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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial

Authors: Michele Heisler, Jennifer Burgess, Jeffrey Cass, John F. Chardos, Alexander B. Guirguis, Sean M. Jeffery, Lorrie A. Strohecker, Adam S. Tremblay, Wen-Chih Wu, Donna M. Zulman

Published in: Trials | Issue 1/2017

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Abstract

Background

Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in clinical and patient-centered outcomes. In order to translate this evidence to system-level interventions, there is a need for large-scale, pragmatic trials that examine the effectiveness, implementation, and costs of SMAs and reciprocal peer support across diverse settings.

Methods

The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study is a multisite, cluster randomized trial that is evaluating the effectiveness and implementation of SMAs with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care. The P2P program comprises periodic peer support group sessions and telephone contact between SMA participant pairs to promote more effective diabetes self-management. We will examine outcomes across three different treatment groups: (1) SMAs, (2) SMAs plus P2P, and (3) usual care. We will collect and analyze data over a 2.5-year implementation period at five geographically diverse Veterans Affairs (VA) health systems. The primary outcome is the relative change in hemoglobin A1c over time. Secondary outcomes are changes in systolic blood pressure, antihypertensive medication use, statin use, and insulin initiation over the study period. The unit of analysis is the individual, adjusted by the individual’s SMA group (the cluster). We will use mixed methods to rigorously evaluate processes and costs of implementing these programs in each of the clinic settings.

Discussion

We hypothesize that patients will experience improved outcomes immediately following participation in SMAs and that augmenting SMAs with reciprocal peer support will help to maintain these gains over time. The results of this study will be among the first to examine the effects of diabetes SMAs alone and in conjunction with P2P in a range of real-life clinical settings. In addition, the study will provide important information on contextual factors associated with successful program implementation.

Trial registration

ClinicalTrials.gov, ID: NCT02132676. Registered on 21 August 2013.
Appendix
Available only for authorised users
Literature
1.
2.
Nicklett EJ, Heisler M, Spencer MS, et al. Direct social support and long-term health among middle-aged and older adults with type 2 diabetes mellitus. J Gerontol B Psychol Sci Soc Sci. 2013;68(6):933–43.CrossRefPubMedPubMedCentral
3.
Rosland AM, Heisler M, Janevic MR, et al. Current and potential support for chronic disease management in the United States: the perspective of family and friends of chronically ill adults. Fam Syst Health. 2013;31(2):119–31.CrossRefPubMedPubMedCentral
4.
5.
Edelman D, Gierisch JM, McDuffie JR, et al. Shared medical appointments for patients with diabetes mellitus: a systematic review. J Gen Intern Med. 2015;30(1):99–106.CrossRefPubMed
6.
7.
Housden L, Wong ST, Dawes M. Effectiveness of group medical visits for improving diabetes care: a systematic review and meta-analysis. CMAJ. 2013;185(13):E635–44.CrossRefPubMedPubMedCentral
8.
Norris SL, Engelgau MM, Narayan KM. Effectiveness of SM training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001;24(3):561–87.CrossRefPubMed
9.
Norris SL, Lau J, Smith SJ, et al. SM education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25(7):1159–71.CrossRefPubMed
10.
Crowley MJ, Holleman R, Klamerus ML, et al. Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control. Chronic Illn. 2014;10(4):291–302.CrossRefPubMedPubMedCentral
11.
Tang TS, Funnell M, Sinco B, et al. Comparative effectiveness of peer leaders and community health workers in diabetes SM support: results of a randomized controlled trial. Diabetes Care. 2014;37(6):1525–34.CrossRefPubMedPubMedCentral
12.
Goldman ML, Ghorob A, Eyre SL, et al. How do peer coaches improve diabetes care for low-income patients?: a qualitative analysis. Diabetes Educ. 2013;39(6):800–10.CrossRefPubMed
13.
Heisler M, Choi H, Piette JD, et al. Adults with cardiovascular disease who help others: a prospective study of health outcomes. J Behav Med. 2013;36(2):199–211. PMC3929385.CrossRefPubMed
14.
Brown SL, Nesse RM, Vinokur AD, et al. Providing social support may be more beneficial than receiving it: results from a prospective study of mortality. Psychol Sci. 2003;14(4):320–7.CrossRefPubMed
15.
Gallant MP. The influence of social support on chronic illness self-management: a review and directions for research. Health Educ Behav. 2003;30(2):170–95.CrossRefPubMed
16.
Heisler M, Hofer TP, Klamerus ML, et al. Study protocol: the Adherence and Intensification of Medications (AIM) study—a cluster randomized controlled effectiveness study. Trials. 2010;11:95.CrossRefPubMedPubMedCentral
17.
Bodenheimer T, Handley MA. Goal-setting for behavior change in primary care: an exploration and status report. Patient Educ Couns. 2009;76(2):174–80.CrossRefPubMed
18.
19.
Rollnick S, Mason P, Butler C. Health behavior change: a guide for practitioners. Edinburgh and New York: Churchill Livingstone; 2008.
20.
Krein SL, Klamerus ML, Vijan S, et al. Case management for patients with poorly controlled diabetes: a randomized trial. Am J Med. 2004;116(11):732–9.CrossRefPubMed
21.
Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013;8:51.CrossRefPubMedPubMedCentral
Metadata
Title
The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial
Authors
Michele Heisler
Jennifer Burgess
Jeffrey Cass
John F. Chardos
Alexander B. Guirguis
Sean M. Jeffery
Lorrie A. Strohecker
Adam S. Tremblay
Wen-Chih Wu
Donna M. Zulman
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1959-7

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