Condition category
Surgery
Date applied
22/10/2010
Date assigned
26/11/2010
Last edited
21/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jo Rycroft-Malone

ORCID ID

Contact details

School of Healthcare Sciences
Fron Heulog
Ffriddoedd Road
Bangor
LL57 2EF
United Kingdom
+44 (0)1248 383119
j.rycroft-malone@bangor.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1247/3737

Study information

Scientific title

Peri-operative Implementation Study Evaluation: Implementing evidence into practice

Acronym

PoISE

Study hypothesis

What is the most effective implementation strategy for the uptake of evidence-based recommendations about peri-operative fasting?

Ethics approval

The South East Research Ethics Committee approved on the 20th of April 2006 (ref: 06MRE01/20)

Study design

Pragmatic randomised trial, with time series and embedded process evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Peri-operative fasting - in elective surgical patients - general surgery, gynaecological and orthopaedics

Intervention

Participating trusts were randomly allocated to one of three implementation strategies (6 trusts in two arms and 7 in one) on the basis of the prestudy sample size calculations the study had 80% power to detect an effect size of 2 (a difference of 4 hours).

1. Standard dissemination
2. Standard dissemination + web-based education resources + opinion leader
3. Standard dissemination + Plan-Do-Study-Act

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Duration of fluid and food fast - from commencement of food fast to induction of anaesthesia and nil by mouth to induction of anaesthesia.

Secondary outcome measures

1. Patient's experiences of fasting
1.1. Qualitative interviews (pre-intervention 35, post-intervention 35)
1.2. Questionnaire (pre intervention 1069, post intervention 1215)
2. Practitioner's experiences of implementing changes to practice
2.1. Interviews with change agents and site contacts (pre intervention 28, post intervention 24)
2.2. Focus groups with staff (5 post intervention)
2.3. Learning Organisation Survey (pre intervention 758, post
intervention 318)

Overall trial start date

16/01/2006

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sites
19 acute hospital trusts across the 4 countries of the UK; England (15), Scotland (2), Wales (1), Northern Ireland (1)

2. Patients:
2.1. Patients over the age of 18
2.2. Patients undergoing elective general, orthopaedic or gynaecological surgery
2.3. Patients who could provide informed consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

19 Trusts (1575 inpatients assessed pre-intervention, 1930 patients assessed post-intervention)

Participant exclusion criteria

1. Patients under the age of 18
2. Patients who are critically ill, had major surgery, in pain or suffering from any
other discomfort
3. Emergency or trauma patients because we wish to look at routine fasting
regimes
4. Patients who are cognitively impaired

Recruitment start date

16/01/2006

Recruitment end date

01/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Healthcare Sciences
Bangor
LL57 2EF
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

c/o Professor Kate Seers
RCN Research Team
School of Health & Social Studies
Coventry
CV4 7AL
United Kingdom
+44 (0)24 7615 0614
kate.seers@warwick.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Health Foundation (UK) - as part of their Engaging with Quality Initiative

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22935241

Publication citations

  1. Results

    Rycroft-Malone J, Seers K, Crichton N, Chandler J, Hawkes CA, Allen C, Bullock I, Strunin L, A pragmatic cluster randomised trial evaluating three implementation interventions., Implement Sci, 2012, 7, 80, doi: 10.1186/1748-5908-7-80.

Additional files

Editorial Notes