Peri-operative Implementation Study Evaluation

ISRCTN	ISRCTN18046709
DOI	https://doi.org/10.1186/ISRCTN18046709
Secondary identifying numbers	1247/3737

Submission date: 22/10/2010
Registration date: 26/11/2010
Last edited: 21/01/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jo Rycroft-Malone
Scientific

School of Healthcare Sciences
Fron Heulog
Ffriddoedd Road
Bangor
LL57 2EF
United Kingdom

Phone	+44 (0)1248 383119
Email	j.rycroft-malone@bangor.ac.uk

Study information

Study design	Pragmatic randomised trial, with time series and embedded process evaluation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Peri-operative Implementation Study Evaluation: Implementing evidence into practice
Study acronym	PoISE
Study objectives	What is the most effective implementation strategy for the uptake of evidence-based recommendations about peri-operative fasting?
Ethics approval(s)	The South East Research Ethics Committee approved on the 20th of April 2006 (ref: 06MRE01/20)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	16/01/2006
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	19 Trusts (1575 inpatients assessed pre-intervention, 1930 patients assessed post-intervention)
Key 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
Key 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
Date of first enrolment	16/01/2006
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

School of Healthcare Sciences

Bangor
LL57 2EF
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

c/o Professor Kate Seers
RCN Research Team
School of Health & Social Studies
Coventry
CV4 7AL
England
United Kingdom

Phone	+44 (0)24 7615 0614
Email	kate.seers@warwick.ac.uk
"ROR"	https://ror.org/01a77tt86

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/08/2012		Yes	No