Preventing postoperative nausea and vomiting - a quality improvement project
| ISRCTN | ISRCTN45566845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45566845 |
| Secondary identifying numbers | METc2018/670 |
- Submission date
- 17/02/2020
- Registration date
- 26/02/2020
- Last edited
- 23/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The percentage of patients experiencing postoperative nausea and vomiting (PONV) is stagnating despite the availability of evidence-based international guidelines. This might be due to lack of adherence to actions to prevent PONV by using adequate preventative medication in the pre- and intra-operative period. The researchers think that adherence to the guideline can be improved with a multifaceted quality improvement intervention consisting of clinical lessons, personalized feedback, group feedback, and installation of reminders in print (posters) and integrated in the electronic health record (EHR) workflow. Furthermore, elements of clinical decision support (best practice advisories) will be added to the clinicians’ workflow.
Who can participate?
EHR data of all adult patients scheduled for elective, non-cardiothoracic surgery during the study period will be used for data analysis. Data from patients who will be transferred to an ICU postoperatively will be excluded.
What does the study involve?
The study involves interventions to improve adherence to the PONVguideline with the focus on prevention of PONV. The interventions include organising clinical lessons for healthcare providers, placing reminders (posters), adding best practice advisories to the electronic health record workflow combined with automatic reminders and giving group feedback (email) as well as personalized feedback, based on advances of the intervention. Results are compared before and after implementing the intervention.
What are the possible benefits and risks of participating?
Participants may benefit from better prevention of PONV, resulting in less PONV after surgery. No risks are expected from the study.
Where is the study run from?
University Medical Center Groningen (The Netherlands)
When is the study starting and how long is it expected to run for?
October 2018 to February 2020 (updated 23/06/2020, previously: March 2020)
Who is funding the study?
University Medical Center Groningen (The Netherlands)
Who is the main contact?
Dr Peter Meyer
p.meyer@umcg.nl
Contact information
Scientific
Principal Investigator
Hanzeplein 1
Groningen
9700RB
Netherlands
| Phone | +31 (0)503616161 |
|---|---|
| p.meyer@umcg.nl |
Study information
| Study design | Observational single-center before-after study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | Improvement of postoperative nausea and vomiting prophylaxis by implementing a multifaceted quality improvement intervention |
| Study objectives | Adherence to postoperative nausea and vomiting (PONV) prophylaxis can be influenced by a multifaceted intervention, using different strategies. Addition to the teaching of healthcare professionals, the implementation of reminders in the electronic healthcare environment and personalized feedback can improve pre- and intra-operative prophylaxis of postoperative nausea and vomiting. |
| Ethics approval(s) | The study qualified for institutional review board exception status ("waiver of consent") on 11/12/2018, UMCG (University Medical Center Groningen) institutional review board (Medical Ethics Review Board, PO Box 30 001, 9700 RB Groningen, The Netherlands; +31 (0)50 361 42 04; metc@umcg.nl), ref: METc 2018/670 |
| Health condition(s) or problem(s) studied | Postoperative nausea and vomiting |
| Intervention | A multifaceted quality improvement intervention is carried out. The intervention in this project consists of organising clinical lessons for healthcare providers, placing reminders (posters), adding best practice advisories to the electronic health record workflow combined with automatic reminders and giving group feedback (email) as well as personalized feedback, based on advances of the intervention. An interrupted time-series design will be used to compare results before and after implementing the multifaceted intervention. The interventions started in August 2019. Clinical lessons, group feedback, and personalized feedback still are active. Advances in EHR software went online 15/09/2019 and are active since. As this study relates to a quality improvement program, the effects of the interventions will be monitored continuously. If effects appear unsatisfactory, interventions will be adjusted. (e.g. best practice advisories will be displayed more prominently by means of pop-up screens). The monitoring of the control cohort started in week 6, 2019. According to the start of interventions in August 2019, follow-up began in week 33, on 12 August. The total duration of follow-up has not been determined yet, as this project has to be seen as a PDCA-cycle. Regarding an upcoming publication, follow-up until week 9, 2020 will be taken into account. |
| Intervention type | Behavioural |
| Primary outcome measure | Percentage of patients with completely filled in preoperative PONV risk scores (Apfel PONV Simplified Risk Scoring System). The weekly change of the percentage of filled in PONV risk scores will be displayed as a run chart and slopes will be compared between the pre- and post-intervention period. |
| Secondary outcome measures | The weekly change will be displayed as a run chart and slopes will be compared between the pre- and post-intervention period: 1. Percentage of patients with complete adherence to pharmaceutical prophylaxis according to individual risk score 2. Percentage of patients receiving therapeutic anti-emetics on POD 0 and POD 1 3. Percentage of patients reporting clinically important PONV, measured by the PONV Intensity Scale |
| Overall study start date | 01/10/2018 |
| Completion date | 29/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | All patients scheduled for operation between February 1st 2019 and February 29th 2020. 7,712 patients’ EHR data have been included. PRO measurements have been obtained from 763 patients. |
| Key inclusion criteria | Adult patients scheduled for elective surgery |
| Key exclusion criteria | 1. Pediatric cases 2. Cardiothoracic surgery 3. Patients who will be admitted to ICU postoperatively |
| Date of first enrolment | 04/02/2019 |
| Date of final enrolment | 29/02/2020 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Groningen
9700RB
Netherlands
Sponsor information
Hospital/treatment centre
Hanzeplein 1
Groningen
9700RB
Netherlands
| Phone | +31 (0)503616161 |
|---|---|
| p.meyer@umccg.nl | |
| Website | http://www.umcg.nl/EN |
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- University Medical Center Groningen, UMCG
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trial results will be published in a Masters thesis in the context of the Masters program "Quality and Safety in Patient Care", organized by the Dutch Federation of University Hospitals (NFU) in June 2020. Thereafter, results will also be published in a scientific journal in the field of perioperative patient care. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Peter Meyer (p.meyer@umcg.nl). |
Editorial Notes
23/06/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2020 to 29/02/2020.
2. The overall end date was changed from 31/03/2020 to 29/02/2020.
3. The target number of participants was changed from "All patients scheduled for operation between February 2019 and March 2020. As to end of January, 7,900 patients’ EHR data have been included. PRO measurements so far have been obtained from 800 patients." to "All patients scheduled for operation between February 1st 2019 and February 29th 2020. 7,712 patients’ EHR data have been included. PRO measurements have been obtained from 763 patients.".
4. The plain English summary was updated to reflect these changes.
25/02/2020: Trial's existence confirmed by University Medical Center Groningen institutional review board.
