Evaluation of a web-based decision aid for couples at risk of transmitting a genetic disease: a randomized controlled trial

Abstract

Research question: What are the immediate and sustained effects of the decision aid on key elements of informed decision-making (decisional conflict, knowledge, realistic expectations and deliberation) among couples at risk of transmitting a genetic disease to their offspring in a multi-centre randomized controlled trial (RCT)? Design: Effects were assessed with individual questionnaires in a multicentre RCT. The intervention group (n = 98) received access to the decision aid, whereas the (active) control group (n = 106) accessed a standardized information page. Outcomes were measured before use (T0), immediately after use (T1), at 1 (T2) and 6 months (T3) after use of the decision aid or standardized information. Results: Between-group analyses showed significant effects of the decision aid on the informed decisional conflict subscale (T1) but not on overall decisional conflict. Immediately after use (T1), participants in the intervention group scored significantly higher on preparation for decision-making and overall appreciation compared with the control group. Within-group analyses revealed that both the decision aid and the standardized information page decreased decisional conflict and increased knowledge and realistic expectations, across all time points (T1–T3). For the control group, deliberation significantly improved at T1, T2 and T3, whereas, for the intervention group, significant improvements were observed only at T2 and T3. Conclusion: The decision aid outperforms the standardized information page in preparation for decision-making and overall appreciation. Future research should explore how to improve tailoring of information tools to individual characteristics and identify which couples benefit most from concise versus comprehensive information at different decision-making stages.