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.
The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland.
The optimum method to maximise the rate and magnitude of recovery following an illness requiring intensive care is unknown.
Rehabilitation is a complex healthcare intervention, which following critical illness involves multiple healthcare professionals including doctors, nurses, physical therapists, dietitians, occupational therapists and other allied professionals.
The RECOVER trial hypothesises that providing more coordinated and intensive rehabilitation, delivered by a specialised generic rehabilitation assistant supported by the existing multidisciplinary team, will improve recovery as judged by a range of patient-centred outcome measures and is cost-effective.
The RECOVER study will evaluate whether enhanced rehabilitation is clinically effective and cost-effective in patients enrolled at the time of ICU discharge.
Both positive and negative results will be clinically important in guiding future research directions and health service improvement.
Strengths and limitations of this study
RECOVER was informed by the recommendations of recent evidence-based NICE guidance, and a significant body of research was used to develop the intervention.
The trial has been designed to adhere closely to recent guidance concerning the evaluation of complex healthcare interventions, especially the measurement of process.
A weakness may be the inclusion of patients with a range of illness severity and disability from a general intensive care population; this could miss important effects in patient subgroups.