Methods: Sixteen diabetologists and 98 patients with type 2 diabetes referred to the subspecialty diabetes clinic were enrolled in a clustered randomized trial with blinded hypothesis, concealed allocation, and conducted under the intention to treat principle of decision aid vs. control. Statin Choice is a personalized decision aid that presents the estimated 10-year cardiovascular risk for the patient along with the relative risk reduction with statins and the downsides of these medications. The control intervention was a traditional educational pamphlet on cholesterol.
Results: Immediately post visit, patients in the decision aid group had greater acceptability of information scores [mean diff. 10.5 of 100 (95% CI 2.1-18.9); P=.01], lower decisional conflict scores [10.6, 95% CI 5.9, 15.4; P<0.0001], and higher trust in their physician [4.2 of 100, 95% CI 0.5-7.8; P = .025] than patients receiving the control intervention. At three months, patients were three-fold more likely to be taking statins regularly if they received the Statin Choice decision aid (94%) vs. control (79%) (P=.03).
Conclusions: A decision aid delivered during the clinical encounter enhances clinical decision-making and favorably impacts patient action on the decision. The results of this trial support the hypothesis that decision aids may enhance patient action and short term adherence to medications.