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.

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.

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.

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.

Understanding feasibility and acceptability of implementation of linking delivery of family planning and infant vaccination care in rural Maharashtra, India: a qualitative study.

BACKGROUND: Linking family planning with infant vaccination care has the potential to increase contraceptive use among postpartum women in rural settings. We explored the multilevel factors that can facilitate or impede uptake of contraception at the time of infant vaccination among postpartum women and couples in rural Maharashtra, India. METHODS: We conducted 60 semi-structured interviews with key stakeholders including: postpartum married women (n = 20), husbands (n = 10), and mothers-in-law (n = 10) of postpartum women, frontline healthcare workers (auxiliary nurse midwives (ANMs) and Accredited Social Health Activists (ASHAs), (n = 10), and community leaders (physician medical officers and village panchayat leaders) (n = 10). We sought to assess the feasibility and acceptability of delivering community-based postpartum family planning care in rural India at the time of infant vaccination. The Consolidated Framework for Implementation Research (CFIR) was used to design a structured interview guide and codebook. Data were analyzed via directed content analysis. RESULTS: Three major themes emerged: (1) Social fertility and gender norms including son preference and male control over contraceptive decision-making influence postpartum contraceptive access and choice. (2) Linking contraceptive care and infant vaccination is perceived as potentially feasible and acceptable to implement by families, health workers, and community leaders. The intervention provides care to women and families in a convenient way where they are in their community. (3) Barriers and facilitators to linked infant postpartum contraception and infant vaccination were identified across the five CFIR domains. Key barriers included limited staff and space (inner setting), and contraceptive method targets for clinics and financial incentives for clinicians who provide specific methods (outer setting). Key facilitators included convenience of timing and location for families (intervention characteristics), the opportunity to engage husbands in decision-making when they attend infant vaccination visits (participant characteristics), and programmatic support from governmental and community leaders (process of implementation). CONCLUSIONS: Linked provision of family planning and infant vaccination care may be feasible and accessible in rural India utilizing strategies identified to reduce barriers and facilitate provision of care. A gender-transformative intervention that addresses gender and social norms has greater potential to impact reproductive autonomy and couples' contraceptive decision-making.

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.

Using ethnographic approaches to document, evaluate, and facilitate virtual community-engaged implementation research.

BACKGROUND: Community Advisory Boards (CABs) have been frequently used to engage diverse partners to inform research projects. Yet, evaluating the quality of engagement has not been routine. We describe a multi-method ethnographic approach documenting and assessing partner engagement in two "virtual" CABs, for which we conducted all meetings remotely. METHODS: Two research projects for increasing equitable COVID-19 testing, vaccination, and clinical trial participation for underserved communities involved remote CAB meetings. Thirty-three partners representing 17 community groups participated in 15 sessions across the two CABs facilitated by a social change organization. We developed ethnographic documentation forms to assess multiple aspects of CAB member engagement (e.g., time spent speaking, modality used, types of interactions). Documenters were trained to observe CAB sub-groups via virtual sessions. Debriefing with the documentation team after CAB meetings supported quality assurance and process refinement. CAB members completed a brief validated survey after each meeting to assess the quality and frequency of engagement. Content and rapid thematic analysis were used to analyze documentation data. Quantitative data were summarized as frequencies and means. Qualitative and quantitative findings were triangulated. RESULTS: A total of 4,540 interactions were identified across 15 meetings. The most frequent interaction was providing information (44%), followed by responding (37-38%). The quality and frequency of stakeholder engagement were rated favorably (average 4.7 of 5). Most CAB members (96%) reported good/excellent engagement. Specific comments included appreciation for the diversity of perspectives represented by the CAB members and suggestions for improved live interpretation. Debriefing sessions led to several methodological refinements for the documentation process and forms. CONCLUSION: We highlight key strategies for documenting and assessing community engagement. Our methods allowed for rich ethnographic data collection that refined our work with community partners. We recommend ongoing trainings, including debriefing sessions and routinely reviewed assessment of data to strengthen meaningful community engagement.

A systematic review of dissemination and implementation science capacity building programs around the globe.

BACKGROUND: Research centers and programs focused on dissemination and implementation science (DIS) training, mentorship, and capacity building have proliferated in recent years. There has yet to be a comprehensive inventory of DIS capacity building program (CBP) cataloging information about activities, infrastructure, and priorities as well as opportunities for shared resources, collaboration, and growth. The purpose of this systematic review is to provide the first inventory of DIS CBPs and describe their key features and offerings. METHODS: We defined DIS CBPs as organizations or groups with an explicit focus on building practical knowledge and skills to conduct DIS for health promotion. CBPs were included if they had at least one capacity building activity other than educational coursework or training alone. A multi-method strategy was used to identify DIS CBPs. Data about the characteristics of DIS CBPs were abstracted from each program's website. In addition, a survey instrument was developed and fielded to gather in-depth information about the structure, activities, and resources of each CBP. RESULTS: In total, 165 DIS CBPs met our inclusion criteria and were included in the final CBP inventory. Of these, 68% are affiliated with a United States (US) institution and 32% are internationally based. There was one CBP identified in a low- and middle-income country (LMIC). Of the US-affiliated CBPs, 55% are embedded within a Clinical and Translational Science Award program. Eighty-seven CBPs (53%) responded to a follow-up survey. Of those who completed a survey, the majority used multiple DIS capacity building activities with the most popular being Training and Education (n=69, 79%) followed by Mentorship (n=58, 67%), provision of DIS Resources and Tools (n=57, 66%), Consultation (n=58, 67%), Professional Networking (n=54, 62%), Technical Assistance (n=46, 52%), and Grant Development Support (n=45, 52%). CONCLUSIONS: To our knowledge, this is the first study to catalog DIS programs and synthesize learnings into a set of priorities and sustainment strategies to support DIS capacity building efforts. There is a need for formal certification, accessible options for learners in LMICs, opportunities for practitioners, and opportunities for mid/later stage researchers. Similarly, harmonized measures of reporting and evaluation would facilitate targeted cross-program comparison and collaboration.

A citation analysis and scoping systematic review of the operationalization of the Practical, Robust Implementation and Sustainability Model (PRISM).

BACKGROUND: The Practical, Robust Implementation and Sustainability Model (PRISM) was developed in 2008 as a contextually expanded version of the broadly used Reach, Adoption, Effectiveness, Implementation, and Maintenance (RE-AIM) framework. PRISM provides researchers a pragmatic and intuitive model to improve translation of research interventions into clinical and community practice. Since 2008, the use of PRISM increased across diverse topics, populations, and settings. This citation analysis and scoping systematic review aimed to assess the use of the PRISM framework and to make recommendations for future research. METHODS: A literature search was conducted using three databases (PubMed, Web of Science, Scopus) for the period of 2008 and September 2020. After exclusion, reverse citation searches and invitations to experts in the field were used to identify and obtain recommendations for additional articles not identified in the original search. Studies that integrated PRISM into their study design were selected for full abstraction. Unique research studies were abstracted for information on study characteristics (e.g., setting/population, design), PRISM contextual domains, and RE-AIM outcomes. RESULTS: A total of 180 articles were identified to include PRISM to some degree. Thirty-two articles representing 23 unique studies integrated PRISM within their study design. Study characteristics varied widely and included studies conducted in diverse contexts, but predominately in high-income countries and in clinical out-patient settings. With regards to use, 19 used PRISM for evaluation, 10 for planning/development, 10 for implementation, four for sustainment, and one for dissemination. There was substantial variation across studies in how and to what degree PRISM contextual domains and RE-AIM outcomes were operationalized and connected. Only two studies directly connected individual PRISM context domains with RE-AIM outcomes, and another four included RE-AIM outcomes without direct connection to PRISM domains. CONCLUSIONS: This is the first systematic review of the use of PRISM in various contexts. While there were low levels of 'integrated' use of PRISM and few reports on linkage to RE-AIM outcomes, most studies included important context domains of implementation and sustainability infrastructure and external environment. Recommendations are provided for more consistent and comprehensive use of and reporting on PRISM to inform both research and practice on contextual factors in implementation.

STOP COVID-19 CA: Community engagement to address the disparate impacts of the COVID-19 pandemic in California.

Objective: To describe the early activities and lessons of the Share, Trust, Organize, Partner COVID-19 California Alliance (STOP COVID-19 CA), the California awardee of the NIH-funded multi-state Community Engagement Alliance (CEAL) against COVID-19. The Alliance was established to ensure equity in Coronavirus-19 disease (COVID-19) research, clinical practice, and public health for communities most impacted by the COVID-19 pandemic. Study setting: The STOP COVID-19 CA Alliance network of 11 universities and affiliated partner community-based organizations (CBOs) across California. Study design: Mixed methods evaluation consisting of an analysis of activity (August 2020 to December 2021) detailed in reports submitted by community-academic teams and a survey (August 2021) of academic investigators and affiliated community-based organization (CBO) partners. Data collection: We summarized activities from the 11 community-academic teams' progress reports and described results from an online survey of academic investigators and CBO partners in the California Alliance. Principal findings: A review of progress reports (n = 256) showed that teams fielded surveys to 11,000 Californians, conducted 133 focus groups, partnered with 29 vaccine/therapeutics clinical trials, and led more than 300 town halls and vaccine events that reached Californians from communities disproportionately impacted by COVID-19. Survey responses from academic investigators and CBO partners emphasized the importance of learning from the successes and challenges of the California Alliance teams' COVID-19 initiatives. Both academic and CBO respondents highlighted the need for streamlined federal and institutional administrative policies, and fiscal practices to promote more effective and timely operations of teams in their efforts to address the numerous underlying health and social disparities that predispose their communities to higher rates of, and poor outcomes from, COVID-19. Conclusions: STOP COVID-19 CA represents a new and potentially sustainable statewide community engagement model for addressing health disparities in multiethnic/multicultural and geographically dispersed communities.

Promoting rigor and sustainment in implementation science capacity building programs: A multi-method study.

Background: The field of Implementation science (IS) continues to evolve, and the number and type of IS capacity building Programs (ISCBPs) are in flux. These changes push the field to revisit the accepted IS competencies and to guide sustainment of ISCBPs. Our objectives were: (1) compare characteristics of current ISCBPs; (2) identify recommendations to support ISCBP sustainment; (3) measure how often ISCBPs address IS competencies; (4) identify novel and important IS competencies for the field. Method: This multi-method study included ISCBPs delivering structured, longitudinal IS training, excluding single courses and brief workshops. We used three complementary methods to meet our objectives. First, we identified ISCBPs via an internet search and snowball sampling methods. Second, we surveyed these ISCBPs to identify areas of program focus, types of trainees, IS competencies addressed, and recommendations to sustain ISCBPs. Third, we conducted a modified Delphi process with IS researchers/leaders to reach consensus on the IS competencies that were both important and novel as compared to the IS competencies published to date. Results: Among 74 eligible ISCBPs identified, 46 responded (62% response rate). Respondent ISCBPs represented diverse areas of focus (e.g., global health, cardiopulmonary disease) and trainee stages (e.g., graduate students, mid-career faculty). While most respondent ISCBPs addressed core IS methods, targeting IS competencies was less consistent (33% for nongraduate/non-fellowship ISCBPs; >90% for graduate/national ISCBPs). Our modified Delphi process identified eight novel and important IS competencies related to increasing health equity or the speed of translation. Recommendations to sustain ISCBPs included securing financial administrative support. Conclusions: Current ISCBPs train learners across varying career stages in diverse focus areas. To promote rigor, we recommend ISCBPs address specific IS competencies, with consideration of these eight novel/emerging competencies. We also recommend ISCBPs report on their IS competencies, focus area(s), and trainee characteristics. ISCBP programs need administrative financial support. Plain Language Summary: There is a limited workforce capacity to conduct implementation science (IS) research. To address this gap, the number and type of IS capacity building Programs (ISCBPs) focusing on training researchers and practitioners in IS methods continue to increase. Our efforts to comprehensively identify and describe ISCBPs for researchers and practitioners highlighted four implications for leaders of ISCBPs related to program sustainment and rigor. First, we identified a range of contextual characteristics of ISCBPs, including the research topics, methods, and IS competencies addressed, and the types of trainees accepted. Second, given the variability of trainee types and research, rigorous ISCBP programs should tailor the IS competencies and methods addressed to the skills needed by the types of trainees in their program. Third, the field of IS needs to periodically revisit the competencies needed with attention to the skills needed in the field. We used a consensus-building process with ISCBP leaders and other IS experts to expand existing IS competencies and identified eight important, novel IS competencies that broadly relate to promoting health equity and speeding the translation of research to practice. Finally, as more institutions consider developing ISCBPs, we identified factors needed to support ISCBP sustainment, including ongoing financial support. In addition to these implications for ISCBP leaders, there are also policy implications. For example, IS journals may enact policies to require manuscripts evaluating ISCBP performance to report on certain contextual characteristics, such as the IS competencies addressed and types of trainees accepted. The field may also consider developing an accreditation body to evaluate the rigor of ISCBP curricula.

Dissemination and Implementation Science Approaches for Occupational Safety and Health Research: Implications for Advancing Total Worker Health.

Total Worker Health® (TWH), an initiative of the U.S. National Institute for Occupational Safety and Health, is defined as policies, programs, and practices that integrate protection from work-related health and safety hazards by promoting efforts that advance worker well-being. Interventions that apply the TWH paradigm improve workplace health more rapidly than wellness programs alone. Evidence of the barriers and facilitators to the adoption, implementation, and long-term maintenance of TWH programs is limited. Dissemination and implementation (D&I) science, the study of methods and strategies for bridging the gap between public health research and practice, can help address these system-, setting-, and worker-level factors to increase the uptake, impact, and sustainment of TWH activities. The purpose of this paper is to draw upon a synthesis of existing D&I science literature to provide TWH researchers and practitioners with: (1) an overview of D&I science; (2) a plain language explanation of key concepts in D&I science; (3) a case study example of moving a TWH intervention down the research-to-practice pipeline; and (4) a discussion of future opportunities for conducting D&I science in complex and dynamic workplace settings to increase worker safety, health, and well-being.

How Shared Is Shared Decision Making? Reaching the Full Potential of Patient-Clinician Collaboration in Mental Health.

ABSTRACT: Shared decision making in mental health is a priority for stakeholders, but faces significant implementation barriers, particularly in settings intended to serve people with serious mental illnesses (SMI). As a result, current levels of shared decision making are low. We highlight these barriers and propose that a novel paradigm, collaborative decision making, will offer conceptual and practical solutions at the systemic and patient/clinician level. Collaborative decision making is tailored for populations like people with SMI and other groups who experience chronic and complex symptoms, along with power imbalances within health systems. Advancing from shared decision making to collaborative decision making clarifies the mission of the model: to facilitate an empowering and recovery-oriented decision-making process that assigns equal power and responsibility to patients and clinicians; to improve alignment of treatment decisions with patient values and priorities; to increase patient trust and confidence in clinicians and the treatment process; and, in the end, to improve treatment engagement, satisfaction, and outcomes. The primary purpose of collaborative decision making is to increase values-aligned care, therefore prioritizing inclusion of patient values, including cultural values and quality of life-related outcomes. Given the broad and constantly changing context of treatment and care for many people with SMI (and also other groups), this model is dynamic and continuously evolving, ready for use across diverse contexts. Implementation of collaborative decision making includes increasing patient knowledge but also patient power, comfort, and confidence. It is one tool to reshape patient-clinician and patient-system relationships and to increase access to value-aligned care for people with SMI and other groups.

Understanding and applying the RE-AIM framework: Clarifications and resources.

INTRODUCTION: Understanding, categorizing, and using implementation science theories, models, and frameworks is a complex undertaking. The issues involved are even more challenging given the large number of frameworks and that some of them evolve significantly over time. As a consequence, researchers and practitioners may be unintentionally mischaracterizing frameworks or basing actions and conclusions on outdated versions of a framework. METHODS: This paper addresses how the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework has been described, summarizes how the model has evolved over time, and identifies and corrects several misconceptions. RESULTS: We address 13 specific areas where misconceptions have been noted concerning the use of RE-AIM and summarize current guidance on these issues. We also discuss key changes to RE-AIM over the past 20 years, including the evolution to Pragmatic Robust Implementation and Sustainability Model, and provide resources for potential users to guide application of the framework. CONCLUSIONS: RE-AIM and many other theories and frameworks have evolved, been misunderstood, and sometimes been misapplied. To some degree, this is inevitable, but we conclude by suggesting some actions that reviewers, framework developers, and those selecting or applying frameworks can do to prevent or alleviate these problems.

Understanding adaptations in the Veteran Health Administration's Transitions Nurse Program: refining methodology and pragmatic implications for scale-up.

BACKGROUND: When complex health services interventions are implemented in real-world settings, adaptations are inevitable. Adaptations are changes made to an intervention, implementation strategy, or context prior to, during, and after implementation to improve uptake and fit. There is a growing interest in systematically documenting and understanding adaptations including what is changed, why, when, by whom, and with what impact. The rural Transitions Nurse Program (TNP) is a program in the Veterans Health Administration (VHA), designed to safely transition a rural veteran from a tertiary hospital back home. TNP has been implemented in multiple cohorts across 11 sites nationwide over 4 years. In this paper, we describe adaptations in five TNP sites from the first cohort of sites and implications for the scale-up of TNP and discuss lessons learned for the systematic documentation and analysis of adaptations. METHODS: We used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) expanded version of the original Stirman framework to guide the rapid qualitative matrix analysis of adaptations. Adaptations were documented using multiple approaches: real-time database, semi-structured midpoint and exit interviews with implementors, and member checking with the implementation team. Interviews were recorded and transcribed. To combine multiple sources of adaptations, we used key domains from our framework and organized adaptations by time when the adaptation occurred (pre-, early, mid-, late implementation; sustainment) and categorized them as proactive or reactive. RESULTS: Forty-one unique adaptations were reported during the study period. The most common type of adaptation was changes in target populations (patient enrollment criteria) followed by personnel changes (staff turnover). Most adaptations occurred during the mid-implementation time period and varied in number and type of adaptation. The reasons for this are discussed, and suggestions for future adaptation protocols are included. CONCLUSIONS: This study demonstrates the feasibility of systematically documenting adaptations using multiple methods across time points. Implementors were able to track adaptations in real time across the course of an intervention, which provided timely and actionable feedback to the implementation team overseeing the national roll-out of the program. Longitudinal semi-structured interviews can complement the real-time database and elicit reflective adaptations.

Skills-based intervention to enhance collaborative decision-making: systematic adaptation and open trial protocol for veterans with psychosis.

BACKGROUND: Collaborative decision-making is an innovative decision-making approach that assigns equal power and responsibility to patients and providers. Most veterans with serious mental illnesses like schizophrenia want a greater role in treatment decisions, but there are no interventions targeted for this population. A skills-based intervention is promising because it is well-aligned with the recovery model, uses similar mechanisms as other evidence-based interventions in this population, and generalizes across decisional contexts while empowering veterans to decide when to initiate collaborative decision-making. Collaborative Decision Skills Training (CDST) was developed in a civilian serious mental illness sample and may fill this gap but needs to undergo a systematic adaptation process to ensure fit for veterans. METHODS: In aim 1, the IM Adapt systematic process will be used to adapt CDST for veterans with serious mental illness. Veterans and Veteran's Affairs (VA) staff will join an Adaptation Resource Team and complete qualitative interviews to identify how elements of CDST or service delivery may need to be adapted to optimize its effectiveness or viability for veterans and the VA context. During aim 2, an open trial will be conducted with veterans in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) to assess additional adaptations, feasibility, and initial evidence of effectiveness. DISCUSSION: This study will be the first to evaluate a collaborative decision-making intervention among veterans with serious mental illness. It will also contribute to the field's understanding of perceptions of collaborative decision-making among veterans with serious mental illness and VA clinicians, and result in a service delivery manual that may be used to understand adaptation needs generally in VA PRRCs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04324944.

VA Care Coordination Program Increased Primary Care Visits and Improved Transitional Care for Veterans Post Non-VA Hospital Discharge.

Veterans are increasingly eligible for non-VA care through the Veteran Health Administration (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks Act while maintaining care in the VA. Continuity of care is challenging when delivered across multiple systems resulting in avoidable complications. The Community Hospital Transitions Program (CHTP) intervention was developed to address challenges veterans face post non-VA hospitalization. Propensity score-matched analysis was used to compare outcomes between 334 intervention and matched control patients who were discharged from non-VA hospitals. Veterans in CHTP were more likely than matched controls to receive a follow-up appointment within 14 days (mean: 0.43 vs 0.34, P < .05) and 30 days (mean: 0.62 vs 0.50, P < .05). There were no significant differences in 30-day readmissions or 30-day emergency department visits. CHTP veterans received timely follow-up care post discharge in VA facilities. Providing quality care to dual-use veterans is dependent on coordinated transitional care.

Perspectives of Clinicians, Staff, and Veterans in Transitioning Veterans from non-VA Hospitals to Primary Care in a Single VA Healthcare System.

BACKGROUND: Veterans with healthcare needs utilize both Veterans Health Administration (VA) and non-VA hospitals. These dual-use veterans are at high risk of adverse outcomes due to the lack of coordination for safe transitions. OBJECTIVES: The aim of this study was to understand the barriers and facilitators to providing high-quality continuum of care for veterans transitioning from non-VA hospitals to the VA primary care setting. DESIGN: Guided by the practical robust implementation and sustainability model (PRISM) and the ideal transitions of care, we conducted a qualitative assessment using semi-structured interviews with clinicians, staff, and patients. SETTING: This study was conducted at a single urban VA medical center and two non-VA hospitals. PARTICIPANTS: A total of 70 participants, including 52 clinicians and staff (23 VA and 29 non-VA) involved in patient transition and 18 veterans recently discharged from non-VA hospitals, were included in this study. APPROACH: Data were analyzed using a conventional content analysis and managed in Atlas.ti (Berlin, Germany). RESULTS: Four major themes emerged where participants consistently discussed that transitions were delayed when they were not able to (1) identify patients as veterans and notify VA primary care of discharge, (2) transfer non-VA hospital medical records to VA primary care, (3) obtain follow-up care appointments with VA primary care, and (4) write VA formulary medications for veterans that they could fill at VA pharmacies. Participants also discussed factors involved in smooth transition and recommendations to improve care coordination. CONCLUSIONS: All participants perceived the current transition-of-care process across healthcare systems to be inefficient. Efforts to improve quality and safety in transitional care should address the challenges clinicians and patients experience when transitioning from non-VA hospitals to VA primary care.

Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial to improve quality of life: a study protocol for a randomized clinical trial.

BACKGROUND: People living with chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (ILD) suffer impaired quality of life due to burdensome symptoms and depression. The Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial aims to determine the effect of a multidisciplinary, team-based intervention on quality of life in people with these common diseases. METHODS/DESIGN: The ADAPT trial is a two-site, patient-level randomized clinical trial that examines the effectiveness of the ADAPT intervention compared to usual care on patient-reported quality of life at 6 months in veterans with CHF, COPD or ILD with poor quality of life and increased risk for hospitalization or death. The ADAPT intervention involves a multidisciplinary team-a registered nurse, social worker, palliative care specialist, and primary care provider (with access to a pulmonologist and cardiologist)-who meet weekly to make recommendations and write orders for consideration by participants' individual primary care providers. The nurse and social worker interact with participants over six visits to identify and manage a primary bothersome symptom and complete a structured psychosocial intervention and advance care planning. The primary outcome is change in patient-reported quality of life at 6 months as measured by the Functional Assessment of Chronic Illness Therapy-General questionnaire. Secondary outcomes at 6 months include change in symptom distress, depression, anxiety, disease-specific quality of life hospitalizations, and advance care planning communication and documentation. Intervention implementation will be assessed using a mixed-methods approach including a qualitative assessment of participants' and intervention personnel experiences and a quantitative assessment of care delivery, resources, and cost. DISCUSSION: The ADAPT trial studies an innovative intervention designed to improve quality of life for veterans with common, burdensome illnesses by targeting key underlying factors-symptoms and depression-that impair quality of life but persist despite disease-specific therapies. Leveraging the skills of affiliate health providers with physician supervision will extend the reach of palliative care and improve quality of life for those with advanced disease within routine outpatient care. The hybrid effectiveness/implementation design of the ADAPT trial will shorten the time to broader dissemination if effective and create avenues for future research. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02713347 . Registered March 19, 2016.

Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs.

There is consensus in dissemination and implementation (D&I) science that addressing contextual factors is critically important for understanding translation of health care delivery interventions but little agreement on which contextual factors are key determinants of implementation outcomes. We describe the application of the Practical Robust Implementation and Sustainability Model (PRISM), which expands the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to identify contextual factors across four diverse programs. Multiple qualitative methods were used to collect multilevel, multistakeholder perspectives from the adopting organizations and staff. We identified measures for evaluating context through the various domains of PRISM to guide health services research across the phases of program implementation. The PRISM domains of Recipients, Implementation and Sustainability Infrastructure, and External Environment identified important multilevel contextual factors, including variability in operational processes and available resources. These domains helped to facilitate planning and implementation phases of the four interventions and guide purposeful adaptations. We found assessments of PRISM domains useful to systematically assess multilevel contextual factors across various content areas as well as phases of program implementation. Additionally, these contextual factors were found to be relevant to RE-AIM outcomes. Lessons learned can be applied to future research as there is a need to investigate the measurement properties of PRISM and continue to test which contextual factors are most important to successful implementation and for which outcomes.