Trial Outcomes & Findings for Behavioral Insights to Encourage Judicious Prescribing of Opioids (NCT NCT02790476)
NCT ID: NCT02790476
Last Updated: 2024-04-29
Results Overview
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.
COMPLETED
NA
851 participants
12 months
2024-04-29
Participant Flow
Participant milestones
| Measure |
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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Control
The control group will involve prescribers not receiving letters
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|---|---|---|
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Overall Study
STARTED
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404
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447
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Overall Study
COMPLETED
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386
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425
|
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Overall Study
NOT COMPLETED
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18
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22
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
We did not collect data on age of prescribers.
Baseline characteristics by cohort
| Measure |
Letter Intervention
n=386 Participants
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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Control
n=425 Participants
The control group will involve prescribers not receiving letters
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Total
n=811 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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—
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—
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0 Participants
We did not collect data on age of prescribers.
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Age, Categorical
Between 18 and 65 years
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—
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—
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0 Participants
We did not collect data on age of prescribers.
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Age, Categorical
>=65 years
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—
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—
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0 Participants
We did not collect data on age of prescribers.
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Sex: Female, Male
Female
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—
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—
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0 Participants
We did not collect data on biological sex from prescribers.
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Sex: Female, Male
Male
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—
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—
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0 Participants
We did not collect data on biological sex from prescribers.
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Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
United States
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386 Participants
n=386 Participants
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425 Participants
n=425 Participants
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811 Participants
n=811 Participants
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PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Letter Intervention
n=386 Participants
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.
|
Control
n=425 Participants
The control group will involve prescribers not receiving letters
|
|---|---|---|
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Average Change Over Time in Dispensed Narcotics
Adjusted per-prescriber mean weekly morphine milligram equivalents (MMEs); Pre intervention
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347.65 Morphine milligram equivalents
Interval 339.27 to 356.03
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350.09 Morphine milligram equivalents
Interval 341.77 to 358.4
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Average Change Over Time in Dispensed Narcotics
Adjusted per-prescriber mean weekly MMEs; 1-3 months Post intervention
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288.36 Morphine milligram equivalents
Interval 281.61 to 295.11
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318.60 Morphine milligram equivalents
Interval 311.03 to 326.17
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Average Change Over Time in Dispensed Narcotics
Adjusted per-prescriber mean weekly MMEs; 4-12 months Post intervention
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167.83 Morphine milligram equivalents
Interval 163.91 to 171.74
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182.67 Morphine milligram equivalents
Interval 178.46 to 186.88
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PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Letter Intervention
n=386 Participants
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.
|
Control
n=425 Participants
The control group will involve prescribers not receiving letters
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|---|---|---|
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Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME
Number of => 50 MME Prescriptions Pre intervention
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3.74 Number of prescriptions
Interval 3.57 to 3.91
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4.59 Number of prescriptions
Interval 4.41 to 4.76
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Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME
Number of => 50 MME Prescriptions 1-3 months Post intervention
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3.45 Number of prescriptions
Interval 3.08 to 3.82
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3.95 Number of prescriptions
Interval 3.59 to 4.3
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Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME
Number of => 50 MME Prescriptions 4-12 months Post-intervention
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3.00 Number of prescriptions
Interval 2.79 to 3.21
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3.15 Number of prescriptions
Interval 2.95 to 3.35
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Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME
Number of > 90 MME Prescriptions Pre intervention
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2.14 Number of prescriptions
Interval 2.02 to 2.27
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2.55 Number of prescriptions
Interval 2.44 to 2.67
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Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME
Number of > 90 MME Prescriptions 1-3 Post intervention
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2.00 Number of prescriptions
Interval 1.76 to 2.25
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2.20 Number of prescriptions
Interval 1.96 to 2.44
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Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME
Number of > 90 MME Prescriptions 4-12 months Post intervention
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1.71 Number of prescriptions
Interval 1.57 to 1.85
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1.74 Number of prescriptions
Interval 1.61 to 1.87
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PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Letter Intervention
n=352 Participants
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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Control
n=390 Participants
The control group will involve prescribers not receiving letters
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|---|---|---|
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Number of Opioid and Benzodiazepine Co-prescriptions
Pre intervention
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12.2 Adjusted mean number of co-prescriptions
Interval 9.8 to 14.6
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13.6 Adjusted mean number of co-prescriptions
Interval 11.0 to 16.1
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Number of Opioid and Benzodiazepine Co-prescriptions
Post intervention
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13.4 Adjusted mean number of co-prescriptions
Interval 12.3 to 14.4
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16.7 Adjusted mean number of co-prescriptions
Interval 15.5 to 17.9
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SECONDARY outcome
Timeframe: 12 monthsPopulation: We were unable to access information on frequency of CURES use and could not conduct the proposed analysis.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Letter Intervention
n=386 Participants
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.
|
Control
n=425 Participants
The control group will involve prescribers not receiving letters
|
|---|---|---|
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Number of "New Start" Prescriptions
Pre intervention
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3.72 patients with new opioid prescriptions
Interval 3.64 to 3.8
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3.51 patients with new opioid prescriptions
Interval 3.44 to 3.59
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Number of "New Start" Prescriptions
1-3 months post intervention
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2.44 patients with new opioid prescriptions
Interval 2.27 to 2.61
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2.26 patients with new opioid prescriptions
Interval 2.1 to 2.43
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Number of "New Start" Prescriptions
4-12 months post intervention
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2.08 patients with new opioid prescriptions
Interval 1.99 to 2.18
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1.84 patients with new opioid prescriptions
Interval 1.76 to 1.93
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Adverse Events
Letter Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place