A pragmatic randomised, controlled trial of intensive care follow up programmes in improving longer-term outcomes from critical illness. The PRACTICAL study.
BACKGROUND
A number of intensive care (ICU) patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study aims to test the hypothesis that intensive care follow up programmes are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge.


METHODS
This is a multi-centre, pragmatic, randomised controlled trial. Patients (n = 270) will be recruited prior to hospital discharge from three intensive care units in the UK, and randomised to one of two groups. The control group will receive standard in-hospital follow-up and the intervention group will participate in an ICU follow-up programme with clinic appointments 2-3 and 9 months after ICU discharge. The primary outcome measure is Health-related Quality of Life (HRQoL) 12 months after ICU discharge as measured by the Short Form-36. Secondary measures include: HRQoL at six months; Quality-adjusted life years using EQ-5D; posttraumatic psychopathology as measured by Davidson Trauma Scale; and anxiety and depression using the Hospital Anxiety and Depression Scale at both six and twelve months after ICU discharge. Contacts with health services in the twelve months after ICU discharge will be measured as part of the economic analysis.


CONCLUSIONS
The provision of intensive care follow-up clinics within the UK has developed in an ad hoc manner, is inconsistent in both the number of hospitals offering such a service or in the type of service offered. This study provides the opportunity to evaluate such services both in terms of patient benefit and cost-effectiveness. The results of this study therefore will inform clinical practice and policy with regard to the appropriate development of such services aimed at improving outcomes after intensive care.


BACKGROUND
ISRCTN24294750.
Cuthbertson
Brian H
BH
Health Service Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, UK. b.h.cuthbertson@abdn.ac.uk <b.h.cuthbertson@abdn.ac.uk>
Rattray
Janice
J
Johnston
Marie
M
Wildsmith
J Anthony
JA
Wilson
Edward
E
Hernendez
Rodolfo
R
Ramsey
Craig
C
Hull
Alastair M
AM
Norrie
John
J
Campbell
Marion
M
D001007:Anxiety / Q000453:epidemiology; D003266:Continuity of Patient Care / Q000458:organization & administration*; D016638:Critical Illness / Q000523:psychology / Q000534:rehabilitation*; D003863:Depression / Q000453:epidemiology; D005500:Follow-Up Studies; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data*; D017063:Outcome Assessment, Health Care; D010044:Outpatient Clinics, Hospital / Q000706:statistics & numerical data*; D010351:Patient Discharge; D015397:Program Evaluation; D011788:Quality of Life / Q000523:psychology*; D019057:Quality-Adjusted Life Years; D040921:Stress Disorders, Traumatic / Q000453:epidemiology; D006113:United Kingdom