Health TrialsbyHealthPanel

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

ConditionsMammographyMedical OveruseEvidence-based PracticeOlder Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Specialists

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Usual Care (EUC)

    Other intervention

    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.

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Enhanced Usual Care (EUC)Active comparator 1 intervention
Group B: Multilevel De-Implementation StrategyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

1

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.

Time frame
18 months
2

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.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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