Evidence-based Practice, Mammography, Medical Overuse, Older Adults
Conditions
Keywords
Mammography, Medical overuse, Implementation science, Aging, Women, Randomized controlled trial, Screening cessation, De-implementation
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.
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.
Interventions
BEHAVIORALMultilevel 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.
OTHEREnhanced 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.
Sponsors
Columbia University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Providers from 2 clinics who are eligible for this study will be randomized (\ 1:1 ratio) into the enhanced usual care group or the intervention group (i.e., those who will receive enhanced usual care 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 enhanced usual group will receive mammography educational materials after study completion.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening mammography overuse | 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider mammography ordering | 18 months | 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. |
| Mammography screening discussion | 18 months | 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. |
Countries
United States
Contacts
CONTACTParisa Tehranifar, DrPH
CONTACTAnita G Karr, MPH
PRINCIPAL_INVESTIGATORParisa Tehranifar, DrPH
Columbia University
PRINCIPAL_INVESTIGATORRachel C Shelton, ScD, MPH
Columbia University
PRINCIPAL_INVESTIGATORNathalie Moise, MD, MS
Columbia University
Outcome results
None listed