跳至主要内容
临床试验/NCT07511621
NCT07511621招募中不适用

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

Columbia University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年3月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Screening mammography overuse

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Enhanced Usual Care

Active Comparator

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.

干预措施: Enhanced Usual Care (Other)

Multilevel De-Implementation Strategy

Experimental

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.

干预措施: Multilevel De-Implementation Strategy (Behavioral)

结局指标

主要结局

Screening mammography overuse

时间窗: 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.

次要结局

  • Provider mammography ordering(18 months)
  • Mammography screening discussion(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Parisa Tehranifar

Professor of Epidemiology

Columbia University

研究点 (1)

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