NCT05070338

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

October 19, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

September 21, 2021

Results QC Date

April 3, 2024

Last Update Submit

March 19, 2025

Conditions

Keywords

Opioid EpidemicInappropriate PrescribingOpioid-Related DisordersPractice GuidelinePeer InfluenceNudges

Outcome Measures

Primary Outcomes (1)

  • Proportion of Discharges With Opioid Prescriptions Above Prescribing Guidelines

    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 Outcomes (7)

  • Morphine Milligram Equivalents (MMEs) Prescribed at Discharge

    12 months

  • Days' Supply of Opioids Prescribed at Discharge

    12 months

  • Proportion of Discharges Where Any Opioid Was Prescribed

    12 months

  • Proportion of Patients on Opioids for Greater Than 3 Months Post-discharge

    3-6 months post-discharge

  • Number of 30-day All-cause Emergency Department Visits

    0-30 days post-discharge

  • +2 more secondary outcomes

Study Arms (3)

Guideline-Based Nudges

EXPERIMENTAL
Behavioral: Guideline-Based (Injunctive Norm) Nudges

Peer-Based Nudges

EXPERIMENTAL
Behavioral: Peer-Based (Social Norm) Nudges

Control

NO INTERVENTION

Interventions

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

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 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.

Peer-Based Nudges

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sutter Health

Sacramento, California, 95833, United States

Location

Related Publications (4)

  • Martinez MC, Bouskill K, Yan XS, Kirkegaard A, Doctor JN, Watkins KE. A qualitative analysis on the implementation of a nudge intervention to reduce post-surgical opioid prescribing. BMC Health Serv Res. 2025 Apr 8;25(1):512. doi: 10.1186/s12913-025-12651-7.

  • Martinez M, Kirkegaard A, Bouskill K, Yan XS, Wagner Z, Watkins KE. Surgeons' views of peer comparison and guideline-based feedback on postsurgery opioid prescriptions: a qualitative investigation. BMJ Open Qual. 2024 Apr 5;13(2):e002750. doi: 10.1136/bmjoq-2024-002750.

  • Wagner Z, Kirkegaard A, Mariano LT, Doctor JN, Yan X, Persell SD, Goldstein NJ, Fox CR, Brummett CM, Romanelli RJ, Bouskill K, Martinez M, Zanocco K, Meeker D, Mudiganti S, Waljee J, Watkins KE. Peer Comparison or Guideline-Based Feedback and Postsurgery Opioid Prescriptions: A Randomized Clinical Trial. JAMA Health Forum. 2024 Mar 1;5(3):e240077. doi: 10.1001/jamahealthforum.2024.0077.

  • Kirkegaard A, Wagner Z, Mariano LT, Martinez MC, Yan XS, Romanelli RJ, Watkins KE. Evaluating the effectiveness of email-based nudges to reduce postoperative opioid prescribing: study protocol of a randomised controlled trial. BMJ Open. 2022 Sep 19;12(9):e061980. doi: 10.1136/bmjopen-2022-061980.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Katherine E. Watkins
Organization
RAND Corporation

Study Officials

  • Katherine E Watkins, MD, MSHS

    RAND

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

October 7, 2021

Study Start

October 19, 2021

Primary Completion

October 18, 2022

Study Completion

October 18, 2023

Last Updated

April 8, 2025

Results First Posted

April 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Deidentified data will be made available upon reasonable request.

Locations