Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Brian Cuthbertson
ORCID ID
Contact details
Health Services Research Unit
University of Aberdeen
3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
ABS5 2ZD
United Kingdom
+44 (0)1224 552730
b.h.cuthbertson@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PRaCTICaL
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Patient information can be found at: https://www.charttrials.abdn.ac.uk/practical/pis.php
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/09/2006
Overall trial end date
30/11/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
270
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
30/11/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Services Research Unit
Aberdeen
ABS5 2ZD
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
King's College
Aberdeen
AB24 3FX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (UK) (ref: CZH/4/2254)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17645791
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19837741
Publication citations
-
Protocol
Cuthbertson BH, Rattray J, Johnston M, Wildsmith JA, Wilson E, Hernendez R, Ramsey C, Hull AM, Norrie J, Campbell M, A pragmatic randomised, controlled trial of intensive care follow up programmes in improving longer-term outcomes from critical illness. The PRACTICAL study., BMC Health Serv Res, 2007, 7, 116, doi: 10.1186/1472-6963-7-116.
-
Results
Cuthbertson BH, Rattray J, Campbell MK, Gager M, Roughton S, Smith A, Hull A, Breeman S, Norrie J, Jenkinson D, Hernández R, Johnston M, Wilson E, Waldmann C, , The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial., BMJ, 2009, 339, b3723.