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

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Cholecystectomy; Inguinal Hernia Repair; Breast Lumpectomy
• Intervention / Treatment: Behavioral: Active de-Implementation

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Greene Jr., MPH; Phone Number: (313)-670-0408; Email: greenejr@med.umich.edu
• Study Contact Backup: Name: Valerie Gavrila; Phone Number: 734-232-9961; Email: gavrilva@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan and other Michigan Surgical Quality Collaborative sites
      • Contact: Dana Greene Jr., MPH; Phone Number: (313)-670-0408; Email: greenejr@med.umich.edu
      • Principal Investigator: Lesly Dossett, MD, MPH
      • Sub-Investigator: Hari Nathan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Site

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wave 1; Each wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 1 Quarter 2	Behavioral: Active de-Implementation; During active de-implementation (3 months), the local team will distribute the strategy components (i.e., clinician education, decision support, evaluation, consensus building around perioperative testing pathways, facility-specific feedback, and a pay-for-performance incentive) at the local site.
Experimental: Wave 2; Each wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 1 Quarter 3	Behavioral: Active de-Implementation; During active de-implementation (3 months), the local team will distribute the strategy components (i.e., clinician education, decision support, evaluation, consensus building around perioperative testing pathways, facility-specific feedback, and a pay-for-performance incentive) at the local site.
Experimental: Wave 3; Each wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 1 Quarter 4	Behavioral: Active de-Implementation; During active de-implementation (3 months), the local team will distribute the strategy components (i.e., clinician education, decision support, evaluation, consensus building around perioperative testing pathways, facility-specific feedback, and a pay-for-performance incentive) at the local site.
Experimental: Wave 4; Each wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 2 Quarter 1	Behavioral: Active de-Implementation; During active de-implementation (3 months), the local team will distribute the strategy components (i.e., clinician education, decision support, evaluation, consensus building around perioperative testing pathways, facility-specific feedback, and a pay-for-performance incentive) at the local site.
Experimental: Wave 5; Each wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 2 Quarter 2	Behavioral: Active de-Implementation; During active de-implementation (3 months), the local team will distribute the strategy components (i.e., clinician education, decision support, evaluation, consensus building around perioperative testing pathways, facility-specific feedback, and a pay-for-performance incentive) at the local site.
Experimental: Wave 6; Each wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 2 Quarter 3	Behavioral: Active de-Implementation; During active de-implementation (3 months), the local team will distribute the strategy components (i.e., clinician education, decision support, evaluation, consensus building around perioperative testing pathways, facility-specific feedback, and a pay-for-performance incentive) at the local site.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Blue Cross Blue Shield of Michigan Foundation
• Investigators: Principal Investigator: Lesly Dossett, MD, MPH, University of Michigan; Principal Investigator: Hari Nathan, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Preoperative testing
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Hernia, Inguinal
• Other Study ID Numbers: HUM00261786; R01HS029306 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No