Substance-Related DisordersNCT02790476

Behavioral Insights to Encourage Judicious Prescribing of Opioids

A study testing Letters in people with Substance-Related Disorders, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Substance-Related Disorders
What is being tested?: Letters
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 851 participants
Where: 1 siteUnited States
Study dates: 27 Jan 2017to 27 Feb 2018
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 Any age
All sexes
No healthy volunteers
Child, 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 San Diego 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)
Prescribers with unknown Drug Enforcement Agency number

Trial locations and contacts

1 site in 1 country.

United States1 site

San Diego County Medical Examiner's Office
San Diego, California, 92123

Other trials in United States

About this study

Official title: Use of Behavioral Insights to Encourage Judicious Prescribing of Opioids

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.

Conditions: Substance-Related Disorders
Being tested: Letters
Keywords: Safe, Prescribing, Opioids
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.

LettersOther
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.

Study groups in NCT02790476
Study group	Role	What they receive
Letter intervention	Experimental	The intervention arm will involve letters sent to prescribers in San Diego County. Receives: Other: Letters
Control	No intervention	The control group will involve prescribers not receiving letters

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months

Secondary outcomes (2)

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.
Measured: 12 months
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 201727 Feb 2018

First posted6 Jun 2016 (estimated)
Study start27 Jan 2017
Primary completion27 May 2017
Study completion27 Feb 2018

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.
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: 851 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02790476
Sponsor's protocol ID: CHCF-16-00053
Status last verified: Nov 2023
First submitted: 27 May 2016
Last updated: 29 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance-Related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Behavioral Insights to Encourage Judicious Prescribing of Opioids
ClinicalTrials.gov ID: NCT02790476
Acronym / sponsor ID: CHCF-16-00053
Conditions: Substance-Related Disorders
Keywords: Safe, Prescribing, Opioids
Study type: Interventional
Recruitment status: Completed
Enrolment: 851 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Study start: 27 Jan 2017 (actual)
Primary completion: 27 May 2017 (actual)
Study completion: 27 Feb 2018 (actual)
First posted: 6 Jun 2016 (estimated)
Results: Posted 29 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Letter intervention	Experimental	Other: LettersThe intervention arm will involve letters sent to prescribers in San Diego County.
Control	No intervention	–The control group will involve prescribers not receiving letters

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, 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 San Diego 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)
Prescribers with unknown Drug Enforcement Agency 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
LettersThe 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.	Other	Letter intervention

Primary outcome

Average Change Over Time in Dispensed Narcotics
Time frame: 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
Time frame: 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
Time frame: 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.

2 secondary outcomes

Frequency of CURES Use
Time frame: 12 months
Number of "New Start" Prescriptions
Time frame: 12 months

Results and safety

Results posted to the registry on 29 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Letter Intervention	404	386
Control	447	425

Primary outcome: Average Change Over Time in Dispensed Narcotics

Time frame: 12 months. Mean (95% Confidence Interval). Unit: Morphine milligram equivalents

Measure	Letter Intervention n = 386	Control n = 425
Adjusted per-prescriber mean weekly morphine milligram equivalents (MMEs); Pre intervention	347.65 (339.27 to 356.03)	350.09 (341.77 to 358.40)
Adjusted per-prescriber mean weekly MMEs; 1-3 months Post intervention	288.36 (281.61 to 295.11)	318.60 (311.03 to 326.17)
Adjusted per-prescriber mean weekly MMEs; 4-12 months Post intervention	167.83 (163.91 to 171.74)	182.67 (178.46 to 186.88)

Letter Intervention: Mean Difference (Final Values): -27.80 (95% CI -38.20 to -17.63), p <0.05, Mixed Models Analysis
Letter Intervention: Mean Difference (Final Values): -12.42 (95% CI -18.40 to -6.55), p <0.01, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME

Time frame: 12 months. Mean (95% Confidence Interval). Unit: Number of prescriptions

Measure	Letter Intervention n = 386	Control n = 425
Number of => 50 MME Prescriptions Pre intervention	3.74 (3.57 to 3.91)	4.59 (4.41 to 4.76)
Number of => 50 MME Prescriptions 1-3 months Post intervention	3.45 (3.08 to 3.82)	3.95 (3.59 to 4.30)
Number of => 50 MME Prescriptions 4-12 months Post-intervention	3.00 (2.79 to 3.21)	3.15 (2.95 to 3.35)
Number of > 90 MME Prescriptions Pre intervention	2.14 (2.02 to 2.27)	2.55 (2.44 to 2.67)
Number of > 90 MME Prescriptions 1-3 Post intervention	2.00 (1.76 to 2.25)	2.20 (1.96 to 2.44)
Number of > 90 MME Prescriptions 4-12 months Post intervention	1.71 (1.57 to 1.85)	1.74 (1.61 to 1.87)

Letter Intervention: Mean Difference (Final Values): -0.35 (95% CI -0.92 to 0.22), p = 0.224, Mixed Models Analysis
Letter Intervention: Mean Difference (Final Values): -0.70 (95% CI -1.08 to -0.33), p <0.001, Mixed Models Analysis
Letter Intervention: Mean Difference (Final Values): -0.21 (95% CI -0.59 to 0.17), p = 0.279, Mixed Models Analysis

Primary outcome: Number of Opioid and Benzodiazepine Co-prescriptions

Time frame: 12 months. Mean (95% Confidence Interval). Unit: Adjusted mean number of co-prescriptions

Measure	Letter Intervention n = 352	Control n = 390
Pre intervention	12.2 (9.8 to 14.6)	13.6 (11.0 to 16.1)
Post intervention	13.4 (12.3 to 14.4)	16.7 (15.5 to 17.9)

Letter Intervention: Mean Difference (Final Values): -1.6 (95% CI -3.2 to -0.1), p <0.05, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months following letter notification (January 28, 2017-January 27, 2018). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Letter Intervention	0 of 386 (0%)	0 of 386 (0%)	0 of 386
Control	0 of 425 (0%)	0 of 425 (0%)	0 of 425

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Letters 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 29 Apr 2024. 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 29 Apr 2024). 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 Change Over Time in Dispensed Narcotics (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT02790476.

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 29 Apr 2024.