A Multi-Level Strategy for De-implementing Mammography Overuse Among Older Women

NCT07511621 | Recruiting

• 2 other identifiers: AAAT2119R01CA255382
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to advance methodological and theoretical approaches for developing, selecting, refining, and piloting a multilevel de-implementation strategy to reduce the overuse of screening mammography in women aged ≥75 years. Informed by an innovative participatory, stakeholder-driven innovation tournament and a discrete choice experiment, the research team identified, prioritized, and tailored a multilevel de-implementation strategy. The research team will conduct a cluster randomized controlled trial (at the provider level) to test the impact of the provider- and patient-level components of the multilevel strategy on screening mammography use, and secondarily, on provider referrals/orders for screening mammography. The organizational level components of the multilevel strategy will be implemented among all participants, not via random assignment.

Conditions

Mammography; Medical Overuse; Evidence-based Practice; Older Adults

Keywords

Mammography; Medical overuse; Implementation science; Aging; Women; Randomized controlled trial; Screening cessation; De-implementation

Outcome Measures

Primary Outcomes (1)

• Screening mammography overuse

  Screening mammography overuse will be defined as the percentage of patients eligible for this study who receive a screening mammogram within 24 months of their prior screening mammogram in the Enhanced Usual Care (EUC) vs. intervention arms.

  18 months

Secondary Outcomes (2)

• Provider mammography ordering

  18 months

• Mammography screening discussion

  18 months

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

The EUC group of providers and their patients from 2 clinics who are eligible for this study will receive the organizational level components of the multilevel de-implementation strategy.

Other: Enhanced Usual Care (EUC)

Multilevel De-Implementation Strategy

EXPERIMENTAL

The intervention group of providers and their patients from 2 clinics who are eligible for this study will receive the organizational level components of the multilevel de-implementation strategy (i.e., EUC as described above) as well as the provider and patient level components of the multilevel de-implementation strategy.

Behavioral: Multilevel De-Implementation Strategy

Interventions

Enhanced Usual Care (EUC) OTHER

EUC entails the organizational level components of the multilevel de-implementation strategy. These organizational components have been implemented within the overarching New York City healthcare system where the 2 clinics receiving the provider and patient components are located. The organizational level components are: 1) Grand Rounds Education: providers and clinic leadership received Grand Rounds education on screening mammography overuse among older women, and 2) Task Force: a multidisciplinary task force (e.g., radiologists, breast oncologists, primary care providers, clinic leadership) have been collaborating with the research team to build consensus around guidelines for clinical practice and revisions to the screening mammography results and reminder letters sent to patients.

Enhanced Usual Care (EUC)

Multilevel De-Implementation Strategy BEHAVIORAL

This multilevel de-implementation strategy includes the organizational level components that comprise EUC (described above) as well as provider and patient level components. At the provider level, the research team will disseminate educational newsletters including the latest guidelines, information, and resources on screening mammography for older women. At the patient level, the research team will disseminate a brief brochure titled the 'Rethink Resource' in which patients are activated and encouraged to speak with their providers about whether continuing to get mammograms is best for them given current guidelines.

Multilevel De-Implementation Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English- or Spanish-speaking women based on preferred language in electronic health record
• Aged 75 and older at the time of their scheduled primary care visit
• Women who have a primary care visit scheduled within the next 2-4 weeks
• Women who have not had a screening mammogram 6 months prior to their scheduled primary care visit but have had a screening mammogram 7-18 months prior to their scheduled primary care visit

You may not qualify if:

• Women with a history of atypical ductal hyperplasia (ADH) or non-invasive or invasive breast cancer (assessed via ICD 10 code)
• Women with dementia (assessed via ICD 10 code)
• Provider level criteria
• Primary care clinicians attributed to the 2 intervention clinics that serve adult patients, including those ≥75 years
• Specialists
• Primary care clinicians for patients \< 18 years old
• Non-clinicians
• Physician assistants

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Study Officials

• Parisa Tehranifar, DrPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Rachel C Shelton, ScD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Nathalie Moise, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parisa Tehranifar, DrPH

CONTACT

212-305-1018; pt140@cumc.columbia.edu

Anita G Karr, MPH

CONTACT

ak5074@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Multiple Principal Investigators and Outcomes Assessor(s) will be prevented from having knowledge of the intervention arms assigned to individual participants. Other research staff (e.g., coordinators) will have knowledge of the intervention arms assigned to individual participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology

Model Details: Providers from 2 clinics who are eligible for this study will be randomized (\~1:1 ratio) into the enhanced usual care (EUC) group or the intervention group (i.e., those who will receive EUC plus educational newsletters). Patients of the providers in the intervention group who are eligible for this study will receive the Rethink Resource (i.e., patient education and activation material) prior to their upcoming appointments with their intervention provider. The EUC group will receive mammography educational materials after study completion.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 6, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

US (1)