Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease

Abstract

OBJECTIVE:To determine the effect of the Ischemic Heart Disease Shared Decision-Making Program (IHD SDP) an interactive videodisc designed to assist patients in the decisionmaking process involving treatment choices for ischemic heart disease, on patient decision-making. DESIGN:Randomized, controlled trial. SETTING:The Toronto Hospital, University of Toronto, Toronto, Ontario, Canada. PARTICIPANTS:Two hundred forty ambulatory patients with ischemic heart disease amenable to elective revascularization and ongoing medical therapy. MEASUREMENTS AND MAIN RESULTS:The primary outcome was patient satisfaction with the decision-making process. This was measured using the 12-item Decision-Making Process Questionnaire that was developed and validated in a randomized trial of the benign prostatic hyperplasia SDP. Secondary outcomes included patient knowledge (measured using 20 questions about knowledge deemed necessary for an informed treatment decision), treatment decision, patient-angiographer agreement on decision, and general health scores. Outcomes were measured at the time of treatment decision and/or at 6 months follow-up. Shared decision-making program scores were similar for the intervention and control group (71% and 70%, respectively; 95% confidence interval [CI] for 1% difference, ؊ 3% to 7%). The intervention group had higher knowledge scores (75% vs 62%; 95% CI for 13% difference, 8% to 18%). The intervention group chose to pursue revascularization less often (58% vs 75% for the controls; 95% CI for 17% difference, 4% to 31%). At 6 months, 52% of the intervention group and 66% of the controls had undergone revascularization (95% CI for 14% difference, 0% to 28%). General health and angina scores were not different between the groups at 6 months. Exposure to the IHD SDP resulted in more patientangiographer disagreement about treatment decisions. CONCLUSIONS:There was no significant difference in satisfaction with decision-making process scores between the IHD SDP and usual practice groups. The IHD SDP patients were more knowledgeable, underwent less revascularization (interventional therapies), and demonstrated increased patient decisionmaking autonomy without apparent impact on quality of life. C ardiovascular disease remains the leading cause of mortality in adults. 1 Standard modes of therapy for ischemic heart disease include medical therapy, coronary artery bypass surgery, and angioplasty. Utilization of bypass surgery and angioplasty has increased significantly over the last decade. [2][3][4] In cases of severe coronary artery disease, such as left main disease and triple vessel disease with poor left ventricular function, there is strong evidence that coronary artery bypass surgery can result in a definite survival advantage. 5 However, with less severe disease this survival advantage is uncertain, so the optimal choice of treatment is less clear. [6][7][8][9][10][11][12] In such circumstances, the selection of treatment must be guided not only by possible survival advantages but also by the probability...

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