A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial.
BACKGROUND
Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland).


METHODS
The intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development.


RESULTS
The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions.


CONCLUSIONS
The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.
Pam
P
Ramsay
Edinburgh Critical Care Research group, Edinburgh University and NHS Lothian, Chancellors Building, 49 Little France Crescent, Old Dalkeith Road, Edinburgh EH16 4SB, UK. Lisa.Salisbury@ed.ac.uk.
Lisa G
LG
Salisbury
Judith L
JL
Merriweather
Guro
G
Huby
Janice E
JE
Rattray
Alastair M
AM
Hull
Stephen J
SJ
Brett
Simon J
SJ
Mackenzie
Gordon D
GD
Murray
John F
JF
Forbes
Timothy Simon
TS
Walsh
D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003299:Cooperative Behavior; D003422:Critical Care; D016638:Critical Illness / Q000534:rehabilitation*; D006801:Humans; D010348:Patient Care Team / Q000145:classification; D020127:Recovery of Function; D012046:Rehabilitation / Q000145:classification / Q000379:methods; D012107:Research Design; D012606:Scotland; D009626:Terminology as Topic; D013997:Time Factors; D016896:Treatment Outcome