Substance-Related Disorders
Conditions
Keywords
Opioids, Safe prescribing
Brief summary
In collaboration with the Los Angeles County 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 12 months and 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 Los Angeles 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 letters 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, resulting in fewer deaths due to misuse and more frequent use of the CURES system.
Interventions
BEHAVIORALComparator letter
The comparator letter includes all the details in the standard letter plus additional text involving an if/when/then statement along with an injunction to providers to share safety information with patients so that they identify as a safe prescriber. Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. If/when/then is a form of pre-suasion that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.
BEHAVIORALStandard letter
The standard letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 morphine milligram equivalents (MME) per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018.
Sponsors
National Institute on Aging (NIA)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 Los Angeles 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) * Prescriptions with unknown Drug Enforcement Agency (DEA) number
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed | 52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout) | Difference in average weekly MME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed. | 52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout) | Difference in average weekly VME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient). |
Countries
United States
Participant flow
Pre-assignment details
The Los Angeles Medical Examiner identified 316 decedents from a schedule II-IV Rx overdose from October 2018 to May 2020. 236 received a schedule II-IV Rx in the 12 months prior to their death from 541 prescribers who were randomized to either the standard letter or comparator. 510 of these clinicians prescribed at least one opioid to 219 decedents and were included in the primary analysis. The secondary analysis included 528 clinicians who prescribed a benzodiazepine to 220 decedents.
Participants by arm
| Arm | Count |
|---|---|
| Standard Letter The intervention arm will involve the Standard Letter sent to prescribers in Los Angeles County.
Standard Letter: The letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 MME per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018. | 284 |
| Comparator Letter The intervention arm will involve the Comparator Letter sent to prescribers in Los Angeles County.
Comparator Letter: This letter includes all the details in the Standard Letter plus additional text involving an if/when/then statement along with an injunction to providers to share safety information with patients so that they identify as a safe prescriber. Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. If/when/then is a form of pre-suasion that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation. | 257 |
| Total | 541 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Prescriber had no opioid prescriptions or was missing prescription information during study period | 15 | 16 |
Baseline characteristics
| Characteristic | Total | Standard Letter | Comparator Letter |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — | — |
| Age, Categorical >=65 years | 0 Participants | — | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 29 Participants | 14 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 10 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 447 Participants | 229 Participants | 218 Participants |
| Race (NIH/OMB) White | 53 Participants | 31 Participants | 22 Participants |
| Region of Enrollment United States | 541 participants | 284 participants | 257 participants |
| Sex: Female, Male Female | 56 Participants | 29 Participants | 27 Participants |
| Sex: Female, Male Male | 203 Participants | 104 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 269 | 0 / 241 |
| other Total, other adverse events | 0 / 269 | 0 / 241 |
| serious Total, serious adverse events | 0 / 269 | 0 / 241 |
Outcome results
Primary
Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed
Difference in average weekly MME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient).
Time frame: 52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)
Population: Prescribers practicing in Los Angeles County with scheduled drug prescribing privileges who prescribed an opioid 52 weeks (1 year) prior to a patient death from a schedule II-IV overdose.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Standard Letter | Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed | 52 weeks pre-letter | 157.70 Estimated average weekly MME dispensed |
| Standard Letter | Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed | 4-52 weeks post-letter | 103.16 Estimated average weekly MME dispensed |
| Comparator Letter | Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed | 52 weeks pre-letter | 157.81 Estimated average weekly MME dispensed |
| Comparator Letter | Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed | 4-52 weeks post-letter | 89.96 Estimated average weekly MME dispensed |
Comparison: Please note that 10% of means in the pre-intervention period were trimmed to remove outliers.p-value: <0.0595% CI: [-0.2, -0.07]Mixed Models Analysis
Secondary
Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.
Difference in average weekly VME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient).
Time frame: 52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout)
Population: Prescribers practicing in Los Angeles County with scheduled drug prescribing privileges who prescribed a benzodiazepine 52 weeks (1 year) prior to a patient death from a schedule II-IV overdose.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Standard Letter | Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed. | 52 weeks pre-intervention | 47.18 Estimated average weekly VME dispensed |
| Standard Letter | Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed. | 4-52 weeks post-intervention | 37.93 Estimated average weekly VME dispensed |
| Comparator Letter | Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed. | 52 weeks pre-intervention | 43.09 Estimated average weekly VME dispensed |
| Comparator Letter | Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed. | 4-52 weeks post-intervention | 31.77 Estimated average weekly VME dispensed |
p-value: <0.0595% CI: [-0.15, -0.02]Mixed Models Analysis