Condition category
Surgery
Date applied
17/02/2020
Date assigned
26/02/2020
Last edited
25/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.umcg.nl/EN

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

Publication citations

Additional files

Editorial Notes

25/02/2020: Trial's existence confirmed by University Medical Center Groningen institutional review board.