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Abstract Background The use of rapid qualitative methods has increased substantially over the past decade in quality improvement and health services research. These methods have gained traction in implementation research and practice, wherein real-time adjustments are often made to optimize processes and outcomes. This brisk increase begs the questions: what does rigor entail in projects that use rapid qualitative analysis (RQA)? How do we define a pragmatic framework to help research teams design and conduct rigorous and valid rapid qualitative projects? How can authors articulate rigor in their methods descriptions? Lastly, how can reviewers evaluate the rigor of rapid qualitative projects?. Methods A team of seven interdisciplinary qualitative methods experts developed a framework for ensuring rigor and validity in RQA and methods suitable for this analytic approach. We conducted a qualitative evidence synthesis to identify gaps in the literature and then drew upon literature, standard procedures within our teams, and a repository of rapid qualitative training materials to create a planning and reporting framework. We iteratively refined this framework through 11 group working meetings (60-90 minutes each) over the course of one year and invited feedback on items to ensure their completeness, clarity, and comprehensibility. Results The Planning for and Assessing Rigor in Rapid Qualitative Analysis (PARRQA) framework is organized progressively across phases from design to dissemination, as follows: 1) rigorous design (rationale and staffing), 2) semi-structured data collection (pilot and planning), 3) RQA: summary template development (accuracy and calibration), 4) RQA: matrix analysis (matrices), and 5) rapid qualitative data synthesis. Eighteen recommendations across these sections specify best practices for rigor and validity. Conclusions Rapid qualitative methods play a central role in implementation evaluations, with the potential to yield prompt information and insights about context, processes, and relationships. However, guidance on how to assess rigor is nascent. The PARRQA framework enhances the literature by offering criteria to ensure appropriate planning for and assessment of rigor in projects that involve RQA. This framework provides a consensus-based resource to support high-level qualitative methodological rigor in implementation science.

Abstract Background The University of California’s Diabetes Prevention Program (UC DPP) Initiative was implemented systemwide to address diabetes and obesity risk on all 10 campuses. As little is known about implementing lifestyle change programs in university settings, we examined implementation partners’ (i.e., UC DPP leaders and campus leads) perceptions of factors influencing program success on UC campuses. Methods We conducted qualitative interviews with UC DPP leaders and campus leads to examine challenges and opportunities with university-based DPP delivery models. Interviews were recorded, professionally transcribed, and reviewed in detail by the research team. Transcripts were analyzed using rapid qualitative analysis (RQA). The study was approved by the UCLA Institutional Review Board. All implementation partners provided verbal informed consent. Results Twenty-six implementation partners (8 UC DPP leaders and 18 campus leads) completed interviews in 2021. Seven themes were identified as critical for implementation, including (1) marketing and recruitment (i.e., market and recruit broadly through established channels as well as target at-risk populations); (2) enrollment (i.e., offer the program during convenient times and let participants know what to expect); (3) use an adaptable, evidence-based program; (4) secure funding for the program, participants, lifestyle coaches, and space; (5) hire experienced and dedicated staff and lifestyle coaches; (6) ensure leadership support; and (7) utilize campus linkages and resources. Perceptions of challenges faced with respect to these themes are also described. Conclusions This is one of the first studies to examine the challenges and opportunities of delivering an intensive lifestyle change program across 10 university sites. Understanding factors that enhance success of university-based diabetes prevention programs can facilitate UC DPP efforts and help inform delivery strategies of health and wellness programs across other university settings more broadly.

Abstract Introduction Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high‐impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, “grey areas,” or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. Discussion A group of IS experts affiliated with NIMH‐funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH‐related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence‐based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. Conclusions HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high‐impact HIV/MH implementation research.

Background Evidence-based practices (EBPs) improve housing and health for persons who have experienced homelessness with serious mental illness (PEH-SMI) but are challenging to implement. We tested a strategy to support pilot implementation of a 12-session housing skills training intervention for PEH-SMI, tailored from effective social skills training interventions. We aimed to optimize the implementation strategy and intervention prior to an implementation trial. Method We provided training and technical assistance to nine providers to support pilot implementation of this intervention to six groups of PEH-SMI ( n = 35) engaged in VA Greater Los Angeles’ homeless services. We used scales and semi-structured interviews with 14 PEH-SMI and all interventionists to inform implementation strategy adaptations, identify factors that impacted implementation, and assess perceptions of the intervention. Attendance was tracked and we observed a random sample of each interventionist's groups to assess treatment fidelity. Results Interventionists perceived the implementation strategy and the intervention favorably. However, interventionists often lacked physical space, staff, and resources (e.g., computers) to conduct the intervention. Interventionists found the content valuable for participants and a few suggested that group engagement should be a prerequisite for obtaining housing services. PEH-SMI were interested in the intervention's content and receptive to the group-based format. Participants attended a mean of 4 ± 3/12 groups; all groups observed had acceptable fidelity. Problems with intervention retention were described, suggesting challenges maintaining group participation when participants transitioned between VA homeless services. Conclusions To support the implementation of an EBP for PEH-SMI in homeless programs, these data suggest the value of training/technical assistance and strategies that enhance program-level buy-in to address resource concerns. Intervention adaptations, e.g., using a drop-in, open group format, in community-based settings that are easily accessible to PEH-SMI, may also increase adoption. This project was registered as “Improving Housing Outcomes for Homeless Veterans” Trial registration NCT03646149, registered 8/24/2018.

BackgroundThe University of California’s Diabetes Prevention Program (UC DPP) Initiative was implemented across all 10 UC campuses in 2018. The COVID-19 pandemic and accompanying mandates required swift changes to program delivery, including pivoting from in-person to virtual delivery (i.e., Zoom). Our goal was to assess multilevel constituent perceptions of the use of a virtual platform to deliver UC DPP due to COVID-19 mandates.MethodsWe conducted qualitative interviews with 68 UC DPP participants, coordinators, and leaders to examine the use of virtual platform delivery on the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of UC DPP. Transcripts were analyzed using rapid qualitative analysis and emergent themes were categorized using domains corresponding to RE-AIM framework.ResultsAmong UC DPP participants (n = 42), virtual delivery primarily impacted perceptions of UC DPP effectiveness and implementation. Some participants perceived program effectiveness to be negatively impacted, given their preference for in-person sessions, which they felt provided more engagement, peer support, and accountability. Implementation challenges included problems with virtual format (e.g., “Zoom fatigue”); however, several benefits were also noted (e.g., increased flexibility, maintenance of DPP connections during campus closures). UC DPP coordinators (n = 18) perceived virtual delivery as positively impacting UC DPP reach, since virtual platforms provided access for some who could not participate in-person, and negatively impacting effectiveness due to reduced engagement and lower peer support. UC leaders (n = 8) perceived that use of the virtual format had a positive impact on reach (e.g., increased availability, accessibility) and negatively impacted effectiveness (e.g., less intensive interactions on a virtual platform). Across constituent levels, the use of a virtual platform had little to no impact on perceptions of adoption and maintenance of UC DPP.ConclusionPerceptions of the reach, effectiveness, and implementation of UC DPP using a virtual platform varied across constituents, although all groups noted a potential negative impact on overall program effectiveness. Unanticipated program adaptations, including virtual delivery, present potential benefits as well as perceived drawbacks, primarily across the effectiveness domain. Understanding differential constituent perceptions of the impact of virtual delivery can help maximize RE-AIM and inform future UC DPP delivery strategies.

This Research Article deploys the frameworks of moral injury and moral agency to explore the experiences of veteran men who completed group therapy for military sexual trauma (MST). The article analyses ethnographically how veteran men with MST experience psychological growth via a replenishment of their sense of moral agency, thereby blending psychological theory about moral injury with anthropological theory about moral agency. It highlights how broader cultural experience can intersect and contribute to shame around MST, then depicts the ways that veterans recovered from a life characterised by pervasive shame, isolation, and compromised identity—psychological signs of moral injury—and made gains toward a life characterised by greater self-acceptance, an ability to tell one’s own story, and intimacy with others—signs of moral agency. In so doing, the article highlights the social and moral dimensions that can constitute psychological injury, and the way that addressing these dimensions can promote moral agency and thus mental health recovery.

Abstract Background Women Veterans are the fastest-growing segment of Veterans Health Administration (VA) users. The VA has invested heavily in delivering care for women Veterans that is effective, comprehensive, and gender-tailored. However, gender disparities persist in cardiovascular (CV) and diabetes risk factor control, and the rate of perinatal depression among women Veterans is higher than that among civilian women. Challenges such as distance, rurality, negative perception of VA, discrimination (e.g., toward sexual and/or gender minority individuals), and harassment on VA grounds can further impede women’s regular use of VA care. Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER) 2.0 builds on work to date by expanding access to evidence-based, telehealth preventive and mental health services for women Veterans with high-priority health conditions in rural and urban-isolation areas. Methods EMPOWER 2.0 will evaluate two implementation strategies, Replicating Effective Practices (REP) and Evidence-Based Quality Improvement (EBQI), in supporting the implementation and sustainment of three evidence-based interventions (Virtual Diabetes Prevention Program; Telephone Lifestyle Coaching Program; and Reach Out, Stay Strong Essentials) focused on preventive and mental health care for women Veterans. We will conduct a mixed-methods implementation evaluation using a cluster-randomized hybrid type 3 effectiveness-implementation trial design to compare the effectiveness of REP and EBQI on improved access to and rates of engagement in telehealth preventive lifestyle and mental health services. Other outcomes of interest include (a) VA performance metrics for telehealth care delivery and related clinical outcomes; (b) progression along the Stages of Implementation Completion; (c) adaptation, sensemaking, and experiences of implementation among multilevel stakeholders; and (d) cost and return on investment. We will also generate implementation playbooks for program partners to support scale-up and spread of these and future evidence-based women’s health programs and policies. Discussion EMPOWER 2.0 provides a model for mixed-methods hybrid type 3 effectiveness-implementation trial design incorporating evaluation of performance metrics, implementation progress, stakeholder experience, and cost and return on investment, with the ultimate goal of improving access to evidence-based preventive and mental telehealth services for women Veterans with high-priority health conditions. Trial registration ClinicalTrials.gov, NCT05050266 . Registered on 20 September 2021.

Abstract Background Approximately one-third of women Veterans Health Administration (VHA) users have substance use disorders (SUD). Early identification of hazardous substance use in this population is critical for the prevention and treatment of SUD. We aimed to understand challenges to identifying women Veterans with hazardous substance use to improve future referral, evaluation, and treatment efforts. Methods Design: We conducted a secondary analysis of semi-structured interviews conducted with VHA interdisciplinary women’s SUD providers at VA Greater Los Angeles Healthcare System. Participants: Using purposive and snowball sampling we interviewed 17 VHA providers from psychology, social work, women’s health, primary care, and psychiatry. Approach: Our analytic approach was content analysis of provider perceptions of identifying hazardous substance use in women Veterans. Results Providers noted limitations across an array of existing identification methodologies employed to identify women with hazardous substance use and believed these limitations were abated through trusting provider-patient communication. Providers emphasized the need to have a process in place to respond to hazardous use when identified. Provider level factors, including provider bias, and patient level factors such as how they self-identify, may impact identification of women Veterans with hazardous substance use. Tailoring language to be sensitive to patient identity may help with identification in women Veterans with hazardous substance use or SUD who are not getting care in VHA but are eligible as well as those who are not eligible for care in VHA. Conclusions To overcome limitations of existing screening tools and processes of identifying and referring women Veterans with hazardous substance use to appropriate care, future efforts should focus on minimizing provider bias, building trust in patient-provider relationships, and accommodating patient identities.

Qualitative research amplifies the voices of marginalized communities and thus plays a critical role in shaping our understanding of health inequities and their social determinants. Traditional qualitative approaches, such as grounded theory or thematic analysis, require extensive training and are time- and labor-intensive; as such, they may not be adequately suited to address healthy equity issues that require a swift response. Rapid qualitative analysis (RQA) is an action-oriented approach to qualitative data analysis that may be used when findings are needed to quickly inform practice. RQA capitalizes on using a team to summarize key points from qualitative data into matrices to explore relevant themes efficiently and systematically. In this paper, we provide case examples from our work applying RQA to health equity research with Latino communities to address community needs, such as responses to public health emergencies and the development of service delivery and technology interventions for infectious and chronic diseases. We draw from our collective experiences to share lessons learned and provide the following specific recommendations (“EARS”) to researchers interested in applying RQA for health equity research: (1) Employ RQA to address rapidly evolving, urgent, health equity challenges; (2) Assure quality and rigor throughout the RQA process; (3) Respond to barriers and problem-solve as needed; and (4) Strengthen community relationships before, during, and after using RQA. Overall, we advocate for the use of RQA to promote health equity due to its ability to integrate the vital perspectives of marginalized communities and efficiently respond to their needs.

The number of internationally adopted children living with perinatally-acquired HIV (IACP) in the U.S. is increasing, yet little is known about their families' experiences. The goal of this paper is to examine the lived experiences of adoptive parents as they navigate disclosure. A purposive sample of parents of IACP was recruited at two pediatric infectious disease clinics and via closed Facebook groups. Parents completed two semi-structured interviews. Interview questions centered on HIV disclosure decisions and child adjustment. Interviews were analyzed using an iterative process. All parents (n ​= ​24) identified as white and 20 had transracial families, with children adopted from 11 different countries. Analyses revealed that anticipated and experienced stigma shaped disclosure decisions and influenced strategies to mitigate HIV stigma. Disclosure to the child and family members was a significant challenge. We identified six child-focused strategies to reduce stigma including incremental disclosure. Once a child knew their HIV status, parents shifted to contextualize societal views of HIV and prepared their child for negative comments. We identified two family-focused strategies: normalizing conversations about HIV as well as race and adoption and limiting disclosure beyond the home. Parents emphasized privacy while trying to avoid the shame that accompanies secrecy. Parents with IACP navigate complex terrain that includes not only their child's stigmatized health condition but also their adoptive status. Despite the identified strategies, families still encountered challenges in communities and healthcare settings. Families with IACP would benefit from health and social systems that support stigma management strategies to minimize potential for negative experiences.

Abstract Background Implementation facilitators support the adoption of evidence-based practices and other improvement efforts in complex healthcare settings. Facilitators are trained to develop essential facilitation skills and facilitator effectiveness is typically evaluated post-implementation, but little is known about how facilitators apply and adapt didactic knowledge after training, or how learning and refining experiential knowledge occurs during the facilitation process. We propose the use of reflective writing as a tool to document and support facilitator learning and facilitator effectiveness. Methods Using an instrumental case study of the Coordination Toolkit and Coaching (CTAC) project, we explore the use of reflective writing by facilitators to support their learning and effectiveness. Six primary care clinics participated in weekly hour-long facilitation calls over a 12-month period to implement quality improvement projects related to care coordination. Two facilitators completed templated reflections after each facilitation call for their assigned sites, totaling 269 reflections. We used the declarative-procedural-reflective model, which defines the process of skill development in clinical practice, to qualitatively analyze the reflections. Two independent coders used content analysis principles to code text that captured facilitators’ observations, evaluations, interpretations, and communication. Descriptive statistics were used to analyze reflections by facilitator and by code within and across reflections. Results CTAC facilitators primarily used the reflections to summarize the calls (observation), assess the facilitation process and the tasks and activities they used (evaluation), document their thoughts about how to improve their own effectiveness (interpretation), and describe their communication with implementing teams. Ninety-one percent of reflections included observations, 42% interpretation, 41% evaluation, and 44% facilitator communication. In total, we coded 677 segments of text within reflections: 39% represented observation, 20% interpretation, 18% evaluation, and 23% facilitator communication. Conclusions The process of reflective writing allowed the CTAC facilitators the time and structure to evaluate their facilitation and to think critically about how to adjust their facilitation in response to their observations and interpretations. Reflective writing is a feasible and acceptable tool to support and document facilitator learning and effectiveness. Trial registration The project was registered with ClinicalTrials.gov ( NCT03063294 ) on February 24, 2017.

Abstract Background Type 2 diabetes can negatively impact long term health outcomes, healthcare costs and quality of life. However, intensive lifestyle interventions, including the Diabetes Prevention Program (DPP), can significantly lower risk of incident type 2 diabetes among overweight adults with prediabetes. Unfortunately, the majority of adults in the US who are at risk of developing diabetes do not engage in DPP-based lifestyle change programs. Increased adoption of evidence-based obesity and diabetes prevention interventions, such as the DPP, may help large employers reduce health risks and improve health outcomes among employees. In 2018, the University of California Office of thePresident (UCOP) implemented the UC DPP Initiative, a novel, multi-component program to address diabetes and obesity prevention across the UC system. Methods The goal of our study is to conduct a multifaceted evaluation of the UC DPP Initiative using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our evaluation will integrate unique and diverse UC data sources, including electronic health record (EHR) data, administrative claims, campus-based DPP cohort data, qualitative interviews and site visits. Our primary outcome of interest is the mean percent weight change among three groups of overweight/obese UC beneficiaries at risk for diabetes at 12-month follow-up. Secondary outcomes include mean percent weight change at 24-month follow-up, barriers and facilitators associated with implementatio, as well as the degree of program adoption and maintenance. Discussion Our study will help inform diabetes and obesity prevention efforts across the UC system. Findings from this evaluation will also be highly applicable to universities and large employers, as well as community organizers, healthcare organizations and insurers implementing the DPP and/or other health promotion interventions.

Abstract Background Implementation facilitators enable healthcare staff to effectively implement change, yet little is known about their affective (e.g., emotional, mental, physical) experiences of facilitation. We propose an expansion to the Integrated Promoting Action on Research in Health Services (i-PARIHS) framework that introduces facilitation intensity and facilitator resilience to better assess facilitators’ affective experiences. Methods We used an instrumental case study and facilitator data (logged reflections and debrief session notes) from the Coordination Toolkit and Coaching initiative to conceptualize facilitation intensity and facilitator resilience and to better understand the psychological impact of the facilitation process on facilitator effectiveness and implementation success. Results We define facilitation intensity as both the quantitative and/or qualitative measure of the volume of tasks and activities needed to engage and motivate recipients in implementation, and the psychological impact on the facilitator of conducting facilitation tasks and activities. We define facilitator resilience as the ability to cope with and adapt to the complexities of facilitation in order to effectively engage and motivate staff, while nurturing and sustaining hope, self-efficacy, and adaptive coping behaviors in oneself. Conclusions Facilitators’ affective experience may help to identify potential relationships between the facilitation factors we propose (facilitation intensity and facilitator resilience). Future studies should test ways of reliably measuring facilitation intensity and facilitator resilience and specify their relationships in greater detail. By supporting facilitator resilience, healthcare delivery systems may help sustain the skilled facilitator workforce necessary for continued practice improvement. Trial registration The project was registered with ClinicalTrials.gov ( NCT03063294 ) on February 24, 2017.

Background Inner context organizational factors proximally shape therapist experiences with evidence-based practice (EBP) implementation and may influence therapist self-efficacy, which has been linked to sustained use of EBPs in community mental health settings. Research has primarily focused on constructs such as implementation leadership and climate. However, the effects of such factors may depend upon other inner context dimensions, such as psychological safety. Psychologically safe environments are conducive to taking risks, speaking up about problems, and requesting feedback and may promote therapist self-efficacy during implementation. This study examines whether organizational sustainment leadership and sustainment climate relate to therapist EBP self-efficacy only under conditions of psychological safety. Methods Data were collected from 410 clinicians in 85 programs during the sustainment phase of a system-driven implementation of multiple EBPs in children's mental health services. Therapists reported on their organization's sustainment leadership, sustainment climate, psychological safety, and their own self-efficacy in delivering specific EBPs. Multilevel regression analyses were conducted to account for nested data structure. Results Among program-level variables, sustainment leadership and psychological safety both significantly predicted therapist self-efficacy. However, there were no significant interactions between program-level sustainment climate and psychological safety. Exploratory post-hoc analyses revealed a significant interaction between program-level sustainment leadership and therapist-level perceptions of psychological safety such that that the conditional effect of psychological safety on EBP self-efficacy was significant at high levels of sustainment leadership, but not at low or average levels. Conclusion We noted independent links between sustainment leadership, organizational psychological safety and therapists feelings of confidence and mastery with EBPs. Therapists’ individual perceptions of psychological safety were linked to self-efficacy only in programs with high sustainment leadership. Thus, sustainment leadership and psychological safety may both represent implementation intervention targets, but it may not be critical to assess for perceptions of psychological safety before deploying organizational leadership strategies. Plain language abstract Therapist self-efficacy is a therapist's belief that they are capable, knowledgeable, and skilled enough to deliver evidence-based practices (EBPs), and is thought to promote improved clinical and implementation outcomes, such as therapists’ sustained use of EBPs. Conditions within community mental health organizations may influence therapists’ sense of EBP self-efficacy. Leaders’ support and expectations for EBP implementation, and collective staff perceptions about the organization's climate to support EBPs are linked to positive therapist attitudes and EBP adoption. However, less is known about how these implementation-specific organizational factors associated with therapist EBP self-efficacy in the long-term, and how this may depend on general workplace conditions. Specifically, psychologically safe environments – where therapists feel safe taking risks such as asking questions, admitting mistakes, and trying new skills – may be needed to promote self-efficacy when therapists are tasked with learning and using complex multi-component EBP innovations. The current study tested the prediction that leader-driven and program-wide focus on EBP sustainment may promote therapist EBP self-efficacy only in organizations where conditions for learning are psychologically safe. Our findings confirmed that fostering strong sustainment focused leadership and psychologically safe environments may each be important for increasing therapists’ EBP self-efficacy. The model results suggested that individual therapist perceptions of psychological safety were more strongly related to EBP self-efficacy in programs with greater implementation leadership. Findings suggest the importance of increasing EBP leadership behavior to fully potentiate other facilitating conditions for therapist learning in the sustainment phase of EBP implementation initiatives.

Abstract Background Women’s Health Services (WHS) in the Veterans Health Administration (VA) has long partnered with VA researchers to evaluate how VA care is organized for women veterans. This partnership has yielded substantial evidence of (1) variations in women veterans’ access to comprehensive healthcare services that contribute to disparities in quality and patient experience and (2) the positive impacts of gender-specific care models for women veterans’ quality and satisfaction. In an effort to provide support specifically to sites that were low-performing in women’s health, WHS and the VA Quality Enhancement Research Initiative co-funded an effort to roll out and evaluate evidence-based quality improvement (EBQI), an implementation strategy with demonstrated effectiveness in a prior cluster randomized trial in women’s health clinics. Methods We will identify 21 low-performing VA facilities through a combination of practice data, VA quality metrics (by gender), and other indicators. In partnership with WHS, an EBQI contractor will deliver the EBQI “package”—local consensus development and priority setting using stakeholder panels, multilevel stakeholder engagement, practice facilitation, local EBQI team training, and formative feedback—to participating sites. We propose a dynamic wait-listed design to evaluate the WHS plans for seven EBQI launches per year over 3 years. The goal is to evaluate (1) barriers and facilitators to achieving delivery of comprehensive women’s health care in low-performing VA facilities; (2) effectiveness of EBQI in supporting low-performing VA facilities to achieve improved practice features (e.g., level of comprehensive services available, care coordination arrangements, Patient Aligned Care Team (PACT) features implemented, environment of care improvements), provider/staff attitudes (e.g., improved gender awareness, women’s health knowledge and practice), quality of care, and patient experience; and (3) contextual factors, local implementation processes, and organizational changes over time. Discussion Access to comprehensive women’s health care reduces fragmentation of care, improves patient satisfaction, and results in better patient outcomes. We hypothesize that EBQI implementation will result in changes in leadership awareness and buy-in, multilevel engagement in problem-solving, an enhanced culture of quality improvement, structural changes in care, improved provider/staff attitudes, and better quality and patient experience. Trial registration ClinicalTrials.gov, NCT03238417 . Registered 3 August 2017. Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT03238417

Background Effective implementation strategies might facilitate patient-centered medical home (PCMH) uptake and spread by targeting barriers to change. Evidence-based quality improvement (EBQI) is a multi-faceted implementation strategy that is based on a clinical-researcher partnership. It promotes organizational change by fostering innovation and the spread of those innovations that are successful. Previous studies demonstrated that EBQI accelerated PCMH adoption within Veterans Health Administration primary care practices, compared with standard PCMH implementation. Research to date has not documented fidelity to the EBQI implementation strategy, limiting usefulness of prior research findings. This paper develops and assesses clinical participants’ fidelity to three core EBQI elements for PCMH (EBQI-PCMH), explores the relationship between fidelity and successful QI project completion and spread (the outcome of EBQI-PCMH), and assesses the role of the clinical-researcher partnership in achieving EBQI-PCMH fidelity. Methods Nine primary care practice sites and seven across-sites, topic-focused workgroups participated (2010–2014). Core EBQI elements included leadership-frontlines priority-setting for QI, ongoing access to technical expertise, coaching, and mentoring in QI methods (through a QI collaborative), and data/evidence use to inform QI. We used explicit criteria to measure and assess EBQI-PCMH fidelity across clinical participants. We mapped fidelity to evaluation data on implementation and spread of successful QI projects/products. To assess the clinical-researcher partnership role in EBQI-PCMH, we analyzed 73 key stakeholder interviews using thematic analysis. Results Seven of 9 sites and 3 of 7 workgroups achieved high or medium fidelity to leadership-frontlines priority-setting. Fidelity was mixed for ongoing technical expertise and data/evidence use. Longer duration in EBQI-PCMH and higher fidelity to priority-setting and ongoing technical expertise appear correlated with successful QI project completion and spread. According to key stakeholders, partnership with researchers, as well as bi-directional communication between leaders and QI teams and project management/data support were critical to achieving EBQI-PCMH fidelity. Conclusions This study advances implementation theory and research by developing measures for and assessing fidelity to core EBQI elements in relationship to completion and spread of QI innovation projects or tools for addressing PCMH challenges. These results help close the gap between EBQI elements, their intended outcome, and the finding that EBQI-PCMH resulted in accelerated adoption of PCMH.

Abstract Background Intimate partner violence (IPV) against women is a global health problem that is a substantial source of human suffering. Within the United States (US), women veterans are at high risk for experiencing IPV. There is an urgent need for feasible, acceptable, and patient-centered IPV counseling interventions for the growing number of women treated in the US’s largest integrated healthcare system, the Veterans Health Administration (VHA). Implementation science and user-centered-design (UCD) can play an important role in accelerating the research-to-practice pipeline. Recovering from IPV through Strengths and Empowerment (RISE) is a flexible, patient-centered, modular-based program that holds promise as a brief counseling intervention for women veterans treated in VHA. We utilized a UCD approach to develop and refine RISE (prior to formal effectiveness evaluations) by soliciting early feedback from the providers where the intervention will ultimately be implemented. The current study reports on the feedback from VHA providers that was used to tailor and refine RISE. Method We conducted and analyzed semi-structured, key-informant interviews with VHA providers working in clinics relevant to the delivery of IPV interventions (n = 23) at two large medical centers in the US. Participants’ mean age was 42.6 years (SD = 11.6), they were predominately female (91.3%) and from a variety of relevant disciplines (39.1% psychologists, 21.7% social workers, 17.4% physicians, 8.7% registered nurses, 4.3% psychiatrists, 4.3% licensed marriage and family therapists, 4.3% peer specialists). We conducted rapid content analysis using a hybrid inductive-deductive approach. Results Providers perceived RISE as highly acceptable and feasible, noting strengths including RISE’s structure, patient-centered agenda, and facilitation of provider comfort in addressing IPV. Researchers identified themes related to content and context modifications, including requests for additional safety check-ins, structure for goal-setting, and suggestions for how to develop and implement RISE-specific trainings. Conclusions These findings have guided refinements to RISE prior to formal effectiveness testing in VHA. We discuss implications for the use of UCD in intervention development and refinement for interventions addressing IPV and other trauma in health care settings globally. Trial registration ClinicalTrials.gov identifier: NCT03261700; Date of registration: 8/25/2017, date of enrollment of first participant in trial: 10/22/2018. Unique Protocol ID: IIR 16–062.

Background: Researchers have argued for the value of ethnographic approaches to implementation science (IS). The contested meanings of ethnography pose challenges and possibilities to its use in IS. The goal of this study was to identify sources of commonality and variation, and to distill a set of recommendations for reporting ethnographic approaches in IS. Methods: We included in our scoping review English-language academic journal articles meeting two criteria: (1) IS articles in the healthcare field and (2) articles that described their approach as ethnographic. In March 2019, we implemented our search criteria in four academic databases and one academic journal. Abstracts were screened for inclusion by at least two authors. We iteratively develop a codebook for full-text analysis and double-coded included articles. We summarized the findings and developed reporting recommendations through discussion. Results: Of the 210 articles whose abstracts were screened, 73 were included in full-text analysis. The number of articles increased in recent years. Ethnographic approaches were used within a wide variety of theoretical approaches and research designs. Articles primarily described using interviews and observational methods as part of their ethnographic approaches, though numerous other methods were also employed. The most cited rationales for using ethnographic approaches were to capture context-specific phenomena, understand insiders’ perspective, and study complex interactions. In reporting on ethnographic approaches, we recommend that researchers provide information on researcher training and position, reflect on researchers’ positionality, describe observational methods in detail, and report results from all the methods used. Conclusion: The number of IS studies using ethnography has increased in recent years. Ethnography holds great potential for contributing further to IS, particularly to studying implementation strategy mechanisms and understanding complex adaptive systems. Plain language summary: Researchers have proposed that ethnographic methods may be valuable to implementation research and practice. Ethnographic approaches have their roots in the field of anthropology, but they are now used in many fields. These approaches often involve a researcher spending time in “real-world” settings, conducting interviews and observation to understand a group of people. That said, researchers disagree on the meaning of ethnography, which presents a challenge to its use in implementation science (IS). We searched for articles in the field of IS that described their methods as ethnographic. We then reviewed the articles, looking for similarities and differences in how and why ethnographic approaches were used. Many of these articles said they used ethnographic methods because they were interested in issues like context, research participants’ views, and complex interactions. We found a large amount of variation in how ethnographic methods were used. We developed recommendations for describing ethnographic methods in a way that readers can clearly understand. We also made several observations of the value ethnographic approaches can bring to IS. Ethnographic methods may be especially useful to studying unplanned and unexpected changes that take place during implementation. These recommendations and observations could be helpful to implementation researchers wishing to use ethnographic methods.

While patient-centered care (PCC) is a widely accepted aspect of health-care quality, its definition is still the subject of debate. We investigated health-care workers’ definitions of PCC by level of patient contact in job roles. Our qualitative study involved semi-structured interviews with key stakeholder employees (n = 66) at 6 Veterans’ Affairs health-care locations in Southern California. Interviews were recorded, transcribed, coded for definitions of PCC, and analyzed by participants’ self-described level of patient contact. Stakeholders whose role primarily involved patient contact tended to define PCC through: patient as a person, patient preferences, and shared decision-making. Stakeholders whose role did not primarily involve patient contact tended to define PCC through: patient-centered redesign, customer service, and access to services. Stakeholders with more patient contact emphasized patient-level and interpersonal concepts, while those with less patient contact emphasized system-level and business-oriented concepts. The focus on PCC-as-access may reflect influence of changing institutional climate on definitions of PCC for some stakeholders. To facilitate successful PCC efforts, health-care systems may need to leverage differing but complementary definitions of PCC within its workforce.

Abstract Background Ethnography has been proposed as a valuable method for understanding how implementation occurs within dynamic healthcare contexts, yet this method can be time-intensive and challenging to operationalize in pragmatic implementation. The current study describes an ethnographically-informed method of guided discussions developed for use by a multi-project national implementation program. Methods The EMPOWER QUERI is conducting three projects to implement innovative care models in VA women’s health for high-priority health concerns – prediabetes, cardiovascular risk, and mental health – utilizing the Replicating Effective Programs (REP) implementation strategy enhanced with stakeholder engagement and complexity science. Drawing on tenets of ethnographic research, we developed a lightly-structured method of guided “periodic reflections” to aid in documenting implementation phenomena over time. Reflections are completed as 30–60 min telephone discussions with implementation team members at monthly or bi-monthly intervals, led by a member of the implementation core. Discussion notes are coded to reflect key domains of interest and emergent themes, and can be analyzed singly or in triangulation with other qualitative and quantitative assessments to inform evaluation and implementation activities. Results Thirty structured reflections were completed across the three projects during a 15-month period spanning pre-implementation, implementation, and sustainment activities. Reflections provide detailed, near-real-time information on projects’ dynamic implementation context, including characteristics of implementation settings and changes in the local or national environment, adaptations to the intervention and implementation plan, and implementation team sensemaking and learning. Reflections also provide an opportunity for implementation teams to engage in recurring reflection and problem-solving. Conclusions To implement new, complex interventions into dynamic organizations, we must better understand the implementation process as it unfolds in real time. Ethnography is well suited to this task, but few approaches exist to aid in integrating ethnographic insights into implementation research. Periodic reflections show potential as a straightforward and low-burden method for documenting events across the life cycle of an implementation effort. They offer an effective means for capturing information on context, unfolding process and sensemaking, unexpected events, and diverse viewpoints, illustrating their value for use as part of an ethnographically-minded implementation approach. Trial registration The two implementation research studies described in this article have been registered as required: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (NCT02991534); and Implementation of Tailored Collaborative Care for Women Veterans (NCT02950961).

Abstract Background People with serious mental illness (SMI) die many years prematurely, with rates of premature mortality two to three times greater than the general population. Most premature deaths are due to “natural causes,” especially cardiovascular disease and cancer. Often, people with SMI are not well engaged in primary care treatment and do not receive high-value preventative and medical services. There have been numerous efforts to improve this care, and few controlled trials, with inconsistent results. While people with SMI often do poorly with usual primary care arrangements, research suggests that integrated care and medical care management may improve treatment and outcomes, and reduce treatment costs. Methods This hybrid implementation-effectiveness study is a prospective, cluster controlled trial of a medical home, the SMI Patient-Aligned Care Team (SMI PACT), to improve the healthcare of patients with SMI enrolled with the Veterans Health Administration. The SMI PACT team includes proactive medical nurse care management, and integrated mental health treatment through regular psychiatry consultation and a collaborative care model. Patients are recruited to receive primary care through SMI PACT based on having a serious mental illness that is manageable with treatment, and elevated risk for hospitalization or death. In a site-level prospective controlled trial, this project studies the effect, relative to usual care, of SMI PACT on provision of appropriate preventive and medical treatments, health-related quality of life, satisfaction with care, and medical and mental health treatment utilization and costs. Research includes mixed-methods formative evaluation of usual care and SMI PACT implementation to strengthen the intervention and assess barriers and facilitators. Investigators examine relationships among organizational context, intervention factors, and patient and clinician outcomes, and identify patient factors related to successful patient outcomes. Discussion This will be one of the first controlled trials of the implementation and effectiveness of a patient centered medical home for people with serious mental illness. It will provide information regarding the value of this strategy, and processes and tools for implementing this model in community healthcare settings. Trial registration ClinicalTrials.gov, NCT01668355. Registered August 20, 2012.

Abstract Background Organizational context plays a critical role in the implementation of evidence-based interventions. Implementation research to date has focused largely on internal, rather than external, context. This paper presents key features of external context and their impact on implementation of Eban II, an evidence-based HIV/AIDS prevention intervention currently being tested in community-based organizations (CBOs). We examine external context factors that have influenced implementation, highlighting the ways in which client needs, agency resources, and changing policies permeate the theorized boundary between internal and external context, affecting both organizational capacity for implementation research and implementation processes themselves. Methods Staff (n = 91) across participating CBOs completed a baseline survey of organizational functioning; a subset of key stakeholders (n = 15) completed semi-structured interviews. Client participants (n = 84) completed a baseline survey. Process notes and organizational documents were also analyzed. Results Organizational readiness for implementation was high across the organizations. However, despite apparent readiness, external contextual barriers to implementation were substantial. Three categories of barriers were identified: (1) client needs as a manifestation of social determinants of poverty, (2) community agency resources, and (3) local and national policy changes. Clients’ psychosocial vulnerability affected their everyday lives and priorities, which thereby affected the regularity and intensity of their interface with CBOs, and hence their participation in our intervention. CBOs typically lacked staffing and space. Furthermore, changing federal and state policy priorities destabilized the CBOs, which had a ripple effect on our study. Drawing on community-engaged research principles, we made numerous adjustments to the intervention format and structure according to the preferences and contexts of the CBOs. Had we not adjusted to external contextual factors, the organizations would not have been able to maintain their involvement and provide the intervention to their clients, despite expressed, genuine commitment to shared goals. Conclusions Community-based implementation studies need to address complex organizational and client needs, using community-engaged research principles. If these studies are community-based among vulnerable populations, they need to more thoroughly evaluate, monitor, and address the ways in which external contextual factors impinge upon implementation processes and outcomes, with a parallel need for more comprehensive measures of fiscal, political, and social determinants of implementation success. Trial registration number NCT01829282 (Registered April 11, 2013).

Abstract Background The Enhancing Mental and Physical health of Women through Engagement and Retention or EMPOWER program represents a partnership with the US Department of Veterans Health Administration (VA) Health Service Research and Development investigators and the VA Office of Women’s Health, National Center for Disease Prevention and Health Promotion, Primary Care-Mental Health Integration Program Office, Women’s Mental Health Services, and the Office of Patient Centered Care and Cultural Transformation. EMPOWER includes three projects designed to improve women Veterans’ engagement and retention in evidence-based care for high-priority health conditions, i.e., prediabetes, cardiovascular, and mental health. Methods/Design The three proposed projects will be conducted in VA primary care clinics that serve women Veterans including general primary care and women’s health clinics. The first project is a 1-year quality improvement project targeting diabetes prevention. Two multi-site research implementation studies will focus on cardiovascular risk prevention and collaborative care to address women Veterans’ mental health treatment needs respectively. All projects will use the evidence-based Replicating Effective Programs (REP) implementation strategy, enhanced with multi-stakeholder engagement and complexity theory. Mixed methods implementation evaluations will focus on investigating primary implementation outcomes of adoption, acceptability, feasibility, and reach. Program-wide organizational-, provider-, and patient-level measures and tools will be utilized to enhance synergy, productivity, and impact. Both implementation research studies will use a non-randomized stepped wedge design. Discussion EMPOWER represents a coherent program of women’s health implementation research and quality improvement that utilizes cross-project implementation strategies and evaluation methodology. The EMPOWER Quality Enhancement Research Initiative (QUERI) will constitute a major milestone for realizing women Veterans’ engagement and empowerment in the VA system. EMPOWER QUERI will be conducted in close partnership with key VA operations partners, such as the VA Office of Women’s Health, to disseminate and spread the programs nationally. Trial registration The two implementation research studies described in this protocol have been registered as required: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans: Trial registration NCT02991534 , registered 9 December 2016. Implementation of Tailored Collaborative Care for Women Veterans: Trial registration NCT02950961 , registered 21 October 2016.

Introduction: Supported housing−which offers permanent, community-based housing and supportive services−effectively addresses homelessness. Yet, many persons with serious mental illness (SMI) struggle to retain housing in these programs. Social skills−which facilitate social interactions and instrumental tasks−predict premature exits from supported housing. Though social skills training effectively improves social skills and functioning for persons with SMI, this intervention is essentially absent from supported housing initiatives. Methods: This study will use literature review, key informant interviews and an expert panel to adapt social skills training for supported housing, aiming to improve housing retention among SMI persons in these programs. In the Department of Housing and Urban Development-VA Supported Housing program (HUD-VASH) at VA Greater Los Angeles, we will conduct an effectiveness-implementation hybrid type I trial of the adapted intervention. Baseline and 6-month assessments (measuring social skills, mental health status, healthcare utilization, social networks, money management, and housing outcomes) will be conducted with intervention participants (n = 30) and a usual care control group (n = 20). We will use the generalized linear mixed model (GLMM) to compare change over 6 months between groups, capturing the intervention's effectiveness on factors strongly associated with housing retention. Qualitative data and surveys with staff, leadership, and participants will gather data on factors relevant to the intervention's future implementation in routine care. Discussion: Few effective psychosocial interventions for persons with SMI have been adapted or studied in supported housing initiatives. To our knowledge, this is the first study to adapt and study the effectiveness and implementation of social skills training in supported housing programs. Keywords: Serious mental illness, Veterans, Homelessness, Supported housing, Hybrid trial

IntroductionGreater specification of implementation strategies is a challenge for implementation science, but there is little guidance for delineating the use of multiple strategies involved in complex interventions. The Cardiovascular (CV) Toolkit project entails implementation of a toolkit designed to reduce CV risk by increasing women’s engagement in appropriate services. The CV Toolkit project follows an enhanced version of Replicating Effective Programs (REP), an evidence-based implementation strategy, to implement the CV Toolkit across four phases: pre-conditions, pre-implementation, implementation, and maintenance and evolution. Our current objective is to describe a method for mapping implementation strategies used in real time as part of the CV Toolkit project. This method supports description of the timing and content of bundled strategies and provides a structured process for developing a plan for implementation evaluation.MethodsWe conducted a process of strategy mapping to apply Proctor and colleagues’ rubric for specification of implementation strategies, constructing a matrix in which we identified each implementation strategy, its conceptual group, and the corresponding REP phase(s) in which it occurs. For each strategy, we also specified the actors involved, actions undertaken, action targets, dose of the implementation strategy, and anticipated outcome addressed. We iteratively refined the matrix with the implementation team, including use of simulation to provide initial validation.ResultsMapping revealed patterns in the timing of implementation strategies within REP phases. Most implementation strategies involving the development of stakeholder interrelationships and training and educating stakeholders were introduced during the pre-conditions or pre-implementation phases. Strategies introduced in the maintenance and evolution phase emphasized communication, re-examination, and audit and feedback. In addition to its value for producing valid and reliable process evaluation data, mapping implementation strategies has informed development of a pragmatic blueprint for implementation and longitudinal analyses and evaluation activities.DiscussionWe update recent recommendations on specification of implementation strategies by considering the implications for multi-strategy frameworks and propose an approach for mapping the use of implementation strategies within complex, multi-level interventions, in support of rigorous evaluation. Developing pragmatic tools to aid in operationalizing the conduct of implementation and evaluation activities is essential to enacting sound implementation research.