The Effectiveness of an Online Decision Aid on Reproductive Options for Couples at Risk of Transmitting a Genetic Disease to their Offspring: Protocol for a Randomized Controlled Trial

Introduction: Couples at high risk of transmitting a genetic disease to their offspring have several reproductive options. As decision making is often experienced as difficult, there is a need for a decision aid (DA), to assist couples in their reproductive decision-making process and to reduce decisional conflict and increase (joint) informed decision-making. This article describes the design of a nationwide randomized controlled trial to assess the efficacy of the online DA. Methods: The development of the DA was based on the International Patient Decision Aid Standards (IPDAS) guidelines. A nationwide multi-centre Randomized Controlled Trial (RCT) will be conducted in the eight genetic centres in the Netherlands to assess the effects of the DA, compared to a website with standardized information based on information provided during standard care. The required sample size is 128 couples. Participants are randomly assigned to either the intervention or control group and are asked to complete four questionnaires within six months to study the effects of the information. The questionnaires will assess decisional conflict, knowledge, attitude, deliberation, and the decision-making process between partners. Discussion: Findings of this study can help to improve the counselling of couples at risk of transmitting a genetic disease to their offspring. Additionally, it provides insight into the joint informed decision-making process of couples. This could help professionals to better support both partners during consultations. Trial registration number: N9415.