Condition category
Signs and Symptoms
Date applied
21/12/2006
Date assigned
21/02/2007
Last edited
21/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.charttrials.abdn.ac.uk/practical/

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 measures

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

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

http://www.abdn.ac.uk/r&i/index.shtml

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. Results

    Cuthbertson BH, Rattray J, Campbell MK, Gager M, Roughton S, Smith A, Hull A, Breeman S, Norrie J, Jenkinson D, Hern√°ndez 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.

Additional files

Editorial Notes