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The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

ABSTRACT: BACKGROUND:Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. METHODS:This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. DISCUSSION:Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

SUBMITTER: Kwan BM

PROVIDER: S-EPMC6954498 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

Kwan Bethany M BM Dickinson L Miriam LM Glasgow Russell E RE Sajatovic Martha M Gritz Mark M Holtrop Jodi Summers JS Nease Don E DE Ritchie Natalie N Nederveld Andrea A Gurfinkel Dennis D Waxmonsky Jeanette A JA

Trials 20200110 1

<h4>Background</h4>Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical ou ...[more]

PMID: 31924249

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Project description:ObjectiveTo examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements.Research design and methodsA multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8-9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs.ResultsBaseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group.ConclusionsDiabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention.Trial registrationClinicalTrials.gov ID NCT02132676.

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:IntroductionType 2 diabetes (T2DM) is a major health concern with significant personal and healthcare system costs. There is growing interest in using shared medical appointments (SMAs) for management of T2DM. We hypothesize that adding mindfulness to SMAs may be beneficial. This study aimed to assess the feasibility and acceptability of SMAs with mindfulness for T2DM within primary care in Australia.Materials and methodsWe conducted a single-blind randomized controlled feasibility study of SMAs within primary care for people with T2DM living in Western Sydney, Australia. People with T2DM, age 21 years and over, with HbA1c > 6.5% or fasting glucose >7.00 mmol/L within the past 3 months were eligible to enroll. The intervention group attended six 2-h programmed SMAs (pSMAs) which were held fortnightly. pSMAs included a structured education program and mindfulness component. The control group received usual care from their healthcare providers. We collected quantitative and qualitative data on acceptability as well as glycemic control (glycated hemoglobin and continuous glucose monitoring), lipids, anthropometric measures, blood pressure, self-reported psychological outcomes, quality of life, diet, and physical activity using an ActiGraph accelerometer.ResultsOver a 2-month period, we enrolled 18 participants (10 females, 8 males) with a mean age of 58 years (standard deviation 9.8). We had 94.4% retention. All participants in the intervention group completed at least four pSMAs. Participants reported that attending pSMAs had been a positive experience that allowed them to accept their diagnosis and empowered them to make changes, which led to beneficial effects including weight loss and better glycemic control. Four pSMA participants found the mindfulness component helpful while two did not. All of the seven participants who contributed to qualitative evaluation reported improved psychosocial wellbeing and found the group setting beneficial. There was a significant difference in total cholesterol levels at 12 weeks between groups (3.86 mmol/L in intervention group vs. 4.15 mmol/L in the control group; p = 0.025) as well as pain intensity levels as measured by the PROMIS-29 (2.11 vs. 2.38; p = 0.034).ConclusionpSMAs are feasible and acceptable to people with T2DM and may result in clinical improvement. A follow-up fully-powered randomized controlled trial is warranted.Clinical trial registrationAustralia and New Zealand Clinical Trial Registry, identifier ACTRN12619000892112.

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: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 .

Dataset Information

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

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The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

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