| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN24294750 |
| Date ISRCTN assigned | 21/02/2007 |
| Local reference number(s) | N/A |
| Public title | A Pragmatic Randomised, Controlled Trial of Intensive Care post-discharge review clinics in improving Longer-term outcomes from critical illness |
| Scientific title |
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| Acronym | PRaCTICaL |
| Disease/condition/study domain | Outcomes following critical illness and ICU discharge |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | 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). |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | Patient information can be found at: https://www.charttrials.abdn.ac.uk/practical/pis.php |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 30/11/2008 |
| Status of trial | Ongoing |
| 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 |
| Trial website | https://www.charttrials.abdn.ac.uk/practical/ |
| Publications | Study protocol: http://www.ncbi.nlm.nih.gov/pubmed/17645791 |
| Sources of funding | Chief Scientist Office (UK) (ref: CZH/4/2254) |
| Sponsor name | University of Aberdeen (UK) |
| Sponsor details | King's College
Aberdeen
United Kingdom
AB24 3FX |
| Sponsor website | http://www.abdn.ac.uk/r&i/index.shtml |
| Contact name | Dr Brian Cuthbertson |
| Contact details | Health Services Research Unit
University of Aberdeen
3rd Floor, Health Sciences Building
Foresterhill
Aberdeen
United Kingdom
ABS5 2ZD |
| Contact telephone | +44 (0)1224 552730 |
| Contact fax | +44 (0)1224 554580 |
| Contact email | b.h.cuthbertson@abdn.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN24294750 |
| Date last extracted from ISRCTN register | 17/04/2008 |
