Within-Trial Cost-Effectiveness Analysis of a Family-Based Structured Lifestyle Modification Intervention Program for Cardiovascular Risk Reduction: Results from the PROLIFIC Trial.

Objective: We performed a within-trial cost-effectiveness analysis of a targeted family-based structured lifestyle modification intervention for cardiovascular risk reduction. Research design and methods: The PROLIFIC study was an open-label, cluster randomised controlled trial in the families (first-degree relatives and spouses older than age 18 years) of individuals with premature coronary heart disease. Families in the intervention group received a comprehensive package of interventions facilitated by non-physician health workers: screening for cardiovascular risk factors, structured lifestyle interventions, linkage to a primary healthcare facility for individuals with established chronic disease risk factors or conditions, and active follow-up for adherence. The usual care group received one-time counselling and annual screening for risk factors. The cost was estimated from a health system perspective, including intervention and treatment costs. Effectiveness was measured as changes in risk factors and quality-adjusted life years (QALYs) elicited using the EQ-5D-5 L instrument. The time horizon was two years, and we performed one-way and probabilistic sensitivity analyses. Results: Over two years, the incremental cost for the intervention compared to usual care was Int$ 157.5 per person (intervention group: Int$ 381.6, usual care group: Int$ 224.1), and the incremental QALY gain was 0.014 (0.0166 Vs 0.0027). The within-trial ICER was 11,352 Int$/QALY. Incremental cost per unit reduction in systolic blood pressure, fasting plasma glucose, HbA1c, total cholesterol, and waist circumference were Int$ 28.5, 26.9, 130.8, 178.7, and 39.8, respectively. Conclusions: A family-based structured lifestyle modification program yields a net gain in quality of life and is cost-effective at a three times gross domestic product per capita threshold. The intervention is expected to be relatively more cost-effective when scaled up to larger populations over longer time horizons. The intervention has the potential for a substantial public health impact if adopted as a strategy at the state or national level.Trial Registration Number: Clinicaltrials.gov, NCT02771873.