Trial Outcomes & Findings for Encouraging Judicious Prescribing of Opioids in Los Angeles County (NCT NCT03856593)
NCT ID: NCT03856593
Last Updated: 2023-03-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
541 participants
Primary outcome timeframe
52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)
Results posted on
2023-03-28
Participant Flow
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.
Participant milestones
| Measure |
Standard Letter
The intervention arm will involve letter A 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.
|
Comparator Letter
The intervention arm will involve the comparator letter B to prescribers in Los Angeles County.
Comparator Letter: This letter includes all the details in 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.
|
|---|---|---|
|
Overall Study
STARTED
|
284
|
257
|
|
Overall Study
COMPLETED
|
269
|
241
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
Reasons for withdrawal
| Measure |
Standard Letter
The intervention arm will involve letter A 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.
|
Comparator Letter
The intervention arm will involve the comparator letter B to prescribers in Los Angeles County.
Comparator Letter: This letter includes all the details in 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.
|
|---|---|---|
|
Overall Study
Prescriber had no opioid prescriptions or was missing prescription information during study period
|
15
|
16
|
Baseline Characteristics
No age data were collected
Baseline characteristics by cohort
| Measure |
Standard Letter
n=284 Participants
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.
|
Comparator Letter
n=257 Participants
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.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
No age data were collected
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
0 Participants
No age data were collected
|
|
Age, Categorical
>=65 years
|
—
|
—
|
0 Participants
No age data were collected
|
|
Sex: Female, Male
Female
|
29 Participants
n=133 Participants • Some participants are missing biological sex information or declined to disclose.
|
27 Participants
n=126 Participants • Some participants are missing biological sex information or declined to disclose.
|
56 Participants
n=259 Participants • Some participants are missing biological sex information or declined to disclose.
|
|
Sex: Female, Male
Male
|
104 Participants
n=133 Participants • Some participants are missing biological sex information or declined to disclose.
|
99 Participants
n=126 Participants • Some participants are missing biological sex information or declined to disclose.
|
203 Participants
n=259 Participants • Some participants are missing biological sex information or declined to disclose.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=284 Participants
|
0 Participants
n=257 Participants
|
0 Participants
n=541 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=284 Participants
|
15 Participants
n=257 Participants
|
29 Participants
n=541 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=284 Participants
|
0 Participants
n=257 Participants
|
0 Participants
n=541 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=284 Participants
|
2 Participants
n=257 Participants
|
12 Participants
n=541 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=284 Participants
|
22 Participants
n=257 Participants
|
53 Participants
n=541 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=284 Participants
|
0 Participants
n=257 Participants
|
0 Participants
n=541 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
229 Participants
n=284 Participants
|
218 Participants
n=257 Participants
|
447 Participants
n=541 Participants
|
|
Region of Enrollment
United States
|
284 participants
n=284 Participants
|
257 participants
n=257 Participants
|
541 participants
n=541 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Standard Letter
n=269 Participants
This 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.
|
Comparator Letter
n=241 Participants
This intervention arm will involve 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.
|
|---|---|---|
|
Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed
52 weeks pre-letter
|
157.70 Estimated average weekly MME dispensed
Interval 153.45 to 161.96
|
157.81 Estimated average weekly MME dispensed
Interval 153.85 to 161.76
|
|
Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed
4-52 weeks post-letter
|
103.16 Estimated average weekly MME dispensed
Interval 100.34 to 105.98
|
89.96 Estimated average weekly MME dispensed
Interval 87.7 to 92.21
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Standard Letter
n=277 Participants
This 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.
|
Comparator Letter
n=251 Participants
This intervention arm will involve 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.
|
|---|---|---|
|
Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.
52 weeks pre-intervention
|
47.18 Estimated average weekly VME dispensed
Interval 45.9 to 48.46
|
43.09 Estimated average weekly VME dispensed
Interval 41.82 to 44.36
|
|
Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.
4-52 weeks post-intervention
|
37.93 Estimated average weekly VME dispensed
Interval 36.93 to 38.94
|
31.77 Estimated average weekly VME dispensed
Interval 30.79 to 32.75
|
Adverse Events
Letter A Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Letter B Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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