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 Gaede; Dagmar Lühmann; Anna Markser; Klaudia 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; ESCAPE consortium

doi:10.1002/ehf2.14294

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

ESC Heart Fail. 2023 Jun;10(3):2051-2065. doi: 10.1002/ehf2.14294. Epub 2023 Mar 12.

Authors

Christine Zelenak¹, Jonas Nagel¹, Kristina Bersch², Lisa Derendorf³, Frank Doyle⁴, Tim Friede^{5

6}, Birgit Herbeck Belnap^{1

7}, Sebastian Kohlmann⁸, Søren T Skou^{9

10}, Carlos A Velasco¹¹, Christian Albus¹², Thomas Asendorf², Christian Axel Bang¹³, Margarita Beresnevaite¹⁴, Niels Eske Bruun^{13

15}, Matthew M Burg¹⁶, Sussi Friis Buhl¹⁷, Peter H Gaede^{18

19}, Dagmar Lühmann²⁰, Anna Markser¹², Klaudia Vivien Nagy²¹, Chiara Rafanelli²², Sanne Rasmussen¹⁷, Jens Søndergaard¹⁷, Jan Sørensen²³, Adrienne Stauder²⁴, Stephanie Stock³, Stefano Urbinati²⁵, Diego Della Riva²⁵, Rolf Wachter²⁶, Florian Walker², Susanne S Pedersen^{27

28}, Christoph Herrmann-Lingen^{1

6}; ESCAPE consortium

Affiliations

¹ Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Centre, Göttingen, Germany.
² Clinical Trial Unit of the University Medical Center Göttingen, Göttingen, Germany.
³ Faculty of Medicine and University Hospital of Cologne, Institute of Health Economics and Clinical Epidemiology, University of Cologne, Cologne, Germany.
⁴ Royal College of Surgeons in Ireland, Dublin, Ireland.
⁵ Department of Medical Statistics, University of Göttingen Medical Centre, Göttingen, Germany.
⁶ German Centre for Cardiovascular Research (DZHK), partner site Göttingen, Göttingen, Germany.
⁷ Center for Behavioral Health, Media, and Technology, Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁸ Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Hamburg Eppendorf, Hamburg, Germany.
⁹ The Research Unit PROgrez, Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospitals, Region Zealand, Slagelse, Denmark.
¹⁰ Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
¹¹ Fraunhofer Institute for Applied Information Technology FIT, Schloss Birlinghoven, Sankt Augustin, Germany.
¹² Faculty of Medicine and University Hospital of Cologne, Department of Psychosomatics and Psychotherapy, University of Cologne, Cologne, Germany.
¹³ Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.
¹⁴ Laboratory of Clinical Cardiology, Institute of Cardiology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
¹⁵ Clinical Institutes, Copenhagen and Aalborg Universities, Copenhagen, Denmark.
¹⁶ Yale University School of Medicine, New Haven, CT, USA.
¹⁷ Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.
¹⁸ Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.
¹⁹ Institute of Regional Health, University of Southern Denmark, Odense, Denmark.
²⁰ University Hospital Hamburg Eppendorf, Hamburg, Germany.
²¹ Heart and Vascular Center, Semmelweis University Budapest, Budapest, Hungary.
²² Department of Psychology, University of Bologna, Bologna, Italy.
²³ Healthcare Outcomes Research Centre, Dublin, Ireland.
²⁴ Institute of Behavioural Sciences, Semmelweis University, Budapest, Hungary.
²⁵ Bellaria Hospital and University of Bologna, Bologna, Italy.
²⁶ University Hospital of Leipzig, Leipzig, Germany.
²⁷ Department of Psychology, University of Southern Denmark, Odense, Denmark.
²⁸ Department of Cardiology, Odense University Hospital, Odense, Denmark.

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.

Keywords: Blended collaborative care; Depression; Heart failure; Multi-morbidity; Multinational trial; Psychological distress; Quality of life.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Cohort Studies
Delivery of Health Care, Integrated*
Heart Failure* / therapy
Humans
Multimorbidity
Observational Studies as Topic
Quality of Life
Randomized Controlled Trials as Topic
Treatment Outcome

Grants and funding

UL1 TR001863/TR/NCATS NIH HHS/United States