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

NCT ID: NCT06934564

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Lumpectomy Laparoscopic Cholecystectomy Inguinal Hernia Repair

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Using a stepped wedge design, sixteen Michigan Value Collaborative (MVC)/Michigan Surgical Quality Collaborative (MSQC) sites in Michigan will implement a multi-level, multi-component de-implementation strategy and collect information on the use of unnecessary preoperative testing.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Active de-Implementation

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Active de-Implementation

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Active de-Implementation

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Active de-Implementation

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Active de-Implementation

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Active de-Implementation

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Blue Cross Blue Shield of Michigan Foundation

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lesly Ann Dossett

Research Professor of Cancer Quality Improvement

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lesly Dossett, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Hari Nathan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan and other Michigan Surgical Quality Collaborative sites

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dana Greene Jr., MPH

Role: CONTACT

(313)-670-0408

Valerie Gavrila

Role: CONTACT

734-232-9961

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dana Greene Jr., MPH

Role: primary

(313)-670-0408

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HS029306

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

HUM00261786

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prehab for Surgery
NCT04155346 ACTIVE_NOT_RECRUITING NA
Intelligent Operating Room
NCT03955614 UNKNOWN NA
Preoperative Survey
NCT05653154 COMPLETED