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Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption.

ABSTRACT: BACKGROUND:Understanding the many factors that influence implementation of new programs, in addition to their success or failure, is extraordinarily complex. This qualitative study examines the implementation and adaptation process of two linked clinical programs within Primary Care, diabetes shared medical appointments (SMAs) and a reciprocal Peer-to-Peer (P2P) support program for patients with poorly controlled diabetes, through the lens of the Consolidated Framework for Implementation Research (CFIR). We illustrate the role and importance of pre-implementation interviews for guiding ongoing adaptations to improve implementation of a clinical program, achieve optimal change, and avoid type III errors. METHODS:We conducted 28 semi-structured phone interviews between September of 2013 and May of 2016, four to seven interviewees at each site. The interviewees were physician champions, chiefs of primary care, pharmacists, dieticians, nurses, health psychologists, peer facilitators, and research coordinators. Modifiable barriers and facilitators to implementation were identified and adaptations documented. Data analysis started with immersion in the data to obtain a sense of the whole and then by cataloging principal themes per CFIR constructs. An iterative consensus-building process was used to code. CFIR constructs were then ranked and compared by the researchers. RESULTS:We identified a subset of CFIR constructs that are most likely to play a role in the effectiveness of the diabetes SMAs and P2P program based on our work with the participating sites to date. Through the identification of barriers and facilitators, a subset of CFIR constructs arose, including evidence strength and quality, relative advantage, adaptability, complexity, patient needs and resources, compatibility, leadership engagement, available resources, knowledge and beliefs, and champions. CONCLUSIONS:We described our method for identification of contextual factors that influenced implementation of complex diabetes clinical programs - SMAs and P2P. The qualitative phone interviews aided implementation through the identification of modifiable barriers or conversely, actionable findings. Implementation projects, and certainly clinical programs, do not have unlimited resources and these interviews allowed us to determine which facets to target and act on for each site. As the study progresses, these findings will be compared and correlated to outcome measures. This comprehensive adaptation data collection will also facilitate and enhance understanding of the future success or lack of success of implementation and inform potential for translation and public health impact. The approach of using the CFIR to guide us to actionable findings and help us better understand barriers and facilitators has broad applicability and can be used by other projects to guide, adapt, and improve implementation of research into practice. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT02132676 .

SUBMITTER: Kowalski CP

PROVIDER: S-EPMC6035791 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption.

Kowalski Christine P CP Veeser Miranda M Heisler Michele M

BMC family practice 20180707 1

<h4>Background</h4>Understanding the many factors that influence implementation of new programs, in addition to their success or failure, is extraordinarily complex. This qualitative study examines the implementation and adaptation process of two linked clinical programs within Primary Care, diabetes shared medical appointments (SMAs) and a reciprocal Peer-to-Peer (P2P) support program for patients with poorly controlled diabetes, through the lens of the Consolidated Framework for Implementation ...[more]

PMID: 29981568

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Project description:BackgroundOpioid addiction and overdose is a public health problem in the United States and is expected to remain with substance use increasing due to the COVID-19 pandemic. Communities that approach this issue through multi-sector partnerships experience more positive health outcomes. Understanding motivation for stakeholder engagement in these efforts is essential to successful adoption, implementation, and sustainability particularly in the shifting landscape of needs and resources.MethodsA formative evaluation was conducted on the C.L.E.A.R. Program in Massachusetts, a state heavily impacted by the opioid epidemic. A stakeholder power analysis identified appropriate stakeholders for the study (n = 9). The Consolidated Framework for Implementation Research (CFIR) guided data collection and analysis. Surveys (n = 8) examined perception and attitudes on the program; motivations and communication for engagement; and, benefits and barriers to collaboration. Stakeholder interviews (n = 6) explored the quantitative findings in more detail. Surveys were analyzed using descriptive statistics and a content analysis with deductive approach was conducted for stakeholder interviews. The Diffusion of Innovation (DOI) Theory guided recommendations for communications to engage stakeholders.ResultsAgencies represented a range of sectors and the majority (n = 5) were familiar with the C.L.E.A.R.ProgramDespite the many strengths of the program and existing collaboration, based on the coding densities of each CFIR construct stakeholders identified crucial gaps in the services the program provided and noted that the overall infrastructure of the program could be enhanced. Opportunities for strategic communication to address the stages of DOI align with the gaps identified in the CFIR domains to result in increased agency collaboration and expansion of services into the surrounding communities to ensure sustainability of the C.L.E.A.R.ProgramConclusionsThis study explored factors necessary for ongoing multi-sector collaboration and sustainability of an existing community-based program especially given the changing context from COVID-19. Findings informed both program revisions and communication strategies to promote the program to new and existing collaborating agencies and the community served, and identify effective communication approaches across sectors. This is essential for successful implementation and sustainability of the program, especially as it is adapted and expanded to address post-pandemic times.Trial registrationThis study does not report results of a health care intervention on human participants, however it was reviewed and determined an exempt study with the Boston University Institutional Review Board (IRB #H-42107).

Project description:BackgroundSelf-management is essential for good outcomes in type 2 diabetes and patients often benefit from self-management education. Shared medical appointments (SMAs) can increase self-efficacy for self management but are difficult for some primary care practices to implement. Understanding how practices adapt processes and delivery of SMAs for patients with type 2 diabetes may provide helpful strategies for other practices interested in implementing SMAs.MethodsThe Invested in Diabetes study was a pragmatic cluster-randomized, comparative effectiveness trial designed to compare two different models of diabetes SMAs delivered in primary care. We used a multi-method approach guided by the FRAME to assess practices' experience with implementation, including any planned and unplanned adaptations. Data sources included interviews, practice observations and field notes from practice facilitator check-ins.ResultsSeveral findings were identified from the data: 1) Modifications and adaptations are common in implementation of SMAs, 2) while most adaptations were fidelity-consistent supporting the core components of the intervention conditions as designed, some were not, 3) Adaptations were perceived to be necessary to help SMAs meet patient and practice needs and overcome implementation challenges, and 4) Content changes in the sessions were often planned and enacted to better address the contextual circumstances such as patient needs and culture.DiscussionImplementing SMAs in primary care can be challenging and adaptations of both implementation processes and content and delivery of SMAS for patients with type 2 diabetes were common in the Invested in Diabetes study. Recognizing the need for adaptations based on practice context prior to implementation may help improve fit and success with SMAs, but care needs to be given to ensure that adaptations do not weaken the impact of the intervention. Practices may be able to assess what might need to adapted for them to be successful prior to implementation but likely will continue to adapt after implementation.ConclusionAdaptations were common in the Invested in Diabetes study. Practices may benefit from understanding common challenges in implementing SMAs and adapting processes and delivery based on their own context.Trial registrationThis trial is registered on clinicaltrials.gov under Trial number NCT03590041, posted 18/07/2018.

Project description:ObjectivesShared medical appointments (SMAs) are an increasingly used system-redesign strategy for improving access to and quality of chronic illness care. We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes.Data sourcesMEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from January 1996 through April 2012. PubMed search updated June 2013.Study selectionEnglish-language peer-reviewed publications of randomized controlled trials (RCTs), nonrandomized cluster controlled trials, controlled before-and-after studies, or interrupted time-series designs conducted among adult patients with diabetes. Two independent reviewers used prespecified criteria to screen titles and abstracts for full text review.Study appraisal and synthesis methodsTwo different reviewers abstracted data and rated study quality and strength of evidence. When possible, we used random-effects models to synthesize the effects quantitatively, reporting by a weighted difference of the means when the same scale was used across studies, and a standardized mean difference when the scales differed. We measured heterogeneity in study effects using Forest Plots, Cochran's Q, and I(2), and explored heterogeneity by using subgroup analyses for categorical variables and meta-regression analyses for continuous or discrete variables. Outcomes not suitable to meta-analysis were summarized qualitatively.ResultsTwenty-five articles representing 17 unique studies compared SMA interventions with usual care. Among patients with diabetes, SMAs improved hemoglobin A1c (? = -0.55 percentage points [95 % CI, -0.11 to -0.99]); improved systolic blood pressure (? = -5.2 mmHg [95 % CI, -3.0 to -7.4]); and did not improve LDL cholesterol (? = -6.6 mg/dl [95 % CI, 2.8 to -16.1]). Nonbiophysical outcomes, including economic outcomes, were reported too infrequently to meta-analyze, or to draw conclusions from. The A1c result had significant heterogeneity among studies, likely secondary to the heterogeneity among included SMA interventions.LimitationHeterogeneity among the components of diabetes SMAs leads to uncertainty about what makes a particular SMA successful.ConclusionSMA interventions improve biophysical outcomes among patients with diabetes. There was inadequate literature to determine SMA effects on patient experience, utilization, and costs.

Project description:Introduction:Type 2 diabetes is a significant problem among uninsured patients. Shared medical appointments (SMA) have been shown to improve outcomes in type 2 diabetes. We hypothesized that the SMA model could be adapted for a non-profit clinic in North Carolina that serves uninsured patients with diabetes that have incomes at/below 150% of the federal poverty line. Research Design and Methods:We implemented and sustained a patient-driven, student-led SMA model that incorporated the monthly rotations of students, physician assistant, and undergraduate students as well as pharmacy residents and an endocrinologist who collectively provide diabetes care at the free clinic. SMA groups are 'open' cohorts and include 4-12 patients scheduled for the monthly clinic. Teams of transdisciplinary trainees work together to perform triage, medication reconciliation, brief history, and physical exam, after which patients participate in the SMA. The endocrinologist evaluates SMA patients individually during and after the visit. Results:Between November 2015 and January 2017, we enrolled 29 patients in SMA. There was high variability in HbA1c at baseline. Among eight type 2 diabetes patients seen in endocrine clinic and with complete data one year before and after SMA implementation, the mean (SD) HbA1c before SMA was 9.7% ± 1.7% (83±7 mmol/ mol); mean HbA1c after SMA was 9.2% ± 1.8% (77 ± 8mmol/mol). The median HbA1c before SMA was 9.5% (80 mmol/mol); median HbA1c after SMA was 8.9% (74 mmol/mol). Overall, 6/8 patients showed decreased HbA1c after SMA although there was variability between individuals in response of glycemic control to SMA. SMA increased clinic efficiency and offered an opportunity to integrate transdisciplinary trainees. Trainees gain experience with novel models of care and the complexities of the patient experience of diabetes. Conclusions:We hope this observation encourages others to implement such programs to enhance the evidence-base for SMA to address health disparities and increase the quality of free diabetes care.

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Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption.

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Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption.

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