Increased Hospital-Based Physical Rehabilitation and Information Provision After Intensive Care Unit Discharge: The RECOVER Randomized Clinical Trial.

JAMA internal medicine

Jun 2015

DOI: 10.1001/jamainternmed.2015.0822

Citations:275

Influential Citations:7

Interventional (Human) Studies

Enhanced Details

Methods

Design: parallel-group, randomized clinical trial with blinded outcome assessment conducted at two hospitals in Edinburgh, Scotland. Participants: 240 adults discharged from the ICU after at least 48 hours of mechanical ventilation (Dec 1, 2010 to Jan 31, 2013), randomized 120 to usual care and 120 to enhanced rehabilitation with information. Exclusions: primary neurologic diagnosis, palliative care, current or planned home ventilation, age <18 years, discharge to a non-study hospital. Baseline characteristics were similar between groups (median age ~62 years; ~55-58% male).

Results

Enhanced post-ICU rehabilitation with increased mobility/exercise, more dietetic input, goal setting, and information provision did not improve mobility (Rivermead Mobility Index at 3 months: 13 in both groups; adjusted mean difference −0.2, 95% CI −1.3 to 0.9; P = 0.71) or health-related quality of life (SF-12 PCS: −0.1, 95% CI −3.3 to 3.1; P = 0.96; SF-12 MCS: 0.2, 95% CI −3.4 to 3.8; P = 0.91). No differences were observed at 6 or 12 months for any outcome. Intervention improved patient satisfaction with rehabilitation-related aspects (physiotherapy, nutritional support, coordination of care, information provision) at 3 months and across six of nine recovery domains. Economic analysis showed no incremental cost-effectiveness; additional rehabilitation assistant staffing added about $1,100 per patient with no gain in quality-adjusted life years. Conclusion: Post-ICU hospital-based rehabilitation intensified with information provision did not improve physical recovery or HRQOL but improved patient satisfaction; results suggest focusing resources on alternative strategies and further research to identify components or subgroups that yield meaningful benefits.

Limitations

Not blinded participants or clinicians; bias mitigated by restricting rehabilitation assistants to the intervention group and blinding outcome assessors. Post-ICU hospital stay was relatively short for many patients, potentially limiting observable improvements. A ceiling effect was observed with the Rivermead Mobility Index (about 25% reached 14/15 at 3 months), reducing responsiveness of the measure. The trial was conducted at two Edinburgh hospitals, limiting generalizability. The multi-component nature of the intervention makes it difficult to isolate which elements drive effects. Some follow-up data were missing up to 12 months, potentially affecting power and subgroup analyses.

Abstract

IMPORTANCE Critical illness results in disability and reduced health-related quality of life (HRQOL), but the optimum timing and components of rehabilitation are uncertain. OBJECTIVE To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities. DESIGN, SETTING, AND PARTICIPANTS A parallel group, randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh, Scotland, of 240 patients discharged from the ICU between December 1, 2010, and January 31, 2013, who required at least 48 hours of mechanical ventilation. Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013; for the 6- and 12-month outcomes and the health economic evaluation, between March and April 2014. INTERVENTIONS During the post-ICU hospital stay, both groups received physiotherapy and dietetic, occupational, and speech/language therapy, but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2- to 3-fold, increased dietetic assessment and treatment, used individualized goal setting, and provided greater illness-specific information. Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner. MAIN OUTCOMES AND MEASURES The Rivermead Mobility Index (RMI) (range 0-15) at 3 months; higher scores indicate greater mobility. Secondary outcomes included HRQOL, psychological outcomes, self-reported symptoms, patient experience, and cost-effectiveness during a 12-month follow-up (completed in February 2014). RESULTS Median RMI at randomization was 3 (interquartile range [IQR], 1-6) and at 3 months was 13 (IQR, 10-14) for the intervention and usual care groups (mean difference, -0.2 [95% CI, -1.3 to 0.9; P = .71]). The HRQOL scores were unchanged by the intervention (mean difference in the Physical Component Summary score, -0.1 [95% CI, -3.3 to 3.1; P = .96]; and in the Mental Component Summary score, 0.2 [95% CI, -3.4 to 3.8; P = .91]). No differences were found for self-reported symptoms of fatigue, pain, appetite, joint stiffness, or breathlessness. Levels of anxiety, depression, and posttraumatic stress were similar, as were hand grip strength and the timed Up & Go test. No differences were found at the 6- or 12-month follow-up for any outcome measures. However, patients in the intervention group reported greater satisfaction with physiotherapy, nutritional support, coordination of care, and information provision. CONCLUSIONS AND RELEVANCE Post-ICU hospital-based rehabilitation, including increased physical and nutritional therapy plus information provision, did not improve physical recovery or HRQOL, but improved patient satisfaction with many aspects of recovery. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN09412438. show less