Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT06934564

Conditions

Breast Lumpectomy

Laparoscopic Cholecystectomy

Inguinal Hernia Repair

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active de-Implementation

Study Details

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.

Conditions

Breast Lumpectomy

Laparoscopic Cholecystectomy

Inguinal Hernia Repair

Study ID

NCT06934564

Start date

Apr 1, 2025

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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

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

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

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

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

Interventions

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.

Primary outcome measure

  • Number of tests within 30 days of surgery not associated with an emergency department visit [ Time Frame: Within 30 days of surgery ]

Central Contacts and Locations

Central contacts

Dana Greene Jr., MPH

(313)-670-0408greenejr@med.umich.edu

Valerie Gavrila

734-232-9961gavrilva@umich.edu

Locations

University of Michigan and other Michigan Surgical Quality Collaborative sites

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Dana Greene Jr., MPH

(313)-670-0408greenejr@med.umich.edu

Principal Investigator:

Lesly Dossett, MD, MPH

More Information

Sponsor

University of Michigan

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Preoperative testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-08.