The impact of explicit values clarification exercises in a patient decision aid emerges after the decision is actually made: evidence from a randomized controlled trial.

PURPOSE: To determine if particular values clarification exercises included in a patient decision aid had discernible impact on postdecisional regret in patients with early-stage prostate cancer.
METHODS: A multicenter randomized controlled trial compared 2 versions of a computerized patient decision aid: only structured information compared to the structured information plus values clarification exercises. Assessments were conducted during the decision aid visit; telephone follow-up interviews were conducted when patients made their decisions with their physician, 3 months after completing treatment, and >1 year later (per a mailing). Outcome measures included the Decisional Conflict Scale, the Preparation for Decision Making Scale, and the Decision Regret Scale.
RESULTS: A total of 156 patients participated, 75 provided information only and 81 provided information plus values clarification exercises. The groups did not differ significantly on any outcome evaluated at the decision aid visit; in both groups, decisional conflict decreased immediately after using the decision aid. Between-group differences emerged after the decision was actually made. The values clarification exercises group reported higher Preparation for Decision Making Scale scores at the decision follow-up and at the >1-year follow-up. Regret did not differ significantly between groups at the 3-month follow-up but was lower for the values clarification exercises group than for the information group at the >1-year follow-up.
CONCLUSION: The results suggest that the values clarification exercises led to better preparation for decision making and to less regret. The impact, however, only emerged after the decision was made.

RCT Entities:   Population Interventions Outcomes