Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041.

Aligning the planning, development, and implementation of complex interventions to local contexts with an equity focus: application of the PRISM/RE-AIM Framework.

For the fields of implementation science and health equity, understanding and being responsive to local contexts is of utmost importance to better inform the development, implementation, and evaluation of healthcare and public health interventions to increase their uptake and sustainment. Contexts are multi-level and include political, historical, economic, and social factors that influence health, as well as organizational characteristics, reflecting the richness of members' views, resources, values, and needs. Poor alignment between solutions and those contextual characteristics could have an impact on inequities. The PRISM (Practical Robust Implementation and Sustainability Model) is a context-based implementation science framework that incorporates RE-AIM outcomes (Reach, Effectiveness, Adoption, Implementation, Maintenance) and offers guidance to researchers, practitioners, and their patient and community partners on how to conceptualize, assess, and address contextual domains with a focus on health equity. Drawing from systems thinking, participatory engagement, and health equity principles, this commentary expands on previous work to 1) offer a novel perspective on how to align an intervention's core functions and forms with the PRISM's contextual domains, and 2) foster an ongoing and iterative engagement process with diverse partners throughout the research and practice process using a co-creation approach. We recommend intervention-to-context alignment through iterative cycles. To that end, we present the RE-AIM Framework's 'outcomes cascade' to illustrate touch points of opportunity and gaps within and across each of the five RE-AIM outcomes to illustrate 'where things go wrong'. We present a case study to illustrate and offer recommendations for research and practice efforts to increase contextual responsiveness, and enhance alignment with context before, during, and after implementation efforts and to ensure equity is being addressed. We strive to make a conceptual contribution to advance the field of pragmatic research and implementation of evidence-based practices through the application of the contextually-based PRISM framework with a focus on health equity.

A case study in science-to-service application of epilepsy self-management.

AIMS: Epilepsy self-management (ESM), the overall approach of reducing seizures and optimizing whole-health, is a targeted approach to improve population health for people with epilepsy (PWE). "Self-management for people with epilepsy and a history of negative health events" (SMART) is an 8-session group-format, remotely delivered ESM. This report describes the evolution of SMART development, testing and scale-up, taking advantage of ESM team expertise, community relationships and infrastructure established by social service agencies that deliver support to PWE. METHODS: This is a case-study dissemination and implementation (D&I) science-to-service model using the RE-AIM framework approach (Reach, Effectiveness, Adoption, Implementation, and Maintenance) focused on 5 dimensions of individual- and setting-level outcomes important to program adoption, impact and sustainability. Performance evaluations include participation representativeness, ESM attendance and acceptability as well as change in relevant health outcomes. RESULTS: SMART D & I is implemented via a collaboration of 3 unique regional, epilepsy-focused nonprofit social service organizations and a university team that developed SMART. The ongoing collaboration is expanding SMART delivery to PWE across 13 U.S. states. Thus far, we have trained 17 Nurse and Peer Educators (NEs and PEs). PEs (N = 10) have a mean age 51.1 (SD 10.4) years and a mean age of epilepsy diagnosis of 29.4 (SD 19.3). Of 128 participants offered SMART, and who provided age data (N = 86) mean age was 37.7 years (SD 14.4). Of participants who provided data on gender and race (N = 89), 65 were women (73.9 %), 18 African-American (20.2 %). Mean age of epilepsy diagnosis was 19.4 years (SD 16.6) and 59 (52.2 %) of PWE reported having seizures in the last 30 days pre-SMART sessions. Among those with attendance data (N = 103), mean number of SMART groups attended was 5.7 (SD 2.3). Mean values for past 30-day seizure frequency, 9-item Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Inventory (GAD-7) and 10-item Quality of Life in Epilepsy Scale (QOLIE-10) for PWE that provided both pre and post SMART data were 7.6 (SD 15.8) vs 2.8 (SD 3.4) p = 0.3, 7.63 (SD 6.6) vs 6.3 (SD 5.7) p = 0.95, 6.6 (SD 5.7) vs 6.67(SD 5.3) p = 0.47 and 2.8 (SD 0.8) vs 2.7 (SD 1.0) p = 0.07 respectively. CONCLUSIONS: Implementing ESM using a RE-AIM/Iterative RE-AIM framework links intervention developers and community partners. While PWE have substantial barriers to health, including frequent seizures, they are able engage in the SMART program. Although a major limitation to patient-level evaluation is challenges in collecting post-SMART follow-up data, preliminary findings suggest a trend for improved quality of life.

Applying Implementation Science to Advance Electronic Health Record-Driven Learning Health Systems: Case Studies, Challenges, and Recommendations.

With the widespread implementation of electronic health records (EHRs), there has been significant progress in developing learning health systems (LHSs) aimed at improving health and health care delivery through rapid and continuous knowledge generation and translation. To support LHSs in achieving these goals, implementation science (IS) and its frameworks are increasingly being leveraged to ensure that LHSs are feasible, rapid, iterative, reliable, reproducible, equitable, and sustainable. However, 6 key challenges limit the application of IS to EHR-driven LHSs: barriers to team science, limited IS experience, data and technology limitations, time and resource constraints, the appropriateness of certain IS approaches, and equity considerations. Using 3 case studies from diverse health settings and 1 IS framework, we illustrate these challenges faced by LHSs and offer solutions to overcome the bottlenecks in applying IS and utilizing EHRs, which often stymie LHS progress. We discuss the lessons learned and provide recommendations for future research and practice, including the need for more guidance on the practical application of IS methods and a renewed emphasis on generating and accessing inclusive data.

Implementation strategies preferred by primary care clinicians to facilitate cancer prevention and control activities.

Key clinical and community members need to be involved in the identification of feasible and impactful implementation strategies for translation of evidence-based interventions into practice. While a wide range of implementation strategies has been developed, there is little research on their applicability for cancer prevention and control (CPC) efforts in primary care. We conducted a survey of primary care physicians to identify implementation strategies they perceive as most feasible and impactful. The survey included both primary prevention behavior change counseling and cancer screening issues. Analyses contrasted ratings of feasibility and impact of nine implementation strategies, and among clinicians in different settings with a focus on comparisons between clinicians in rural vs. non-rural settings. We recruited a convenience sample of 326 respondents from a wide range of practice types from four practice-based research networks in 49 states and including 177 clinicians in rural settings. Ratings of impact were somewhat higher than those for feasibility. Few of the nine implementation strategies were high on both impact and feasibility. Only 'adapting to my practice' was rated higher than a 4 ("moderate") on both impact and feasibility. There were relatively few differences between rural and non-rural clinicians or associated with other clinician or setting characteristics. There is considerable variability in perceived impact and feasibility of implementation strategies for CPC activities among family medicine clinicians. It is important to assess both feasibility and impact of implementation strategies as well as their generalizability across settings. Our results suggest that optimal strategies to implement evidence-based CPC activities will likely need to be adapted for primary care settings. Future research is needed to replicate these findings and identify practical, implementation partner informed implementation strategies.

RE-AIM implementation outcomes and service outcomes: what's the connection? results of a cross-sectional survey.

BACKGROUND: Implementation science and health services outcomes research each focus on many constructs that are likely interrelated. Both fields would be informed by increased understanding of these relationships. However, there has been little to no investigation of the relationships between implementation outcomes and service outcomes, despite general acknowledgement that both types of outcomes are important in the pathway to individual and population health outcomes. Given the lack of objective data about the links between implementation and service outcomes, an initial step in elucidating these relationships is to assess perceptions of these relationships among researchers and practitioners in relevant fields. The purpose of this paper is to assess perceived relationships between Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework outcomes and service outcomes, testing five a priori hypotheses about which perceived relationships may be strongest. METHODS: A cross-sectional online survey was administered to a convenience sample of implementation scientists, health services researchers, and public health and medical practitioners from a variety of settings. Respondents provided information on their discipline, training, practice and research settings, and levels of experience in health service outcomes research, implementation science, and the RE-AIM framework. Next, they rated perceived relationships between RE-AIM and service outcomes. Repeated measures analysis of variance were used to test a priori hypotheses. Exploratory analyses assessed potential differences in mean ratings across groups of respondents categorized by discipline, setting, and levels of implementation science, health services, and RE-AIM experience. RESULTS: Surveys were completed by 259 respondents, most of whom were employed in academic and medical settings. The majority were doctoral-level researchers and educators or physicians. Reported levels of experience with implementation research, health services research, and the RE-AIM framework varied. The strongest perceived relationships overall were between Implementation/Fidelity and Effectiveness (as a service outcome); Maintenance and Efficiency; Reach and Equity; Adoption and Equity; Implementation/Adaptation and Patient-Centeredness; Adoption and Patient-Centeredness; and Implementation/Fidelity and Safety. All but one of the a priori hypotheses were supported. No significant differences in ratings of perceived relationships were observed among subgroups of respondents. CONCLUSIONS: This study is an initial step in developing conceptual understanding of the links between implementation outcomes, health services outcomes, and health outcomes. Our findings on perceived relationships between RE-AIM and services outcomes suggest some areas of focus and identify several areas for future research to advance both implementation science and health services research toward common goals of improving health outcomes.

A Multi-Method Study of Patient Reach and Attendance in a Pragmatic Trial of Diabetes Shared Medical Appointments.

Shared medical appointments (SMAs) are an evidence-based approach to diabetes care in primary care settings, yet practices can struggle to ensure participation, especially among racial and ethnic minority and low-income patients. We conducted a multimethod evaluation of reach and attendance in the Invested in Diabetes study of the comparative effectiveness of two SMA delivery models (standardized and patient-driven) in two practice settings (federally qualified health centers [FQHCs] and clinics serving more commercially insured patients). Through this study, 22 practices reached 6.2% of patients with diabetes through SMAs over 3 years, with good attendance for both practice types and both SMA delivery models. FQHCs were especially successful at enrolling underserved populations and improved attendance with virtual SMAs.

Psychosocial Interventions for Pain Management in Breast Cancer Survivors: A RE-AIM Evaluation.

Psychosocial interventions for breast-cancer-related pain are effective, yet over 45% of survivors continue to struggle with this often-chronic side effect. This study evaluated multilevel indicators that can influence successful translation of interventions into clinical practice. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was applied to evaluate reporting of individual and setting/staff-level intervention indicators. A systematic search and multi-step screening process identified 31 randomized controlled trials for psychosocial interventions for breast cancer-related pain. Average reporting of indicators for individual-level dimensions (Reach and Effectiveness) were 65.2% and 62.3%, respectively. Comparatively, indicators for setting/staff-level dimensions were reported at a lower average frequency (Implementation, 46.8%; Adoption, 15.2%; Maintenance, 7.7%). Low reporting of setting/staff-level dimensions suggests gaps in the sustained implementation of psychosocial interventions. Implementation science methods and frameworks could improve trial design and accelerate the translation of psychosocial interventions for breast cancer-related pain into clinical practice.

Designing for Dissemination and Sustainability to Promote Equitable Impacts on Health.

Designing for dissemination and sustainability (D4DS) refers to principles and methods for enhancing the fit between a health program, policy, or practice and the context in which it is intended to be adopted. In this article we first summarize the historical context of D4DS and justify the need to shift traditional health research and dissemination practices. We present a diverse literature according to a D4DS organizing schema and describe a variety of dissemination products, design processes and outcomes, and approaches to messaging, packaging, and distribution. D4DS design processes include stakeholder engagement, participatory codesign, and context and situation analysis, and leverage methods and frameworks from dissemination and implementation science, marketing and business, communications and visualarts, and systems science. Finally, we present eight recommendations to adopt a D4DS paradigm, reflecting shifts in ways of thinking, skills and approaches, and infrastructure and systems for training and evaluation.

Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .

Hypertension in Guatemala's Public Primary Care System: A Needs Assessment Using the Health System Building Blocks Framework.

BACKGROUND: Uncontrolled hypertension represents a substantial and growing burden in Guatemala and other low and middle-income countries. As a part of the formative phase of an implementation research study, we conducted a needs assessment to define short- and long-term needs and opportunities for hypertension services within the public health system. METHODS: We conducted a multi-method, multi-level assessment of needs related to hypertension within Guatemala's public system using the World Health Organization's health system building blocks framework. We conducted semi-structured interviews with stakeholders at national (n = 17), departmental (n = 7), district (n = 25), and community (n = 30) levels and focus groups with patients (3) and frontline auxiliary nurses (3). We visited and captured data about infrastructure, accessibility, human resources, reporting, medications and supplies at 124 health posts and 53 health centers in five departments of Guatemala. We conducted a thematic analysis of transcribed interviews and focus group discussions supported by matrix analysis. We summarized quantitative data observed during visits to health posts and centers. RESULTS: Major challenges for hypertension service delivery included: gaps in infrastructure, insufficient staffing and high turnover, limited training, inconsistent supply of medications, lack of reporting, low prioritization of hypertension, and a low level of funding in the public health system overall. Key opportunities included: prior experience caring for patients with chronic conditions, eagerness from providers to learn, and interest from patients to be involved in managing their health. The 5 departments differ in population served per health facility, accessibility, and staffing. All but 7 health posts had basic infrastructure in place. Enalapril was available in 74% of health posts whereas hydrochlorothiazide was available in only 1 of the 124 health posts. With the exception of one department, over 90% of health posts had a blood pressure monitor. CONCLUSIONS: This multi-level multi-method needs assessment using the building blocks framework highlights contextual factors in Guatemala's public health system that have been important in informing the implementation of a hypertension control trial. Long-term needs that are not addressed within the scope of this study will be important to address to enable sustained implementation and scale-up of the hypertension control approach.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

Integrating the Practical Robust Implementation and Sustainability Model With Best Practices in Clinical Decision Support Design: Implementation Science Approach.

BACKGROUND: Clinical decision support (CDS) design best practices are intended to provide a narrative representation of factors that influence the success of CDS tools. However, they provide incomplete direction on evidence-based implementation principles. OBJECTIVE: This study aims to describe an integrated approach toward applying an existing implementation science (IS) framework with CDS design best practices to improve the effectiveness, sustainability, and reproducibility of CDS implementations. METHODS: We selected the Practical Robust Implementation and Sustainability Model (PRISM) IS framework. We identified areas where PRISM and CDS design best practices complemented each other and defined methods to address each. Lessons learned from applying these methods were then used to further refine the integrated approach. RESULTS: Our integrated approach to applying PRISM with CDS design best practices consists of 5 key phases that iteratively interact and inform each other: multilevel stakeholder engagement, designing the CDS, design and usability testing, thoughtful deployment, and performance evaluation and maintenance. The approach is led by a dedicated implementation team that includes clinical informatics and analyst builder expertise. CONCLUSIONS: Integrating PRISM with CDS design best practices extends user-centered design and accounts for the multilevel, interacting, and dynamic factors that influence CDS implementation in health care. Integrating PRISM with CDS design best practices synthesizes the many known contextual factors that can influence the success of CDS tools, thereby enhancing the reproducibility and sustainability of CDS implementations. Others can adapt this approach to their situation to maximize and sustain CDS implementation success.

Making Health Research Matter: A Call to Increase Attention to External Validity.

Most of the clinical research conducted with the goal of improving health is not generalizable to nonresearch settings. In addition, scientists often fail to replicate each other's findings due, in part, to lack of attention to contextual factors accounting for their relative effectiveness or failure. To address these problems, we review the literature on assessment of external validity and summarize approaches to designing for generalizability. When investigators conduct systematic reviews, a critical need is often unmet: to evaluate the pragmatism and context of interventions, as well as their effectiveness. Researchers, editors, and grant reviewers can implement key changes in how they consider and report on external validity issues. For example, the recently published expanded CONSORT figure may aid scientists and potential program adopters in summarizing participation in and representativeness of a program across different settings, staff, and patients. Greater attention to external validity is needed to increase reporting transparency, improve program dissemination, and reduce failures to replicate research.

An Adaptive, Contextual, Technology-Aided Support (ACTS) System for Chronic Illness Self-Management.

Policy Points Fundamental changes are needed in how complex chronic illness conditions are conceptualized and managed. Health management plans for chronic illness need to be integrated, adaptive, contextual, technology aided, patient driven, and designed to address the multilevel social environment of patients' lives. Such primary care-based health management plans are feasible today but will be even more effective and sustainable if supported by systems thinking, technological advances, and policies that create and reinforce home, work, and health care collaborations. CONTEXT: The current health care system is failing patients with chronic illness, especially those with complex comorbid conditions and social determinants of health challenges. The current system combined with unsustainable health care costs, lack of support for primary care in the United States, and aging demographics create a frightening probable future. METHODS: Recent developments, including integrated behavioral health, community resources to address social determinants, population health infrastructure, patient-centered digital-health self-management support, and complexity science have the potential to help address these alarming trends. This article describes, first, the opportunity to integrate these trends and, second, a proposal for an integrated, patient-directed, adaptive, contextual, and technology-aided support (ACTS) system, based on a patient's life context and home/primary care/work-setting "support triangle." FINDINGS: None of these encouraging trends is a panacea, and although most have been described previously, they have not been integrated. Here we discuss an example of integration using these components and how our proposed model (termed My Own Health Report) can be applied, along with its strengths, limitations, implications, and opportunities for practice, policy, and research. CONCLUSIONS: This ACTS system builds on and extends the current chronic illness management approaches. It is feasible today and can produce even more dramatic improvements in the future.

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.

Pragmatic Applications of RE-AIM for Health Care Initiatives in Community and Clinical Settings.

The RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) planning and evaluation framework has been applied broadly, but users often have difficulty in applying the model because of data collection needs across multiple domains and sources. Questions in the more common "who, what, where, how, when, and why" format may be an effective guide to ensure that individual participants, organization staff, and the perspectives of the setting are considered in planning and evaluation. Such a format can also help users in typical community and clinical settings to identify which outcomes are most valued and to focus limited measurement resources. Translations of RE-AIM that are easy to understand and apply are needed for application in real-world community and clinical settings where research and evaluation resources are limited. The purpose of this article is to provide simplified, pragmatic, user-centered and stakeholder-centered recommendations to increase the use of RE-AIM in community and clinical settings and in translational research.

Pragmatic dissemination and implementation research models, methods and measures and their relevance for nursing research.

BACKGROUND: Pragmatic dissemination and implementation (D&I) research approaches can benefit patient care because they emphasize real-world settings and populations. Nurse scientists have an opportunity to reduce the gap between science and practice by using pragmatic D&I research and sustainability strategies. PURPOSE: This article discusses pragmatic models, methods, and measures used in D&I research and their relevance for nursing research and enhancing population health. METHODS: Summary of pragmatic D&I models and related methods for designing a pragmatic studies. We discuss the RE-AIM framework and the PRECIS-2 planning aid and figure in detail. A case study is provided and application to nursing research is discussed. DISCUSSION: Successful translation of pragmatic D&I research demands an approach that addresses external validity, and customization at multiple levels including the patient, clinician, and setting. Context is critically important, and it is never too early to design for dissemination. CONCLUSIONS: Pragmatic D&I approaches are needed to speed research translation, reduce avoidable waste of funding, improve clinical care, and enhance population health. Pragmatic D&I research is an area of tremendous opportunity for the nursing science community.

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.