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.

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.

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.

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.

Financial difficulty, worry about affording care, and benefit finding in long-term survivors of cancer.

OBJECTIVE: To examine the associations of worry about affording care and reporting financial difficulties with benefit finding in long-term cancer survivors. METHODS: Long-term survivors of cancer (n = 547) in 3 integrated health care delivery systems completed the Medical Expenditure Panel Survey Cancer Survivorship Supplement. The relationship between benefit finding (becoming a stronger person, coping better, and making positive changes) and the potentially interacting factors of worry about affording care and financial difficulties was examined using multivariate logistic regression models. RESULTS: Of the total sample, 20% reported worry and 15% reported financial difficulty. Among those who reported no worry, financial difficulty was positively associated with becoming a stronger person (odds ratio [OR] = 2.89, 95% CI: 1.07, 7.80). Coping better was not associated with worry, financial difficulties, or the interaction of the two. Among those with no financial difficulty, worry was positively associated with making positive changes (OR = 2.64, 95% CI: 1.41, 4.96), and among those reporting no worry, financial difficulty had a non-significant positive association with making positive changes (OR = 1.98, 95% CI: 0.91, 4.31). Among those reporting worry, having financial difficulties was associated with lower odds of making positive changes (OR = 0.32, 95% CI: 0.13, 0.78). CONCLUSIONS: Our results suggest a complex relationship between financial difficulty, worry, and benefit finding. The combination of worry about affording care and financial difficulty needs to be addressed and further studied among cancer survivors, as the presence of both, but not alone, was negatively associated with making positive changes, an aspect of benefit finding.

Qualitative approaches to use of the RE-AIM framework: rationale and methods.

BACKGROUND: There have been over 430 publications using the RE-AIM model for planning and evaluation of health programs and policies, as well as numerous applications of the model in grant proposals and national programs. Full use of the model includes use of qualitative methods to understand why and how results were obtained on different RE-AIM dimensions, however, recent reviews have revealed that qualitative methods have been used infrequently. Having quantitative and qualitative methods and results iteratively inform each other should enhance understanding and lessons learned. METHODS: Because there have been few published examples of qualitative approaches and methods using RE-AIM for planning or assessment and no guidance on how qualitative approaches can inform these processes, we provide guidance on qualitative methods to address the RE-AIM model and its various dimensions. The intended audience is researchers interested in applying RE-AIM or similar implementation models, but the methods discussed should also be relevant to those in community or clinical settings. RESULTS: We present directions for, examples of, and guidance on how qualitative methods can be used to address each of the five RE-AIM dimensions. Formative qualitative methods can be helpful in planning interventions and designing for dissemination. Summative qualitative methods are useful when used in an iterative, mixed methods approach for understanding how and why different patterns of results occur. CONCLUSIONS: In summary, qualitative and mixed methods approaches to RE-AIM help understand complex situations and results, why and how outcomes were obtained, and contextual factors not easily assessed using quantitative measures.

Association of worry about cancer to benefit finding and functioning in long-term cancer survivors.

PURPOSE: Worry about cancer recurrence or progression is associated with negative effects of cancer, such as worse physical functioning, but associations with positive changes post-cancer, such as benefit finding, are unknown. We measured the proportion of patients reporting frequent worry about cancer recurrence or progression and examined the association between worry about cancer recurrence or progression to benefit finding and functioning in cancer. METHODS: We surveyed 594 long-term (5-10 years post-diagnosis) survivors of cancer (breast, prostate, colorectal, lung, melanoma) in this cross-sectional study. The survey asked about worry about cancer recurrence/progression, negative effects of cancer on mental and physical function, and benefit finding as a result of the cancer (positive effects). Multivariate regressions estimated associations of worry about cancer with negative and positive effects of cancer. RESULTS: Worrying about cancer often or all the time was reported by 19.6% of survivors. Worry about cancer was related to worse functioning (odds ratio (OR) range 1.40 to 1.46, all p's < .01). Worry about recurrence/progression was unrelated to benefit finding (all p's > .10). CONCLUSIONS: Worry about cancer was associated with negative, but not positive, effects of cancer. Treating worry about cancer is unlikely to reduce benefit finding after cancer. Given the high prevalence of worry about cancer and relationship to negative effects of cancer, clinical care should attempt to address this worry for long-term survivors.

Study protocol: improving the transition of care from a non-network hospital back to the patient's medical home.

BACKGROUND: The process of transitioning Veterans to primary care following a non-Veterans Affairs (VA) hospitalization can be challenging. Poor transitions result in medical complications and increased hospital readmissions. The goal of this transition of care quality improvement (QI) project is to identify gaps in the current transition process and implement an intervention that bridges the gap and improves the current transition of care process within the Eastern Colorado Health Care System (ECHCS). METHODS: We will employ qualitative methods to understand the current transition of care process back to VA primary care for Veterans who received care in a non-VA hospital in ECHCS. We will conduct in-depth semi-structured interviews with Veterans hospitalized in 2015 in non-VA hospitals as well as both VA and non-VA providers, staff, and administrators involved in the current care transition process. Participants will be recruited using convenience and snowball sampling. Qualitative data analysis will be guided by conventional content analysis and Lean Six Sigma process improvement tools. We will use VA claim data to identify the top ten non-VA hospitals serving rural and urban Veterans by volume and Veterans that received inpatient services at non-VA hospitals. Informed by both qualitative and quantitative data, we will then develop a transitions care coordinator led intervention to improve the transitions process. We will test the transition of care coordinator intervention using repeated improvement cycles incorporating salient factors in value stream mapping that are important for an efficient and effective transition process. Furthermore, we will complete a value stream map of the transition process at two other VA Medical Centers and test whether an implementation strategy of audit and feedback (the value stream map of the current transition process with the Transition of Care Dashboard) versus audit and feedback with Transition Nurse facilitation of the process using the Resource Guide and Transition of Care Dashboard improves the transition process, continuity of care, patient satisfaction and clinical outcomes. DISCUSSION: Our current transition of care process has shortcomings. An intervention utilizing a transition care coordinator has the potential to improve this process. Transitioning Veterans to primary care following a non-VA hospitalization is a crucial step for improving care coordination for Veterans.

A Framework for Enhancing the Value of Research for Dissemination and Implementation.

A comprehensive guide that identifies critical evaluation and reporting elements necessary to move research into practice is needed. We propose a framework that highlights the domains required to enhance the value of dissemination and implementation research for end users. We emphasize the importance of transparent reporting on the planning phase of research in addition to delivery, evaluation, and long-term outcomes. We highlight key topics for which well-established reporting and assessment tools are underused (e.g., cost of intervention, implementation strategy, adoption) and where such tools are inadequate or lacking (e.g., context, sustainability, evolution) within the context of existing reporting guidelines. Consistent evaluation of and reporting on these issues with standardized approaches would enhance the value of research for practitioners and decision-makers.

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 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.

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.

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.

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.

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.

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.

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.

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.