Evaluating the Impact of a Lifestyle-Focused Approach on Cardiovascular Risk in Inpatients With Mental Illness: Analyzing Effectiveness and Fidelity in a Stepped Wedge Cluster Randomized Trial (MULTI+ Study V)

Abstract

Objective: People with mental illness have worse health outcomes and up to 20 years shorter life expectancy than the general population. Lifestyle interventions are promising to improve their physical and mental health but implementing these in real-world practice remains challenging. This study evaluated the impact of a multidisciplinary lifestyle-focused approach (MULTI+) on cardiovascular risk among inpatients with mental illness. Methods: In an open-cohort stepped wedge cluster randomized controlled trial, we compared changes in estimated 10-year risk of a cardiovascular event (QRISK3) between MULTI+ and care as usual (CAU) across inpatient wards at GGz Centraal (the Netherlands). Using linear mixed models, we assessed intervention effectiveness and explored whether implementation fidelity influenced outcomes. Results: We included 3603 individuals, with an unadjusted mean QRISK3 score of 15.1% in CAU and 15.4% in MULTI+. After adjusting for confounders, there was a small but statistically significant increase in the logit-transformed QRISK3 score in MULTI+ (OR = 1.1; 95% CI: [1.05–1.17], p < 0.001). Exploratory analyses suggested no association between implementation fidelity and cardiovascular risk. Conclusions: In this large-scale study, we observed no improvements—and even slight deterioration—in cardiovascular risk among people receiving MULTI+ compared to CAU. Challenges in implementation likely contributed to these outcomes. More intensive, tailored, and sustained implementation efforts, alongside broader systemic and societal support, may be required to reduce cardiovascular risk in this population. Relevance to clinical practice: The large-scale real-world setting provides valuable insights into MULTI+'s effectiveness, highlighting challenges in improving cardiovascular risk and the need for sustained efforts for successful integration.