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
-
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.