- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04776928
Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing
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.
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Surgeons not identified in the MSQC data as having a valid National Provider Identifier (NPI)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Provider-level push report notifications
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.
|
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. |
No Intervention: No intervention
Sites who did not sign Exhibit B-1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 5 months from enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer F Waljee, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HUM00186352
- 5R01DA042859-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opioid Prescribing
-
University of MichiganThe Benter FoundationActive, not recruitingOpioid PrescribingUnited States
-
Vanderbilt University Medical CenterNational Institute on Aging (NIA)CompletedSurgical Procedure, Unspecified | Opioid PrescribingUnited States
-
University of Massachusetts, WorcesterUMass Memorial Health CareCompletedDelivery of Health Care | Analgesics, Opioid | Practice Guidelines as Topic | Drug Prescribing | Over Prescribing | Prescribing Patterns, Physician | Practice Management, MedicalUnited States
-
Northwestern UniversityCompletedPain Management | Opioid Prescribing | Postpartum PainUnited States
-
University of MichiganMichigan Department of Health and Human ServicesCompletedPain Management | Opioid PrescribingUnited States
-
RANDUniversity of California, Los Angeles; University of Michigan; University of... and other collaboratorsActive, not recruiting
-
UConn HealthFood and Drug Administration (FDA); University of ConnecticutRecruitingOpioid Use | Opioid Prescribing, Dispensing, and Patient UseUnited States
-
Yale UniversityFood and Drug Administration (FDA)CompletedOpioid Use | Opioid PrescribingUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)Completed
-
Centre Hospitalier Universitaire VaudoisUnknownInappropriate PrescribingSwitzerland
Clinical Trials on Push reports
-
Duke UniversityNorthern Piedmont Carolina Community Care Partners; North Carolina Division...CompletedCoronary Artery Disease | Hypertension | Diabetes | Asthma | Congestive Heart FailureUnited States
-
Phedra DoddsSwansea University; The Health FoundationCompletedElectronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports (ELIJAH)Inflammatory Bowel DiseasesUnited Kingdom
-
University of AlbertaAlberta Innovates Health Solutions; Institute of Health Economics, CanadaRecruitingCritical Illness | Acute Kidney FailureCanada
-
University of AlbertaAlberta Innovates Health SolutionsRecruitingAcute Renal InjuryCanada
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI)CompletedLung Diseases | AsthmaUnited States
-
University of MichiganCompletedSubstance UseUnited States
-
University Hospital, MontpellierInserm U1061 : NeuropsychiatryCompleted
-
Unity Health TorontoActive, not recruitingGastrointestinal Diseases | Obscure Gastrointestinal Bleeding | Gastrointestinal Bleed | Angiodysplasia IntestineCanada
-
African Population and Health Research CenterAmsterdam Institute for Global Health and Development; PharmAccessUnknown
-
Roswell Park Cancer InstituteActive, not recruitingMedication AdherenceUnited States