Reducing Unnecessary Testing for Low-Risk Surgeries

Overseen By Dana Greene Jr., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Under 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Active de-Implementation for reducing unnecessary testing for low-risk surgeries?

A systematic review found that various interventions, such as education and system-based changes, effectively reduced unnecessary test utilization, which suggests that similar strategies could support the Active de-Implementation treatment in reducing unnecessary testing for low-risk surgeries. ^{1 2 3 4 5}

Is the approach of reducing unnecessary testing for low-risk surgeries safe for humans?

The research articles provided do not contain specific safety data about reducing unnecessary testing for low-risk surgeries or Active de-Implementation. They focus on methods for detecting adverse events in hospitals, which is related to patient safety but not directly about the safety of this specific approach. ^{6 7 8 9 10}

How is the treatment Active de-Implementation different from other treatments for reducing unnecessary testing before low-risk surgeries?

Active de-Implementation is unique because it focuses on reducing unnecessary preoperative tests by changing healthcare practices and behaviors, rather than using medications or physical interventions. It aims to stop the routine use of tests that are not needed, which can help prevent unnecessary costs and potential harm from follow-up procedures. ^{1 3 4 11 12}

What is the purpose of this trial?

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.

Research Team

Lesly Dossett, MD, MPH

Principal Investigator

University of Michigan

Hari Nathan, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for patients scheduled for low-risk surgeries like inguinal hernia repair, breast lump removal, or laparoscopic cholecystectomy. It's focused on reducing unnecessary preoperative tests using a new strategy.

Inclusion Criteria

Over 30% of my surgeries were breast lumpectomies, gallbladder removals, or hernia repairs.

Exclusion Criteria

Not applicable.

Timeline

Preparation

Preparation phase includes usual care and preparation activities before the intervention

8 weeks

Active De-implementation Interventions

Implementation of multi-level, multi-component strategies to reduce unnecessary preoperative testing

Varies by wave

Sustainment

Phase to maintain the reduction in unnecessary testing after active interventions

Follow-up

Participants are monitored for the number of tests within 30 days of surgery and other secondary outcomes

30 days

Treatment Details

Interventions

• Active de-Implementation

Trial Overview The study is testing a 'de-implementation' approach to cut down on unneeded pre-surgery tests. This includes educating doctors, providing decision aids, reviewing performance data, and offering financial incentives at certain Michigan medical sites.

Participant Groups

Group I: Wave 6 Experimental Treatment 1 Intervention

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 II: Wave 5 Experimental Treatment 1 Intervention

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 III: Wave 4 Experimental Treatment 1 Intervention

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 IV: Wave 3 Experimental Treatment 1 Intervention

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 V: Wave 2 Experimental Treatment 1 Intervention

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 VI: Wave 1 Experimental Treatment 1 Intervention

Each wave will include usual care, preparation (8 weeks before intervention), active de-implementation interventions, and sustainment phases. Intervention is Year 1 Quarter 2

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Blue Cross Blue Shield of Michigan Foundation

Collaborator

Trials

28

Recruited

51,200+

Findings from Research

A study involving 30 healthcare professionals identified that unnecessary preoperative testing before low-risk surgeries is influenced by shared values prioritizing patient safety, knowledge gaps about testing guidelines, and communication breakdowns among interdisciplinary teams.

Addressing these knowledge gaps and improving communication through consensus guidelines could help reduce unnecessary testing and align practices with evidence-based recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targets for De-implementation of Unnecessary Testing Before Low-Risk Surgery: A Qualitative Study. Richburg, CE., Pesavento, CM., Vastardis, A., et al.[2023]

A study comparing three methods of detecting adverse medical events in hospitalized patients revealed that voluntary reporting and the Patient Safety Indicators missed 90% of adverse events, highlighting their ineffectiveness.

In contrast, the Global Trigger Tool identified at least ten times more serious adverse events, indicating that one-third of hospital admissions involved adverse events, which suggests a significant underestimation of patient safety issues in the US healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured. Classen, DC., Resar, R., Griffin, F., et al.[2022]

The Trigger Tool (TT) identified 89.9% of adverse events (AEs) in patients undergoing general surgery, compared to only 28.48% detected by the Minimum Basic Data Set (MBDS), highlighting TT's superior effectiveness in AE detection.

The study found a high prevalence of AEs at 36.8% among surgical patients, indicating that the risk of complications in general surgery may be greater than previously estimated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery]. Pérez Zapata, AI., Gutiérrez Samaniego, M., Rodríguez Cuéllar, E., et al.[2018]

In a study of 906,902 patients undergoing low-risk surgeries in Ontario, 30.1% had preoperative blood work, with significant variation in testing rates across institutions (0.0% to 98.1%).

Factors such as atrial fibrillation, preoperative medical consultations, previous mitral valve replacements, and liver disease were strong predictors for preoperative testing, indicating that clinical history significantly influences testing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Laboratory Investigations: Rates and Variability Prior to Low-risk Surgical Procedures. Kirkham, KR., Wijeysundera, DN., Pendrith, C., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Resident-Sensitive Processes of Care: Impact of Surgical Residents on Inpatient Testing. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Targets for De-implementation of Unnecessary Testing Before Low-Risk Surgery: A Qualitative Study. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Preoperative testing before low-risk surgical procedures. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Choosing Wisely Campaign for Nursing. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Measurement of adverse events using "incidence flagged" diagnosis codes. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a mandatory quality assurance data capture in anesthesia: a secure electronic system to capture quality assurance information linked to an automated anesthesia record. [2019]

9. Spain pubmed.ncbi.nlm.nih.gov

[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery]. [2018]

10. Austria pubmed.ncbi.nlm.nih.gov

A complication conference for internal quality control at the Neurosurgical Department of the University of Heidelberg. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing the Drivers of Medical Test Overuse and Cascades: User-Centered Design to Improve Patient-Doctor Communication. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Preoperative Laboratory Investigations: Rates and Variability Prior to Low-risk Surgical Procedures. [2022]