Peri-operative Implementation Study Evaluation
| ISRCTN | ISRCTN18046709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18046709 |
| Protocol serial number | 1247/3737 |
| Sponsor | University of Warwick (UK) |
| Funder | The Health Foundation (UK) - as part of their Engaging with Quality Initiative |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
School of Healthcare Sciences
Fron Heulog
Ffriddoedd Road
Bangor
LL57 2EF
United Kingdom
| Phone | +44 (0)1248 383119 |
|---|---|
| j.rycroft-malone@bangor.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic randomised trial, with time series and embedded process evaluation |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Duration of fluid and food fast - from commencement of food fast to induction of anaesthesia and nil by mouth to induction of anaesthesia. |
| Key secondary outcome measure(s) |
1. Patient's experiences of fasting |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 3505 |
| 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
LL57 2EF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
