gms | German Medical Science

Background: Following steady progress in pediatric critical care and an increase in survival, more children leave Pediatric Intensive Care Unit (PICU)-treatment with complex chronic illnesses and long-term complications, collectively called post-intensive-care syndrome (PICS). It consists of physical, cognitive, emotional and social sequelae in patients and alterations of health-related quality of life and psychological problems like post-traumatic stress disorder, sleep and anxiety disorders. These aspects also affect parents and siblings. Promising secondary preventive measures are available in ABCDEF-Bundles, improving short term outcome during PICU-stay and long-term impairment.

Objective: The aim is to implement an evidence-based, integrative and family-centered intensive care treatment approach based on the ICU Liberation Bundle (ABCDEF-Bundle) at the University Hospitals of Tübingen, Freiburg, Mannheim and Heidelberg to improve the management of critical treatment events and reduce the incidence of post intensive care syndrome in children and their parents.

Methods: The complex intervention will be evaluated within a naturalist controlled, cluster-randomized multicenter study with the confirmatory evaluation referring to the patient level using a stepped wedge design. Primary outcome of the evaluation at patient level is the identification of PICS in patients (PICS-p) and families (PICS-f) measured by FSS (Functional Status Scale), by PedsQL (Pediatric Quality of Live Inventory) and IES-R (Impact of Event Scale - Revised). Secondary outcomes include short term parameters like depth of sedation, duration of mechanical ventilation and length of stay (assessed at PICU-discharge T1) and long-term parameters like health related quality of life in children and parents and signs of posttraumatic stress disorder, assessed at 3 (T2), 6 (T3) and 12 months after PICU-discharge (T4) and set in comparison to baseline-evaluation (T0).

From April 2024 to December 2026, 1,680 families will be included. A qualitative-quantitative process evaluation using interviews, focus groups and questionnaires will examine relevant barriers and supporting factors for a later implementation of this novel approach in other institutions. Furthermore, the development of the interprofessional teams will be assessed. A health economic evaluation will complement these analyses. Approval by the local ethics committee was granted on 28th February 2024.

Results: The study design will be presented at the conference.

Implication for research and/or (healthcare) practice: The new form of care is intended to improve the secondary preventive care of children in the PICU and, thus, demonstrate that a structural change in PICUs leads to a reduction in PICS-p and PICS-f. The mandatory use of written protocols and standardized and validated scoring tools will improve the early detection and treatment of complications and ensure the full implementation of evidence-based measures. The project is funded by G-BA Innovationsfonds 01NVF22113.

Funding: Innovationsfonds/Versorgungsforschung; Project name: Kinderintensivmedizin neu gedacht – Vermeidung von Post Intensive Care Syndrom bei kritisch kranken Kindern und deren Familien NoPICS-Kids; Grant number: 01NVF22113