An interventional study of Letters in Substance-Related Disorders, sponsored by University of Southern California. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by University of Southern California · Not applicable, Interventional, and Other
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 851 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
The intervention arm will involve letters sent to prescribers in San Diego County.
Other: Letters
The control group will involve prescribers not receiving 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
| Milestone | Letter Intervention | Control |
|---|---|---|
| Started | 404 | 447 |
| Completed | 386 | 425 |
| Not completed | 18 | 22 |
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.
| Morphine milligram equivalents | Letter Intervention | Control |
|---|---|---|
| Adjusted per-prescriber mean weekly morphine milligram equivalents (MMEs); Pre intervention | 347.65 (339.27 to 356.03) | 350.09 (341.77 to 358.40) |
| Adjusted per-prescriber mean weekly MMEs; 1-3 months Post intervention | 288.36 (281.61 to 295.11) | 318.60 (311.03 to 326.17) |
| Adjusted per-prescriber mean weekly MMEs; 4-12 months Post intervention | 167.83 (163.91 to 171.74) | 182.67 (178.46 to 186.88) |
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.
| Number of prescriptions | Letter Intervention | Control |
|---|---|---|
| Number of => 50 MME Prescriptions Pre intervention | 3.74 (3.57 to 3.91) | 4.59 (4.41 to 4.76) |
| Number of => 50 MME Prescriptions 1-3 months Post intervention | 3.45 (3.08 to 3.82) | 3.95 (3.59 to 4.30) |
| Number of => 50 MME Prescriptions 4-12 months Post-intervention | 3.00 (2.79 to 3.21) | 3.15 (2.95 to 3.35) |
| Number of > 90 MME Prescriptions Pre intervention | 2.14 (2.02 to 2.27) | 2.55 (2.44 to 2.67) |
| Number of > 90 MME Prescriptions 1-3 Post intervention | 2.00 (1.76 to 2.25) | 2.20 (1.96 to 2.44) |
| Number of > 90 MME Prescriptions 4-12 months Post intervention | 1.71 (1.57 to 1.85) | 1.74 (1.61 to 1.87) |
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.
| Adjusted mean number of co-prescriptions | Letter Intervention | Control |
|---|---|---|
| Pre intervention | 12.2 (9.8 to 14.6) | 13.6 (11.0 to 16.1) |
| Post intervention | 13.4 (12.3 to 14.4) | 16.7 (15.5 to 17.9) |
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.
No measurements were reported for this outcome.
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.
| patients with new opioid prescriptions | Letter Intervention | Control |
|---|---|---|
| Pre intervention | 3.72 (3.64 to 3.80) | 3.51 (3.44 to 3.59) |
| 1-3 months post intervention | 2.44 (2.27 to 2.61) | 2.26 (2.10 to 2.43) |
| 4-12 months post intervention | 2.08 (1.99 to 2.18) | 1.84 (1.76 to 1.93) |
Collected over 12 months following letter notification (January 28, 2017-January 27, 2018). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Letter Intervention | 0/386 (0%) | 0/386 (0%) | 0/386 (0%) |
| Control | 0/425 (0%) | 0/425 (0%) | 0/425 (0%) |
We removed prescribers with missing data or lack of prescriptions during the study period, resulting in an analysis population of 811 prescribers.
| Age, Categorical(Participants) | Letter Intervention | Control | Total |
|---|---|---|---|
| <=18 years | — | — | 0 |
| Between 18 and 65 years | — | — | 0 |
| >=65 years | — | — | 0 |
| Sex: Female, Male(Participants) | Letter Intervention | Control | Total |
|---|---|---|---|
| Female | — | — | 0 |
| Male | — | — | 0 |
| Race and Ethnicity Not Collected(Participants) | Letter Intervention | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Letter Intervention | Control | Total |
|---|---|---|---|
| United States | 386 | 425 | 811 |
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University of Southern California