Opioid PrescribingPOST-OPNCT05070338

Postoperative Nudges to Reduce Opioid Prescribing

A study testing Guideline-Based (Injunctive Norm) Nudges and Peer-Based (Social Norm) Nudges in people with Opioid Prescribing, run by RAND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Prescribing
What is being tested?: Guideline-Based (Injunctive Norm) Nudges and Peer-Based (Social Norm) Nudges
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 640 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2021to 18 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sutter Health
Sacramento, California, 95833

Other trials in United States

About this study

Official title: 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.

Conditions: Opioid Prescribing
Being tested: Guideline-Based (Injunctive Norm) Nudges, Peer-Based (Social Norm) Nudges
Keywords: Opioid Epidemic, Inappropriate Prescribing, Opioid-Related Disorders, Practice Guideline, Peer Influence, Nudges
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guideline-Based (Injunctive Norm) NudgesBehavioural
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]
Peer-Based (Social Norm) NudgesBehavioural
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.

Study groups in NCT05070338
Study group	Role	What they receive
Guideline-Based Nudges	Experimental	Not described Receives: Behavioral: Guideline-Based (Injunctive Norm) Nudges
Peer-Based Nudges	Experimental	Not described Receives: Behavioral: Peer-Based (Social Norm) Nudges
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (7)

Morphine Milligram Equivalents (MMEs) Prescribed at Discharge
Continuous measure of the total morphine milligram equivalents prescribed at discharge
Measured: 12 months
Days' Supply of Opioids Prescribed at Discharge
Continuous variable indicating the number of days' supply of opioids prescribed at discharge
Measured: 12 months
Proportion of Discharges Where Any Opioid Was Prescribed
Derived from a binary variable indicating whether any opioid was prescribed at discharge
Measured: 12 months
Proportion of Patients on Opioids for Greater Than 3 Months Post-discharge
Derived from a binary variable indicating whether the patient has any opioid prescriptions between 3 and 6 months after surgery
Measured: 3-6 months post-discharge
Number of 30-day All-cause Emergency Department Visits
Number of emergency department visits the post-operative patient has in the 30 days after the initial procedure
Measured: 0-30 days post-discharge
Number of 30-day All-cause Hospitalizations
Number of hospital admissions the post-operative patient has in the 30 days after the initial procedure
Measured: 0-30 days post-discharge
Proportion of Discharge Opioid Prescriptions Above Prescribing Guidelines in the Year After the Intervention Ends
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.
Measured: 12 months (months 13-24 of the study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202118 Oct 2023

First posted7 Oct 2021
Study start19 Oct 2021
Primary completion18 Oct 2022
Study completion18 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Opioid PrescribingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 640 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070338
Sponsor's protocol ID: R01DA046226
Acronym: POST-OP
Status last verified: Mar 2025
First submitted: 21 Sep 2021
Last updated: 8 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified data will be made available upon reasonable request.

Publications

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.
PubMed 40200214
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.
PubMed 38580444
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.
PubMed 38488780
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.
PubMed 36123066

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Prescribing trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Inappropriate Prescription Opioid Prescribing at Hospital Discharge
ClinicalTrials.gov ID: NCT05070338
Acronym / sponsor ID: POST-OP / R01DA046226
Conditions: Opioid Prescribing
Keywords: Opioid Epidemic, Inappropriate Prescribing, Opioid-Related Disorders, Practice Guideline, Peer Influence, Nudges
Study type: Interventional
Recruitment status: Completed
Enrolment: 640 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Sutter Health, University of California, Los Angeles, University of Southern California, University of Michigan
Study start: 19 Oct 2021 (actual)
Primary completion: 18 Oct 2022 (actual)
Study completion: 18 Oct 2023 (actual)
First posted: 7 Oct 2021 (actual)
Results: Posted 8 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Guideline-Based Nudges	Experimental	Behavioral: Guideline-Based (Injunctive Norm) Nudges
Peer-Based Nudges	Experimental	Behavioral: Peer-Based (Social Norm) Nudges
Control	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Guideline-Based (Injunctive Norm) NudgesSurgeons 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]	Behavioural	Guideline-Based Nudges
Peer-Based (Social Norm) NudgesSurgeons 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.	Behavioural	Peer-Based Nudges

Primary outcome

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.

7 secondary outcomes

Morphine Milligram Equivalents (MMEs) Prescribed at Discharge
Time frame: 12 months
Days' Supply of Opioids Prescribed at Discharge
Time frame: 12 months
Proportion of Discharges Where Any Opioid Was Prescribed
Time frame: 12 months
Proportion of Patients on Opioids for Greater Than 3 Months Post-discharge
Time frame: 3-6 months post-discharge
Number of 30-day All-cause Emergency Department Visits
Time frame: 0-30 days post-discharge
Number of 30-day All-cause Hospitalizations
Time frame: 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)

Results and safety

Results posted to the registry on 8 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guideline-Based Nudges	216	216
Peer-Based Nudges	207	207
Control	217	217

Primary outcome: Proportion of Discharges With Opioid Prescriptions Above Prescribing Guidelines

Time frame: 12 months. Number (95% Confidence Interval). Unit: Proportion of discharges

Measure	Guideline-Based Nudges n = 216	Peer-Based Nudges n = 207	Control n = 217
Value	0.254 (0.247 to 0.261)	0.275 (0.267 to 0.284)	0.368 (0.359 to 0.376)

Population analysed: The units analyzed are the discharges of patients operated on by surgeons enrolled in the study.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Guideline-Based Nudges	1,096 of 15,459 (7.1%)	3,045 of 15,459 (19.7%)
Peer-Based Nudges	755 of 10,752 (7%)	1,752 of 10,752 (16.3%)
Control	849 of 12,024 (7.1%)	1,617 of 12,024 (13.4%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40200214Martinez 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.
Derived from this study: PubMed 38580444Martinez 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.
Derived from this study: PubMed 38488780Wagner 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.
Derived from this study: PubMed 36123066Kirkegaard 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.
Individual participant dataSharing planned: Yes. Deidentified data will be made available upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katherine E Watkins, MD, MSHS principal investigator

RAND

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Guideline-Based (Injunctive Norm) Nudges and Peer-Based (Social Norm) Nudges in people with Opioid Prescribing, run by RAND at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Discharges With Opioid Prescriptions Above Prescribing Guidelines (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070338, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.