Protocol for the health economic evaluation of nature-based social prescribing against loneliness alongside the RECETAS trials

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BACKGROUND: Loneliness has become a global public health problem associated with serious diseases and early mortality. A promising non-medical group-based strategy to address loneliness is nature-based social prescribing (NBSP). The aim of this paper is to describe the design of a health economic evaluation of NBSP interventions alongside trials conducted in the EU H2020 project RECETAS. METHODS: The health economic evaluation will be conducted alongside the RECETAS randomized controlled trials in Barcelona, Prague, and Helsinki, and comprises cost-utility, cost-effectiveness, and cost-capability analyses. Depending on each study site's specific setting and target population, the economic evaluation will be performed from a societal and/or a healthcare perspective. NBSP interventions, which include referring lonely people to participate in activities organized in a natural environment and providing a selection of nearby nature-based community resources, will be evaluated against usual care. Effectiveness measures include health-related quality of life assessed with the EQ-5D-5 L questionnaire, changes in loneliness obtained from the De Jong Gierveld Loneliness Scale, and capability derived from the ICECAP-A questionnaire. Direct healthcare costs, indirect and informal costs as well as the actual costs of the intervention will be included. The data on health outcome and health care resource utilization will be collected at baseline and at three-, six- and twelve-months follow-up of the trial. The incremental cost-utility ratio, incremental cost-effectiveness ratio, and incremental cost-capability ratio will be calculated. National willingness-to-pay thresholds will be applied where available. DISCUSSION: Our study protocol provides a systematic framework designed prospectively for conducting the health economic evaluation of the NBSP intervention for people suffering from loneliness. Through the publication of the study protocol, the research process becomes transparent and reproducible. This reduces bias when interpreting the results and conclusions and ensures good evidence-based practice, so that decision makers can provide evidence-based recommendations without arbitrariness to support NBSP implementation. TRIAL REGISTRATION: Barcelona (Spain) trial ClinicalTrials.gov, ID NCT05488496. Registered 29 July 2022 Prague (Czech Republic) trial ClinicalTrials.gov, ID NCT05522140. Registered August 25, 2022 Helsinki (Finland) trial ClinicalTrials.gov, ID NCT05507684. Registered August 12, 2022.

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