Intensive Care Medicine

, Volume 42, Issue 11, pp 1733–1743 | Cite as

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

  • Janet F. Jensen
  • Ingrid Egerod
  • Morten H. Bestle
  • Doris F. Christensen
  • Ask Elklit
  • Randi L. Hansen
  • Heidi Knudsen
  • Louise B. Grode
  • Dorthe Overgaard
Original

Abstract

Purpose

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.

Methods

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 (≥18 years) after receiving mechanical ventilation (≥48 h) 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 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and post-traumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months.

Results

At 12 months, we found no differences in HRQOL between groups (mean difference in the Physical Component Summary score, 1.41 [95 % CI, −1.53 to 4.35; p = 0.35] (n = 235); and in the Mental Component 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 3 months favoring the intervention (8.8 % vs. 16.2 %, p = 0.04).

Conclusions

The tested recovery program was not superior to standard care during the first 12 months post-ICU.

Trial registration

The trial is registered at Clinicaltrials.gov, identification no. NCT01721239.

Keywords

Intensive care Aftercare ICU clinic Follow-up Rehabilitation Multicenter randomized clinical controlled trial 

Supplementary material

134_2016_4522_MOESM1_ESM.docx (22.6 mb)
Supplementary material 1 (DOCX 23161 kb)

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Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2016

Authors and Affiliations

  • Janet F. Jensen
    • 1
  • Ingrid Egerod
    • 2
  • Morten H. Bestle
    • 1
  • Doris F. Christensen
    • 1
  • Ask Elklit
    • 3
  • Randi L. Hansen
    • 1
  • Heidi Knudsen
    • 4
  • Louise B. Grode
    • 5
  • Dorthe Overgaard
    • 6
  1. 1.Department of AnesthesiologyNordsjællands Hospital, University of CopenhagenHilleroedDenmark
  2. 2.Neurointensive Care UnitRigshospitalet, University of Copenhagen and Health & Medical Sciences, University of CopenhagenCopenhagenDenmark
  3. 3.Department of PsychologyUniversity of Southern DenmarkOdense MDenmark
  4. 4.Department of AnesthesiologyHerlev Hospital, University of CopenhagenHerlevDenmark
  5. 5.Department of AnesthesiologyHospital of HorsensHorsensDenmark
  6. 6.Research Unit, Nordsjællands Hospital, and Department of NursingMetropolitan University CollegeCopenhagenDenmark

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