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

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

Christine Zelenak  1 , Jonas Nagel  1 , Kristina Bersch  2 , Lisa Derendorf  3 , Frank Doyle  4 , Tim Friede  5   6 , Birgit Herbeck Belnap  1   7 , Sebastian Kohlmann  8 , Søren T Skou  9   10 , Carlos A Velasco  11 , Christian Albus  12 , Thomas Asendorf  2 , Christian Axel Bang  13 , Margarita Beresnevaite  14 , Niels Eske Bruun  13   15 , Matthew M Burg  16 , Sussi Friis Buhl  17 , Peter H Gaede  18   19 , Dagmar Lühmann  20 , Anna Markser  12 , Klaudia Vivien Nagy  21 , Chiara Rafanelli  22 , Sanne Rasmussen  17 , Jens Søndergaard  17 , Jan Sørensen  23 , Adrienne Stauder  24 , Stephanie Stock  3 , Stefano Urbinati  25 , Diego Della Riva  25 , Rolf Wachter  26 , Florian Walker  2 , Susanne S Pedersen  27   28 , Christoph Herrmann-Lingen  1   6 ; ESCAPE consortium
Affiliations

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

Christine Zelenak et al. ESC Heart Fail. 2023 Jun.

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.

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Conflict of interest statement

The following authors declare conflicts of interest: Christoph Herrmann‐Lingen, Susanne S. Pedersen, Søren T. Skou, Christian Albus, Dagmar Lühmann, Tim Friede, Niels E. Bruun, Jens Søndergaard. For details, see Appendix S2 .

The following authors declare they have no conflicts of interest: Christine Zelenak, Jonas Nagel, Kristina Bersch, Lisa Derendorf, Frank Doyle, Birgit Herbeck Belnap, Sebastian Kohlmann, Carlos A. Velasco, Thomas Asendorf, Christian Axel Bang, Margarita Beresnevaite, Matthew M. Burg, Sussi Friis Buhl, Peter H. Gæde, Anna Markser, Klaudia Vivien Nagy, Chiara Rafanelli, Sanne Rasmussen, Jan Sørensen, Adrienne Stauder, Stephanie Stock, Stefano Urbinati, Diego Della Riva, Rolf Wachter and Florian Walker.

See Appendix S2 for information on role of funders and legal sponsor in study design, trial governance, trial registration, data safety and monitoring board, ethics advisory board, availability of data and materials, and declaration of interest.

Figures

Figure 1
Figure 1
ESCAPE study flow chart. A delay before inclusion into the randomized controlled trial was chosen to ensure that patients' somatic diseases are chronic and distress or mental disorders persistent. Patients will receive standard of care between initial screening and rescreening. n, number of people. Wording for patients: ‘Scoping study’ = for cohort, ‘Core study’ for RCT.
Figure 2
Figure 2
Presentation of the imergo® Integrated Care Platform: overview page for an individual patient.
See this image and copyright information in PMC

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