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| Name | Class |
|---|---|
| Sutter Health | OTHER |
| University of California, Los Angeles | OTHER |
| University of Southern California | OTHER |
| University of Michigan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guideline-Based Nudges | Experimental |
| |
| Peer-Based Nudges | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guideline-Based (Injunctive Norm) Nudges | Behavioral | 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] |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Milligram Equivalents (MMEs) Prescribed at Discharge | Continuous measure of the total morphine milligram equivalents prescribed at discharge | 12 months |
| Days' Supply of Opioids Prescribed at Discharge |
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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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine E Watkins, MD, MSHS | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Health | Sacramento | California | 95833 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40200214 | Derived | 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. | |
| 38580444 | Derived | 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. |
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Deidentified data will be made available upon reasonable request.
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Start date: October 19, 2021; Primary Completion Date: October 18, 2022; Study completion date: October 18, 2023. Participants were recruited from hospitals in the Sutter care health system.
| ID | Title | Description |
|---|---|---|
| FG000 | Guideline-Based Nudges | 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] |
| FG001 | Peer-Based Nudges | 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. |
| FG002 | Control | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Surgeons in the Sutter Health hospital system
Note: Only surgeons were enrolled in the study. Patients were not enrolled in the study and so their characteristics were not assessed at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Guideline-Based Nudges | 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] |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The units analyzed are the discharges of patients operated on by surgeons enrolled in the study. | Posted | Number | 95% Confidence Interval | Proportion of discharges | 12 months | Patient discharges | Patient discharges |
|
13 months
A data and safety monitoring board monitored adverse events within 30 days of discharge among patients of enrolled surgeons. The numbers of participants at risk reported reflect the number of patient discharges. Surgeons were not monitored for adverse effects given the minimal risk of receiving emails.
Only hospitalizations, ED visits, and opioid refills were monitored. Mortality was not monitored because the intervention did not pose a mortality risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guideline-Based Nudges | 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] |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-Cause Hospitalizations | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Opioid Refills | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine E. Watkins | RAND Corporation | 310-393-0411 | 6509 | kwatkins@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2021 | May 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OTHER |
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|
| Peer-Based (Social Norm) Nudges | Behavioral | 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. |
|
Continuous variable indicating the number of days' supply of opioids prescribed at discharge
| 12 months |
| Proportion of Discharges Where Any Opioid Was Prescribed | 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 | 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 | 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 | 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 | 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) |
| 38488780 | Derived | 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. |
| 36123066 | Derived | 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. |
| BG001 | Peer-Based Nudges | 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. |
| BG002 | Control | No intervention |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Peer-Based Nudges | 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. |
| OG002 | Control | No intervention |
|
|
| Secondary | Morphine Milligram Equivalents (MMEs) Prescribed at Discharge | Continuous measure of the total morphine milligram equivalents prescribed at discharge | The units analyzed are the discharges of patients operated on by surgeons enrolled in the study. | Posted | Mean | 95% Confidence Interval | Morphine milligram equivalents (MMEs) | 12 months | Patient discharges | Patient discharges |
|
|
|
| Secondary | Days' Supply of Opioids Prescribed at Discharge | Continuous variable indicating the number of days' supply of opioids prescribed at discharge | Contrary to initial expectations, the days' supply of opioids prescribed at discharge was not captured by the Sutter Health electronic health records system. This outcome measure could therefore not be assessed. The quantity of opioids prescribed at discharge is still captured similarly by the outcome measure Morphine Milligram Equivalents (MMEs) Prescribed at Discharge. | Posted | 12 months |
|
|
| Secondary | Proportion of Discharges Where Any Opioid Was Prescribed | Derived from a binary variable indicating whether any opioid was prescribed at discharge | The units analyzed are the discharges of patients operated on by surgeons enrolled in the study. | Posted | Number | 95% Confidence Interval | Proportion of discharges | 12 months | Patient discharges | Patient discharges |
|
|
|
| Secondary | 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 | The units analyzed are the discharges of patients operated on by surgeons enrolled in the study. | Posted | Number | 95% Confidence Interval | Proportion of discharges | 3-6 months post-discharge | Patient discharges | Patient discharges |
|
|
|
| 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 | The units analyzed are the post-operative discharges of patients operated on by surgeons enrolled in the study. For patients who had multiple procedures in multiple admissions over the study period, each discharge is counted separately. | Posted | Mean | 95% Confidence Interval | Emergency department visits | 0-30 days post-discharge | Patient discharges | Patient discharges |
|
|
|
| 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 | The units analyzed are the post-operative discharges of patients operated on by surgeons enrolled in the study. For patients who had multiple procedures in multiple admissions over the study period, each discharge is counted separately. | Posted | Mean | 95% Confidence Interval | Hospital admissions | 0-30 days post-discharge | Patient discharges | Patient discharges |
|
|
|
| Secondary | 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. | The units analyzed are the discharges of patients operated on by surgeons enrolled in the study. | Posted | Number | 95% Confidence Interval | Proportion of discharges | 12 months (months 13-24 of the study) | Patient discharges | Patient discharges |
|
|
|
| 0 |
| 0 |
| 1,096 |
| 15,459 |
| 3,045 |
| 15,459 |
| EG001 | Peer-Based Nudges | 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. | 0 | 0 | 755 | 10,752 | 1,752 | 10,752 |
| EG002 | Control | No intervention | 0 | 0 | 849 | 12,024 | 1,617 | 12,024 |
| All-Cause Emergency Department Visits | General disorders | Systematic Assessment |
|
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| Male |
|