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

May 5, 2026 updated by: Hari Nathan, University of Michigan
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan and other Michigan Surgical Quality Collaborative sites
        • Contact:
        • Principal Investigator:
          • Lesly Dossett, MD, MPH
        • Sub-Investigator:
          • Hari Nathan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
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
Time Frame: Up to year 2, quarter 4
Example related operations: laparoscopic hysterectomy, knee arthroscopy
Up to year 2, quarter 4
30-day episode-based spending
Time Frame: Up to Year 2, Quarter 2
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
Time Frame: Up to year 2, quarter 4
Example related operations: laparoscopic hysterectomy, knee arthroscopy
Up to year 2, quarter 4
Number of intraoperative complications
Time Frame: Up to year 2, quarter 4
Examples: myocardial infarction, stroke
Up to year 2, quarter 4
Number of same-day case cancellations
Time Frame: Up to year 2, quarter 4
Up to year 2, quarter 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

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.

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