Abstract Study question Does a Decision-Aid for those considering elective egg-freezing impact decisional conflict, the decision-making process, and quality of the decision made, compared to existing information? Summary answer The Decision-Aid significantly reduced decisional conflict and improved preparedness for decision-making. What is known already Elective egg-freezing offers women the potential to extend their reproductive years. The decision to freeze eggs is complex, and our previous data shows that 78% of women had high decisional conflict (uncertainty) when they considered elective egg-freezing. Decision-Aids are the gold-standard for supporting complex health-related decisions. They have been shown to reduce decisional conflict and improve knowledge, risk perception, and decision alignment with personal values, when compared to standard care alone across a range of health conditions. We developed an online Decision-Aid to support women considering elective egg-freezing. Study design, size, duration A single-blinded, two-arm parallel group Randomised Control Trial. Participants were recruited September 2020-March 2021 (target n = 286). Randomisation was 1:1 to the intervention (Decision-Aid plus existing information) or control (existing information only) group, stratified by Australian state/territory and prior consultation with an IVF specialist about elective egg-freezing. Existing information was the Victorian Assisted Reproductive Treatment Authority website. Online surveys were completed at recruitment (baseline), 6, and 12-months. Participants/materials, setting, methods Australian women aged ≥18 years, considering elective egg-freezing, proficient in English, and with internet access were recruited using various methods including social media, Google advertising, newsletters, and clinic referrals. Participants completing the baseline survey were randomised (intervention n = 150, control n = 156) and emailed their allocated resources. Subsequent surveys were emailed 6 and 12-months post-randomisation. Surveys covered decisional conflict (primary outcome), distress, egg-freezing and fertility knowledge, decision made/not made, preparedness for decision-making, informed choice, and decisional regret. Main results and the role of chance Of 306 participants (mean age=30 years, SD: 5.2), 50% were single and 65% worked in professional occupations. At 6-months, the intervention group was substantially more prepared for decision-making than the control (Preparation for Decision-Making Scale; mean score difference: 9.22 [95% CI: 2.35, 16.08], p = 0.009). Overall, 77% of participants completed the primary outcome at 12-months (intervention n = 113, control n = 124). Between baseline and 12-months, the mean reduction in Decisional Conflict Scale (DCS) scores was greater for the intervention group than the control (mean score difference: -6.99 [95% CI: -12.96, -1.02], p = 0.022), whilst there were no group differences in distress (Depression Anxiety and Stress Scale; mean score difference: 0.61 [95% CI: -3.72, 4.93], p = 0.783), knowledge (study-specific scale; mean score difference: 0.23 [95% CI: -0.21, 0.66], p = 0.309) and whether a decision had been made about egg-freezing (odds ratio: 1.95 (95% CI: 0.67, 5.69), p = 0.221). No differences were observed between groups in informed choice (Multi-Dimensional Measure of Informed Choice; relative risk: 1.00 [95% CI: 0.81, 1.25]) or decision regret (Decisional Regret Scale; median score difference: -5.00 [95% CI: -15.30, 5.30]) for participants who had made their decision about egg-freezing at 12-months (intervention n = 48, control n = 45). Limitations, reasons for caution The total eligible population reached cannot be calculated due to the broad recruitment methods used. Adaption of some scales to improve relevancy may impact validity. Biases from self-selection and the use of self-reported data are possible, and some results had small sample sizes limiting the inferences made. Wider implications of the findings This is the first study to evaluate the effectiveness of a Decision-Aid for women considering elective egg-freezing. It demonstrates the benefit of a Decision-Aid in supporting women’s decision-making. Given these results, the Decision-Aid will be made publicly available. There is also potential to adapt the tool for international relevancy. Trial registration number ACTRN12620001032943
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