title: A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan.
  
  
  BACKGROUND
  The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland.
authors: Centre for Inflammation Research, Queens Medical Research Institute, Edinburgh, UK.
authors: Timothy Simon
authors: TS
authors: Walsh
authors: Lisa G
authors: LG
authors: Salisbury
authors: Julia
authors: J
authors: Boyd
authors: Pamela
authors: P
authors: Ramsay
authors: Judith
authors: J
authors: Merriweather
authors: Guro
authors: G
authors: Huby
authors: John
authors: J
authors: Forbes
authors: Janice Z
authors: JZ
authors: Rattray
authors: David M
authors: DM
authors: Griffith
authors: Simon J
authors: SJ
authors: Mackenzie
authors: Alastair
authors: A
authors: Hull
authors: Steff
authors: S
authors: Lewis
authors: Gordon D
authors: GD
authors: Murray