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.
OBJECTIVE
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.


BACKGROUND
The trial is registered at Clinicaltrials.gov, identification no. NCT01721239.
Department of Anesthesiology, Nordsjællands Hospital, University of Copenhagen, 3400, Hilleroed, Denmark. janet.froulund.jensen@regionh.dk.
Janet F
JF
Jensen
Neurointensive Care Unit, Rigshospitalet, University of Copenhagen and Health & Medical Sciences, University of Copenhagen, 2100, Copenhagen, Denmark.
Ingrid
I
Egerod
Department of Anesthesiology, Nordsjællands Hospital, University of Copenhagen, 3400, Hilleroed, Denmark.
Morten H
MH
Bestle
Department of Anesthesiology, Nordsjællands Hospital, University of Copenhagen, 3400, Hilleroed, Denmark.
Doris F
DF
Christensen
Department of Psychology, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark.
Ask
A
Elklit
Department of Anesthesiology, Nordsjællands Hospital, University of Copenhagen, 3400, Hilleroed, Denmark.
Randi L
RL
Hansen
Department of Anesthesiology, Herlev Hospital, University of Copenhagen, 2730, Herlev, Denmark.
Heidi
H
Knudsen
Department of Anesthesiology, Hospital of Horsens, 8700, Horsens, Denmark.
Louise B
LB
Grode
Research Unit, Nordsjællands Hospital, and Department of Nursing, Metropolitan University College, 2200, Copenhagen, Denmark.
Dorthe
D
Overgaard
D000368:Aged; D016638:Critical Illness / Q000523:psychology* / Q000534:rehabilitation*; D005260:Female; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data*; D008875:Middle Aged; D015399:Nursing Research; D017063:Outcome Assessment, Health Care; D057184:Practice Patterns, Nurses'; D015397:Program Evaluation; D011788:Quality of Life; D012121:Respiration, Artificial / Q000009:adverse effects; D060685:Sense of Coherence; D017741:Survivors / Q000523:psychology*; D013997:Time Factors
Aftercare; Follow-up; ICU clinic; Intensive care; Multicenter randomized clinical controlled trial; Rehabilitation
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