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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

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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.

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Acknowledgments

We wish to thank all the patients and relatives for their participation in the RAPIT study and the nurses in RAPIT Group for their engagement and collaboration. The RAPIT Steering Committee: Jensen, Overgaard, Christensen, Bestle, and Egerod. RAPIT Group (in addition to the authors): Department of Anesthesiology: Kjerrumgård H, Nordsjælland Hospital, Copenhagen University Hospital; Figgé CFN, Østergaard K, Nykøbing Falster Hospital; Jeppesen MJ, Klausholm AD, Joergensen JV, Bødker K, Lehmkuhl L, Svendborg Hospital, Odense University Hospital; Pedersen ASB, Brix LD, Hospitalsenheden Horsens; Christoffersen S, Milling RW, Næstved Hospital, Copenhagen University Hospital; Wiborg E, Bundgaard BS, Aabenraa Hospital, South Jutland Hospital; Mortensen CB, Larsen CF, Herlev Hospital, Copenhagen University Hospital; Markussen HB, Eriksen C, Jensen U, Sønderborg Hospital, South Jutland Hospital; Nielsen S, Larsen MC, Heart Centre, Rigshospitalet, Copenhagen University Hospital; Skjølstrup KK, Knudsen B, Fischer S, Esbjerg, Sydvestjysk Hospital. We wish to thank statistician AEK Jensen, Section of Biostatistics, University of Copenhagen and Nordsjælland Hospital, Copenhagen University Hospital, and statistician T Lange, Section of Biostatistics, University of Copenhagen for their assistance.

Author information

Authors and Affiliations

  1. Department of Anesthesiology, Nordsjællands Hospital, University of Copenhagen, 3400, Hilleroed, Denmark

    Janet F. Jensen, Morten H. Bestle, Doris F. Christensen & Randi L. Hansen

  2. Neurointensive Care Unit, Rigshospitalet, University of Copenhagen and Health & Medical Sciences, University of Copenhagen, 2100, Copenhagen, Denmark

    Ingrid Egerod

  3. Department of Psychology, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark

    Ask Elklit

  4. Department of Anesthesiology, Herlev Hospital, University of Copenhagen, 2730, Herlev, Denmark

    Heidi Knudsen

  5. Department of Anesthesiology, Hospital of Horsens, 8700, Horsens, Denmark

    Louise B. Grode

  6. Research Unit, Nordsjællands Hospital, and Department of Nursing, Metropolitan University College, 2200, Copenhagen, Denmark

    Dorthe Overgaard

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  1. Janet F. Jensen
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Corresponding author

Correspondence to Janet F. Jensen.

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Conflicts of interest

No conflicts of interest have been declared by the authors.

Source of funding

The study was supported by grants from the Danish Nursing Organization, The Novo Nordisk Foundation and Nordsjællands Hospital, University of Copenhagen, Denmark. None of these had any influence on the design or conduct of the study; data collection, data management, analysis, and interpretation of the data; or findings. They are not responsible for the content in this paper.

Additional information

This work was performed at 10 ICUs in Denmark: Nordsjællands Hospital; Herlev Hospital; Hospitalsenheden Horsens; Nykøbing Falster Sygehus; Næstved Sygehus; Rigshospitalet, Heart Center 2143; Sygehus Sønderjylland, Department at Aabenraa and Sønderborg; Sydvestjysk Sygehus, Esbjerg Sygehus; Odense Universitetshospital, Svendborg.

Take-home message: Our nurse-led ICU recovery program failed to effectively improve patients’ health-related quality of life during the first year after ICU discharge.

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Jensen, J.F., Egerod, I., Bestle, M.H. et al. 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. Intensive Care Med 42, 1733–1743 (2016). https://doi.org/10.1007/s00134-016-4522-1

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