A Pragmatic Randomised, Controlled Trial of Intensive Care post-discharge review clinics in improving Longer-term outcomes from critical illness

ISRCTN	ISRCTN24294750
DOI	https://doi.org/10.1186/ISRCTN24294750
Protocol serial number	N/A
Sponsor	University of Aberdeen (UK)
Funder	Chief Scientist Office (UK) (ref: CZH/4/2254)

Submission date: 21/12/2006
Registration date: 21/02/2007
Last edited: 21/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian Cuthbertson
Scientific

Health Services Research Unit
University of Aberdeen
3rd Floor, Health Sciences Building
Foresterhill
Aberdeen
ABS5 2ZD
United Kingdom

Phone	+44 (0)1224 552730
Email	b.h.cuthbertson@abdn.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	PRaCTICaL
Study objectives	The hypothesis is that intensive care post-discharge review clinics are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge.
Ethics approval(s)	Fife and Forth Valley Local Research Ethics Committee, approval was issued on 21st June 2006. An amendment was submitted and approved on 28 October 2006 (ref: 06/S0501/26).
Health condition(s) or problem(s) studied	Outcomes following critical illness and ICU discharge
Intervention	Eligible patients will be randomised to one of two intervention groups after ICU discharge but prior to hospital discharge: 1. ICU post-discharge review clinic group - these patients will be randomised to visit an ICU post-discharge review clinic at two to three months and nine months after hospital discharge. 2. Standard care group - in line with standard clinical practice in the UK patients allocated to the standard care group will have no intensive care post-discharge follow-up after hospital discharge. Patients will be followed-up for the trial outcome measures and end points only over the first year after ICU discharge. In line with good clinical practice, if there are concerns about the well being of these patients at trial follow-up, a General Practitioner (GP) letter will be generated.
Intervention type	Other
Primary outcome measure(s)	Health Related Quality Of Life (HR-QOL) 12 months after ICU discharge as measured by the physical and mental component scores of the Short Form health survey (SF-36).
Key secondary outcome measure(s)	1. HR-QOL six months after ICU discharge assessed by SF-36 2. Quality-Adjusted Life Years (QALYs) at 12 months using Euro-Quality of Life (EQ-5D) questionnaire 3. Incidence and severity of PTSD measured by Davidson Trauma Score (DTS) at six and 12 months 4. Anxiety and depression using HADS at six and 12 months 5. Contacts with health services measured as part of the economic analysis 6. Patient satisfaction at 12 months using a patient satisfaction survey 7. Primary and secondary health care costs in the year after hospital discharge 8. Mortality in 12 months after ICU discharge
Completion date	30/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	270
Key inclusion criteria	Patients receiving level three dependency care (Intensive Care Unit [ICU]) for more than one hour at any time during their hospital stay and who survive until the time of hospital discharge.
Key exclusion criteria	1. Age less than 18 years 2. Not expected to survive to leave hospital 3. Unable to complete questionnaires 4. Unable to attend clinics 5. Patients who do not consent
Date of first enrolment	01/09/2006
Date of final enrolment	30/11/2008

Locations

Countries of recruitment

United Kingdom

Study participating centre

Health Services Research Unit

Aberdeen
ABS5 2ZD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/10/2009		Yes	No
Protocol article	protocol	23/07/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes