Michele Heisler, MD, MPA *; Hwajung Choi, PhD; Gloria Palmisano, BA; Rebecca Mase, MSW; Caroline Richardson, MD *; Angela Fagerlin, PhD; Victor M. Montori, MD, MSc; Michael Spencer, MSW, PhD; Laurence C. An, MD *
Acknowledgment: The authors thank the very dedicated community health workers who participated in this intervention. The principal investigator, Michele Heisler, had full access to all of the data in the study and takes responsibility for the integrity of the data and accuracy of the data analysis.
Grant Support: By a grant from the Agency for Healthcare Research and Quality (R18 DK078558/1R18HS019256-01) and by grant P30DK092926 (MCDTR) from the National Institute of Diabetes and Digestive and Kidney Diseases.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-3012.
Reproducible Research Statement:Study protocol: Available at Clinical Trials.gov (NCT01427660). Statistical code and data set: Available from Dr. Heisler (e-mail, email@example.com).
Requests for Single Reprints: Michele Heisler, MD, MPA, University of Michigan Medical School/Veterans Affairs Ann Arbor Health System, PO Box 130170, MS 152, Ann Arbor, MI 48113-0170; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Heisler, Choi, Richardson, and Fagerlin and Ms. Mase: University of Michigan Medical School/Veterans Affairs Ann Arbor Health System, PO Box 130170, MS 152, Ann Arbor, MI 48113-0170.
Ms. Palmisano: CHASS/REACH Detroit Partnership, 5635 West Fort Street, Detroit, MI 48209.
Dr. Montori: Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Dr. Spencer: School of Social Work, University of Michigan, 1080 South University Avenue, Ann Arbor, MI 48109.
Dr. An: Center for Health Communications Research, University of Michigan, North Campus Research Complex, 2800 Plymouth Road, Building 16, Room G027, Ann Arbor, MI 48109-2800.
Author Contributions: Conception and design: M. Heisler, H. Choi, C. Richardson, A. Fagerlin, M. Spencer, L.C. An.
Analysis and interpretation of the data: M. Heisler, H. Choi, G. Palmisano, V.M. Montori, L.C. An.
Drafting of the article: M. Heisler, G. Palmisano, R. Mase.
Critical revision of the article for important intellectual content: M. Heisler, H. Choi, C. Richardson, A. Fagerlin, V.M. Montori, L.C. An.
Final approval of the article: M. Heisler, G. Palmisano, R. Mase, C. Richardson, A. Fagerlin, V.M. Montori, M. Spencer, L.C. An.
Provision of study materials or patients: G. Palmisano, M. Spencer.
Statistical expertise: H. Choi.
Obtaining of funding: M. Heisler, R. Mase, M. Spencer, L.C. An.
Administrative, technical, or logistic support: M. Heisler, R. Mase, C. Richardson, M. Spencer.
Collection and assembly of data: M. Heisler, G. Palmisano, R. Mase.
Health care centers serving low-income communities have scarce resources to support medication decision making among patients with poorly controlled diabetes.
To compare outcomes between community health worker use of a tailored, interactive, Web-based, tablet computer–delivered tool (iDecide) and use of print educational materials.
Randomized, 2-group trial conducted from 2011 to 2013 (ClinicalTrials.gov: NCT01427660).
Community health center in Detroit, Michigan, serving a Latino and African American low-income population.
188 adults with a hemoglobin A1c value greater than 7.5% (55%) or those who reported questions, concerns, or difficulty taking diabetes medications.
Participants were randomly assigned to receive a 1- to 2-hour session with a community health worker who used iDecide or printed educational materials and 2 follow-up calls.
Primary outcomes were changes in knowledge about antihyperglycemic medications, patient-reported medication decisional conflict, and satisfaction with antihyperglycemic medication information. Also examined were changes in diabetes distress, self-efficacy, medication adherence, and hemoglobin A1c values.
Ninety-four percent of participants completed 3-month follow-up. Both groups improved across most measures. iDecide participants reported greater improvements in satisfaction with medication information (helpfulness, P = 0.007; clarity, P = 0.03) and in diabetes distress compared with the print materials group (P < 0.001). The other outcomes did not differ between the groups.
The study was conducted at 1 health center during a short period. The community health workers were experienced in behavioral counseling, thereby possibly mitigating the need for additional support tools.
Most outcomes were similarly improved among participants receiving both types of decision-making support for diabetes medication. Longer-term evaluations are necessary to determine whether the greater improvements in satisfaction with medication information and diabetes distress achieved in the iDecide group at 3 months translate into better longer-term diabetes outcomes.
Agency for Healthcare Research and Quality and National Institute of Diabetes and Digestive and Kidney Diseases.
Table 1. Comparison of Content and Mode of Delivery Between the iDecide Study Group and the Printed Materials Group
Study flow diagram.
CHW = community health worker; DM = diabetes mellitus; HbA1c = hemoglobin A1c.
Table 2. Participant Baseline Screening Characteristics (n = 188)
Table 3. Summary of Within-Group and Between-Group Outcomes*
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Heisler M, Choi H, Palmisano G, Mase R, Richardson C, Fagerlin A, et al. Comparison of Community Health Worker–Led Diabetes Medication Decision-Making Support for Low-Income Latino and African American Adults With Diabetes Using E-Health Tools Versus Print Materials: A Randomized, Controlled Trial. Ann Intern Med. 2014;161:S13–S22. doi: 10.7326/M13-3012
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Published: Ann Intern Med. 2014;161(10_Supplement):S13-S22.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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