Periodic Reporting for period 2 - ESCAPE (Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multi-morbid elderly patients)
Okres sprawozdawczy: 2022-10-01 do 2024-03-31
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.
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. Annual two-day project meeting for the ESCAPE consortium in 2023, including the External Advisory Board and the Ethics Advisory Board, at the Royal College of Surgeons in Ireland (RSCI) on 20-21 April 2023o, the Annual two-day project meeting for the ESCAPE consortium in 2024, including the External Advisory Board and the Ethics Advisory Board, at the premises of UMG in Göttingen, Germany, on 16-17 May 2024 (organised as a hybrid meeting); with extensive coordination backup from UMG. Also the EC technical review for the ESCAPE consortium on 8 December 2022.
WP2:
The ESCAPE BCC intervention was developed and implemented. The imergo® IT-platform was – in close collaboration with WP3 – developed and customized for the ESCAPE BCC intervention. The Care Manager Manual version 1.0 was created and translated into relevant languages. An accompanying document was developed, containing step-by-step instructions for the conduct of the BCC-intervention (Manual of Operations, MoO). 17 hours of online training (“Train-the Trainer”) was held. A Training Manual was composed and made available in the relevant languages. Regular biweekly trainer meetings are held with care manager trainers for all ESCAPE study sites. A guideline for regular case reviews by the clinical specialist teams was prepared and distributed to recruiting.
WP3:
• Update of the ETL process according to the requirements of the clinical applications to incorporate the initial data into the platform.
• Maintenance and update of the e-health platform. Timely delivery of the prototypes.
• Maintenance and update of the infrastructure, including security updates.
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, SEG, and SDU.
Continued patient screening and re-screening for cohort and RCT ongoing beyond M27 to help compensate for delays in recruitment. ESCAPE study protocol has been published. N = 217 patients (72% of target number) were randomized as of March 31st, 2024.
WP5:
• Publication of the Health Economic Analysis Plan (all partners).
• Refining the concepts and methods of analysis and all data collection methods have been implemented (UHC)
• Implementation of care manager survey (UHC, UMG, UKE and sites)
• Contribution to the protocol for the ESCAPE randomized trial and cohort study (all partners
WP6:
The partners involved in the clinical trials have obtained the ethical approvals from relevant local ethics committees.
WP7:
• The PEDR was updated M36 to outline the relevant progress made in WP7 as related to the dissemination, communication and exploitation activities from all partners.
• The Portfolio of communication, dissemination and exploitation resources and tools: Delivered to the EC on time (M6) with a variety of high-quality materials. Other related Results:
o LinkedIn Page Development: Established in May 2023, and, currently, the account has a growing network, with 272 followers and approximately 20,000 impressions.
o A 45-minute podcast episode produced
o ESCAPE Explainer Video Series: A series of short videos produced
o Publication of the Clinical Trial Protocol: https://doi.org/10.1002/ehf2.14294(odnośnik otworzy się w nowym oknie).
WP8:
Compliance with the 'ethics requirements' is ensured, and the Ethics Advisory Board oversees ESCAPE.
Administrative and financial management are ensured. Monitoring and following up on progress, respect of deadlines and ESCAPE staying within budget and on schedule. Annual two-day project meeting for the ESCAPE consortium in 2023, including the External Advisory Board and the Ethics Advisory Board, at the Royal College of Surgeons in Ireland (RSCI) on 20-21 April 2023o, the Annual two-day project meeting for the ESCAPE consortium in 2024, including the External Advisory Board and the Ethics Advisory Board, at the premises of UMG in Göttingen, Germany, on 16-17 May 2024 (organised as a hybrid meeting); with extensive coordination backup from UMG. Also the EC technical review for the ESCAPE consortium on 8 December 2022.
WP2:
The ESCAPE BCC intervention was developed and implemented. The imergo® IT-platform was – in close collaboration with WP3 – developed and customized for the ESCAPE BCC intervention. The Care Manager Manual version 1.0 was created and translated into relevant languages. An accompanying document was developed, containing step-by-step instructions for the conduct of the BCC-intervention (Manual of Operations, MoO). 17 hours of online training (“Train-the Trainer”) was held. A Training Manual was composed and made available in the relevant languages. Regular biweekly trainer meetings are held with care manager trainers for all ESCAPE study sites. A guideline for regular case reviews by the clinical specialist teams was prepared and distributed to recruiting.
WP3:
• Update of the ETL process according to the requirements of the clinical applications to incorporate the initial data into the platform.
• Maintenance and update of the e-health platform. Timely delivery of the prototypes.
• Maintenance and update of the infrastructure, including security updates.
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, SEG, and SDU.
Continued patient screening and re-screening for cohort and RCT ongoing beyond M27 to help compensate for delays in recruitment. ESCAPE study protocol has been published. N = 217 patients (72% of target number) were randomized as of March 31st, 2024.
WP5:
• Publication of the Health Economic Analysis Plan (all partners).
• Refining the concepts and methods of analysis and all data collection methods have been implemented (UHC)
• Implementation of care manager survey (UHC, UMG, UKE and sites)
• Contribution to the protocol for the ESCAPE randomized trial and cohort study (all partners
WP6:
The partners involved in the clinical trials have obtained the ethical approvals from relevant local ethics committees.
WP7:
• The PEDR was updated M36 to outline the relevant progress made in WP7 as related to the dissemination, communication and exploitation activities from all partners.
• The Portfolio of communication, dissemination and exploitation resources and tools: Delivered to the EC on time (M6) with a variety of high-quality materials. Other related Results:
o LinkedIn Page Development: Established in May 2023, and, currently, the account has a growing network, with 272 followers and approximately 20,000 impressions.
o A 45-minute podcast episode produced
o ESCAPE Explainer Video Series: A series of short videos produced
o Publication of the Clinical Trial Protocol: https://doi.org/10.1002/ehf2.14294(odnośnik otworzy się w nowym oknie).
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.
• 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.