Substance-Related DisordersNCT03856593
Encouraging Judicious Prescribing of Opioids in Los Angeles County
A study testing Standard letter and Comparator letter in people with Substance-Related Disorders, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Standard letter and Comparator letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2019to 8 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County Medical Examiner's Office
Los Angeles, California, 90033
About this study
Official title: Comparative Effectiveness of Two Letters to Encourage Judicious Prescribing of Opioids: A County-wide Project in Los Angeles
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.
- Conditions
- Substance-Related Disorders
- Being tested
- Standard letter, Comparator letter
- Keywords
- Opioids, Safe prescribing
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard letterBehavioural
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.
Comparator letterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard letter | Experimental | Prescribers randomized to this arm will be sent the standard letter. Receives: Behavioral: Standard letter |
| Comparator letter | Experimental | Prescribers randomized to this arm will be sent the comparator letter. Receives: Behavioral: Comparator letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)
Secondary outcomes (1)
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).
Measured: 52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start5 Apr 2019
- Primary completion8 Aug 2021
- Study completion8 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jason Doctor, University of Southern California
- Investigators
- Jason Doctor, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856593
- Sponsor's protocol ID
- UP-19-00172
- Other IDs
- P30AG024968
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2019
- Last updated
- 28 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doctor JN, Kelley MA, Goldstein NJ, Lucas J, Knight T, Stewart EP. A randomized trial looking at planning prompts to reduce opioid prescribing. Nat Commun. 2024 Jan 12;15(1):263. doi: 10.1038/s41467-023-44573-5.
PubMed 38216566
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Two Letters to Encourage Judicious Prescribing of Opioids: A County-wide Project in Los Angeles
- ClinicalTrials.gov ID
- NCT03856593
- Acronym / sponsor ID
- UP-19-00172
- Conditions
- Substance-Related Disorders
- Keywords
- Opioids, Safe prescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 8 Aug 2021 (actual)
- Study completion
- 8 Aug 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 28 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard letter | Experimental | Behavioral: Standard letterPrescribers randomized to this arm will be sent the standard letter. |
| Comparator letter | Experimental | Behavioral: Comparator letterPrescribers randomized to this arm will be sent the comparator letter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard letterThe 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. | Behavioural | Standard letter |
| Comparator letterThe 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. | Behavioural | Comparator letter |
Primary outcome
Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed
Time frame: 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).
1 secondary outcome
Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.
Time frame: 52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38216566Doctor JN, Kelley MA, Goldstein NJ, Lucas J, Knight T, Stewart EP. A randomized trial looking at planning prompts to reduce opioid prescribing. Nat Commun. 2024 Jan 12;15(1):263. doi: 10.1038/s41467-023-44573-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Doctor, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard letter and Comparator letter in people with Substance-Related Disorders, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed (time frame: 52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.