NCT04776928

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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

March 17, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

February 25, 2021

Results QC Date

August 21, 2023

Last Update Submit

November 16, 2023

Conditions

Keywords

Surgery

Outcome Measures

Primary Outcomes (1)

  • Change in Opioid Prescribed Following the Intervention

    Oral morphine equivalents prescribed adjusted for surgery type as reported through MSQC data.

    up to 5 months from enrollment

Study Arms (2)

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.

Behavioral: Push reports

No intervention

NO INTERVENTION

Sites who did not sign Exhibit B-1.

Interventions

Push reportsBEHAVIORAL

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.

Provider-level push report notifications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Surgeons not identified in the MSQC data as having a valid National Provider Identifier (NPI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

Title
Jennifer Waljee
Organization
University of Michigan

Study Officials

  • Jennifer F Waljee, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery and Associate Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 2, 2021

Study Start

March 17, 2022

Primary Completion

August 17, 2022

Study Completion

August 17, 2022

Last Updated

November 21, 2023

Results First Posted

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations