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

NCT06934564 | Recruiting

• 2 other identifiers: HUM00261786R01HS029306
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Preoperative testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of unnecessary preoperative testing before low-risk surgery at MVC/MSQC sites not participating in the trial

  Up to year 2, quarter 4

• 30-day episode-based spending

  Up to Year 2, Quarter 2

• Number of unnecessary preoperative testing before low-risk surgery at trial sites

  Up to year 2, quarter 4

• Number of intraoperative complications

  Up to year 2, quarter 4

• Number of same-day case cancellations

  Up to year 2, quarter 4

Study Arms (6)

Wave 1

EXPERIMENTAL

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

Wave 2

EXPERIMENTAL

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

Wave 3

EXPERIMENTAL

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

Wave 4

EXPERIMENTAL

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

Wave 5

EXPERIMENTAL

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

Wave 6

EXPERIMENTAL

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

Interventions

Active de-Implementation 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 1; Wave 2; Wave 3; Wave 4; Wave 5; Wave 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none
• Surgical participants must be over 18 years old.

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (1)

University of Michigan and other Michigan Surgical Quality Collaborative sites

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Lesly Dossett, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Hari Nathan, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Greene Jr., MPH

CONTACT

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

Valerie Gavrila

CONTACT

734-232-9961; gavrilva@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Cancer Quality Improvement

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)