A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study
- Timothy Simon Walsh1,2,
- Lisa G Salisbury2,3,
- Julia Boyd4,
- Pamela Ramsay2,3,5,
- Judith Merriweather2,3,5,
- Guro Huby3,
- John Forbes6,
- Janice Z Rattray7,
- David M Griffith2,5,
- Simon J Mackenzie5,
- Alastair Hull8,
- Steff Lewis4,6,
- Gordon D Murray6
- 1Centre for Inflammation Research, Queens Medical Research Institute, Edinburgh, UK
- 2Edinburgh Critical Care Research group, Edinburgh University and NHS Lothian, Edinburgh, UK
- 3Interdisciplinary Social Science in Health/Nursing Studies, University of Edinburgh, Edinburgh, UK
- 4Edinburgh Clinical Trials Unit, Edinburgh University, Edinburgh, UK
- 5Lothian University Hospitals Division, Edinburgh, UK
- 6Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK
- 7School of Nursing and Midwifery, University of Dundee, Dundee, UK
- 8NHS Tayside, Dundee, UK
- Correspondence to Professor Timothy Simon Walsh;
- Received 12 May 2012
- Accepted 18 May 2012
- Published 2 July 2012
Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life.
Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers.
Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan.
Trial registration The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland.
To cite: Walsh TS, Salisbury LG, Boyd J, et al. A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study. BMJ Open 2012;2:e001475. doi:10.1136/bmjopen-2012-001475
Contributors The following is taken from the submitted manuscript. The initials refer to the listed co-authors: TSW, LGS, PR, JM and GH conceived the project and completed pilot and feasibility work. Specialist clinical input to protocol design was provided by TSW and SJM (critical care perspective), LGS (physiotherapy/rehabilitation), PR and JZR (nursing) and JM (dietetics). Statistical advice was provided by GDM and SL and the health economic evaluation designed by JF. The qualitative studies were conceived and designed by PR, GH and JZR. The inflammatory biomarker substudy was designed by TSW and DMG. Advice on health service reorganisation aspects was provided by SJM and GH. Advice on psychological outcomes and interventions was provided by AH and JZR. JB is trial manager. All authors contributed to the design of the final protocol and set-up of the trial.
Funding Funded by the Chief Scientists Office, Scotland (grant number CZH/4/53). Additional funding has been provided through the Edinburgh Critical Care Research Group.
Competing interests None.
Ethics approval Ethics approval was provided by Scotland A REC.
Provenance and peer review Not commissioned; internally peer reviewed.
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.