BACKGROUND: Experts have called for the inclusion of values clarification (VC) exercises in decision aids (DAs) as a means of improving their effectiveness, but little research has examined the effects of such exercises. OBJECTIVE: To determine whether adding a VC exercise to a DA on heart disease prevention improves decision-making outcomes. DESIGN: Randomized trial. SETTING: UNC Decision Support Laboratory. PATIENTS: Adults ages 40 to 80 with no history of cardiovascular disease. INTERVENTION: A Web-based heart disease prevention DA with or without a VC exercise. MEASUREMENTS: Pre- and postintervention decisional conflict and intent to reduce coronary heart disease (CHD) risk and postintervention self-efficacy and perceived values concordance. RESULTS: The authors enrolled 137 participants (62 in DA; 75 in DA + VC with moderate decisional conflict (DA 2.4; DA + VC 2.5) and no baseline differences among groups. After the interventions, they found no clinically or statistically significant differences between groups in decisional conflict (DA 1.8; DA + VC 1.9; absolute difference VC-DA 0.1, 95% confidence interval [CI]: -0.1 to 0.3), intent to reduce CHD risk (DA 98%; DA + VC 100%; absolute difference VC-DA: 2%, 95% CI: -0.02% to 5%), perceived values concordance (DA 95%; DA + VC 92%; absolute difference VC-DA -3%, 95% CI: -11% to +5%), or self-efficacy for risk reduction (DA 97%; DA + VC 92%; absolute difference VC-DA -5%, 95% CI: -13% to +3%). However, DA + VC tended to change some decisions about risk reduction strategies. LIMITATIONS: Use of a hypothetical scenario; ceiling effects for some outcomes. CONCLUSIONS: Adding a VC intervention to a DA did not further improve decision-making outcomes in a population of highly educated and motivated adults responding to scenario-based questions. Work is needed to determine the effects of VC on more diverse populations and more distal outcomes.
RCT Entities:
BACKGROUND: Experts have called for the inclusion of values clarification (VC) exercises in decision aids (DAs) as a means of improving their effectiveness, but little research has examined the effects of such exercises. OBJECTIVE: To determine whether adding a VC exercise to a DA on heart disease prevention improves decision-making outcomes. DESIGN: Randomized trial. SETTING: UNC Decision Support Laboratory. PATIENTS: Adults ages 40 to 80 with no history of cardiovascular disease. INTERVENTION: A Web-based heart disease prevention DA with or without a VC exercise. MEASUREMENTS: Pre- and postintervention decisional conflict and intent to reduce coronary heart disease (CHD) risk and postintervention self-efficacy and perceived values concordance. RESULTS: The authors enrolled 137 participants (62 in DA; 75 in DA + VC with moderate decisional conflict (DA 2.4; DA + VC 2.5) and no baseline differences among groups. After the interventions, they found no clinically or statistically significant differences between groups in decisional conflict (DA 1.8; DA + VC 1.9; absolute difference VC-DA 0.1, 95% confidence interval [CI]: -0.1 to 0.3), intent to reduce CHD risk (DA 98%; DA + VC 100%; absolute difference VC-DA: 2%, 95% CI: -0.02% to 5%), perceived values concordance (DA 95%; DA + VC 92%; absolute difference VC-DA -3%, 95% CI: -11% to +5%), or self-efficacy for risk reduction (DA 97%; DA + VC 92%; absolute difference VC-DA -5%, 95% CI: -13% to +3%). However, DA + VC tended to change some decisions about risk reduction strategies. LIMITATIONS: Use of a hypothetical scenario; ceiling effects for some outcomes. CONCLUSIONS: Adding a VC intervention to a DA did not further improve decision-making outcomes in a population of highly educated and motivated adults responding to scenario-based questions. Work is needed to determine the effects of VC on more diverse populations and more distal outcomes.
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