Postoperative Nudges to Reduce Opioid Prescribing (POST-OP)

March 19, 2025 updated by: RAND

Reducing Inappropriate Prescription Opioid Prescribing at Hospital Discharge

This study tests the effectiveness of two email-based behavioral nudges, one based on peer behavior and one based on best practice guidelines, in reducing excessive opioid prescriptions after surgery. It will be conducted in three surgical specialties (general surgery, orthopedic surgery, and obstetric/gynecological surgery) at 19 hospitals within one healthcare system. These specialties will each be randomized to a control group or one of two nudge groups. Each month for one year, surgeons in the nudge groups will receive emails comparing their opioid prescribing either to their peers' prescribing or to prescribing guidelines. Both types of email-based nudges are expected to reduce opioid prescribing after surgery.

Study Overview

Study Type

Interventional

Enrollment (Actual)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95833
        • Sutter Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

The nudges that a surgeon in either intervention arm will receive are based on that surgeon's eligible discharge opioid prescriptions in the previous month. Eligible prescriptions meet all of the following criteria:

  • the patient is at least 18 years old at the date of surgery
  • the patient is discharged to their home
  • the surgical procedure has an applicable post-operative opioid prescribing guideline
  • the surgical procedure is the only surgical procedure performed during the patient's hospital stay
  • the prescription is for an opioid taken orally (tablets, capsules, or liquid solution)

To avoid contamination between the intervention arms, surgeons who operate across multiple surgical specialties (defined as surgeons who performed less than 90% of their total procedures in one specialty between June 2020 and May 2021) will not be eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Guideline-Based Nudges

Surgeons in this arm will receive an email with the following content at the end of each month in which at least two of their patients are discharged with an opioid prescription that exceeds the prescribing guideline for the procedure performed.

Dear Dr. [Name],

In [month], at least XX of your patients were discharged with opioid prescriptions exceeding the amounts recommended by safety guidelines for these procedures.

For patient safety, Sutter Health recommends prescribing within the ranges below for these procedures. Doing so will also meet best-practice safety guidelines for post-operative opioid prescribing.

We will continue to send you opioid prescribing safety reports.

Sincerely, [Signature]

[Table displaying recommended ranges of 5mg oxycodone tablets for each procedure]

Experimental: Peer-Based Nudges

Surgeons in this arm will receive an email with the following content at the end of each month in which at least two of their patients are discharged with an opioid prescription that exceeds the prescribing guideline for the procedure performed.

Dear Dr. [Name],

In [month], at least XX of your patients were discharged with opioid prescriptions exceeding the amount prescribed by YY% of your peers for these procedures.

YY% of [specialty] surgeons at Sutter Health prescribe within the ranges below for these procedures.

We will continue to send you opioid prescribing safety reports.

Sincerely, [Signature]

[Table displaying recommended ranges of 5mg oxycodone tablets for each procedure]

The ranges of 5mg oxycodone tablets displayed will be the same as the ranges stipulated by the prescribing guidelines, but this nudge will not mention guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Discharges With Opioid Prescriptions Above Prescribing Guidelines
Time Frame: 12 months
Prescriptions will be compared to prescribing guidelines via morphine milligram equivalents (MMEs) and coded as within or above guidelines. If no opioid is prescribed at discharge, this will be coded as within guidelines.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Milligram Equivalents (MMEs) Prescribed at Discharge
Time Frame: 12 months
Continuous measure of the total morphine milligram equivalents prescribed at discharge
12 months
Days' Supply of Opioids Prescribed at Discharge
Time Frame: 12 months
Continuous variable indicating the number of days' supply of opioids prescribed at discharge
12 months
Proportion of Discharges Where Any Opioid Was Prescribed
Time Frame: 12 months
Derived from a binary variable indicating whether any opioid was prescribed at discharge
12 months
Proportion of Patients on Opioids for Greater Than 3 Months Post-discharge
Time Frame: 3-6 months post-discharge
Derived from a binary variable indicating whether the patient has any opioid prescriptions between 3 and 6 months after surgery
3-6 months post-discharge
Number of 30-day All-cause Emergency Department Visits
Time Frame: 0-30 days post-discharge
Number of emergency department visits the post-operative patient has in the 30 days after the initial procedure
0-30 days post-discharge
Number of 30-day All-cause Hospitalizations
Time Frame: 0-30 days post-discharge
Number of hospital admissions the post-operative patient has in the 30 days after the initial procedure
0-30 days post-discharge
Proportion of Discharge Opioid Prescriptions Above Prescribing Guidelines in the Year After the Intervention Ends
Time Frame: 12 months (months 13-24 of the study)
Prescriptions will be compared to prescribing guidelines via morphine milligram equivalents (MMEs) and coded as within or above guidelines. If no opioid is prescribed at discharge, this will be coded as within guidelines.
12 months (months 13-24 of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Katherine E Watkins, MD, MSHS, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2021

Primary Completion (Actual)

October 18, 2022

Study Completion (Actual)

October 18, 2023

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • R01DA046226 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be made available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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