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 Christensen; Ask Elklit; Randi L Hansen; Heidi Knudsen; Louise B Grode; Dorthe Overgaard

doi:10.1007/s00134-016-4522-1

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 Christensen, Ask Elklit, Randi L Hansen, Heidi Knudsen, Louise B Grode, Dorthe Overgaard

Department of Clinical Medicine

49 Citations (Scopus)

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.

Original language	English
Journal	Intensive Care Medicine
Volume	42
Issue number	11
Pages (from-to)	1733-1743
Number of pages	11
ISSN	0342-4642
DOIs	https://doi.org/10.1007/s00134-016-4522-1
Publication status	Published - 1 Nov 2016

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Journal Article

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10.1007/s00134-016-4522-1

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Jensen, J. F., Egerod, I., Bestle, M. H., Christensen, D., Elklit, A., Hansen, R. L., Knudsen, H., Grode, L. B., & Overgaard, D. (2016). 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 Medicine, 42(11), 1733-1743. https://doi.org/10.1007/s00134-016-4522-1

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. / Jensen, Janet F; Egerod, Ingrid ; Bestle, Morten H et al.
In: Intensive Care Medicine, Vol. 42, No. 11, 01.11.2016, p. 1733-1743.

Research output: Contribution to journal › Journal article › Research › peer-review

Jensen, JF, Egerod, I , Bestle, MH, Christensen, D, Elklit, A, Hansen, RL, Knudsen, H, Grode, LB & Overgaard, D 2016, '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 Medicine, vol. 42, no. 11, pp. 1733-1743. https://doi.org/10.1007/s00134-016-4522-1

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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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AU - Jensen, Janet F

AU - Egerod, Ingrid

AU - Bestle, Morten H

AU - Christensen, Doris

AU - Elklit, Ask

AU - Hansen, Randi L

AU - Knudsen, Heidi

AU - Grode, Louise B

AU - Overgaard, Dorthe

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N2 - 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.

AB - 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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DO - 10.1007/s00134-016-4522-1

M3 - Journal article

C2 - 27695894

SN - 0342-4642

VL - 42

SP - 1733

EP - 1743

JO - Intensive Care Medicine

JF - Intensive Care Medicine

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ER -

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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