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Recruiting NCT06934564

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

No phase Interventional Breast Lumpectomy Laparoscopic Cholecystectomy Inguinal Hernia Repair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active de-Implementation.
Who it may be relevant to
Registry conditions: Breast Lumpectomy, Laparoscopic Cholecystectomy, Inguinal Hernia Repair. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Number of tests within 30 days of surgery not associated with an emergency department visit [Time frame: Within 30 days of surgery]
Secondary outcome measures (5)
  • 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]
  • 30-day episode-based spending [Time frame: 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]
  • Number of intraoperative complications [Time frame: Up to year 2, quarter 4]
  • Number of same-day case cancellations [Time frame: Up to year 2, quarter 4]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Michigan and other Michigan Surgical Quality Collaborative sites — Ann Arbor

Identifiers

NCT: NCT06934564 · HUM00261786 · R01HS029306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗