Integrated care for older multimorbid heart failure patients: protocol for the ESCAPE randomized trial and cohort study

Christine Zelenak*, Jonas Nagel*, Kristina Bersch, Lisa Derendorf, Frank Doyle, Tim Friede, Birgit Herbeck Belnap, Sebastian Kohlmann, Søren T. Skou, Carlos A. Velasco, Christian Albus, Thomas Asendorf, Christian Axel Bang, Margarita Beresnevaite, Niels Eske Bruun, Matthew M. Burg, Sussi Friis Buhl, Peter H. Gæde, Dagmar Lühmann, Anna MarkserKlaudia Vivien Nagy, Chiara Rafanelli, Sanne Rasmussen, Jens Søndergaard, Jan Sørensen, Adrienne Stauder, Stephanie Stock, Stefano Urbinati, Diego Della Riva, Rolf Wachter, Florian Walker, Susanne S. Pedersen, Christoph Herrmann-Lingen, the ESCAPE consortium

*Corresponding author for this work

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Abstract

ESCAPE: Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. Therapeutic Area: Healthcare interventions for the management of older patients with multiple morbidities. Aims: Multi-morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. Hypothesis: A holistic, patient-centred pro-active 9-month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health-related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. Methods: Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co-morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor-blinded two-arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan—customized to the patients' individual needs and preferences—into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ-5D-5L as primary endpoint, and secondary outcomes, that is, medical and patient-reported outcomes, healthcare costs, cost-effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. Conclusions: If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Original languageEnglish
JournalESC Heart Failure
Volume10
Issue number3
Pages (from-to)2051-2065
ISSN2055-5822
DOIs
Publication statusPublished - Jun 2023

Keywords

  • Blended collaborative care
  • Depression
  • Heart failure
  • Multi-morbidity
  • Multinational trial
  • Psychological distress
  • Quality of life
  • Delivery of Health Care, Integrated
  • Humans
  • Treatment Outcome
  • Multimorbidity
  • Randomized Controlled Trials as Topic
  • Observational Studies as Topic
  • Quality of Life
  • Aged
  • Heart Failure/therapy
  • Cohort Studies

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