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
Contact information
Dr Brian Cuthbertson
Scientific
Scientific
Health Services Research Unit
University of Aberdeen
3rd Floor, Health Sciences Building
Foresterhill
Aberdeen
ABS5 2ZD
United Kingdom
| Phone | +44 (0)1224 552730 |
|---|---|
| b.h.cuthbertson@abdn.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Patient information can be found at: https://www.charttrials.abdn.ac.uk/practical/pis.php |
| 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 | 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 measures | 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 |
| Overall study start date | 01/09/2006 |
| Completion date | 30/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
ABS5 2ZD
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk/r&i/index.shtml |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Chief Scientist Office (UK) (ref: CZH/4/2254)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
