Clinical trial NCT02830412: Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis
Official title: A Prospective Randomized Evaluation of an Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis Guideline Adherence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project intends to develop and implement an electronic reminder for post-operative nausea and vomiting (PONV) prophylaxis into the Anesthesia Record Keeping System.

Each patient will have his or her PONV risk classified based on the following risk factors: Female gender, History of PONV, History of Motion Sickness, Non-smoker and Duration of procedure \> 60 minutes.

Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis displayed on the Anesthesia Record Keeping System (ARKS) screen at the beginning of the case.

At the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines.

If the current status is compatible or exceeds the recommended status the reminder will silently document compliance.

If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence.

The reminder will not recommend a specific medication, intervention or therapy.

It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient.

Subjects randomized to not receive the electronic display will have it deactivated.

Detailed description: Each patient will have his or her PONV risk classified based on the following risk factors Female gender, History of PONV or Motion Sickness, Non-smoker and Duration of procedure \> 60 min utilizing information already entered into the Anesthesia Record Keeping System. Patients having 0-1 risks factors present will be low risk. 2 risks factors present are medium risk and more than 2 risk factors present are high risk.

Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis will be displayed on the ARKS screen at the beginning of the case.

In a second step at the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines.

If the current status is compatible or exceeds the recommended status the reminder will silently document compliance.

If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence.

The reminder will display the PONV risk assessment information, current status of PONV prophylaxis as well as the information that current guidelines recommend additional PONV prophylaxis.

The reminder will not recommend a specific medication, intervention or therapy.

It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient.

Subjects randomized to not receive the electronic display will have it deactivated.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Procedure with General Anesthesia

Exclusion Criteria:

* Postoperative admission to the Intensive Care Unit
* Postoperative fast-track to Phase II
* Patient remains sedated/intubated at the end of the procedure

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: 6 hours
Secondary outcomes:
measure: Duration of postoperative anesthesia care unit (PACU) stay
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Saager leif, M.D.
role: PRINCIPAL_INVESTIGATOR
References: