Acute PainREDUCENCT03825549
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
A study testing Individual audit feedback and Peer comparison feedback in people with Acute Pain, run by University of Pennsylvania at 1 site in United States.
Trial summary
In this study, the investigators will evaluate the effect of a health system initiative aiming to change clinician opioid prescribing behaviors using two behavioral economic interventions - individual audit feedback and peer comparison feedback of clinicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Individual audit feedback and Peer comparison feedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2019to 2 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinicians
- 1. Practiced primarily at participating emergency department or urgent care center
- Patients
- Presented to a participating emergency department or urgent care center during the study period
- Discharged to home from the visit
Who cannot join
- Clinicians
- Saw less than 100 patients in the prior year
- Practiced primarily at another site that is not in the main trial
- Did not practice at Sutter Health in the prior 90 days
- Patients
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators will evaluate the effect of a health system initiative aiming to change clinician opioid prescribing behaviors using two behavioral economic interventions - individual audit feedback and peer comparison feedback of clinicians.
Read the detailed description
Opioid-related abuse and overdose represent a growing national epidemic in the United States. Clinician practice patterns play an important role: opioid prescriptions impact the likelihood that patients will misuse or become dependent on these medications, with longer prescriptions leading to greater sustained use. In this study, we will evaluate a Sutter Health System quality improvement initiative using monthly individual audit feedback and/or monthly peer comparison feedback to clinicians to change opioid prescribing patterns. In partnership with Sutter Health System, this will be conducted using randomization to evaluate its effect. We will also conduct a process evaluation to understand factors associated with better or worse performance at the clinician level.
- Conditions
- Acute Pain
- Being tested
- Individual audit feedback, Peer comparison feedback
- Keywords
- Opioids, Nudges, Emergency Medicine, Urgent Care, Feedback
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual audit feedbackBehavioural
Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.
Peer comparison feedbackBehavioural
Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a "low prescriber."
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Individual Audit | Experimental | Clinicians will receive individual audit feedback informing them of their performance. Receives: Behavioral: Individual audit feedback |
| Peer Comparison | Experimental | Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers. Receives: Behavioral: Peer comparison feedback |
| Individual Audit and Peer Comparison | Experimental | Clinicians will receive individual audit feedback informing them of their performance and peer comparison feedback informing them of how their performance compares to their peers. Receives: Behavioral: Individual audit feedback; Behavioral: Peer comparison feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean number of pills per opioid prescription
The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.
Measured: Six months
Secondary outcomes (1)
Change in proportion of patient visits with an opioid prescription
The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start3 Sep 2019
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Donaghue Medical Research Foundation, Sutter Health
- Responsible party
- Sponsor
- Investigators
- Mitesh Patel, MD, MBA, MS, Principal investigator, University of PennsylvaniaAmol Navathe, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825549
- Sponsor's protocol ID
- 829269
- Acronym
- REDUCE
- Status last verified
- Mar 2020
- First submitted
- 17 Jan 2019
- Last updated
- 6 Mar 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
- ClinicalTrials.gov ID
- NCT03825549
- Acronym / sponsor ID
- REDUCE / 829269
- Conditions
- Acute Pain
- Keywords
- Opioids, Nudges, Emergency Medicine, Urgent Care, Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Donaghue Medical Research Foundation, Sutter Health
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 31 Jan 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.
In this study, the investigators will evaluate the effect of a health system initiative aiming to change clinician opioid prescribing behaviors using two behavioral economic interventions - individual audit feedback and peer comparison feedback of clinicians.
Detailed description
Opioid-related abuse and overdose represent a growing national epidemic in the United States. Clinician practice patterns play an important role: opioid prescriptions impact the likelihood that patients will misuse or become dependent on these medications, with longer prescriptions leading to greater sustained use. In this study, we will evaluate a Sutter Health System quality improvement initiative using monthly individual audit feedback and/or monthly peer comparison feedback to clinicians to change opioid prescribing patterns. In partnership with Sutter Health System, this will be conducted using randomization to evaluate its effect. We will also conduct a process evaluation to understand factors associated with better or worse performance at the clinician level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Individual Audit | Experimental | Behavioral: Individual audit feedbackClinicians will receive individual audit feedback informing them of their performance. |
| Peer Comparison | Experimental | Behavioral: Peer comparison feedbackClinicians will receive peer comparison feedback informing them of how their performance compares to their peers. |
| Individual Audit and Peer Comparison | Experimental | Behavioral: Individual audit feedback, Behavioral: Peer comparison feedbackClinicians will receive individual audit feedback informing them of their performance and peer comparison feedback informing them of how their performance compares to their peers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinicians
- 1. Practiced primarily at participating emergency department or urgent care center
- Patients
Key exclusion criteria (6 listed)
- Clinicians
- Patients
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 |
|---|---|---|
| Individual audit feedbackPractice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher. | Behavioural | Individual Audit, Individual Audit and Peer Comparison |
| Peer comparison feedbackPractice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a "low prescriber." | Behavioural | Individual Audit and Peer Comparison, Peer Comparison |
Primary outcome
Change in the mean number of pills per opioid prescription
Time frame: Six months
The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.
1 secondary outcome
Change in proportion of patient visits with an opioid prescription
Time frame: Six 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 6 Mar 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.
Mitesh Patel, MD, MBA, MS principal investigator
University of Pennsylvania
Amol Navathe, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual audit feedback and Peer comparison feedback in people with Acute Pain, run by University of Pennsylvania 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 5 inclusion and 6 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 6 Mar 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 the mean number of pills per opioid prescription (time frame: Six months). 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 6 Mar 2020.