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A Pragmatic Randomised, Controlled Trial of Intensive Care post-discharge review clinics in improving Longer-term outcomes from critical illness
DOI 10.1186/ISRCTN24294750
ClinicalTrials.gov identifier
EudraCT number
Public title A Pragmatic Randomised, Controlled Trial of Intensive Care post-discharge review clinics in improving Longer-term outcomes from critical illness
Scientific title
Acronym PRaCTICaL
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval 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).
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Outcomes following critical illness and ICU discharge
Participants - 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.
Participants - 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
Anticipated start date 01/09/2006
Anticipated end date 30/11/2008
Status of trial Completed
Patient information material Patient information can be found at: https://www.charttrials.abdn.ac.uk/practical/pis.php
Target number of participants 270
Interventions 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.
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).
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
Sources of funding Chief Scientist Office (UK) (ref: CZH/4/2254)
Trial website https://www.charttrials.abdn.ac.uk/practical/
Publications 1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17645791
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19837741
Contact name Dr  Brian  Cuthbertson
  Address Health Services Research Unit
University of Aberdeen
3rd Floor, Health Sciences Building
  City/town Aberdeen
  Zip/Postcode ABS5 2ZD
  Country United Kingdom
  Tel +44 (0)1224 552730
  Fax +44 (0)1224 554580
  Email b.h.cuthbertson@abdn.ac.uk
Sponsor University of Aberdeen (UK)
  Address King's College
  City/town Aberdeen
  Zip/Postcode AB24 3FX
  Country United Kingdom
  Sponsor website: http://www.abdn.ac.uk/r&i/index.shtml
Date applied 21/12/2006
Last edited 21/10/2009
Date ISRCTN assigned 21/02/2007
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