Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities
Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities
Breast cancer is the second most common cause of cancer death in women. Black women are less likely than white women to develop breast cancer but, they are more likely to die of the disease. Some of this survival discrepancy is likely due to underuse of adjuvant therapies proven to increase survival. Breast cancer treatment often requires coordination among surgeons, pathologists, primary care physicians, medical and radiation oncologists. In NYC, black and Hispanic women who accessed care and underwent surgical treatment of their breast cancer were twice as likely as whites to experience underuse of adjuvant treatment. Disturbingly, 1/3 of these underuse cases were episodes in which the surgeon recommended treatment, the patient did not refuse and yet, care did not ensue. Underuse in such circumstances is attributable to system failures than to specific provider or patient factors.
In this proposed randomized controlled trial, the investigators aim to test the effectiveness of a Tracking and Feedback (T&F) registry innovation to increase rates of completed oncology consultation and reduce both underuse of needed adjuvant therapy and racial disparities in receipt of these treatments. The investigators also aim to assess the feasibility of implementing a T&F Registry in these high-risk hospitals by evaluating implementation effectiveness for that innovation. The investigators have recruited 10 hospitals that serve large proportions of minority women with breast cancer. The investigators will randomize hospitals and aim to recruit 354 women with a new breast cancer, 177 per intervention arm. The investigators choose these "high risk" hospitals because they serve predominantly minority populations, and such hospitals have higher rates of the system failure cause of underuse, and particularly, the type of underuse targeted by our Tracking and Feedback Registry.
研究概览
详细说明
Breast cancer is the second most common cause of cancer death in women. Black women are less likely than white women to develop breast cancer but, they are more likely to die of the disease. Some of this survival discrepancy is likely due to underuse of adjuvant therapies proven to increase survival. Breast cancer treatment often requires coordination among surgeons, pathologists, primary care physicians, medical and radiation oncologists. In NYC, black and Hispanic women who accessed care and underwent surgical treatment of their breast cancer were twice as likely as whites to experience underuse of proven-effective adjuvant treatment. Disturbingly, 1/3 of these underuse cases were episodes in which the surgeon recommended treatment, the patient did not refuse and yet, care did not ensue. Underuse in these circumstances was attributed to system failures rather than to provider or patient factors. Such system failures occurred more often among minority women and among women treated at hospitals serving predominantly minority patients. To target these system failures at 6 NYC hospitals, 4 of which served predominantly minority patients, we used a quasi-experimental pre-post test design to implement a tracking and feedback registry. The Tracking and Feedback registry closed the referral loop between surgeons and oncologists, increased the rate of completed oncology consultations, increased treatment rates and eliminated the racial disparity in underuse. Its effects were greatest at the 4 hospitals serving predominantly minority women, sites that had an EMR and patient navigation prior to and during the T&F implementation. However, the trial was not randomized, tracking and feedback functions were performed by study personnel and not embedded in the hospital's workflow and details of what the surgeons did in response to the feedback was not assessed, resulting in a call for more work in this area.
In this proposed randomized controlled trial, we will implement the Tracking and Feedback (T&F) innovation in hospitals serving predominantly minority women. We will test the effectiveness of the Tracking and Feedback registry innovation to increase rates of completed oncology consultation, reduce underuse of needed adjuvant therapy and racial disparities in receipt of these treatments. We will also assess the feasibility of implementing a T&F Registry in these high-risk hospitals by evaluating implementation effectiveness for this innovation. We have recruited 10 hospitals that serve large proportions of minority women with breast cancer. We will randomize hospitals and will recruit 354 women with a new breast cancer, 177 per intervention arm. We choose these "high risk" hospitals because they serve predominantly minority populations, and such hospitals have higher rates of the system failure cause of underuse, specifically, the type of underuse targeted by our Tracking and Feedback Registry. We will: adapt existing laptop-based Tracking & Feedback software to create a protected web-based format easily accessible to all participating hospitals; tailor the Tracking & Feedback registry to each of the participating hospitals' appropriate workflows including the areas of pathology, surgery, medical and radiation oncology and tumor registry personnel in the process; and embed the tracking and feedback tasks within existing hospital structures and personnel to increase likelihood of sustainability beyond the grant. We will include in the web-based T&F Registry an electronic data capture system to assess responses and actions to the tracking information that is fed back to the surgeons. To assess the T&F Registry's effectiveness, we will compare rates of underuse of patients treated at intervention versus control hospitals. To assess implementation effectiveness at each hospital, we will assess process and outcomes using qualitative and quantitative methods. Qualitatively, we will conduct pre- & post-intervention interviews with key stakeholders to assess the implementation climate and stakeholders' views of the Registry's utility. Quantitatively, we will measure and track actions taken in response to the feedback information. As there is variability across hospitals, we will also assess each hospital's treatment rates both pre- (N=540) and post-intervention (N=354) to provide additional quantitative measures of implementation effectiveness.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Jersey
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Newark、New Jersey、美国、07052
- Newark Beth Israel Medical Center
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New York
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Bronx、New York、美国、10461
- Montefiore Medical Center
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Bronx、New York、美国、10461
- Jacobi Medical Center
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Bronx、New York、美国、10457
- Bronx-Lebanon Hospital
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Brooklyn、New York、美国、11201
- Brooklyn Hospital Center
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Brooklyn、New York、美国、11203
- Kings County Hospital
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Brooklyn、New York、美国、11201
- University Hospital of Brooklyn at Long Island College Hospital
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Brooklyn、New York、美国、11209
- Lutheran Medical Center
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Elmhurst、New York、美国、11373
- Elmhurst Hospital Center
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Jamaica、New York、美国、11433
- Queens Hospital Center
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New York、New York、美国、10029
- Metropolitan Hospital Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients, who are English or Spanish speaking, with a new primary stage 1 or 2 and with tumors > 1 cm or < 1 cm and poorly differentiated breast cancer who have undergone either breast conserving surgery or mastectomy at 1 of 10 participating hospitals in the NY Metropolitan Area.
- All surgeons performing breast surgery at study participating hospitals
Exclusion Criteria:
- Patients with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Tracking & Feedback
Systems based intervention tracking oncology consultations and feeding back information to surgeons
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Systems based intervention tracking oncology consultations and feeding back information to surgeons
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无干预:Control- no intervention
Usual Care
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in intervention effect of adjuvant treatment
大体时间:at baseline and at one year
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We will compare at initiation and completion of adjuvant treatment on all enrolled patients to determine the intervention's effect
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at baseline and at one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Organizational Characteristics
大体时间:at 5 years
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To describe the organizational characteristics and the implementation climate of the hospitals and their relationship to the hospitals' change in rates of guideline concordant adjuvant treatment pre- and post-intervention.
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at 5 years
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合作者和调查者
调查人员
- 首席研究员:Nina A Bickell, MD, MPH、Icahn School of Medicine Mount Sinai
出版物和有用的链接
一般刊物
- Bickell NA, Shah A, Castaldi M, Lewis T, Sickles A, Arora S, Clarke K, Kemeny M, Srinivasan A, Fei K, Franco R, Parides M, Pappas P, McAlearney AS. Caution Ahead: Research Challenges of a Randomized Controlled Trial Implemented to Improve Breast Cancer Treatment at Safety-Net Hospitals. J Oncol Pract. 2018 Mar;14(3):e158-e167. doi: 10.1200/JOP.2017.026534. Epub 2018 Jan 3.
- Bickell NA, Moss AD, Castaldi M, Shah A, Sickles A, Pappas P, Lewis T, Kemeny M, Arora S, Schleicher L, Fei K, Franco R, McAlearney AS. Organizational Factors Affect Safety-Net Hospitals' Breast Cancer Treatment Rates. Health Serv Res. 2017 Dec;52(6):2137-2155. doi: 10.1111/1475-6773.12605. Epub 2016 Nov 14.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- GCO 09-1155
- 5R01CA149025 (美国 NIH 拨款/合同)
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