高齢女性におけるマンモグラフィー過剰使用を段階的に削減する多面的戦略
人種的・民族的に多様な高齢女性における乳がん検診マンモグラフィーの過剰実施の削減
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Parisa Tehranifar, DrPH
- 電話番号：212-305-1018
- メール：pt140@cumc.columbia.edu
研究連絡先のバックアップ
- 名前：Anita G Karr, MPH
- メール：ak5074@cumc.columbia.edu
研究場所
-
-
New York
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New York、New York、アメリカ、10032
- 募集
- Columbia University Irving Medical Center
-
コンタクト：
- Nathalie Moise, MD, MS
- メール：nm2562@cumc.columbia.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Enhanced Usual Care (EUC)
The EUC 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. |
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. |
|
実験的：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., EUC as described above) as well as the provider and patient level components of the multilevel de-implementation strategy. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Screening mammography overuse
時間枠：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 Enhanced Usual Care (EUC) vs. intervention arms. |
18 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Provider mammography ordering
時間枠：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. |
18 months
|
|
Mammography screening discussion
時間枠：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. |
18 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nathalie Moise, MD, MS、Columbia University
- 主任研究者：Parisa Tehranifar, DrPH、Columbia University
- 主任研究者：Rachel C Shelton, ScD, MPH、Columbia University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。