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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG057395-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Northwestern University | OTHER |
| AltaMed Health Services Corporation | OTHER |
| The Children's Clinic |
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There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. Interventions will leverage the electronic health record (EHR) to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.
There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. In 2017, the Centers for Disease Control and Prevention (CDC) issued the "CDC Guideline for Prescribing Opioids for Chronic Pain" to encourage safe and effective alternatives to opioids, discontinuation of opioids when patients do not resume normal activities and prudent dosing strategies. However, poor guideline adherence is a general concern and may impede uptake. Our prior studies have used insights from behavioral economics and social psychology to increase guideline adherence. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. At the time of opioid prescribing, clinicians will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three mutually exclusive categories: Opioid naïve, At-risk for long term use, or Long-term opioid recipient. The primary outcome is average weekly morphine milligram equivalents (MME) prescribed per-clinician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Decision Support | Experimental | Clinical decision support nudges within the electronic health record to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice. Participating clinicians will receive any of three nudges when eligibility criteria are met within a patient's chart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid naive | Behavioral | Visit where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average Weekly Milligram Morphine Equivalent (MME) | Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention | 34 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason N Doctor, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33636344 | Background | Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Rowe TA, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges. Contemp Clin Trials. 2021 Apr;103:106329. doi: 10.1016/j.cct.2021.106329. Epub 2021 Feb 24. |
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Only clinicians listed as a treating member of the clinic receive the intervention.
41 primary care clinicians from 3 clinics at Northwestern Medicine in Chicago, Illinois were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinical Decision Support Nudges |
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-intervention |
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| Post-intervention |
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41 clinicians from 3 Northwestern Medicine clinics were enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Decision Support | Participating clinicians will receive any of three clinical decision support nudges within the electronic health record when eligibility criteria are met within a patient's chart: Opioid naïve: Visit where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days At risk for long term use: Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days Long term opioid recipient: Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Average Weekly Milligram Morphine Equivalent (MME) | Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention | Of the 41 clinicians enrolled in the study, 5 were excluded due to lack of prescribing information. | Posted | Mean | Standard Deviation | Weekly MME per clinician | 34 weeks |
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6 months
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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 | Clinical Decision Support Nudges |
Details can be found in the Arms and Interventions section. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Doctor | University of Southern California | 213-821-8142 | jdoctor@usc.edu |
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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 | Sep 30, 2021 | May 16, 2022 | Prot_SAP_000.pdf |
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| OTHER |
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| At-risk for long term use | Behavioral | Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days |
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| Long-term opioid recipient | Behavioral | Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Average weekly milligram morphine equivalent (MME) | Mean | Standard Deviation | Weekly MME |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
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