Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): Feasibility of a pragmatic randomised controlled trial

Abstract

Background ICU survivors often suffer from prolonged physical and mental impairments resulting in the so called “Post-Intensive Care Syndrome” (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomized trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care. Methods This pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, relatives, health professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT’s primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire. Results Principal findings related to feasibility were 85% consent rate (N = 48), 34% attrition rate (N = 41) and 77% completeness of outcome measurements. 41 participants (15 women, median age 60 years) were included of whom 66% completed the study (12/21 in the intervention group, 15/20 in the control group). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. 62% of the intervention group (N = 21) fully completed all components of the intervention (fidelity). Six-month follow-up assessment was planned for all study participants and performed after 197 days (median). The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). Conclusion The participatory developed intervention of an ICU follow-up clinic and the pilot RCT both seem to be feasible. We recommend to start the pragmatic RCT on the effectiveness of the ICU follow-up clinic. Trial registration ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468