Opioid UseNCT04628832
Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms
A study testing PMP Use Mandate Letter, Prescribing Information Letter and Prescribing Information + PMP Use Mandate Letter in people with Opioid Use, run by Columbia University at 2 sites in United States.
Trial summary
Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- PMP Use Mandate Letter, Prescribing Information Letter and Prescribing Information + PMP Use Mandate Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2021to 12 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Wrote concurrent prescription for opioids and benzodiazepines OR opioids and gabapentinoids
Who cannot join
- Specialization in oncology or palliative medicine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Minnesota Board of Pharmacy
Minneapolis, Minnesota, 55414
Minnesota Management and Budget Agency
Saint Paul, Minnesota, 55155
About this study
Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.
- Conditions
- Opioid Use
- Being tested
- PMP Use Mandate Letter, Prescribing Information Letter, Prescribing Information + PMP Use Mandate Letter
- Keywords
- opioids, prescribing, benzodiazepines, gabapentinoids, clinical guidelines, overprescribing, Benzodiazepine Use, Gabapentin Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMP Use Mandate LetterBehavioural
A letter with reminders about the mandate to check the PMP when prescribing opioids.
Prescribing Information LetterBehavioural
A letter with information about the prescriber's patients who received co-prescriptions. The letters will provide clinical background on the harms of co-prescribing and encourage prescribers to avoid co-prescribing in the future.
Prescribing Information + PMP Use Mandate LetterBehavioural
A letter combining the content of the PMP Use Mandate Letter and the Prescribing Information Letter. This letter will remind prescribers about the PMP use mandate and provide information about the prescriber's patients who received co-prescriptions.
| Study group | Role | What they receive |
|---|---|---|
| PMP Use Mandate | Experimental | Not described Receives: Behavioral: PMP Use Mandate Letter |
| Prescribing Information | Experimental | Not described Receives: Behavioral: Prescribing Information Letter |
| Prescribing Information + PMP Use Mandate | Experimental | Not described Receives: Behavioral: Prescribing Information + PMP Use Mandate Letter |
| Control / As-Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Patients with Co-Prescriptions
The number of patients with co-prescriptions from the prescriber in the 60 days after the letters are sent.
Measured: 60 days
Rate of Prescribers Checking PMP
Indicator for whether the prescriber checks the PMP at least once in the 60 days after the letters are sent.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start15 Apr 2021
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Minnesota Management and Budget Agency, Minnesota Board of Pharmacy
- Responsible party
- Sponsor
- Investigators
- Adam Sacarny, PhD, Principal investigator, Columbia UniversityMireille Jacobson, PhD, Principal investigator, University of Southern CaliforniaDavid Powell, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628832
- Sponsor's protocol ID
- AAAT2489
- Status last verified
- Sep 2022
- First submitted
- 9 Nov 2020
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms
- ClinicalTrials.gov ID
- NCT04628832
- Acronym / sponsor ID
- AAAT2489
- Conditions
- Opioid Use
- Keywords
- opioids, prescribing, benzodiazepines, gabapentinoids, clinical guidelines, overprescribing, Benzodiazepine Use, Gabapentin Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Southern California, Minnesota Management and Budget Agency, Minnesota Board of Pharmacy
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PMP Use Mandate | Experimental | Behavioral: PMP Use Mandate Letter |
| Prescribing Information | Experimental | Behavioral: Prescribing Information Letter |
| Prescribing Information + PMP Use Mandate | Experimental | Behavioral: Prescribing Information + PMP Use Mandate Letter |
| Control / As-Usual | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Wrote concurrent prescription for opioids and benzodiazepines OR opioids and gabapentinoids
Key exclusion criteria (1 listed)
- Specialization in oncology or palliative medicine
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 |
|---|---|---|
| PMP Use Mandate LetterA letter with reminders about the mandate to check the PMP when prescribing opioids. | Behavioural | PMP Use Mandate |
| Prescribing Information LetterA letter with information about the prescriber's patients who received co-prescriptions. The letters will provide clinical background on the harms of co-prescribing and encourage prescribers to avoid co-prescribing in the future. | Behavioural | Prescribing Information |
| Prescribing Information + PMP Use Mandate LetterA letter combining the content of the PMP Use Mandate Letter and the Prescribing Information Letter. This letter will remind prescribers about the PMP use mandate and provide information about the prescriber's patients who received co-prescriptions. | Behavioural | Prescribing Information + PMP Use Mandate |
Primary outcome
Count of Patients with Co-Prescriptions
Time frame: 60 days
The number of patients with co-prescriptions from the prescriber in the 60 days after the letters are sent.
Rate of Prescribers Checking PMP
Time frame: 60 days
Indicator for whether the prescriber checks the PMP at least once in the 60 days after the letters are sent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- 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.
Adam Sacarny, PhD principal investigator
Columbia University
Mireille Jacobson, PhD principal investigator
University of Southern California
David Powell, PhD principal investigator
RAND
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMP Use Mandate Letter, Prescribing Information Letter and Prescribing Information + PMP Use Mandate Letter in people with Opioid Use, run by Columbia University at 2 sites 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 1 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 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Count of Patients with Co-Prescriptions (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2022.