16 Participants Needed

Reducing Unnecessary Testing for Low-Risk Surgeries

VG
DG
Overseen ByDana Greene Jr., MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on reducing unnecessary tests before low-risk surgeries such as breast lumpectomies, laparoscopic gallbladder removal, and hernia repairs. The researchers aim to evaluate a new strategy, called Active de-Implementation, which includes tools like clinician education and performance feedback to effectively reduce these tests. Surgical sites with a history of conducting over 30% unnecessary tests for these procedures will participate. The trial will proceed in phases, each including preparation, active interventions, and follow-up to assess the sustainability of changes. As an unphased trial, this study provides a unique opportunity to enhance surgical practices and patient care.

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 prior data suggests that this de-implementation strategy is safe?

Research shows that the strategies tested in this study are generally safe for participants. Studies have found that altering procedures and reducing unnecessary medical tests can significantly decrease these tests without harming patients. For example, one study reported a 19.6% reduction in unnecessary tests. Importantly, there were no major negative effects on the patient-doctor relationship, suggesting these changes are well-accepted. Thus, while the trial aims to reduce unnecessary testing, existing evidence indicates it does not pose risks to patient safety.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on reducing unnecessary testing for low-risk surgeries. Unlike traditional approaches that often involve extensive pre-surgery testing, this method aims to streamline care by actively de-implementing redundant procedures. By minimizing unnecessary tests, the approach has the potential to enhance patient experience, reduce healthcare costs, and focus medical resources where they are truly needed. This innovative strategy could lead to more efficient surgical protocols and better patient outcomes.

What evidence suggests that this trial's de-implementation strategy could be effective in reducing unnecessary preoperative testing?

Research has shown that reducing unnecessary medical tests, such as those conducted before surgery, can significantly decrease their frequency. One study found a typical reduction of 19.6% in these low-value practices. This trial will implement active de-implementation strategies to achieve similar reductions by changing procedures and educating doctors. Importantly, these unnecessary tests do not improve patient health or prevent problems. Overall, strategies to reduce these tests are effective and safe for patients.26789

Who Is on the Research Team?

LD

Lesly Dossett, MD, MPH

Principal Investigator

University of Michigan

HN

Hari Nathan, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Wave 6Experimental Treatment1 Intervention
Group II: Wave 5Experimental Treatment1 Intervention
Group III: Wave 4Experimental Treatment1 Intervention
Group IV: Wave 3Experimental Treatment1 Intervention
Group V: Wave 2Experimental Treatment1 Intervention
Group VI: Wave 1Experimental Treatment1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
Preoperative Laboratory Investigations: Rates and Variability Prior to Low-risk Surgical Procedures.Kirkham, KR., Wijeysundera, DN., Pendrith, C., et al.[2022]
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.
'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]
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.
Targets for De-implementation of Unnecessary Testing Before Low-Risk Surgery: A Qualitative Study.Richburg, CE., Pesavento, CM., Vastardis, A., et al.[2023]

Citations

Provider perspectives on de-implementation strategies in ...This study offers a detailed examination of the level of adoption of de-implementation. The findings emphasize the need for sustainable maintenance strategies.
De-implementing Low Value Preoperative Care Wisely | ...Low value preoperative testing does not improve patient outcomes or reduce adverse events. Low value preoperative testing costs patients and healthcare ...
Effectiveness of de-implementation of low-value healthcare ...Infrastructure and workflow changes enabled a median relative reduction of 19.6% (IQR: 10.4โ€“36.1%) and a statistically significant reduction in ...
Effectiveness of de-implementation strategies for low-value ...This review offers insight into the intervention strategies, potential barriers, facilitators and consequences that may affect the de-implementation of low- ...
What are Effective Strategies to Reduce Low-Value Care? ...Most deimplementation strategies achieved a considerable reduction of low-value care. We found no signs that a particular type or number of interventions works ...
developing the evidence base to reduce low-value careThis paper describes the Choosing Wisely De-Implementation Framework (CWDIF), a novel framework that builds on previous work in the field of implementation ...
Does de-implementation of low-value care impact the patient ...In this vignette-based study, we observed minimal impact of LVC de-implementation on the patient-clinician relationship, although service-specific differences ...
Effectiveness of de-implementation strategies for low-value ...This review offers insight into the intervention strategies, potential barriers, facilitators and consequences that may affect the de-implementation of low- ...
Targets for De-implementation of Unnecessary Testing ...The goal of this study as to elicit determinants of unnecessary testing before low-risk surgery to inform de-implementation efforts.
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