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Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multi-morbid elderly patients

Periodic Reporting for period 1 - ESCAPE (Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multi-morbid elderly patients)

Reporting period: 2021-04-01 to 2022-09-30

ESCAPE rethinks current practice for treating multimorbidity in elderly patients, breaking down healthcare silos, that impede integrated care, and lead to adverse outcomes. Care is coordinated and optimized, prioritizing integration of treatment for mental distress and disorders in the treatment of multimorbidity. The interdisciplinary multinational consortium of experts from general and hospital medical practice, psychology, health economics, information and communication technology (ICT) development and social innovation as well as patient and informal carer representatives, develops a holistic, patient-centered intervention based on the blended collaborative care (BCC) approach, enhanced by cutting-edge ICT. Trained Care Managers work closely with the patient’s general practitioner under supervision of a Clinical Specialist Team, using a meta-algorithm (MAM) mirrored in the interactive imergo® e-health Integrated Care Platform to customise patients’ treatment to their individual needs and preferences and liaise among providers. The platform empowers patients and informal carers to increase their intrinsic capacities.

ESCAPE decreases the disease burden for patients, informal carers, and ultimately society, improving quality of life, prioritised as the most important treatment outcome by patients, carers, and multimorbidity guidelines. ESCAPE conducts for the first time a randomised controlled trial embedded in a comprehensive cohort study design to compare BCC and usual care, including patients with heart failure, at least two other somatic comorbidities, and psychological distress.

The primary effectiveness endpoint is patients’ health-related QoL. Other medical outcomes, cost-effectiveness and several other patient-relevant outcomes are secondary endpoints. An active exploitation strategy is applied to derive maximum impact from the new pathway for multimorbidity care.
WP1: Administrative and financial management are ensured. Monitoring and following up on progress, respect of deadlines and ESCAPE staying within budget and on schedule. Kickoff meeting held online on 8 April 2021 and organisation of Annual Meeting 2022 in Odense on 1 September.

WP2: For the ESCAPE blended collaborative care (BCC) intervention, a Care Manager Manual version 1.0 was developed, translated and made available to partners with a step-by-step instruction. Integration of the MAM into the care management process and the e-health platform (imergo®) was refined. Development of the prototype e-health platform (imergo®-registry) was supported by Fraunhofer. Online training for trainers of care managers was held and a Training Manual was available in relevant languages. To support BCC implementation and supervision, trainer meetings are held with care manager trainers for the sites. For the feasibility study, the team developed a scaled down care management registry, trained and supervised care managers and conducted the case review sessions. Results of a patient and public involvement-study (PPI) are submitted for publication. Structure of the BCC-intervention and main results of the feasibility trial, and results of the PPI-study were presented June 2022 at the EAPM-conference in Vienna.

WP3: Development and sustainable operation of a flexible and scalable online e-Health platform based on the imergo® e-health Integrated Care Platform (ICP), built upon previous experiences of Fraunhofer within the PICASO and POLYCARE H2020 projects, supporting the coordination and synchronisation of healthcare services across different clinical providers and patients with multimorbidities.

WP4: The feasibility trial was completed in June 2022 at UMG, including 9 patients receiving the BCC intervention for 3 months. Setup of the main clinical study infrastructure was developed and included creation and translation of study documents, submission to ethics committees for approval, drawing up site contracts, recruitment and training of site staff, development of standard operating procedures, programming of the study database, initiation of study sites. Recruitment for the clinical trial started with UMG followed by UHC, UKE, ULEI, ZEA (Roskilde, Slagelse), LSMU, BEL and SDU. SEG and RCSI/Beaumont are not initiated yet. As of 30 September, UMG has included 13 patients in the randomized controlled trial and began the BCC intervention. The other initiated sites are in the screening phase and will conduct their first baseline visits and randomizations in fall 2022. UMG, in collaboration with ESCAPE partners, drafted the clinical trial protocol, which was submitted for publication in fall 2022.

WP5: The Statistical Analysis Plan was prepared with pre-specified analysis methods for the evaluation of the effectiveness of the intervention and contributions were made to the publication of the study protocol. The economic impact of the BCC implementation from a payer perspective is examined, and documents for the health economic evaluation are prepared.

WP6: The partners involved in the clinical trials have obtained the ethical approvals from relevant local ethics committees.

WP7: The communication, dissemination and exploitation strategy for ESCAPE is outlined in a Plan for the Exploitation and Dissemination of Project Results (PEDR), which was expanded upon and implemented at project start. The PEDR serves as a practical guide for partners, detailing the EC’s best practice guidance, requirements related to dissemination, ERINN’s knowledge management and transfer methodology. A range of tools and resources have been developed including the project logo, presentation templates, video. Twitter and ResearchGate profiles are actively maintained, and the project website is regularly updated. Partner’s dissemination activities have resulted in 18 articles shared in external magazines and newspapers and five presentations at academic conferences. ESCAPE’s Knowledge Management methodology was established and implemented, with the first round of knowledge outputs collected. This process aims to capture the project outputs and ensure sufficient exploitation for long-term impact. The Exploitation and IPR Management Committee and associated Publication Sub-Committee were established to support ESCAPE’s overall impact.

WP8: Compliance with the 'ethics requirements' is ensured, and the Ethics Advisory Board oversees ESCAPE.
ESCAPE contributes to better management of multimorbid elderly patients and cost containment in healthcare through a holistic, patient-centered, technology-supported integrated care approach, leading to better experiences and outcomes for individual patients, informal and formal carers, and society, informing new guidelines for multimorbidity. Multimorbidity affects 50 million people in Europe and a likely higher number of informal carers and relatives. Three out of every four aged over 65 suffer from multimorbidity. ESCAPE will have individual, economic, innovation-related, societal, and scientific impacts, including following expected impacts:

• Health benefits
• Treatment cost savings
• Technology development

With millions of Europeans suffering from multimorbidity, large potential benefits from ESCAPE are better targeted and coordinated services, better management of patients with multimorbidity and more efficient use of resources. ESCAPE serves as a model for other multimorbidity combinations known to affect individual patients, their families and society at large.
Overview of the enhanced BCC approach used in ESCAPE and its main impact