Recruiting

De-Implementation Strategy

Sponsor:

Columbia University

Code:

NCT07511621

Conditions

Mammography

Medical Overuse

Evidence-based Practice

Older Adults

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Enhanced Usual Care

Multilevel De-Implementation Strategy

Study Details

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

Study ID

NCT07511621

Start date

Mar 11, 2026

Status verified date

Mar, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Screening mammography overuse [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Parisa Tehranifar, DrPH

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

Anita G Karr, MPH

ak5074@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Nathalie Moise, MD, MS

nm2562@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-06.