Plain English Summary
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 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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Peter Meyer
ORCID ID
Contact details
Principal Investigator
Hanzeplein 1
Groningen
9700RB
Netherlands
+31 (0)503616161
p.meyer@umcg.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
METc2018/670
Study information
Scientific title
Improvement of postoperative nausea and vomiting prophylaxis by implementing a multifaceted quality improvement intervention
Acronym
Study hypothesis
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
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
Study design
Observational single-center before-after study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/10/2018
Overall trial end date
31/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients scheduled for elective surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
All patients scheduled for operation between February 2019 and March 2020. As to end of January, 7900 patients’ EHR data have been included. PRO measurements so far have been obtained from 800 patients.
Participant exclusion criteria
1. Pediatric cases
2. Cardiothoracic surgery
3. Patients who will be admitted to ICU postoperatively
Recruitment start date
04/02/2019
Recruitment end date
28/02/2020
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Hanzeplein 1
Groningen
9700RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen
Sponsor details
Hanzeplein 1
Groningen
9700RB
Netherlands
+31 (0)503616161
p.meyer@umccg.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Universitair Medisch Centrum Groningen
Alternative name(s)
University Medical Center Groningen, UMCG
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Netherlands
Results and Publications
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 statement
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).
Intention to publish date
01/10/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
none