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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05070338
Other study ID # R01DA046226
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date October 18, 2023

Study information

Verified date March 2023
Source RAND
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 778
Est. completion date October 18, 2023
Est. primary completion date October 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Guideline-Based (Injunctive Norm) 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]
Peer-Based (Social Norm) 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.

Locations

Country Name City State
United States Sutter Health Sacramento California

Sponsors (5)

Lead Sponsor Collaborator
RAND Sutter Health, University of California, Los Angeles, University of Michigan, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Share of discharge 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 Morphine milligram equivalents (MMEs) prescribed at discharge Continuous measure of the total morphine milligram equivalents prescribed at discharge 12 months
Secondary Days' supply of opioids prescribed at discharge Continuous variable indicating the number of days' supply of opioids prescribed at discharge 12 months
Secondary Share of discharges where any opioid was prescribed Derived from binary variable indicating if any opioid was prescribed at discharge 12 months
Secondary Share of patients on opioids for greater than 3 months post-discharge Derived from binary variable indicating if the patient has any opioid prescriptions between 3 and 6 months after surgery 3-6 months post-discharge
Secondary 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 0-30 days post-discharge
Secondary Number of 30-day all-cause hospitalizations Number of hospital admissions the post-operative patient has in the 30 days after the initial procedure 0-30 days post-discharge
Secondary Share 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. 12 months
See also
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Completed NCT05299528 - A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing N/A
Completed NCT04425668 - Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry N/A