Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study)

Abstract

Background Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. Methods An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. Results The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (− 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. Conclusion The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. Trial registration Clinicaltrials.gov NCT03136211. Registered 02 May 2017 – Retrospectively registered

The Effect and Cost-Effectiveness of Offering a Combined Lifestyle Intervention for the Prevention of Cardiovascular Disease in Primary Care: Results of the Healthy Heart Stepped-Wedge Trial

“…Van der Bruggen et al [ 15 ] suggested in a large modelling study that offering lifestyle interventions to people at risk could be cost-effective, in contrast to offering the intervention to the full population. However, our study showed—in line with the EIRA trial [ 17 ]—similar (CVRM-related) costs and similar or worse QALYs in the intervention period compared to the control period. The lower utilities in our intervention period may be partly explained by the stepped-wedge design, which may have induced selection bias.…”

“…In contrast, the comparable Spanish EIRA trial [ 35 ] implemented a lifestyle intervention on an individual, group-based and community level. Although it was, like our study, not cost-effective [ 17 ], it showed positive outcomes on lifestyle behaviour in the intervention group on a population level. The personalised approach based on stage of motivation may have contributed to the positive effects of the EIRA trial, where in our study, one group-based programme was offered for all.…”

“…Furthermore, implementation still faces several barriers [ 9 , 10 , 11 , 12 ] and may be more difficult in a socio-economically diverse urban area [ 13 , 14 ]. Additionally, the evidence of the cost-effectiveness of lifestyle programmes is inconclusive, especially when analysed on a population level [ 15 , 16 , 17 ].…”

Proactive Behavior Change Techniques (ProBCTs) in Physical Activity and Healthy Eating

“…Thus, people are interrupted from the outside in their unhealthy lifestyle and a health-promoting strategy is tried to be implemented. However, interventions are expensive [12][13][14], and still commonly reach only a relatively small proportion of individuals [15]. Approaches and attempts to scale up interventions to promote physical activity [16] and healthy eating [17] are encouraging.…”

Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial

“…The EIRA study [ 13 ], through a hybrid trial, evaluates, as the main objective, the cost-effectiveness and implementation of a complex intervention that addresses multiple lifestyles (diet, physical activity and smoking) to promote healthy behaviours in a large sample of patients between 45 and 75 years of age attended in primary healthcare. The full trial results were published separately [ 14 , 15 ]. This manuscript reports the effectiveness of this intervention to increase adherence to the MD.…”