Evaluation of a patient-centred biopsychoSocial blended collaborative CAre Pathway for the treatment of multi-morbid Elderly patients – The ESCAPE clinical study

Objective A Blended Collaborative Care strategy (BCC) can improve treatment of patients with medical-mental comorbidity. However, patients often suffer from multiple chronic conditions. The European Union-funded ESCAPE project will examine the impact of a BCC intervention targeting patients aged 65+ with heart failure, 2+ medical comorbidities plus mental distress / disorder. Methods After developing an extended and modified BCC strategy (presented by Luhmann et al., Kohlmann et al., Gostoli et al.) and a dedicated web-based platform (Velasco et al.), we will examine this strategy in an RCT (n = 300) embedded in a comprehensive cohort study following 450 patients over 18+ months. Our primary hypothesis is that the ESCAPE BCC intervention improves health-related quality of life (QoL) measured by EQ-5D-5L by ES >0.35 compared to physicians' usual care. Secondary outcomes include medical endpoints (morbidity, mortality), psychological well-being, and treatment satisfaction. Furthermore, we will assess caregiver burden and QoL, indicators for quality of care, and health-economic parameters. The non-randomized cohort will serve as external reference for the RCT findings. Results We will present the study design and its implementation across participating countries including Al-supported translation of study materials into the local languages. Results from a feasibility study will also be reported. Conclusion ESCAPE expands the BCC strategy to support treatment of multimorbid older patients and involve their carers, actively integrate CPs treatment plans and state-of-the art information technology. If proven effective, the ESCAPE BCC strategy can serve as a template for patients with different multimorbidities across diverse health care systems throughout Europe.