Substance-Related Disorders
Conditions
Keywords
Safe, Prescribing, Opioids
Brief summary
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.
Interventions
OTHERLetters
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.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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: * Prescribers in California for whom at least one of their prescription(s) was filled by a patient who died of an opioid poisoning in San Diego County
Exclusion criteria
* Prescriber is licensed outside the State of California and does not hold a California license, but the prescription was filled in California * The prescriber does not have a CURES report on record * The prescriber has issued only one opioid prescription in the last 12 months since the time of the deceased death (and the prescription was to the deceased) * Prescribers with unknown Drug Enforcement Agency number
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change Over Time in Dispensed Narcotics | 12 months | 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. |
| Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | 12 months | 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 Opioid and Benzodiazepine Co-prescriptions | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of CURES Use | 12 months | 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. |
| Number of New Start Prescriptions | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 386 |
| Control The control group will involve prescribers not receiving letters | 425 |
| Total | 811 |
Baseline characteristics
| Characteristic | Total | Letter Intervention | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — | — |
| Age, Categorical >=65 years | 0 Participants | — | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — | — |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 811 Participants | 386 Participants | 425 Participants |
| Sex: Female, Male Female | 0 Participants | — | — |
| Sex: Female, Male Male | 0 Participants | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 386 | 0 / 425 |
| other Total, other adverse events | 0 / 386 | 0 / 425 |
| serious Total, serious adverse events | 0 / 386 | 0 / 425 |
Outcome results
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Letter Intervention | Average Change Over Time in Dispensed Narcotics | Adjusted per-prescriber mean weekly morphine milligram equivalents (MMEs); Pre intervention | 347.65 Morphine milligram equivalents |
| Letter Intervention | Average Change Over Time in Dispensed Narcotics | Adjusted per-prescriber mean weekly MMEs; 1-3 months Post intervention | 288.36 Morphine milligram equivalents |
| Letter Intervention | Average Change Over Time in Dispensed Narcotics | Adjusted per-prescriber mean weekly MMEs; 4-12 months Post intervention | 167.83 Morphine milligram equivalents |
| Control | Average Change Over Time in Dispensed Narcotics | Adjusted per-prescriber mean weekly morphine milligram equivalents (MMEs); Pre intervention | 350.09 Morphine milligram equivalents |
| Control | Average Change Over Time in Dispensed Narcotics | Adjusted per-prescriber mean weekly MMEs; 1-3 months Post intervention | 318.60 Morphine milligram equivalents |
| Control | Average Change Over Time in Dispensed Narcotics | Adjusted per-prescriber mean weekly MMEs; 4-12 months Post intervention | 182.67 Morphine milligram equivalents |
Comparison: 1-3 months post interventionp-value: <0.0595% CI: [-38.2, -17.63]Mixed Models Analysis
p-value: <0.0195% CI: [-18.4, -6.55]Mixed Models Analysis
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Letter Intervention | Number of Opioid and Benzodiazepine Co-prescriptions | Pre intervention | 12.2 Adjusted mean number of co-prescriptions |
| Letter Intervention | Number of Opioid and Benzodiazepine Co-prescriptions | Post intervention | 13.4 Adjusted mean number of co-prescriptions |
| Control | Number of Opioid and Benzodiazepine Co-prescriptions | Pre intervention | 13.6 Adjusted mean number of co-prescriptions |
| Control | Number of Opioid and Benzodiazepine Co-prescriptions | Post intervention | 16.7 Adjusted mean number of co-prescriptions |
p-value: <0.0595% CI: [-3.2, -0.1]Mixed Models Analysis
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Letter Intervention | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of => 50 MME Prescriptions Pre intervention | 3.74 Number of prescriptions |
| Letter Intervention | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of => 50 MME Prescriptions 1-3 months Post intervention | 3.45 Number of prescriptions |
| Letter Intervention | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of => 50 MME Prescriptions 4-12 months Post-intervention | 3.00 Number of prescriptions |
| Letter Intervention | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of > 90 MME Prescriptions Pre intervention | 2.14 Number of prescriptions |
| Letter Intervention | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of > 90 MME Prescriptions 1-3 Post intervention | 2.00 Number of prescriptions |
| Letter Intervention | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of > 90 MME Prescriptions 4-12 months Post intervention | 1.71 Number of prescriptions |
| Control | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of > 90 MME Prescriptions 1-3 Post intervention | 2.20 Number of prescriptions |
| Control | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of => 50 MME Prescriptions Pre intervention | 4.59 Number of prescriptions |
| Control | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of > 90 MME Prescriptions Pre intervention | 2.55 Number of prescriptions |
| Control | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of => 50 MME Prescriptions 1-3 months Post intervention | 3.95 Number of prescriptions |
| Control | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of > 90 MME Prescriptions 4-12 months Post intervention | 1.74 Number of prescriptions |
| Control | Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME | Number of => 50 MME Prescriptions 4-12 months Post-intervention | 3.15 Number of prescriptions |
Comparison: Change in mean number of =\> 50 MME prescriptions pre- to 1-3 months post-interventionp-value: 0.22495% CI: [-0.92, 0.22]Mixed Models Analysis
Comparison: Change in mean number of =\> 50 MME prescriptions pre- to 4-12 months post-interventionp-value: <0.00195% CI: [-1.08, -0.33]Mixed Models Analysis
Comparison: Change in mean number of \> 90 MME prescriptions pre- to 1-3 months post-interventionp-value: 0.27995% CI: [-0.59, 0.17]Mixed Models Analysis
Comparison: Change in mean number of \> 90 MME prescriptions pre- to 4-12 months post-interventionp-value: <0.0195% CI: [-0.63, -0.12]Mixed Models Analysis
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.
Time frame: 12 months
Population: We were unable to access information on frequency of CURES use and could not conduct the proposed analysis.
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Letter Intervention | Number of New Start Prescriptions | Pre intervention | 3.72 patients with new opioid prescriptions |
| Letter Intervention | Number of New Start Prescriptions | 1-3 months post intervention | 2.44 patients with new opioid prescriptions |
| Letter Intervention | Number of New Start Prescriptions | 4-12 months post intervention | 2.08 patients with new opioid prescriptions |
| Control | Number of New Start Prescriptions | Pre intervention | 3.51 patients with new opioid prescriptions |
| Control | Number of New Start Prescriptions | 1-3 months post intervention | 2.26 patients with new opioid prescriptions |
| Control | Number of New Start Prescriptions | 4-12 months post intervention | 1.84 patients with new opioid prescriptions |
Comparison: Change in mean number of new patients pre- to 1-3 months post-interventionp-value: 0.82395% CI: [-0.23, 0.29]Mixed Models Analysis
Comparison: Change in mean number of new patients pre- to 4-12 months post-interventionp-value: 0.69295% CI: [-0.2, 0.14]Mixed Models Analysis