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Peri-operative Implementation Study Evaluation
ISRCTN ISRCTN18046709
DOI 10.1186/ISRCTN18046709
ClinicalTrials.gov identifier
EudraCT number
Public title Peri-operative Implementation Study Evaluation
Scientific title Peri-operative Implementation Study Evaluation: Implementing evidence into practice
Acronym PoISE
Serial number at source 1247/3737
Study hypothesis What is the most effective implementation strategy for the uptake of evidence-based recommendations about peri-operative fasting?
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Peri-operative fasting - in elective surgical patients - general surgery, gynaecological and orthopaedics
Participants - 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
Participants - 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
Anticipated start date 16/01/2006
Anticipated end date 01/06/2009
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 19 Trusts (1575 inpatients assessed pre-intervention, 1930 patients assessed post-intervention)
Interventions 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
Primary outcome measure(s) 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 measure(s) 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)
Sources of funding The Health Foundation (UK) - as part of their Engaging with Quality Initiative
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22935241
Contact name Prof  Jo  Rycroft-Malone
  Address School of Healthcare Sciences
Fron Heulog
Ffriddoedd Road
  City/town Bangor
  Zip/Postcode LL57 2EF
  Country United Kingdom
  Tel +44 (0)1248 383119
  Email j.rycroft-malone@bangor.ac.uk
Sponsor University of Warwick (UK)
  Address c/o Professor Kate Seers
RCN Research Team
School of Health & Social Studies
  City/town Coventry
  Zip/Postcode CV4 7AL
  Country United Kingdom
  Tel +44 (0)24 7615 0614
  Email kate.seers@warwick.ac.uk
Date applied 22/10/2010
Last edited 21/01/2013
Date ISRCTN assigned 26/11/2010
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