De-Implementation of Low-value Testing in Patients Undergoing Low-Risk Surgery

Not Applicable

Recruiting

• Conditions: Breast Lumpectomy; Laparoscopic Cholecystectomy; Inguinal Hernia Repair

• Registration Number: NCT06934564
• Lead Sponsor: University of Michigan

Brief Summary

This trial aims to evaluate the effectiveness of a multi-level, multi-component de-implementation strategy to reduce unnecessary preoperative testing. Sixteen Michigan Value Collaborative (MVC)/Michigan Surgical Quality Collaborative (MSQC) sites in Michigan will implement several tools that have been proven to reduce unnecessary testing at a single site, including clinician education, a decision aid, audit and feedback on performance, and a pay-for-performance incentive. The researchers believe that, through the use of these strategies, there will be a significant reduction in unnecessary preoperative testing during the intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Over 30% of testing rates on at least one of the three index procedures (breast lumpectomy, laparoscopic cholecystectomy, and inguinal hernia repair)

Exclusion Criteria

• none

Surgical participants must be over 18 years old.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of tests within 30 days of surgery not associated with an emergency department visit	Within 30 days of surgery	Only tests relating to three index procedures; breast lumpectomy, laparoscopic cholecystectomy, and inguinal hernia repair; Data collected using MVC/MSQC database

Secondary Outcome Measures

Name	Time	Method
Number of unnecessary preoperative testing before low-risk surgery at MVC/MSQC sites not participating in the trial	Up to year 2, quarter 4	Example related operations: laparoscopic hysterectomy, knee arthroscopy
30-day episode-based spending	Up to Year 2, Quarter 2	Using the MVC claims data for total spending amounts
Number of unnecessary preoperative testing before low-risk surgery at trial sites	Up to year 2, quarter 4	Example related operations: laparoscopic hysterectomy, knee arthroscopy
Number of intraoperative complications	Up to year 2, quarter 4	Examples: myocardial infarction, stroke
Number of same-day case cancellations	Up to year 2, quarter 4

Trial Locations

Locations (1)

University of Michigan and other Michigan Surgical Quality Collaborative sites; 🇺🇸 Ann Arbor, Michigan, United States