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| ID | Type | Description | Link |
|---|---|---|---|
| R33AG057395 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| AltaMed Health Services Corporation | OTHER |
| National Institute on Aging (NIA) | NIH |
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The opioid epidemic is the largest man-made public health crisis the United States has faced. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) study, is to discourage unnecessary opioid prescribing by increasing the salience of negative patient outcomes associated with opioid use.
In AESOPS-2, a multi-site study, random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual-care (control). The AESOPS-2 trial will take place in 3 diverse health systems in the U.S. - Northwestern Medicine, AltaMed Health Services, and The Children's Clinic. At Northwestern Medicine, clinicians in the intervention group receive a letter notifying them of their patient's fatal or nonfatal ED overdose. At AltaMed Health Services, and The Children's Clinic, clinicians in the intervention group receive a letter notifying them of their patient's nonfatal ED overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) dose prescribed in 6-month periods before and after receiving the letter. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME weekly dose. The AESOPS-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering unnecessary population exposure to these drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Physicians in the control group will receive no notification of their patient's fatal or nonfatal overdose. | |
| Overdose Notification Group | Experimental | The overdose notifications will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overdose Notification | Behavioral | We will identify overdoses from state vital records and insurance claims data linked to emergency departments. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a non-fatal or fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased or surviving patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Average Number of 5 MME Pill Counts | The primary outcome is the change in daily average number of 5 morphine milligram equivalent (MME) pill counts ordered by clinicians during the last week of baseline (week 26) and the last week of the intervention period (week 53) letter intervention. | 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician-level, Pre-to-post Mean Proportion of High Dose (=> 50 MME) Patient Visits | The change in the clinician-level, pre-to-post mean proportion of high dose (=> 50 MME) patient visits by study arm. The numerator is whether a patient visit was => 50 MME, and the denominator is the number of opioids. We quantified this measure using logistic regression. Higher dose prescriptions are not recommended and are associated with the potential for greater patient harm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason 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 |
|---|---|---|---|
| 34896295 | Derived | Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety trial 2 (AESOPS-2): Availability of opioid harm. Contemp Clin Trials. 2022 Jan;112:106650. doi: 10.1016/j.cct.2021.106650. Epub 2021 Dec 8. |
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Patients who experienced an opioid overdose were randomized to either the letter intervention (fatal or non fatal overdose) or control; however, patients were not considered enrolled in the study. We analyze how the prescribing behavior of clinicians who had prescribed opioids to these patients changed pre-to-post intervention.
Prescriber did or did not receive the letter based on the randomization assignment (intervention or control) of the overdose victim. Clinician prescribing data was collected during the study timeframe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonfatal Control Group | Physicians in the nonfatal control group will receive no notification of their patient's nonfatal overdose. |
| FG001 | Non Fatal Overdose Notification Group | Non Fatal Overdose Notification: We will identify overdoses from insurance claims data linked to emergency departments. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a non-fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. |
| FG002 | Fatal Control Group | Physicians in the fatal control group will receive no notification of their patient's fatal overdose. |
| FG003 | Fatal Overdose Notification Group | Fatal Overdose Notification: We will identify overdoses from state vital records. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non Fatal Control Group | Physicians in the non fatal control group will receive no notification of their patient's nonfatal overdose. |
| BG001 | Non Fatal Overdose Notification Group |
| 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, Customized | Age data not collected. | Age data not collected. |
| 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 | Change in Daily Average Number of 5 MME Pill Counts | The primary outcome is the change in daily average number of 5 morphine milligram equivalent (MME) pill counts ordered by clinicians during the last week of baseline (week 26) and the last week of the intervention period (week 53) letter intervention. | Participating clinicians from Northwestern Medicine and AltaMed who prescribed an opioid during the study period | Posted | Mean | 95% Confidence Interval | Difference in estimated mean pill counts | 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention) |
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6 months
Adverse event collection is based on the patients of randomized clinicians, not the clinicians themselves. Deaths and adverse events were not collected for clinicians.
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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 | Non Fatal Control Group | Physicians in the non fatal control group will receive no notification of their patient's non fatal overdose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department or Hospitalization for Opioid Withdrawal | Nervous system disorders | Non-systematic Assessment | Emergency Department or Hospitalization for Opioid Withdrawal for any patients of randomized clinicians with an opioid prescription in the 6 month post-intervention period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 18, 2025 | Sep 18, 2025 | 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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| 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention) |
Non Fatal Overdose Notification: We will identify overdoses from insurance claims data linked to emergency departments. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a non-fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased or surviving patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics.
| BG002 | Fatal Control Group | Physicians in the fatal control group will receive no notification of their patient's fatal overdose. |
| BG003 | Fatal Overdose Notification Group | Fatal Overdose Notification: We will identify overdoses from state vital records. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased or surviving patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex/Gender, Customized | 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Non Fatal Overdose Notification Group |
Non Fatal Overdose Notification: We will identify overdoses from insurance claims data linked to emergency departments. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a non-fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. |
| OG002 | Fatal Control Group | Physicians in the fatal control group will receive no notification of their patient's fatal overdose. |
| OG003 | Fatal Overdose Notification Group | Fatal Overdose Notification: We will identify overdoses from state vital records. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. |
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| Secondary | Change in Clinician-level, Pre-to-post Mean Proportion of High Dose (=> 50 MME) Patient Visits | The change in the clinician-level, pre-to-post mean proportion of high dose (=> 50 MME) patient visits by study arm. The numerator is whether a patient visit was => 50 MME, and the denominator is the number of opioids. We quantified this measure using logistic regression. Higher dose prescriptions are not recommended and are associated with the potential for greater patient harm. | Posted | Mean | 95% Confidence Interval | proportion of high dose patient visits | 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention) |
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|
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|
| 0 |
| 861 |
| 1 |
| 861 |
| 0 |
| 861 |
| EG001 | Non Fatal Overdose Notification Group | The overdose notifications will alert prescribers to the patient's opioid-related non fatal overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. Overdose Notification: We will identify overdoses from insurance claims data linked to emergency departments. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a non-fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the surviving patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. | 0 | 973 | 1 | 973 | 0 | 973 |
| EG002 | Fatal Control Group | Physicians in the fatal control group will receive no notification of their patient's fatal overdose. | 0 | 524 | 1 | 524 | 0 | 524 |
| EG003 | Fatal Overdose Notification Group | The fatal overdose notifications will alert prescribers to the patient's fatal opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. Overdose Notification: We will identify overdose deaths from state vital records. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics. | 0 | 801 | 0 | 801 | 0 | 801 |
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| Slope |
| -0.72 |
| 2-Sided |
| 95 |
| -1.9 |
| 0.46 |
| Superiority |