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. 2020 Jan 10;21(1):65.
doi: 10.1186/s13063-019-3938-7.

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

Bethany M Kwan  1 , L Miriam Dickinson  2 , Russell E Glasgow  2   3 , Martha Sajatovic  4 , Mark Gritz  2 , Jodi Summers Holtrop  2 , Don E Nease Jr  2 , Natalie Ritchie  2   5 , Andrea Nederveld  2 , Dennis Gurfinkel  2 , Jeanette A Waxmonsky  2   3
Affiliations

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

Bethany M Kwan et al. Trials. .

Erratum in

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.

Keywords: Cluster randomized pragmatic trial; Diabetes; Diabetes distress; Diabetes self-management; Implementation; Mixed methods; Peer mentors; RE-AIM; Replicating effective programs; Shared medical appointments.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Invested in Diabetes study conceptual model
Fig. 2
Fig. 2
SPIRIT Figure for Invested in Diabetes project timeline
See this image and copyright information in PMC

References

    1. Centers for Disease Control and Prevention . National Diabetes Statistics Report: estimates of diabetes and its burden in the United States. Atlanta: CDC; 2017.
    1. Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014;103(2):137–149. doi: 10.1016/j.diabres.2013.11.002. - DOI - PubMed
    1. Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl J Med. 2013;368(17):1613–1624. doi: 10.1056/NEJMsa1213829. - DOI - PubMed
    1. Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metrics. 2010;8:29. doi: 10.1186/1478-7954-8-29. - DOI - PMC - PubMed
    1. Gregg EW, Li Y, Wang J, Burrows NR, Ali MK, Rolka D, et al. Changes in diabetes-related complications in the United States, 1990-2010. N Engl J Med. 2014;370(16):1514–1523. doi: 10.1056/NEJMoa1310799. - DOI - PubMed

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