Reducing unnecessary screening mammograms for women 75 and older
De-implementation of Overuse of Mammography Screening in Older Racially and Ethnically Diverse Women
This project tests a multilevel approach to help doctors and patients decide whether to stop routine mammograms for women aged 75 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07511621 on ClinicalTrials.gov |
What this trial studies
The team used a participatory stakeholder-driven innovation tournament and a discrete choice experiment to design a tailored multilevel de-implementation strategy targeting routine screening mammography in women aged 75 and older. Organizational components of the strategy will be rolled out for all sites, while provider- and patient-level components will be tested in a cluster randomized trial at the provider level. Primary outcomes are changes in screening mammography use and provider orders/referrals, with secondary analyses of implementation processes and contextual factors. The project aims both to reduce low-value care for older women and to advance methods for selecting and testing de-implementation strategies.
Who should consider this trial
Good fit: English- or Spanish-speaking women aged 75 or older who have a primary care visit scheduled in the next 2–4 weeks and who had a screening mammogram 7–18 months earlier but not in the past 6 months, and who do not have a history of breast cancer, atypical ductal hyperplasia, or dementia.
Not a fit: Women with a history of breast cancer or atypical ductal hyperplasia, those with dementia, or those who recently had a screening or require diagnostic mammography are unlikely to benefit from this de-implementation approach.
Why it matters
Potential benefit: If successful, the approach could reduce unnecessary mammograms and the related harms of false positives, anxiety, and invasive follow-up for older women.
How similar studies have performed: De-implementation research is relatively new and few randomized trials have tested multilevel strategies to reduce screening mammography overuse, so this approach is fairly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Parisa Tehranifar, DrPH — Columbia University
- Study coordinator: Parisa Tehranifar, DrPH
- Email: pt140@cumc.columbia.edu
- Phone: 212-305-1018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.