- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05070338
Postoperative Nudges to Reduce Opioid Prescribing (POST-OP)
Reducing Inappropriate Prescription Opioid Prescribing at Hospital Discharge
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95833
- Sutter Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine E Watkins, MD, MSHS, RAND
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01DA046226 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Opioid Prescribing
-
University of North Carolina, Chapel HillNot yet recruitingOpioid PrescribingUnited States
-
University of MichiganThe Benter FoundationCompletedOpioid PrescribingUnited States
-
University of MichiganNational Institute on Drug Abuse (NIDA)CompletedOpioid PrescribingUnited States
-
Vanderbilt University Medical CenterNational Institute on Aging (NIA)CompletedSurgical Procedure, Unspecified | Opioid PrescribingUnited States
-
University of Massachusetts, WorcesterUMass Memorial Health CareCompletedDelivery of Health Care | Analgesics, Opioid | Practice Guidelines as Topic | Drug Prescribing | Over Prescribing | Prescribing Patterns, Physician | Practice Management, MedicalUnited States
-
Northwestern UniversityCompletedPain Management | Opioid Prescribing | Postpartum PainUnited States
-
University of MichiganMichigan Department of Health and Human ServicesCompletedPain Management | Opioid PrescribingUnited States
-
Yale UniversityFood and Drug Administration (FDA)CompletedOpioid Use | Opioid PrescribingUnited States
-
University of SouthamptonCompletedPrescribing Practices | Prescribing Tendencies | Prescribing | Prescribing DecisionsUnited Kingdom
-
University of Colorado, DenverNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)Not yet recruitingOpioid Use Disorder | Harm Reduction | Prevention | Opioid Overdose | Opioid Prescribing | Medication Abuse
Clinical Trials on Guideline-Based (Injunctive Norm) Nudges
-
The Hong Kong Polytechnic UniversityThe University of Hong KongRecruiting
-
University of California, MercedCompleted
-
University of BirminghamEconomic and Social Research Council, United KingdomCompletedEating BehaviourUnited Kingdom
-
NYU Langone HealthRobert Wood Johnson FoundationCompleted
-
Beth Israel Deaconess Medical CenterPatient-Centered Outcomes Research InstituteNot yet recruitingPacemaker | Implantable DefibrillatorUnited States
-
University of PittsburghPatient-Centered Outcomes Research Institute; Medical University of South Carolina and other collaboratorsCompletedLow Back PainUnited States
-
University of Maryland, BaltimoreCompleted
-
Beth Israel Deaconess Medical CenterPatient-Centered Outcomes Research InstituteRecruitingPacemaker DDD | Implantable Defibrillator UserUnited States
-
The First Affiliated Hospital of University of...Not yet recruiting
-
Nepal Health Research CouncilUniversity of NottinghamCompletedDiabetes Mellitus | Diabetes | Type2DiabetesNepal