Creating research-ready partnerships: the initial development of seven implementation laboratories to advance cancer control.

BACKGROUND: In 2019-2020, with National Cancer Institute funding, seven implementation laboratory (I-Lab) partnerships between scientists and stakeholders in 'real-world' settings working to implement evidence-based interventions were developed within the Implementation Science Centers in Cancer Control (ISC3) consortium. This paper describes and compares approaches to the initial development of seven I-Labs in order to gain an understanding of the development of research partnerships representing various implementation science designs. METHODS: In April-June 2021, members of the ISC3 Implementation Laboratories workgroup interviewed research teams involved in I-Lab development in each center. This cross-sectional study used semi-structured interviews and case-study-based methods to collect and analyze data about I-Lab designs and activities. Interview notes were analyzed to identify a set of comparable domains across sites. These domains served as the framework for seven case descriptions summarizing design decisions and partnership elements across sites. RESULTS: Domains identified from interviews as comparable across sites included engagement of community and clinical I-Lab members in research activities, data sources, engagement methods, dissemination strategies, and health equity. The I-Labs use a variety of research partnership designs to support engagement including participatory research, community-engaged research, and learning health systems of embedded research. Regarding data, I-Labs in which members use common electronic health records (EHRs) leverage these both as a data source and a digital implementation strategy. I-Labs without a shared EHR among partners also leverage other sources for research or surveillance, most commonly qualitative data, surveys, and public health data systems. All seven I-Labs use advisory boards or partnership meetings to engage with members; six use stakeholder interviews and regular communications. Most (70%) tools or methods used to engage I-Lab members such as advisory groups, coalitions, or regular communications, were pre-existing. Think tanks, which two I-Labs developed, represented novel engagement approaches. To disseminate research results, all centers developed web-based products, and most (n = 6) use publications, learning collaboratives, and community forums. Important variations emerged in approaches to health equity, ranging from partnering with members serving historically marginalized populations to the development of novel methods. CONCLUSIONS: The development of the ISC3 implementation laboratories, which represented a variety of research partnership designs, offers the opportunity to advance understanding of how researchers developed and built partnerships to effectively engage stakeholders throughout the cancer control research lifecycle. In future years, we will be able to share lessons learned for the development and sustainment of implementation laboratories.

The Psychosocial Needs of Patients Participating in Diabetes Shared Medical Appointments.

BACKGROUND: Patient reported outcomes (PROs) for diabetes are self-reported and often give insight into outcomes important to people with diabetes. Federally Qualified Health Centers (FQHCs) see patients who may have higher levels of diabetes distress and lower levels of self-care behaviors. METHODS: The Invested in Diabetes study is a comparative effectiveness trial of diabetes Shared Medical Appointments (SMAs) in FQHCs and non-FQHC settings. PROs measure outcomes including validated measures on diabetes distress. SETTING AND PARTICIPANTS: 616 people from 22 practices completed PROs prior to SMAs. At FQHCs, participants were younger (average 57.7 years vs 66.9 years, p < 0.0001), more likely to be female (36.8% vs 46.1%, p = 0.02), and fewer spoke English (72.7% vs 99.6%, p < 0.0001). RESULTS: At FQHCs, diabetes distress was higher (2.1 vs 1.8, P = .02), more people were current smokers (14.3% vs 4.7%, P = .0002), on insulin (48.9% vs 22.3%, P < .0001) and reported food insecurity (52.7% vs 26.2%, P < .0001). After controlling for sociodemographic factors, these differences were nonsignificant. CONCLUSIONS: Higher numbers of patients at FQHCs report diabetes distress and food insecurity compared with patients in non-FQHC settings, indicating that patient social circumstances need to be considered as part of program implementation.

IMAGINE: A Trial of Messaging Strategies for Social Needs Screening and Referral.

INTRODUCTION: Health-related social needs are associated with poor health outcomes. Many primary care practices now screen and refer patients with health-related social needs to assistance organizations, but some patients decline screening or assistance. Improving communication about health-related social needs screening and referral could increase screening response and assistance acceptance rates. STUDY DESIGN: This is a pragmatic, nonrandomized 3-stage trial of messages and communication strategies for health-related social needs screening and referral. Messages and strategies were informed by qualitative analysis of stakeholder interviews and were developed through an iterative, patient-, and stakeholder-engaged process. SETTING/PARTICIPANTS: Settings included 3 primary care clinics serving primarily low-income patients in western Colorado. INTERVENTION: Stage 1 includes usual clinic processes for health-related social needs screening (form given to patients at the front desk without additional explanation), Stage 2 includes adding written patient-friendly messages regarding the purpose of health-related social needs screening and referral to usual clinic processes, and Stage 3 includes adding verbal messages delivered by a medical assistant (form given to patients by a medical assistant during the rooming process). MAIN OUTCOME MEASURES: Primary outcomes include (1) screening form response rate and (2) acceptance of referral for assistance rate among patients with health-related social needs. Secondary outcomes include (1) comfort with screening, (2) perceived helpfulness of screening, and (3) receipt of explanation about screening. RESULTS: All data collection and analysis occurred in 2021. Study Stage 2 was not associated with significant changes in any outcomes. Stage 3 was associated with decreased odds of screening form response at 2 of the 3 clinics relative to those of Stage 1 (OR=0.1, 95% CI=0.1, 0.3; OR=0.4, 95% CI=0.2, 0.7) but with increased odds of assistance acceptance (OR=2.1, 95% CI=1.1, 4.0) among patients with needs who responded to the screening form. Stage 3 was also associated with higher odds of patients perceiving screening as helpful and receiving an explanation about screening. CONCLUSIONS: Altering practice workflows to provide verbal explanations of health-related social needs screening may reduce response rates but may encourage responders to accept assistance referrals. Optimal communication strategies and workflows will likely differ depending on the intended goals of health-related social needs screening and referral.

Adapting Diabetes Shared Medical Appointments to Fit Context for Practice-Based Research (PBR).

INTRODUCTION: Complex behavioral interventions such as diabetes shared medical appointments (SMAs) should be tested in pragmatic trials. Partnerships between dissemination and implementation scientists and practice-based research networks can support adaptation and implementation to ensure such interventions fit the context. This article describes adaptations to and implementation of the Targeted Training in Illness Management (TTIM) intervention to fit the primary care diabetes context. METHODS: The Invested in Diabetes pragmatic trial engaged 22 practice-based research network practices to compare 2 models of diabetes SMAs, based on TTIM. We used surveys, interviews, and observation to assess practice contextual factors, such as practice size, location, payer mix, change and work culture, motivation to participate, and clinical and administrative capacity. The enhanced Replicating Effective Programs framework was used to guide adaptations to TTIM and implementation in participating practices. RESULTS: Practices varied in size and patient demographics. All practices had integrated behavioral health, but limited health educators or prescribing providers. Adaptations to SMA delivery accommodated the need for flexibility in personnel and reduced scheduling burden. Adaptations to TTIM content were designed to fit general primary care diabetes and Spanish-speaking patients. CONCLUSION: Enhanced Replicating Effective Programs is a useful process framework for adaptation, implementation, and testing of diabetes SMAs in primary care. Adapting intervention content, delivery, and training to fit context can help ensure pragmatic trials have both internal and external validity. Attention to intervention fit to context can support continued practice engagement in research and sustainability of evidence-based interventions.

How can clinical practices pragmatically increase physical activity for patients with type 2 diabetes? A systematic review.

Although regular physical activity (PA) is a cornerstone of treatment for type 2 diabetes (T2D), most adults with T2D are sedentary. Randomized controlled trials (RCTs) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare settings. We sought to identify PA interventions that are effective and practical to implement in clinical practice settings. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool to assess the potential for future implementation of PA interventions in clinical practice settings. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores. We searched PubMed MEDLINE from January 1980 through May 2015 for RCTs of behavioral PA interventions coordinated by clinical practices for patients with T2D. Dual investigators assessed pragmatism by PRECIS-2 scores, and study effectiveness was extracted from original RCT publications. The PRECIS-2 scores of the 46 behavioral interventions (n = 13,575 participants) ranged from 3.0 to 4.8, where 5 is the most pragmatic score. In the most pragmatic tertile of interventions (n = 16) by PRECIS-2 scores, 30.8 and 31.3% of interventions improved PA outcomes and hemoglobin A1c, respectively. A minority of published evidence-based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation. These should be tested for dissemination using implementation trial designs.