Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing

• ClinicalTrials.gov Identifier: NCT04776928
• Recruitment Status: Not yet recruiting
• First Posted: March 2, 2021
• Last Update Posted: February 2, 2022
• Sponsor: University of Michigan
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Jennifer Waljee, University of Michigan

Study Description

Brief 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 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 (112 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 surgeons receiving the provider-level push notifications in two waves at least three months apart. For the first wave 112 surgeons will be approached. At this time the number of surgeons belonging to the second wave is yet to be determined. MSQC sites that sign the Exhibit B-1 form after the study start date will be eligible for participation in the second wave.

Condition or disease	Intervention/treatment	Phase
Opioid Prescribing	Behavioral: Push reports	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 217 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing - Aim 3 Phase 1
• Estimated Study Start Date: February 1, 2022
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: March 31, 2022

Arms and Interventions

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.	Behavioral: Push reports; 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. Following receipt of the push report surgeons will also be invited to participate in a qualitative interview. The purpose of this interview is to learn about surgeons' preferences and experiences with the push reports.
No Intervention: No intervention; Sites who did not sign Exhibit B-1.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: Heather Lipkovich; 734-764-6745; hlipkovi@med.umich.edu

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Contact: Heather Lipkovich 734-764-6745 hlipkovi@med.umich.edu

Sponsors and Collaborators

University of Michigan

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Jennifer F Waljee, MD; University of Michigan

More Information

• Responsible Party: Jennifer Waljee, Associate Professor of Surgery and Associate Professor of Orthopaedic Surgery, University of Michigan
• ClinicalTrials.gov Identifier: NCT04776928
• Other Study ID Numbers: HUM00186352; 5R01DA042859-04 ( U.S. NIH Grant/Contract )
• First Posted: March 2, 2021
• Last Update Posted: February 2, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Waljee, University of Michigan:

Surgery