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(se abrirá en una nueva ventana).
WP8:
Compliance with the 'ethics requirements' is ensured, and the Ethics Advisory Board oversees ESCAPE.
