A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study.

Abstract

The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge. A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012 and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18years) after receiving mechanical ventilation (≥48h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC). Primary outcome was health-related quality of life (HRQOL) at 12months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and post-traumatic stress disorder (PTSD) assessed at 3 and 12months after ICU discharge including utilization of healthcare services at 12months. At 12months, we found no differences in HRQOL between groups (mean difference in the PhysicalComponent Summary score, 1.41 [95% CI, -1.53 to 4.35; p=0.35] (n=235); and in the MentalComponent Summary score, 1.92 [95% CI, -1.06 to 4.90; p=0.11] (n=235). No differences were found on self-reported SOC (p=0.63), anxiety (p=0.68), depression (p=0.67), PTSD (p=0.27), or the utilization of healthcare services including rehabilitation. We found a difference on anxiety, when a cut-off point ≥11 was applied, in per protocol analysis of complete cases at 3months favoring the intervention (8.8% vs. 16.2%, p=0.04). The tested recovery program was not superior to standard care during the first 12months post-ICU. The trial is registered at Clinicaltrials.gov, identification no. NCT01721239.