides users on how to plan, select, combine, adapt, use, and assess theories, models, and frameworks. This paper describes usability testing to update the web tool. Iterative user testing was conducted with implementation science research and clinical participants to facilitate updates and optimize the functionality of the tool. A multi-step protocol involved quantitative and qualitative data collection including a survey, interviews, and a usability testing session. Data from the pre-testing surveys were summarized as frequencies. Data from the usability testing sessions were analyzed using a hybrid adapted deductive rapid matrix qualitative analysis. Data from the interviews were analyzed by deductive a priori coding. Fifteen interviewees represented different research and clinical groups and levels of expertise utilizing D&I TMFs. Participants were purposively selected to represent a range of disciplines and D&I expertise, all invited via one-time email. The 847 total interview comments were reduced by similarity to 259 comments, and 142 were feasible changes fitting the priorities of the web tool. Changes to content, format, and functionality are described in this paper. The iterative usability testing elicited improvements to the web tool including adding more examples, definitions, visuals, and tutorials and simplifying the written content. The web tool remains flexible for additions concerning health equity, de-implementation, and other issues. Supplementary Information: The online version contains supplementary material available at 10.1007/s43477-024-00125-7.

Gaps in communication theory paradigms when conducting implementation science research: qualitative observations from interviews with administrators, implementors, and evaluators of rural health programs.

BACKGROUND: Communication is considered an inherent element of nearly every implementation strategy. Often it is seen as a means for imparting new information between stakeholders, representing a Transaction orientation to communication. From a Process orientation, communication is more than information-exchange and is acknowledged as being shaped by (and shaping) the individuals involved and their relationships with one another. As the field of Implementation Science (IS) works to strengthen theoretical integration, we encourage an interdisciplinary approach that engages communication theory to develop richer understanding of strategies and determinants of practice. METHODS: We interviewed 28 evaluators, 12 implementors, and 12 administrators from 21 Enterprise-Wide Initiatives funded by the Department of Veteran Affairs Office of Rural Health. Semi-structured interviews focused on experiences with implementation and evaluation strategies. We analyzed the interviews using thematic analysis identifying a range of IS constructs. Then we deductively classified those segments based on a Transaction or Process orientation to communication. RESULTS: We organized findings using the two IS constructs most commonly discussed in interviews: Collaboration and Leadership Buy-in. The majority of segments coded as Collaboration (n = 34, 74%) and Leadership Buy-in (n = 31, 70%) discussed communication from a Transaction orientation and referred to communication as synonymous with information exchange, which emphasizes the task over the relationships between the individuals performing the tasks. Conversely, when participants discussed Collaboration and Leadership Buy-in from a Process orientation, they acknowledged both constructs as the result of long-term efforts to develop positive relationships based on trust and respect, and emphasized the time costliness of such strategies. Our findings demonstrate that participants who discussed communication from a Process orientation recognized the nuance and complexity of interpersonal interactions, particularly in the context of IS. CONCLUSIONS: Efficient, reliable information exchange is a critical but often overemphasized element of implementation. Practitioners and researchers must recognize and incorporate the larger role of communication in IS. Two suggestions for engaging a Process orientation to communication are to: (a) use interview probes to learn how communication is enacted, and (b) use process-oriented communication theories to develop interventions and evaluation tools.

Designing for data sharing: Considerations for advancing health equity in data management and dissemination.

Data sharing, the act of making scientific research data available to others, can accelerate innovation and discoveries, and ultimately enhance public health. The National Cancer Institute Implementation Science Centers in Cancer Control convened a diverse group of research scientists, practitioners, and community partners in three interactive workshops (May-June 2022) to identify and discuss factors that must be considered when designing research for equitable data sharing with a specific emphasis on implementation science and social, behavioral, and population health research. This group identified and operationalized a set of seven key considerations for equitable data sharing-conceptualized as an inclusive process that fairly includes the perspectives and priorities of all partners involved in and impacted by data sharing, with consideration of ethics, history, and benefits-that were integrated into a framework. Key data-sharing components particularly important for health equity included: elevating data sharing into a core research activity, incorporating diverse perspectives, and meaningfully engaging partners in data-sharing decisions throughout the project lifecycle. As the process of data sharing grows in research, it is critical to continue considering the potential positive and adverse impact of data sharing on diverse beneficiaries of health data and research.

Data sharing is a key strategy for advancing our understanding of human health and healthcare. Three interactive workshops that included researcher scientists, physicians, and community members were held by the National Cancer Institute Implementation Science Centers in Cancer Control. The group discussed ways to incorporate health equity and equitable data sharing into implementation science and social, behavioral, and population health research. Equitable data sharing is an inclusive process that considers the points of view and priorities of all partners involved with data sharing and considers ethics, history, and benefits. Seven key components emerged from these discussions and were included in a framework. The components included elevating data sharing into a core research activity, incorporating diverse perspectives, and meaningfully engaging partners in data-sharing decisions throughout the project lifecycle. As the process of data sharing grows in research, it is critical to continue considering the potential positive and negative impacts of data sharing on diverse beneficiaries of health data and research.

Exercise and nutrition to improve cancer Treatment-Related outcomes (ENICTO).

Chemotherapy treatment-related side-effects are common and increase the risk of suboptimal outcomes. Exercise interventions during cancer treatment improve self-reported physical functioning, fatigue, anxiety, and depression, but it is unclear whether these interventions improve important clinical outcomes, such as chemotherapy relative dose intensity (RDI). The National Cancer Institute funded the Exercise and Nutrition to Improve Cancer Treatment-Related Outcomes (ENICTO) Consortium, to address this knowledge gap. This paper describes the mechanisms hypothesized to underpin intervention effects on clinically-relevant treatment outcomes, briefly outlines each project's distinct research aims, summarizes the scope and organizational structure of ENICTO, and provides an overview of the integrated common data elements used to pursue research questions collectively. In addition, the paper includes a description of consortium-wide activities and broader research community opportunities for collaborative research. Findings from the ENICTO Consortium have the potential to accelerate a paradigm shift in oncology care such that cancer patients could receive exercise and nutrition programming as the standard of care in tandem with chemotherapy to improve RDI for a curative outcome.

Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial.

BACKGROUND: Goals of care conversations explore seriously ill patients' values to guide medical decision making and often inform decisions about life sustaining treatments. Ideally, conversations occur before a health crisis between patients and clinicians in the outpatient setting. In the United States Veterans Affairs (VA) healthcare system, most conversations still occur in the inpatient setting. Strategies are needed to improve implementation of outpatient, primary care goals of care conversations. METHODS: We plan a cluster randomized (clinician-level) sequential, multiple assignment randomized trial to evaluate the effectiveness of patient implementation strategies on the outcome of goals of care conversation documentation when delivered in combination with clinician implementation strategies. Across three VA healthcare system sites, we will enroll primary care clinicians with low rates of goals of care conversations and their patients with serious medical illness in the top 10th percentile of risk of hospitalization or death. We will compare the effectiveness of sequences of implementation strategies and explore how patient and site factors modify implementation strategy effects. Finally, we will conduct a mixed-methods evaluation to understand implementation strategy success or failure. The design includes two key innovations: (1) strategies that target both clinicians and patients and (2) sequential strategies with increased intensity for non-responders. CONCLUSION: This study aims to determine the effect of different sequences and combinations of implementation strategies on primary care documentation of goals of care conversations. Study partners, including the VA National Center for Ethics in Health Care and Office of Primary Care, can consider policies based on study findings.

Use of the iPRISM webtool in a learning community to assess implementation context and fit of a novel clinical decision support tool for physical therapy triage in acute care hospitals.

BACKGROUND: The iPRISM webtool is an interactive tool designed to aid the process of applying the Practical, Robust Implementation and Sustainability Model (PRISM) for the assessment of and fit with context. A learning community (LC) is a multidisciplinary group of partners addressing a complex problem. Our LC coproduced the Physical TheraPy frEqueNcy Clinical decIsion support tooL (PT-PENCIL) to guide the use of physical therapist services in acute care hospitals. OBJECTIVE: To describe our LC's activities to co-produce the PT-PENCIL, use of the iPRISM webtool to assess its preimplementation context and fit, and develop a multicomponent implementation strategy for the PT-PENCIL. DESIGN: A descriptive research design. SETTING: Three tertiary care hospitals. PARTICIPANTS: Thirteen LC partners: six clinical physical therapists, three rehabilitation managers, three researchers, and a bioinformaticist. INTERVENTIONS: Not applicable. OUTCOME MEASURES: Using the iPRISM webtool, expected fit of the PT-PENCIL was rated 1 (not aligned) to 6 (well aligned) for each PRISM domain and expected reach, effectiveness, adoption, implementation, and maintenance were rated 1 (not likely at all) to 6 (very likely). Discrete implementation strategies were identified from the Expert Recommendations for Implementing Change. RESULTS: The process spanned 18 meetings over 8 months. Ten LC partners completed the iPRISM webtool. PRISM domains with the lowest expected alignment were the "implementation and sustainability infrastructure" (mean = 4.7 out of 6; range = 3-6) and the "external environment" (mean = 4.9 of 6; range = 4-6). Adoption was the outcome with the lowest expected likelihood (mean = 4.5 out of 6; range = 1-6). Six discrete implementation strategies were identified and combined into a multicomponent strategy. CONCLUSIONS: Within a LC, we used existing implementation science resources to co-produce a novel clinical decision support tool for acute care physical therapists and develop a strategy for its implementation. Our methodology can be replicated for similar projects given the public availability of each resource used.

Enhancing patient-clinician collaboration during treatment decision-making: study protocol for a community-engaged, mixed method hybrid type 1 trial of collaborative decision skills training (CDST) for veterans with psychosis.

BACKGROUND: Patient participation in treatment decision making is a pillar of recovery-oriented care and is associated with improvements in empowerment and well-being. Although demand for increased involvement in treatment decision-making is high among veterans with serious mental illness, rates of involvement are low. Collaborative decision skills training (CDST) is a recovery-oriented, skills-based intervention designed to support meaningful patient participation in treatment decision making. An open trial among veterans with psychosis supported CDST's feasibility and demonstrated preliminary indications of effectiveness. A randomized control trial (RCT) is needed to test CDST's effectiveness in comparison with an active control and further evaluate implementation feasibility. METHODS: The planned RCT is a hybrid type 1 trial, which will use mixed methods to systematically evaluate the effectiveness and implementation feasibility of CDST among veterans participating in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) in Southern California. The first aim is to assess the effectiveness of CDST in comparison with the active control via the primary outcome, collaborative decision-making behavior during usual care appointments between veterans and their VA mental health clinicians, and secondary outcomes (i.e., treatment engagement, satisfaction, and outcome). The second aim is to characterize the implementation feasibility of CDST within the VA PRRC using the Practical Robust Implementation and Sustainability Model framework, including barriers and facilitators within the PRRC context to support future implementation. DISCUSSION: If CDST is found to be effective and feasible, implementation determinants gathered throughout the study can be used to ensure sustained and successful implementation at this PRRC and other PRRCs and similar settings nationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT04324944. Registered on March 27, 2020. Trial registration data can be found in Appendix 1.

A pragmatic randomized trial of mailed fecal immunochemical testing to increase colorectal cancer screening among low-income and minoritized populations.

BACKGROUND: Colorectal cancer (CRC) screening is underused, particularly among low-income and minoritized populations, for whom the coronavirus disease 2019 (COVID-19) pandemic has challenged progress in achieving equity. METHODS: A hub-and-spoke model was used. The hub was a nonacademic organization and the spokes were three community health center (CHC) systems overseeing numerous clinic sites. Via a cluster-randomized trial design, nine clinic sites were randomized to intervention and 16 clinic sites were randomized to usual care. Patient-level interventions included invitation letters, mailed fecal immunochemical tests (FITs), and call/text-based reminders. Year 1 intervention impact, which took place during the COVID-19 pandemic, was assessed as the proportion completing screening among individuals not up to date at baseline, which compared intervention and nonintervention clinics accounting for intraclinic cluster variation; confidence intervals (CIs) around differences not including 0 were interpreted as statistically significant. RESULTS: Among 26,736 patients who met eligibility criteria, approximately 58% were female, 55% were Hispanic individuals, and 44% were Spanish speaking. The proportion completing screening was 11.5 percentage points (ppts) (95% CI, 6.1-16.9 ppts) higher in intervention versus usual care clinics. Variation in differences between intervention and usual care clinics was observed by sex (12.6 ppts [95% CI, 7.2-18.0 ppts] for females; 8.8 ppts [95% CI, 4.7-13.9 ppts] for males) and by racial and ethnic group (13.8 ppts [95% CI, 7.0-20.6 ppts] for Hispanic individuals; 13.0 ppts [95% CI, 3.6-22.4 ppts] for Asian individuals; 11.3 ppts [95% CI, 5.8-16.8 ppts] for non-Hispanic White individuals; 6.1 ppts [95% CI, 0.8-10.4 ppts] for Black individuals). CONCLUSIONS: A regional mailed FIT intervention was effective for increasing CRC screening rates across CHC systems serving diverse, low-income populations.

RE-AIM for rural health innovations: perceptions of (mis) alignment between the RE-AIM framework and evaluation reporting in the Department of Veterans Affairs Enterprise-Wide Initiatives program.

Background: The Department of Veterans Affairs (VA) Office of Rural Health (ORH) supports national VA program offices' efforts to expand health care to rural Veterans through its Enterprise-Wide Initiatives (EWIs) program. In 2017, ORH selected Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM), an implementation science framework, to structure the EWI evaluation and reporting process. As part of its mandate to improve EWI program evaluation, the Center for the Evaluation of Enterprise-Wide Initiatives conducted a qualitative evaluation to better understand EWI team' perceptions of, and barriers and facilitators to, the EWI evaluation process. Methods: We conducted 43 semi-structured interviews with 48 team members (e.g., evaluators, program office leads, and field-based leads) representing 21 EWIs from April-December 2020. Questions focused on participants' experiences using strategies targeting each RE-AIM dimension. Interviews were inductively analyzed in MAXQDA. We also systematically reviewed 51 FY19-FY20 EWI annual reports to identify trends in misapplications of RE-AIM. Results: Participants had differing levels of experience with RE-AIM. While participants understood ORH's rationale for selecting a common framework to structure evaluations, the perceived misalignment between RE-AIM and EWIs' work emerged as an important theme. Concerns centered around 3 sub-themes: (1) (Mis)Alignment with RE-AIM Dimensions, (2) (Mis)Alignment between RE-AIM and the EWI, and (3) (Mis)Alignment with RE-AIM vs. other Theories, Models, or Frameworks. Participants described challenges differentiating between and operationalizing dimensions in unique contexts. Participants also had misconceptions about RE-AIM and its relevance to their work, e.g., that it was meant for established programs and did not capture aspects of initiative planning, adaptations, or sustainability. Less commonly, participants shared alternative models or frameworks to RE-AIM. Despite criticisms, many participants found RE-AIM useful, cited training as important to understanding its application, and identified additional training as a future need. Discussion: The selection of a shared implementation science framework can be beneficial, but also challenging when applied to diverse initiatives or contexts. Our findings suggest that establishing a common understanding, operationalizing framework dimensions for specific programs, and assessing training needs may better equip partners to integrate a shared framework into their evaluations.

The Effects of a Single-Session Virtual Rumination Intervention to Enhance Cognitive Functioning in Veterans With Subjective Cognitive Symptoms: Multimethod Pilot Study.

BACKGROUND: Subjective cognitive concerns (SCCs) entail perceived difficulties in thinking or memory, often reported without substantial objective evidence of cognitive impairment. These concerns are prevalent among individuals with a history of brain injuries, neurological conditions, or chronic illnesses, contributing to both psychological distress and functional limitations. They are increasingly considered to be a risk factor for future objective decline. A considerable number of individuals reporting SCCs also exhibit mental health symptoms, such as a history of trauma, depression, or anxiety. Interventions that address modifiable emotional and cognitive factors related to SCC could improve functioning and quality of life. Therefore, the use of emotion regulation strategies, especially those directed at minimizing rumination, could serve as a promising focus for interventions aimed at mitigating subjective cognitive concerns in veteran populations. OBJECTIVE: This pilot study explored the feasibility, acceptability, and preliminary efficacy of a brief, 1-session emotion regulation intervention called "Worry Less, Remember More." The Worry Less, Remember More intervention was designed to reduce rumination and improve subjective cognitive functioning in veterans with subjective cognitive changes (N=15). METHODS: We randomized 15 veterans to either the active telehealth condition or waitlist control and completed the intervention. Participants were aged between 31 and 67 (mean 49.5, SD 10.1) years, and the sample was primarily male (12/15, 83%) and White (10/15, 67%). The most common diagnoses were posttraumatic stress disorder and depression. Following the intervention, veteran input was sought through semistructured interviews with a subset of 12 participants, examining feasibility, acceptability, and perceived efficacy. Preliminary efficacy was also measured using pre- and postintervention self-report measures. RESULTS: Veterans reported that this intervention was acceptable, with 92% (11/12) of the sample reporting that they benefited from the intervention and would recommend the intervention to others with similar difficulties. Semistructured interviews revealed difficulties with feasibility, including problems with the remote consenting process, forgetting appointments, and needing additional strategies to remember to consistently use the interventions. The intervention improved self-reported cognitive symptoms on quantitative measures but did not improve self-reported rumination. CONCLUSIONS: This pilot study establishes the preliminary feasibility, acceptability, and efficacy of the Worry Less, Remember More intervention for veterans with subjective cognitive symptoms. Future iterations of the intervention may benefit from simplifying the electronic consent process, providing reminders for appointments, and incorporating compensatory cognitive strategies to assist with using the telehealth system, as well as applying the strategies learned in the intervention. While future research is needed with larger samples, including nonveteran populations, the intervention may also be a useful clinical tool to bridge care between neuropsychology clinics and mental health treatment.

An implementation strategy postmortem method developed in the VA rural Transitions Nurse Program to inform spread and scale-up.

BACKGROUND: High-quality implementation evaluations report on intervention fidelity and adaptations made, but a practical process for evaluating implementation strategies is needed. A retrospective method for evaluating implementation strategies is also required as prospective methods can be resource intensive. This study aimed to establish an implementation strategy postmortem method to identify the implementation strategies used, when, and their perceived importance. We used the rural Transitions Nurse Program (TNP) as a case study, a national care coordination intervention implemented at 11 hospitals over three years. METHODS: The postmortem used a retrospective, mixed method, phased approach. Implementation team and front-line staff characterized the implementation strategies used, their timing, frequency, ease of use, and their importance to implementation success. The Expert Recommendations for Implementing Change (ERIC) compilation, the Quality Enhancement Research Initiative phases, and Proctor and colleagues' guidance were used to operationalize the strategies. Survey data were analyzed descriptively, and qualitative data were analyzed using matrix content analysis. RESULTS: The postmortem method identified 45 of 73 ERIC strategies introduced, including 41 during pre-implementation, 37 during implementation, and 27 during sustainment. External facilitation, centralized technical assistance, and clinical supervision were ranked as the most important and frequently used strategies. Implementation strategies were more intensively applied in the beginning of the study and tapered over time. CONCLUSIONS: The postmortem method identified that more strategies were used in TNP than planned and identified the most important strategies from the perspective of the implementation team and front-line staff. The findings can inform other implementation studies as well as dissemination of the TNP intervention.

Adaptation of the brainwriting premortem technique to inform the co-creation of COVID-19 testing strategies in underserved communities in South San Diego.

INTRODUCTION: Meaningful engagement of partners in co-creating and refining health-related programs can increase the initial uptake, sustained implementation, broad reach, and effectiveness of these programs. This is especially important for underserved communities where resources are limited and need to be prioritized. Brainwriting premortem is a novel qualitative approach to partner engagement that combines the strengths of individual idea generation with the concept of premortem exercise that addresses failure points prior to the implementation of new programs. METHODS: An adapted form of brainwriting premortem was used to inform iterative refinements to a COVID-19 testing program at a Federally Qualified Health Center (FQHC) in San Diego. Patients and providers from the FQHC participated in interviews at two time points (early- and mid-implementation of the program). Interview data were transcribed, translated, and analyzed using a rapid qualitative approach. Key themes and sub-themes were identified and used to inform refinements to the program. RESULTS: A total of 11 patients (7 Spanish- and 4 English-speaking) and 8 providers participated in the brainwriting premortem interviews. Key themes related to possible reasons for COVID-19 testing program failure: advertising/sharing information; access to testing; handling of test results; staff and patient safety; patient beliefs and views regarding the SARS-CoV-2 virus; and COVID-19 testing options offered. Proposed solutions were offered for the key failures except for patient beliefs and views regarding the SARS-CoV-2 virus. Additional solutions offered were related to education, physical operations, and recruitment strategies. Real-time changes to the program flow and components were made in response to 7 suggestions from patients and 11 from providers. Changes related to the process of returning results were the most common, and included sending results via email with distinct workflows based on the test result. CONCLUSION: The implementation of the adapted brainwriting premortem technique allowed us to incorporate the perspective of key partners in the delivery and iterative refinement of the COVID-19 testing program. This was an effective tool in the context of an FQHC and can be a promising and approach to incorporate iterative input from patients and providers to ensure successful program implementation. Future studies, particularly those requiring rapid response to public health emergencies, should consider the use of this technique.

Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol.

BACKGROUND: Guidelines recommend screening for colorectal cancer (CRC), but participation and abnormal test follow up rates are suboptimal, with disparities by demography. Evidence-based interventions exist to promote screening, but community adoption and implementation are limited. METHODS: The San Diego Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) program is an academic-community partnership testing regional implementation of a Hub-and-Spoke model for increasing CRC screening and follow-up. The "hub" is a non-academic, non-profit organization that includes 17 community health center (CHC) systems, serving over 190 rural and urban clinic sites. The "spokes" are 3 CHC systems that oversee 11-28 clinics each, totaling over 60 clinics. Using a cluster-randomized trial design, 9 clinics were randomized to intervention and 16 to usual care. Within intervention clinics, approximately 5000 eligible patients not up-to-date with CRC screening per year were identified for intervention. Interventions include an invitation primer, a mailed fecal immunochemical test with completion instructions, and phone and text-based reminders (hub) and patient navigation protocol to promote colonoscopy completion after abnormal FIT (spoke). Outcomes include: 1) proportion of patients up-to-date with screening after three years in intervention versus non-intervention clinics; 2) proportion of patients with abnormal FIT completing colonoscopy within six months of the abnormal result. Implementation science measures are collected to assess acceptability, intervention and usual care adaptations, and sustainability of the intervention strategies. CONCLUSION: This large-scale, regional cluster randomized trial among CHCs serving diverse populations is anticipated to accelerate progress in CRC prevention in underserved populations. TRIAL REGISTRATION: NCT04941300.

Community-engaged optimization of COVID-19 rapid evaluation and testing experiences: roll-out implementation optimization trial.

BACKGROUND: There continues to be a need for COVID-19 testing that is pragmatic, community-centered, and sustainable. This study will refine and test implementation strategies prioritized by community partners: (1) walk-up no-cost testing, (2) community health worker (promotores)-facilitated testing and preventive care counseling, (3) vending machines that dispense no-cost, self-testing kits. METHODS: A co-designed Theory of Change from an earlier study phase and the Practical, Robust Implementation and Sustainment Model (PRISM) will guide the study design, measures selection, and evaluation. The first aim is to refine and operationalize a multi-component implementation strategy bundle and outcome measures for COVID-19 testing. A Community and Scientific Advisory Board (CSAB) will be established and include community members, clinical providers/staff from the partnering Federally Qualified Health Center (FQHC), public health researchers, policymakers, and a county health department ambassador. Engagement of CSAB members will be assessed through structured ethnography and a survey about the quality and quantity of engagement practices. The second aim is to implement and evaluate the impact of the implementation strategy bundle to optimize COVID-19 testing in communities using a roll-out implementation optimization (ROIO) design. Seven thousand and five hundred community members will be enrolled across four FQHC clinics over 18 months. Participants will be invited to complete an electronic survey about their demographics, health, and COVID-19 testing results and experiences. CSAB members and clinic partners will participate in PRISM fit and determinant assessments prior to each clinic rollout and post-trial. Interviews will be conducted with 60 community participants and 12 providers/staff following a 3-month rollout period at each clinic, inquiring about their experiences with the implementation strategies. Quantitative data will be analyzed using hierarchical multilevel models to determine the impact of implementation strategies. Qualitative data will be analyzed using rapid qualitative approaches to summarize implementation experiences and identify necessary changes prior to subsequent rollouts. A matrix approach will be used to triangulate data from quantitative and qualitative sources based on PRISM domains. DISCUSSION: This is one of the first pragmatic implementation trials to use a ROIO design and aims to co-create a sustainable and equitable COVID-19 testing program. Findings are likely to generalize to other public health prevention efforts. TRIAL REGISTRATION: NCT05894655 March 2, 2023.

Process evaluation of an academic dissemination and implementation science capacity building program.

The UC San Diego Altman Clinical and Translational Research Institute Dissemination and Implementation Science Center (DISC) launched in 2020 to provide dissemination and implementation science (DIS) training, technical assistance, community engagement, and research advancement. DISC developed a program-wide logic model to inform a process evaluation of member engagement and impact related to DISC services. The DISC Logic Model (DLM) served as the framework for a process evaluation capturing quantitative and qualitative information about scientific activities, outputs, and outcomes. The evaluation involved a multimethod approach with surveys, attendance tracking, feedback forms, documentation of grant outcomes, and promotions metrics (e.g., Twitter engagement). There were 540 DISC Members at the end of year 2 of the DISC. Engagement in the DISC was high with nearly all members endorsing at least one scientific activity. Technical assistance offerings such as DISC Journal Club and consultation were most frequently used. The most common scientific outputs were grant submission (65, 39%), formal mentoring for career award (40, 24%), and paper submission (34, 21%). The DLM facilitated a comprehensive process evaluation of our center. Actionable steps include prioritizing technical assistance, strengthening networking opportunities, identifying streamlined approaches to facilitate DIS grant writing through writing workshops, as well as "office hours" or organized writing leagues.

The iPRISM webtool: an interactive tool to pragmatically guide the iterative use of the Practical, Robust Implementation and Sustainability Model in public health and clinical settings.

BACKGROUND: To increase uptake of implementation science (IS) methods by researchers and implementers, many have called for ways to make it more accessible and intuitive. The purpose of this paper is to describe the iPRISM webtool (Iterative, Practical, Robust Implementation and Sustainability Model) and how this interactive tool operationalizes PRISM to assess and guide a program's (a) alignment with context, (b) progress on pragmatic outcomes, (c) potential adaptations, and (d) future sustainability across the stages of the implementation lifecycle. METHODS: We used an iterative human-centered design process to develop the iPRISM webtool. RESULTS: We conducted user-testing with 28 potential individual and team-based users who were English and Spanish speaking from diverse settings in various stages of implementing different types of programs. Users provided input on all aspects of the webtool including its purpose, content, assessment items, visual feedback displays, navigation, and potential application. Participants generally expressed interest in using the webtool and high likelihood of recommending it to others. The iPRISM webtool guides English and Spanish-speaking users through the process of iteratively applying PRISM across the lifecycle of a program to facilitate systematic assessment and alignment with context. The webtool summarizes assessment responses in graphical and tabular displays and then guides users to develop feasible and impactful adaptations and corresponding action plans. Equity considerations are integrated throughout. CONCLUSIONS: The iPRISM webtool can intuitively guide individuals and teams from diverse settings through the process of using IS methods to iteratively assess and adapt different types of programs to align with the context across the implementation lifecycle. Future research and application will continue to develop and evaluate this IS resource.

Factors associated with COVID-19 vaccine uptake in a US/Mexico border community: demographics, previous influenza vaccination, and trusted sources of health information.

Background: COVID-19 vaccine uptake has been uneven, particularly across racial/ethnic and age groups. This study seeks to understand factors associated with COVID-19 vaccine uptake in a large cross-sectional sample of predominantly Latinos/Latinas individuals living near the US/Mexico border. Methods: Data are extracted from a 176-item survey conducted as part of a parent study focused on the co-creation of a COVID-19 testing program for underserved communities developed through a partnership between an academic institution and a Federally Qualified Health Center. The following participant variables were examined: health history, COVID-19 symptoms, COVID-19 testing and vaccine experiences, and perceptions of sources of health information. Participant characteristics were compared using chi-square tests. Multivariate logistic regressions were used for the final statistical model. Results: From 1 May 2021 to 30 April 2022, 4,964 adults, 66% of whom were identified as women, completed the survey. Approximately 80% of participants reported having received at least one COVID-19 vaccine. Female sex, older age, Hispanic/Latino(a) ethnicity, previous influenza vaccination, advanced education, and perceived elevated risk of COVID-19 were significantly (p < 0.05) associated with having received a COVID-19 vaccine. Regarding sources of health information, individuals who indicated they trust their doctor, healthcare provider, or the US government "a great deal" were more likely to have received a COVID-19 vaccine compared to individuals who indicated that they trusted these sources "not at all." In contrast, those who reported having "a great deal" of trust in their faith leader or their social media contacts were significantly less likely to have received a COVID-19 vaccine than those who reported that they trusted these sources "not at all." Conclusion: Sex, education, past influenza vaccination, perceived risk of COVID-19 infection, and trust in specific sources of information were correlated with the uptake of COVID-19 vaccination. Additional research is needed to better understand why this confluence of factors, particularly the unique findings about trusted sources of information, are associated with vaccine uptake. Understanding these associations, specifically within underserved, Latino/Hispanic communities, is an important first step to inform efforts aimed at increasing and sustaining COVID-19 vaccine uptake and adoption of other public health interventions.

Scaling and sustaining COVID-19 vaccination through meaningful community engagement and care coordination for underserved communities: hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial.

BACKGROUND: COVID-19 inequities are abundant in low-income communities of color. Addressing COVID-19 vaccine hesitancy to promote equitable and sustained vaccination for underserved communities requires a multi-level, scalable, and sustainable approach. It is also essential that efforts acknowledge the broader healthcare needs of these communities including engagement in preventive services. METHODS: This is a hybrid type 3 effectiveness-implementation study that will include a multi-level, longitudinal, mixed-methods data collection approach designed to assess the sustained impact of a co-created multicomponent strategy relying on bidirectional learning, shared decision-making, and expertise by all team members. The study capitalizes on a combination of implementation strategies including mHealth outreach with culturally appropriate messaging, care coordination to increase engagement in high priority preventive services, and the co-design of these strategies using community advisory boards led by Community Weavers. Community Weavers are individuals with lived experience as members of an underserved community serving as cultural brokers between communities, public health systems, and researchers to co-create community-driven, culturally sensitive public health solutions. The study will use an adaptive implementation approach operationalized in a sequential multiple assignment randomized trial design of 300 participants from three sites in a Federally Qualified Health Center in Southern California. This design will allow examining the impact of various implementation strategy components and deliver more intensive support to those who benefit from it most. The primary effectiveness outcomes are COVID-19 vaccine completion, engagement in preventive services, and vaccine confidence. The primary implementation outcomes are reach, adoption, implementation, and maintenance of the multicomponent strategy over a 12-month follow-up period. Mixed-effects logistic regression models will be used to examine program impacts and will be triangulated with qualitative data from participants and implementers. DISCUSSION: This study capitalizes on community engagement, implementation science, health equity and communication, infectious disease, and public health perspectives to co-create a multicomponent strategy to promote the uptake of COVID-19 vaccination and preventive services for underserved communities in San Diego. The study design emphasizes broad engagement of our community and clinic partners leading to culturally sensitive and acceptable strategies to produce lasting and sustainable increases in vaccine equity and preventive services engagement. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05841810 May 3, 2023.