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Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

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

Authors: Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr., Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel, Jeanette A. Waxmonsky

Published in: Trials | Issue 1/2020

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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.
Appendix
Available only for authorised users
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Metadata
Title
The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments
Authors
Bethany M. Kwan
L. Miriam Dickinson
Russell E. Glasgow
Martha Sajatovic
Mark Gritz
Jodi Summers Holtrop
Don E. Nease Jr.
Natalie Ritchie
Andrea Nederveld
Dennis Gurfinkel
Jeanette A. Waxmonsky
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3938-7

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