500 Participants NeededMy employer runs this trial

De-Implementation Strategy for Mammogram Overuse in Aging Adults

PT
AG
Overseen ByAnita G Karr, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
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 tests a new approach to reduce unnecessary mammograms in women aged 75 and older. Researchers aim to determine if changing how doctors and patients perceive and use mammograms can decrease unneeded screenings. The trial includes two groups: one receives standard care with some improvements, while the other receives a comprehensive multilevel de-implementation strategy to reduce overuse. Women who speak English or Spanish, are 75 or older, and haven't had a mammogram in the last 6 months but did in the 7-18 months prior, might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to research that could improve healthcare practices for older women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing mammogram overuse in older women, so it's best to discuss your medications with the trial team or your doctor.

What prior data suggests that this multilevel de-implementation strategy is safe for reducing mammogram overuse?

Research shows that the strategy under study aims to reduce unnecessary screening mammograms in women aged 75 and older. This approach changes behaviors and practices at various levels, including patients and healthcare providers, to improve mammogram decision-making.

Regarding safety, this strategy does not involve new drugs or medical procedures, so it poses no direct risks to physical health. Instead, it focuses on healthcare decision-making, which generally poses minimal risk to participants. No specific data on negative effects related to this strategy exist, as it primarily involves communication and decision-making processes. Overall, it is considered safe for those involved.12345

Why are researchers excited about this trial?

Researchers are excited about the Multilevel De-Implementation Strategy because it aims to tackle the issue of mammogram overuse in older adults by focusing on reducing unnecessary screenings. Unlike the usual care approach, which often includes routine mammograms without considering individual patient needs, this strategy incorporates both provider and patient education to tailor decisions more closely to each patient's health status. By engaging at multiple levels—organizational, provider, and patient—this approach has the potential to optimize healthcare resources and improve patient outcomes by avoiding unnecessary procedures. This strategy could lead to more personalized care and reduce the risks and costs associated with over-screening.

What evidence suggests that this multilevel de-implementation strategy is effective for reducing mammogram overuse in aging adults?

This trial will compare two approaches to reduce mammogram overuse in aging adults. The Multilevel De-Implementation Strategy, used in one arm of this trial, involves both doctors and patients to help reduce unnecessary mammograms. Studies have shown that excessive mammograms in older women can lead to unnecessary stress and medical treatments. Surveys indicate that many older women feel pressured to have yearly mammograms due to their doctors' recommendations, even when the benefits at their age might be unclear. By addressing these issues, this strategy aims to reduce unwanted mammograms, improving care without risking health. Early studies suggest this approach could effectively balance the pros and cons of screening in older adults. Meanwhile, the other arm of this trial will receive Enhanced Usual Care, which includes organizational-level components of the strategy.13467

Who Is on the Research Team?

PT

Parisa Tehranifar, DrPH

Principal Investigator

Columbia University

RC

Rachel C Shelton, ScD, MPH

Principal Investigator

Columbia University

NM

Nathalie Moise, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for women aged 75 or older who speak English or Spanish, have a primary care visit scheduled in the next 2-4 weeks, and had a mammogram between 7-18 months ago but not in the last 6 months.

Inclusion Criteria

I am 75 years old or older.
Patient level criteria
I am a woman who speaks English or Spanish.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of multilevel de-implementation strategy at patient, provider, and organizational levels

18 months
Regular visits as per primary care schedule

Follow-up

Participants are monitored for changes in mammography screening practices and provider ordering behavior

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Multilevel De-Implementation Strategy

Trial Overview

The study compares a new strategy to reduce unnecessary mammograms with usual care. Providers are randomly assigned to use either the multilevel de-implementation approach or enhanced usual care. Some strategies are used for all participants.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Multilevel De-Implementation StrategyExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

A mixed-methods study of multi-level factors influencing ... - PMC

Survey findings show that 87.2% of older women believe it is important to plan for an annual mammogram, 80.8% received a provider recommendation, and 78.9% ...

Use of a Discrete Choice Experiment to Inform De ...

A mixed-methods study of multi-level factors influencing mammography overuse: implications for de-implementation. Implement Sci Commun. 2021 ...

De-Implementation Strategy for Mammogram Overuse in ...

This project aims to advance methodological and theoretical approaches for developing, selecting, refining, and piloting a multilevel ...

Multilevel Predictive Study of Breast Cancer Screening ...

Results The study identified women in minority groups (aOR: 0.659, P < .01) have decreased odds of being screened for breast cancer, with the ...

Collaborative Modeling to Compare Different Breast ...

Benefits of DBT were comparable with those of digital mammography but resulted in fewer false-positive recalls and similar benign biopsies.

A Multi-Level Strategy for De-implementing Mammography ...

This project aims to advance methodological and theoretical approaches for developing, selecting, refining, and piloting a multilevel de-implementation ...

Division of Cancer Control & Population Sciences - Grant Details

Our preliminary research identified multi-level barriers and facilitators to de-implementation of mammography overuse among older women at the organizational ( ...