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

De-implementation of Overuse of Mammography Screening in Older Racially and Ethnically Diverse Women

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.

Study Overview

• Status: Recruiting
• Conditions: Older Adults; Mammography; Evidence-based Practice; Medical Overuse
• Intervention / Treatment: Other: Enhanced Usual Care; Behavioral: Multilevel De-Implementation Strategy

Detailed Description

De-implementation, defined as "reducing (frequency and/or intensity) or stopping the use or delivery of health services or practices that are ineffective, unproven, harmful, overused, inappropriate, and/or low-value by practitioners and delivery systems to patients", is recognized as a critical but understudied area within implementation science. Despite growing research on determinants of and strategies for implementation of evidence-based practices, there has been little empirical work on factors that influence de-implementation, or effective strategies for facilitating de-implementation. Further, there are gaps in knowledge in determining optimal methods and approaches for identifying and selecting de-implementation strategies to match barriers to de-implementation. Addressing screening mammography overuse among older women offers excellent opportunities for both improving healthcare delivery and outcomes among older women and advancing the science of de-implementation.

Routine screening mammography is widely implemented among older women despite the following: 1) screening mammography does not significantly reduce breast cancer mortality among older women who have shorter life expectancies, greater competing health risks, and lower risk for clinically significant or rapidly progressive breast tumors, and 2) screening mammography among older women poses substantial harms including anxiety and complications from follow-up diagnostic tests, false positive results, and potential over-diagnosis and over-treatment of tumors that would not have progressed. The current American College of Physicians guidelines recommend discontinuation (e.g., removal) of mammography in women aged ≥75 years at average risk for breast cancer; other national guidelines (e.g., United States Preventive Services Task Force, American Cancer Society) do not support routine screening mammography in older women and recommend consideration of morbidities, life expectancy and patients' informed preferences.

Informed by (1) multi-level qualitative interviews among patients and providers on the drivers of routine screening mammography in older women (n=36); (2) the Knowledge-to-Action Model and the Dual Process Model; (3) an innovation tournament - a crowdsourcing method, successfully applied as an emerging participatory approach for generating implementation solutions (n=47); and (4) a discrete choice experiment among patients (n=673), the research team identified, designed, and tailored a multilevel de-implementation strategy involving the patient, provider, and organizational levels. 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, across a large New York City healthcare system serving a racially and ethnically diverse population. The organizational level components of the multilevel strategy will be implemented among all participants, not via random assignment.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Parisa Tehranifar, DrPH; Phone Number: 212-305-1018; Email: pt140@cumc.columbia.edu
• Study Contact Backup: Name: Anita G Karr, MPH; Email: ak5074@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Nathalie Moise, MD, MS; Email: nm2562@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Patient level criteria

Inclusion criteria

• 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

Exclusion Criteria

• 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)
• ICD codes to use across exclusion criteria: F01-F03, Z85.3, G30-G31, N60, C50, or D05

Provider level criteria

Inclusion Criteria

• Primary care clinicians attributed to the 2 intervention clinics that serve adult patients, including those ≥75 years

Exclusion Criteria

• Specialists
• Primary care clinicians for patients < 18 years old
• Non-clinicians
• Physician assistants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Usual Care; The enhanced usual care 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; Enhanced usual care 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.
Experimental: Multilevel De-Implementation Strategy; 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., enhanced usual care as described above) as well as the provider and patient level components of the multilevel de-implementation strategy.	Behavioral: Multilevel De-Implementation Strategy; This multilevel de-implementation strategy includes the organizational level components that comprise enhanced usual care (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 EUC vs. intervention arms.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider mammography ordering	Provider mammography ordering will be defined as the percentage of patients eligible for this study whose primary care provider orders a screening mammogram within 24 months of their prior screening mammogram in the EUC vs. intervention arms.	18 months
Mammography screening discussion	Mammography screening discussion will be defined as the percentage of patients eligible for this study whose primary care provider documents mammography screening discussion at the time of the scheduled primary care visit based on chart extraction in the intervention vs. EUC arms.	18 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nathalie Moise, MD, MS, Columbia University; Principal Investigator: Parisa Tehranifar, DrPH, Columbia University; Principal Investigator: Rachel C Shelton, ScD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Women; Randomized controlled trial; Aging; Mammography; Implementation science; De-implementation; Medical overuse; Screening cessation
• Other Study ID Numbers: AAAT2119; R01CA255382 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No