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

Abstract Objective To 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 Methods A 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. Results Baseline 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. Conclusions Diabetes 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 Registration ClinicalTrials.gov ID NCT02132676

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Problem-solving in caregiver-counselling (PLiP Study): study protocol of a cluster randomized pragmatic trial

BMC Geriatrics ◽

10.1186/s12877-017-0456-x ◽

2017 ◽

Vol 17 (1) ◽

Cited By ~ 4

Author(s):

Klaus Pfeiffer ◽

Martin Hautzinger ◽

Margarete Patak ◽

Julia Grünwald ◽

Clemens Becker ◽

...

Keyword(s):

Problem Solving ◽

Study Protocol ◽

Pragmatic Trial ◽

Cluster Randomized

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Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial

Trials ◽

10.1186/s13063-019-3375-7 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 2

Author(s):

Jan Kottner ◽

Elisabeth Hahnel ◽

Monira El Genedy ◽

Konrad Neumann ◽

Katrin Balzer

Keyword(s):

Study Protocol ◽

Pragmatic Trial ◽

Health And Safety ◽

Aged Care ◽

Cluster Randomized

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Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients

BMC Family Practice ◽

10.1186/s12875-016-0413-3 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 4

Author(s):

Keyword(s):

General Practice ◽

Randomized Trial ◽

Study Protocol ◽

Drug Screening ◽

Pragmatic Trial ◽

Cluster Randomized Trial ◽

Urine Drug ◽

Cluster Randomized ◽

Urine Drug Screening

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

Trials ◽

10.1186/s13063-019-3938-7 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 2

Author(s):

Bethany M. Kwan ◽

L. Miriam Dickinson ◽

Russell E. Glasgow ◽

Martha Sajatovic ◽

Mark Gritz ◽

...

Keyword(s):

Clinical Outcomes ◽

Pragmatic Trial ◽

Multidisciplinary Care ◽

Self Management ◽

Illness Management ◽

Medical Provider ◽

Patient Centered ◽

Health Educator ◽

Shared Medical Appointments ◽

Cluster Randomized

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.

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