Opioid PrescribingNCT04776928
Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing
A study testing Push reports in people with Opioid Prescribing, run by University of Michigan at 1 site in United States.
Trial summary
The objective of this project is to leverage the Michigan Surgical Quality Collaborative's (MSQC) existing network and surgeon performance feedback platform to improve opioid prescribing practices for surgeons within the network found to be prescribing in a manner discordant with published guidelines and to inform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Prescribing
- What is being tested?
- Push reports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2022to 17 Aug 2022
- 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
- Surgeons already participating in and sharing data with the Michigan Surgical Quality Collaborative (MSQC) who perform procedures of interest
- Surgeons within MSQC who have median prescribing > 1 pill equivalents over the published recommendation
- Surgeons within MSQC who perform surgeries at a hospital that have agreed to participate in this research
Who cannot join
- Surgeons not identified in the MSQC data as having a valid National Provider Identifier (NPI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing - Aim 3 Phase 1
The objective of this project is to leverage the Michigan Surgical Quality Collaborative's (MSQC) existing network and surgeon performance feedback platform to improve opioid prescribing practices for surgeons within the network found to be prescribing in a manner discordant with published guidelines and to inform best practices for future surgical quality improvement initiatives.
The study is being completed to learn more about the effectiveness, feasibility, and acceptability and that the goal is both to evaluate how effective this intervention and mechanism are for changing surgeon opioid prescribing behavior and to inform best practices for future quality initiatives. The study hypothesizes that provider-level feedback will allow clinicians to tailor postoperative prescribing more closely to patient consumption, and reduce excess postoperative prescribing.
Read more
The cohort of surgeons which have been identified as outliers by the Michigan Surgical Quality Collaborative (MSQC) will be be invited to participate in this trial. The study team will send surgeons belonging to sites that signed the Exhibit B-1 form the provider-level push notifications (98 participants). In this study de-identified prescribing data will also be analyzed for sites that do not sign the Exhibit B-1 form (105 participants).
The study team will approach 98 surgeons receiving the provider-level push notifications in one wave.
- Conditions
- Opioid Prescribing
- Being tested
- Push reports
- Keywords
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Push reportsBehavioural
Surgeons in the experimental arm will receive provider-level push report notifications through an email displaying their personal prescribing performance compared to Michigan Opioid Prescribing Engagement Network (OPEN) prescribing guidelines and their de-identified peers.
The push report will also include a link to the secure MSQC data platform that displays more information about the case so the surgeon can further investigate prescribing information. The email will also contain contact information for the study team so as to help any surgeons troubleshoot, learn more, request to stop receiving reports, etc.
| Study group | Role | What they receive |
|---|---|---|
| Provider-level push report notifications | Experimental | Push reports will be sent via using a secure email client. The email will be sent to the email address provided to the study team by the surgeon or site. Receives: Behavioral: Push reports |
| No intervention | No intervention | Sites who did not sign Exhibit B-1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Opioid Prescribed Following the Intervention
Oral morphine equivalents prescribed adjusted for surgery type as reported through MSQC data.
Measured: up to 5 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start17 Mar 2022
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
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 Opioid PrescribingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jennifer Waljee, University of Michigan
- Investigators
- Jennifer F Waljee, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776928
- Sponsor's protocol ID
- HUM00186352
- Other IDs
- 5R01DA042859-04
- Status last verified
- Nov 2023
- First submitted
- 25 Feb 2021
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing - Aim 3 Phase 1
- ClinicalTrials.gov ID
- NCT04776928
- Acronym / sponsor ID
- HUM00186352
- Conditions
- Opioid Prescribing
- Keywords
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to leverage the Michigan Surgical Quality Collaborative's (MSQC) existing network and surgeon performance feedback platform to improve opioid prescribing practices for surgeons within the network found to be prescribing in a manner discordant with published guidelines and to inform best practices for future surgical quality improvement initiatives.
The study is being completed to learn more about the effectiveness, feasibility, and acceptability and that the goal is both to evaluate how effective this intervention and mechanism are for changing surgeon opioid prescribing behavior and to inform best practices for future quality initiatives. The study hypothesizes that provider-level feedback will allow clinicians to tailor postoperative prescribing more closely to patient consumption, and reduce excess postoperative prescribing.
The cohort of surgeons which have been identified as outliers by the Michigan Surgical Quality Collaborative (MSQC) will be be invited to participate in this trial. The study team will send surgeons belonging to sites that signed the Exhibit B-1 form the provider-level push notifications (98 participants). In this study de-identified prescribing data will also be analyzed for sites that do not sign the Exhibit B-1 form (105 participants).
The study team will approach 98 surgeons receiving the provider-level push notifications in one wave.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider-level push report notifications | Experimental | Behavioral: Push reportsPush reports will be sent via using a secure email client. The email will be sent to the email address provided to the study team by the surgeon or site. |
| No intervention | No intervention | –Sites who did not sign Exhibit B-1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgeons already participating in and sharing data with the Michigan Surgical Quality Collaborative (MSQC) who perform procedures of interest
- Surgeons within MSQC who have median prescribing > 1 pill equivalents over the published recommendation
- Surgeons within MSQC who perform surgeries at a hospital that have agreed to participate in this research
Key exclusion criteria (1 listed)
- Surgeons not identified in the MSQC data as having a valid National Provider Identifier (NPI)
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 |
|---|---|---|
| Push reportsSurgeons in the experimental arm will receive provider-level push report notifications through an email displaying their personal prescribing performance compared to Michigan Opioid Prescribing Engagement Network (OPEN) prescribing guidelines and their de-identified peers. The push report will also include a link to the secure MSQC data platform that displays more information about the case so the surgeon can further investigate prescribing information. The email will also contain contact information for the study team so as to help any surgeons troubleshoot, learn more, request to stop receiving reports, etc. | Behavioural | Provider-level push report notifications |
Primary outcome
Change in Opioid Prescribed Following the Intervention
Time frame: up to 5 months from enrollment
Oral morphine equivalents prescribed adjusted for surgery type as reported through MSQC data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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.
Jennifer F Waljee, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Push reports in people with Opioid Prescribing, run by University of Michigan 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 3 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 21 Nov 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 21 Nov 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?
Change in Opioid Prescribed Following the Intervention (time frame: up to 5 months from enrollment). 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 21 Nov 2023.