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In collaboration with the San Diego Medical Examiner's Office and the State of California's controlled Substance Utilization Review and Evaluation System (CURES), the investigators propose to review opioid poisonings over the past 12 months and will send letters to prescribers in California when at least one of the provider's prescription(s) was filled by a patient who died of an opioid poisoning in San Diego County. The letters will be non-judgmental and factual, explaining that a patient of the provider who was being treated with prescription narcotics died of an opioid poisoning. The letter will also encourage judicious prescribing including use of the CURES system before prescribing. The investigators will evaluate physician prescribing practices over 24 months 12 months pre- and 12 months post-letter using data from the CURES database. The investigators' hypothesis is that letters will make the risk of opioids more cognitively available and that physicians will respond by prescribing opioids more carefully. This will result in fewer deaths due to misuse and more frequent use of the CURES system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letter intervention | Experimental | The intervention arm will involve letters sent to prescribers in San Diego County. |
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| Control | No Intervention | The control group will involve prescribers not receiving letters |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letters | Other | The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. "do not fire your patient for signs of addiction.") The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change Over Time in Dispensed Narcotics | The hypothesis is that the average change over time in dispensed narcotic represented as monthly morphine milligram equivalent (MME) dose will be larger for prescribers receiving the letter intervention, compared to the average change over time for the control prescribers not receiving the letter intervention. | 12 months |
| Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | The hypothesis is that there will be fewer opioid prescriptions both at a dose > 90 morphine milligram equivalent (MME) and at a dose ≥ 50 MME among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. | 12 months |
| Number of Opioid and Benzodiazepine Co-prescriptions | The hypothesis is that there will be fewer opioid and benzodiazepine co-prescriptions for prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of CURES Use | The hypothesis is that there will be more frequent use of CURES among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. | 12 months |
| Number of "New Start" Prescriptions |
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The investigators will not be enrolling subjects. This is an evaluation of a public health intervention involving sending prescriber's factual and nonjudgmental letters, signed by the County Medical Examiner, that would state that a patient the provider had treated with controlled substances died of an opioid poisoning.
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 |
|---|---|---|---|---|---|---|
| San Diego County Medical Examiner's Office | San Diego | California | 92123 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Letter Intervention | The intervention arm will involve letters sent to prescribers in San Diego County. Letters: The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. "do not fire your patient for signs of addiction.") The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone. |
| FG001 | Control | The control group will involve prescribers not receiving letters |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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We removed prescribers with missing data or lack of prescriptions during the study period, resulting in an analysis population of 811 prescribers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Letter Intervention | The intervention arm will involve letters sent to prescribers in San Diego County. Letters: The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. "do not fire your patient for signs of addiction.") The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | We did not collect data on age of prescribers. |
| 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 Change Over Time in Dispensed Narcotics | The hypothesis is that the average change over time in dispensed narcotic represented as monthly morphine milligram equivalent (MME) dose will be larger for prescribers receiving the letter intervention, compared to the average change over time for the control prescribers not receiving the letter intervention. | Clinicians and allied health professionals with scheduled drug prescribing privileges in California who prescribed a schedule II, III, or IV drug to a person who died as a result of a schedule II, III, or IV accidental overdose between the period of 1 July 2015 and 30 June 2016 in San Diego County. | Posted | Mean | 95% Confidence Interval | Morphine milligram equivalents | 12 months |
|
12 months following letter notification (January 28, 2017-January 27, 2018)
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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 | Letter Intervention | The intervention arm will involve letters sent to prescribers in San Diego County. Letters: The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. "do not fire your patient for signs of addiction.") The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone. |
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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 | Feb 23, 2016 | Aug 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
The hypothesis is that there will be fewer prescriptions for opioid naïve patients by prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. |
| 12 months |
| BG001 | Control | The control group will involve prescribers not receiving letters |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | We did not collect data on biological sex from prescribers. | Count of Participants | Participants |
|
| 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 | Count of Participants | Participants |
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| OG001 | Control | The control group will involve prescribers not receiving letters |
|
|
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| Primary | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | The hypothesis is that there will be fewer opioid prescriptions both at a dose > 90 morphine milligram equivalent (MME) and at a dose ≥ 50 MME among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. | Clinicians and allied health professionals with scheduled drug prescribing privileges in California who prescribed a schedule II, III, or IV drug to a person who died as a result of a schedule II, III, or IV accidental overdose between the period of 1 July 2015 and 30 June 2016 in San Diego County. | Posted | Mean | 95% Confidence Interval | Number of prescriptions | 12 months |
|
|
|
|
| Primary | Number of Opioid and Benzodiazepine Co-prescriptions | The hypothesis is that there will be fewer opioid and benzodiazepine co-prescriptions for prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. | Posted | Mean | 95% Confidence Interval | Adjusted mean number of co-prescriptions | 12 months |
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|
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| Secondary | Frequency of CURES Use | The hypothesis is that there will be more frequent use of CURES among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. | We were unable to access information on frequency of CURES use and could not conduct the proposed analysis. | Posted | 12 months |
|
|
| Secondary | Number of "New Start" Prescriptions | The hypothesis is that there will be fewer prescriptions for opioid naïve patients by prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention. | Clinicians and allied health professionals with scheduled drug prescribing privileges in California who prescribed a schedule II, III, or IV drug to a person who died as a result of a schedule II, III, or IV accidental overdose between the period of 1 July 2015 and 30 June 2016 in San Diego County. | Posted | Mean | 95% Confidence Interval | patients with new opioid prescriptions | 12 months |
|
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|
|
| 0 |
| 386 |
| 0 |
| 386 |
| 0 |
| 386 |
| EG001 | Control | The control group will involve prescribers not receiving letters | 0 | 425 | 0 | 425 | 0 | 425 |
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| Number of => 50 MME Prescriptions 4-12 months Post-intervention |
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| Number of > 90 MME Prescriptions Pre intervention |
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| Number of > 90 MME Prescriptions 1-3 Post intervention |
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| Number of > 90 MME Prescriptions 4-12 months Post intervention |
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| Change in mean number of => 50 MME prescriptions pre- to 4-12 months post-intervention | Mixed Models Analysis | <0.001 | The threshold for statistical significance was p=0.05. | Mean Difference (Final Values) | -0.70 | 2-Sided | 95 | -1.08 | -0.33 | This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.00-3.74 = -0.74) and control (3.15-4.59= -1.44) arms, resulting in a difference of -0.70. | Superiority |
| Change in mean number of > 90 MME prescriptions pre- to 1-3 months post-intervention | Mixed Models Analysis | 0.279 | The threshold for statistical significance was p=0.05. | Mean Difference (Final Values) | -0.21 | 2-Sided | 95 | -0.59 | 0.17 | This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.00-2.14 = -0.14) and control (2.20-2.55= -0.35) arms, resulting in a difference of -0.21. | Superiority |
| Change in mean number of > 90 MME prescriptions pre- to 4-12 months post-intervention | Mixed Models Analysis | <0.01 | The threshold for statistical significance was p=0.05. | Mean Difference (Final Values) | -0.38 | 2-Sided | 95 | -0.63 | -0.12 | This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (1.71-2.14 = -0.43) and control (1.74-2.55= -0.81) arms, resulting in a difference of -0.38. | Superiority |
| 4-12 months post intervention |
|
| Change in mean number of new patients pre- to 4-12 months post-intervention | Mixed Models Analysis | 0.692 | The threshold for statistical significance is p=0.05. | Mean Difference (Final Values) | -0.03 | 2-Sided | 95 | -0.20 | 0.14 | This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.08-3.72 = -1.64) and control (1.84-3.51= -1.67) arms, resulting in a difference of -0.03. | Superiority |