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HEALTH CARE REFORM
The Diabetes Mellitus Medication Choice Decision AidA Randomized Trial
Rebecca J. Mullan, MS;
Victor M. Montori, MD, MSc;
Nilay D. Shah, PhD;
Teresa J. H. Christianson, BSc;
Sandra C. Bryant, MS;
Gordon H. Guyatt, MD, MSc;
Lilisbeth I. Perestelo-Perez, PhD;
Robert J. Stroebel, MD;
Barbara P. Yawn, MD;
Victor Yapuncich, MD;
Maggie A. Breslin, MDes;
Laurie Pencille, BSc;
Steven A. Smith, MD
Arch Intern Med. 2009;169(17):1560-1568.
Background Patient involvement in the choice of antihyperglycemic agents could improve adherence and optimize glycemic control in patients with type 2 diabetes mellitus.
Methods We conducted a pilot, cluster randomized trial of Diabetes Medication Choice, a decision aid that describes 5 antihyperglycemic drugs, their treatment burden (adverse effects, administration, and self-monitoring demands), and impact on hemoglobin A1c (HbA1c) levels. Twenty-one clinicians were randomized to use the decision aid during the clinical encounter and 19 to dispense usual care and an educational pamphlet. We used surveys and video analysis to assess postvisit decisional outcomes, and medical and pharmacy records to assess 6-month medication adherence and HbA1c levels.
Results Compared with usual care patients (n = 37), patients receiving the decision aid (n = 48) found the tool more helpful (clustered-adjusted mean difference [AMD] in a 7-point scale, 0.38; 95% confidence interval [CI], 0.04-0.72); had improved knowledge (AMD, 1.10 of 10 questions; 95% CI, 0.11-2.09); and had more involvement in making decisions about diabetes medications (AMD, 21.8 of 100; 95% CI, 13.0-30.5). At 6-month follow-up, both groups had nearly perfect medication use (median, 100% of days covered), with better adherence (AMD, 9% more days covered; 95% CI, 4%-14%) and persistence (AMD, 12 more days covered; 95% CI, 3-21 days) in the usual care group, and no significant impact on HbA1c levels (AMD, 0.01; 95% CI, –0.49 to 0.50).
Conclusion An innovative decision aid effectively involved patients with type 2 diabetes mellitus in decisions about their medications but did not improve adherence or HbA1c levels.
Trial Registration clinicaltrials.gov Identifier: NCT00388050
Author Affiliations: Knowledge and Encounter Research Unit, Mayo Center for Translational Science Activities (Mss Mullan, Breslin, and Pencille and Drs Montori, Shah, Perestelo-Perez, and Smith), Department of Health Sciences Research, Divisions of Health Care Policy and Research (Drs Montori, Shah, and Smith) and Biomedical Statistics and Informatics (Mss Christianson and Bryant), Divisions of Endocrinology, Diabetes, Metabolism, and Nutrition and Medicine (Drs Montori and Smith) and Primary Care Internal Medicine (Dr Stroebel), and Department of Family Medicine (Dr Yapuncich), Mayo Clinic, and Mayo Clinic Patient Education (Dr Smith), Rochester, Minnesota; Departments of Clinical Epidemiology and Biostatistics and Medicine, McMaster University, Hamilton, Ontario, Canada (Dr Guyatt); Evaluation Unit of the Canary Islands Health Service and CIBER en Epidemiologia y Salud Publica (CIBERESP), Tenerife, Spain (Dr Perestelo-Perez); Department of Research, Olmsted Medical Center, Rochester (Dr Yawn); and Department of Family and Community Health, University of Minnesota, Minneapolis (Dr Yawn).
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