Effect of a Family History– and Risk Score–Based Decision Aid on Shared Decision-Making and Screening Outcomes: A Precision Prevention Randomized Trial

Abstract

Background: Effective shared decision-making is central to cardiovascular disease prevention, yet patients frequently experience decisional conflict, limited confidence, and inadequate engagement when risk information is conveyed through usual care alone. Decision aids have been shown to improve decision quality, but comparative evidence on the impact of decision aid intensity remains limited, particularly in primary care settings within low- and middle-income countries. Objective: To evaluate the comparative effectiveness of two decision aid intensities, strong and moderate, versus usual care in improving decision quality among adults undergoing cardiovascular risk assessment. Methods: A single-center, parallel-group randomized controlled trial was conducted at Lahore General Hospital, Lahore, enrolling 39 participants allocated equally to control, moderate decision aid, or strong decision aid groups. Continuous outcomes included decisional conflict, decision self-efficacy, knowledge, decisional regret, and participation/satisfaction, while binary outcomes assessed decision attainment, family history behaviors, lifestyle changes, and screening completion. Group differences were analyzed using analysis of variance with effect sizes, followed by Bonferroni-adjusted pairwise comparisons, and categorical outcomes were evaluated using chi-square tests and odds ratios. Results: Significant between-group differences were observed across all continuous outcomes (all p ≤ 0.002), with the strong decision aid demonstrating the largest effects, including marked improvements in decision self-efficacy (d = 3.42) and participation/satisfaction (d = 2.82), and substantial reductions in decisional conflict (d = −1.45) and regret (d = −1.92). Binary outcomes showed favorable trends for decision aids but were underpowered for statistical significance. Conclusion: Decision aids significantly enhance decision quality in cardiovascular risk assessment, with greater benefits observed with higher intervention intensity, supporting the clinical value of comprehensive decision aids in primary prevention. Keywords: shared decision-making; decision aids; cardiovascular risk; primary prevention; randomized controlled trial