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
Secondary identifying numbers N/A
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

Study website

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Patient information can be found at: https://www.charttrials.abdn.ac.uk/practical/pis.php
Scientific title
Study acronymPRaCTICaL
Study objectivesThe 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) studiedOutcomes following critical illness and ICU discharge
InterventionEligible 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 typeOther
Primary outcome measureHealth 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).
Secondary outcome measures1. 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
Overall study start date01/09/2006
Completion date30/11/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants270
Key inclusion criteriaPatients 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 criteria1. 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 enrolment01/09/2006
Date of final enrolment30/11/2008

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

Health Services Research Unit
Aberdeen
ABS5 2ZD
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom

Website http://www.abdn.ac.uk/r&i/index.shtml
ROR logo "ROR" https://ror.org/016476m91

Funders

Funder type

Government

Chief Scientist Office (UK) (ref: CZH/4/2254)
Government organisation / Local government
Alternative name(s)
CSO
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 23/07/2007 Yes No
Results article results 16/10/2009 Yes No