Opioid Use, UnspecifiedOHSNCT04069403
An Opioid Prescribing Nudge
A study testing Automated Reports on prescription patterns for their patients in people with Opioid Use, Unspecified and Prescription Drug Abuse (Not Dependent), run by Duke University at 1 site in United States.
Trial summary
Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures. Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent benzo within… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Unspecified, Prescription Drug Abuse (Not Dependent), Prescription Drug Abuse and Dependency
- What is being tested?
- Automated Reports on prescription patterns for their patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 15 Jun 2020
- 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
- The primary population of focus for this study is:
- attending physicians
- residents
- advanced practice providers
- hereby referred to as opioid prescribers in Duke University Health System and may include these departments and clinics:
- Emergency Department
Show all 11Show fewer
- Neurology, Pain Management
- Primary Care
- Psychiatry, Sleep Disorder Clinic
- Spine
- All opioid prescribers in these settings will be identified in partnership with Duke University Health System.
Who cannot join
- Providers not identified above
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: An Opioid Prescribing Nudge: Leveraging Behavioral Economics to Reduce Opioid Harms Within Health Systems
Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures.
Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period.
Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.
Read the detailed description
The Concurrent Opioid Prescribing Nudge project intends to address multiple points within the opioid-use cycle through the development of standardized and scalable reporting mechanisms to provide social comparisons and feedback to physicians across the Duke Health System regarding their concurrent and co- opioid, benzodiazepines, and muscle relaxant prescribing practices. Concurrent are hereby defined as:
- writing a new opioid prescription for a patient with a benzodiazepine prescription within the last 3 months,
- writing a new benzodiazepine prescription for a patient with a opioid prescription within the last 3 months,
- writing a new muscle relaxant prescription for a patient with an opioid prescription within the last 3 months,
- writing a new opioid prescription for a patient with muscle relaxant prescription within the last 3 months, or
- writing a new prescription for both an opioid and benzodiazepine or opioid and muscle relaxant.
The proposed project will leverage insights from behavioral economics to design informational and social incentives to reduce concurrent practices and mitigate opioid harm. Opioid prescribers (attending physicians, residents, and advanced practice providers) at participating departments and clinics in the Duke Health System will be randomized to a control or intervention arm. Over six month reporting periods beginning fall 2019, providers in the intervention arms will receive monthly reports with their individual prescribing patterns and comparison to peer prescribing patterns for the following measures: number of prescriptions with concurrent opioid active prescriptions of opioid/ benzodiazepines, number of prescriptions with concurrent opioid active prescriptions of opioid/muscle relaxants, and number of missed opportunities to prescribe naloxone to patients with any opioid-related diagnosis. The control arm will receive usual clinical education and feedback. Interventions will be implemented at participating departments and clinics utilizing a stepped-wedge timeline.
- Conditions
- Opioid Use, Unspecified, Prescription Drug Abuse (Not Dependent), Prescription Drug Abuse and Dependency, Health Behavior, Benzodiazepine Abuse, Benzodiazepine Dependent
- Being tested
- Automated Reports on prescription patterns for their patients
- Keywords
- Opioids, Prescription, Patterns, Nudge, Practices
- Medical subject headings
- Substance-Related Disorders, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Reports on prescription patterns for their patientsOther
Also called de-identified reports, prescribers' prescribing patterns
de-identified aggregate reports
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm- Automated Reports | Experimental | Receives automated reports on prescription patterns monthly Receives: Other: Automated Reports on prescription patterns for their patients |
| Control Arm: Usual clinical education and feedback | No intervention | Receive no reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Opioid prescribing habits
Using baseline concurrent opioid prescribing metrics obtained (at the individual prescriber level) during their initial month and month prior in the Duke Health System, measure changes in Opioid n prescription orders as measured by provider prescriptions
Measured: Baseline, 6 Months
number of prescriptions with concurrent benzo within reporting period
Identify the number of prescriptions with concurrent benzo over 6 months
Measured: 6 Months
number of prescriptions with concurrent muscle relaxants within reporting period
Identify the number of prescriptions with concurrent muscle relaxants over 6 months
Measured: 6 Months
number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period
Identify the number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis over 6 months
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start10 Sep 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Duke 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
- Model description
- Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures. Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent or benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period. Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.
- Masking
- None (open label)
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlene Wong, MD, Principal investigator, Duke UniversityCharles Scales, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069403
- Sponsor's protocol ID
- Pro00102219
- Acronym
- OHS
- Status last verified
- Apr 2020
- First submitted
- 23 Aug 2019
- Last updated
- 30 Jun 2020
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Opioid Prescribing Nudge: Leveraging Behavioral Economics to Reduce Opioid Harms Within Health Systems
- ClinicalTrials.gov ID
- NCT04069403
- Acronym / sponsor ID
- OHS / Pro00102219
- Conditions
- Opioid Use, Unspecified, Prescription Drug Abuse (Not Dependent), Prescription Drug Abuse and Dependency, Health Behavior, Benzodiazepine Abuse, Benzodiazepine Dependent
- Keywords
- Opioids, Prescription, Patterns, Nudge, Practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 28 Aug 2019 (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.
Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures.
Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period.
Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.
Detailed description
The Concurrent Opioid Prescribing Nudge project intends to address multiple points within the opioid-use cycle through the development of standardized and scalable reporting mechanisms to provide social comparisons and feedback to physicians across the Duke Health System regarding their concurrent and co- opioid, benzodiazepines, and muscle relaxant prescribing practices. Concurrent are hereby defined as:
- writing a new opioid prescription for a patient with a benzodiazepine prescription within the last 3 months,
- writing a new benzodiazepine prescription for a patient with a opioid prescription within the last 3 months,
- writing a new muscle relaxant prescription for a patient with an opioid prescription within the last 3 months,
- writing a new opioid prescription for a patient with muscle relaxant prescription within the last 3 months, or
- writing a new prescription for both an opioid and benzodiazepine or opioid and muscle relaxant.
The proposed project will leverage insights from behavioral economics to design informational and social incentives to reduce concurrent practices and mitigate opioid harm. Opioid prescribers (attending physicians, residents, and advanced practice providers) at participating departments and clinics in the Duke Health System will be randomized to a control or intervention arm. Over six month reporting periods beginning fall 2019, providers in the intervention arms will receive monthly reports with their individual prescribing patterns and comparison to peer prescribing patterns for the following measures: number of prescriptions with concurrent opioid active prescriptions of opioid/ benzodiazepines, number of prescriptions with concurrent opioid active prescriptions of opioid/muscle relaxants, and number of missed opportunities to prescribe naloxone to patients with any opioid-related diagnosis. The control arm will receive usual clinical education and feedback. Interventions will be implemented at participating departments and clinics utilizing a stepped-wedge timeline.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures. Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent or benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period. Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm- Automated Reports | Experimental | Other: Automated Reports on prescription patterns for their patientsReceives automated reports on prescription patterns monthly |
| Control Arm: Usual clinical education and feedback | No intervention | –Receive no reports |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- attending physicians
- residents
- advanced practice providers
- hereby referred to as opioid prescribers in Duke University Health System and may include these departments and clinics:
- Emergency Department
Key exclusion criteria (1 listed)
- Providers not identified above
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 |
|---|---|---|
| Automated Reports on prescription patterns for their patientsAlso: de-identified reports, prescribers' prescribing patternsde-identified aggregate reports | Other | Intervention Arm- Automated Reports |
Primary outcome
Change in Opioid prescribing habits
Time frame: Baseline, 6 Months
Using baseline concurrent opioid prescribing metrics obtained (at the individual prescriber level) during their initial month and month prior in the Duke Health System, measure changes in Opioid n prescription orders as measured by provider prescriptions
number of prescriptions with concurrent benzo within reporting period
Time frame: 6 Months
Identify the number of prescriptions with concurrent benzo over 6 months
number of prescriptions with concurrent muscle relaxants within reporting period
Time frame: 6 Months
Identify the number of prescriptions with concurrent muscle relaxants over 6 months
number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period
Time frame: 6 Months
Identify the number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis over 6 months
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 30 Jun 2020.
- 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.
Charlene Wong, MD principal investigator
Duke University
Charles Scales, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Reports on prescription patterns for their patients in people with Opioid Use, Unspecified and Prescription Drug Abuse (Not Dependent), run by Duke University 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 11 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 30 Jun 2020. 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?
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?
Change in Opioid prescribing habits (time frame: Baseline, 6 Months). The study lists 4 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 30 Jun 2020.