Evaluating the feasibility and effectiveness of a critical care discharge information pack for patients and their families; a pilot cluster randomized controlled trial
Evaluating the feasibility and effectiveness of a critical care discharge information pack for patients and their families; a pilot cluster randomized controlled trial
Objectives
To evaluate the feasibility and effectiveness of an information pack, based on self-regulation theory, designed to support patients and their families immediately before, during and after discharge from an intensive care unit.
Design and setting
Prospective assessor-blinded pilot cluster randomized controlled trial (in conjunction with a questionnaire survey of trial participants’ experience) in two intensive care units in England.
Participants
Patients (+/- a family member) who had spent at least 72 hours in an intensive care unit, declared medically fit for discharge to a general ward.
Randomization
Cluster randomization (by day of discharge decision) was used to allocate participants to one of three study groups.
Intervention
A user centred critical care discharge information pack (UCCDIP) containing two booklets; one for the patient (which included a personalized discharge summary) and one for the family, given prior to discharge to the ward.
Primary outcome
Psychological well-being measured using hospital anxiety and depression scores (HADS), assessed at 5+/-1 days post unit discharge and 28 days/hospital discharge. Statistical significance (p ? 0.05) was determined using Chi Square (?2) and Kruskal Wallis (H).
Results
One hundred and fifty eight patients were allocated to: intervention (UCCDIP) (n=51), control 1: ad-hoc verbal information (n=59), control 2: booklet published by ICUsteps (n=48). There were no statistically significant differences in the primary outcome. The a priori enrolment goal was not reached and attrition was high. Using HADS as a primary outcome measure, an estimated sample size of 286 is required to power a definitive trial.
Conclusions
Findings from this pilot RCT provide important preliminary data regarding the circumstances under which an intervention based on the principles of UCCDIP could be effective, and the sample size required to demonstrate this.
randomized controlled trial, critical illness, patient discharge, patient education handout, rehabilitation
1-36
Bench, Suzanne
83dc9bd9-6c4e-4009-9192-e260ebab2bbc
Day, Tina
e2c49070-9670-44d0-bfe0-bffb4999ca70
Heelas, Karina
fd1386e3-3cbb-4cfb-b2c5-49a497be008b
Hopkins, Philip
8628682a-8e4f-4ec8-9e99-db09c273d8d1
White, Catherine
b0102300-5744-4458-a793-c447ac015a68
Griffiths, Peter
ac7afec1-7d72-4b83-b016-3a43e245265b
Bench, Suzanne
83dc9bd9-6c4e-4009-9192-e260ebab2bbc
Day, Tina
e2c49070-9670-44d0-bfe0-bffb4999ca70
Heelas, Karina
fd1386e3-3cbb-4cfb-b2c5-49a497be008b
Hopkins, Philip
8628682a-8e4f-4ec8-9e99-db09c273d8d1
White, Catherine
b0102300-5744-4458-a793-c447ac015a68
Griffiths, Peter
ac7afec1-7d72-4b83-b016-3a43e245265b
Bench, Suzanne, Day, Tina, Heelas, Karina, Hopkins, Philip, White, Catherine and Griffiths, Peter
(2015)
Evaluating the feasibility and effectiveness of a critical care discharge information pack for patients and their families; a pilot cluster randomized controlled trial.
British Medical Journal, 5 (e006852), .
(doi:10.1136/bmjopen-2014-006852).
Abstract
Objectives
To evaluate the feasibility and effectiveness of an information pack, based on self-regulation theory, designed to support patients and their families immediately before, during and after discharge from an intensive care unit.
Design and setting
Prospective assessor-blinded pilot cluster randomized controlled trial (in conjunction with a questionnaire survey of trial participants’ experience) in two intensive care units in England.
Participants
Patients (+/- a family member) who had spent at least 72 hours in an intensive care unit, declared medically fit for discharge to a general ward.
Randomization
Cluster randomization (by day of discharge decision) was used to allocate participants to one of three study groups.
Intervention
A user centred critical care discharge information pack (UCCDIP) containing two booklets; one for the patient (which included a personalized discharge summary) and one for the family, given prior to discharge to the ward.
Primary outcome
Psychological well-being measured using hospital anxiety and depression scores (HADS), assessed at 5+/-1 days post unit discharge and 28 days/hospital discharge. Statistical significance (p ? 0.05) was determined using Chi Square (?2) and Kruskal Wallis (H).
Results
One hundred and fifty eight patients were allocated to: intervention (UCCDIP) (n=51), control 1: ad-hoc verbal information (n=59), control 2: booklet published by ICUsteps (n=48). There were no statistically significant differences in the primary outcome. The a priori enrolment goal was not reached and attrition was high. Using HADS as a primary outcome measure, an estimated sample size of 286 is required to power a definitive trial.
Conclusions
Findings from this pilot RCT provide important preliminary data regarding the circumstances under which an intervention based on the principles of UCCDIP could be effective, and the sample size required to demonstrate this.
Text
Evaluating the feasibility revisions 2.docx
- Accepted Manuscript
Text
e006852.full.pdf
- Version of Record
More information
Accepted/In Press date: 20 July 2015
e-pub ahead of print date: 27 November 2015
Keywords:
randomized controlled trial, critical illness, patient discharge, patient education handout, rehabilitation
Organisations:
Faculty of Health Sciences
Identifiers
Local EPrints ID: 379774
URI: http://eprints.soton.ac.uk/id/eprint/379774
ISSN: 0959-8138
PURE UUID: 45d17c0d-3e99-46ff-a1ba-0cc91d518d7f
Catalogue record
Date deposited: 18 Aug 2015 11:11
Last modified: 15 Mar 2024 03:37
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Contributors
Author:
Suzanne Bench
Author:
Tina Day
Author:
Karina Heelas
Author:
Philip Hopkins
Author:
Catherine White
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