Breast LumpectomyNCT06934564
De-Implementation of Low-value Testing in Patients Undergoing Low-Risk Surgery
A study testing Active de-Implementation in people with Breast Lumpectomy and Laparoscopic Cholecystectomy, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Lumpectomy, Laparoscopic Cholecystectomy, Inguinal Hernia Repair
- What is being tested?
- Active de-Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 30% of testing rates on at least one of the three index procedures (breast lumpectomy, laparoscopic cholecystectomy, and inguinal hernia repair)
Who cannot join
- none
- Surgical participants must be over 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan and other Michigan Surgical Quality Collaborative sites
Ann Arbor, Michigan, 48109
Dana Greene Jr., MPH, (313)-670-0408, greenejr@med.umich.edu
Lesly Dossett, MD, MPH
About this study
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.
- Being tested
- Active de-Implementation
- Keywords
- Preoperative testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active de-ImplementationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Active de-Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Example related operations: laparoscopic hysterectomy, knee arthroscopy
Measured: Up to year 2, quarter 4
30-day episode-based spending
Using the MVC claims data for total spending amounts
Measured: Up to Year 2, Quarter 2
Number of unnecessary preoperative testing before low-risk surgery at trial sites
Example related operations: laparoscopic hysterectomy, knee arthroscopy
Measured: Up to year 2, quarter 4
Number of intraoperative complications
Examples: myocardial infarction, stroke
Measured: Up to year 2, quarter 4
Number of same-day case cancellations
Measured: Up to year 2, quarter 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast LumpectomyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Hari Nathan, University of Michigan
- Investigators
- Lesly Dossett, MD, MPH, Principal investigator, University of MichiganHari Nathan, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934564
- Sponsor's protocol ID
- HUM00261786
- Other IDs
- R01HS029306
- Status last verified
- May 2026
- First submitted
- 11 Apr 2025
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-Implementation of Low-value Testing in Patients Undergoing Low-Risk Surgery
- ClinicalTrials.gov ID
- NCT06934564
- Acronym / sponsor ID
- HUM00261786
- Keywords
- Preoperative testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Blue Cross Blue Shield of Michigan Foundation
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wave 1 | Experimental | Behavioral: Active de-ImplementationEach wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 1 Quarter 2 |
| Wave 2 | Experimental | Behavioral: Active de-ImplementationEach wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 1 Quarter 3 |
| Wave 3 | Experimental | Behavioral: Active de-ImplementationEach wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 1 Quarter 4 |
| Wave 4 | Experimental | Behavioral: Active de-ImplementationEach wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 2 Quarter 1 |
| Wave 5 | Experimental | Behavioral: Active de-ImplementationEach wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 2 Quarter 2 |
| Wave 6 | Experimental | Behavioral: Active de-ImplementationEach wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 2 Quarter 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 30% of testing rates on at least one of the three index procedures (breast lumpectomy, laparoscopic cholecystectomy, and inguinal hernia repair)
Key exclusion criteria (2 listed)
- none
- Surgical participants must be over 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active de-ImplementationDuring 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. | Behavioural | Wave 1, Wave 2, Wave 3, Wave 4, Wave 5, Wave 6 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lesly Dossett, MD, MPH principal investigator
University of Michigan
Hari Nathan, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active de-Implementation in people with Breast Lumpectomy and Laparoscopic Cholecystectomy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Greene Jr., MPH ((313)-670-0408, greenejr@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.