Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,725
- 试验地点
- 5
- 主要终点
- Time-to-treatment Post-diagnosis
研究概览
简要总结
The TRIP Project aims to overcome barriers to widespread implementation and dissemination of evidence-based practices that will improve the delivery of guideline-concordant care to vulnerable women with breast cancer. To accomplish this goal the study team will create (a) regional patient registries; (b) systematic screening for social barriers to care with a personalized referral plan; and (c) patient navigation services that integrate into one model of care to improve the quality and effectiveness of care delivery, for minority and/or low-income women with breast cancer in Boston.
详细描述
This community-engaged program will demonstrate the feasibility of community-academic partnerships to provide innovations in information sharing and systems implementation targeted to reduce treatment disparities. Patient navigators will be able to utilize the patient database to track their patients throughout their treatment, and receive guidance regarding recommended social resources to patients experiencing hardships via the social determinants platform.
Who: The four Massachusetts Clinical and Translational Science Award (CTSA) hubs (Boston University, Harvard University, Tufts University, and University of Massachusetts) partnered with the Boston Breast Cancer Equity Coalition, and the 5 hospitals that care for women with breast cancer.
Patient population: about 1,300 vulnerable inner city women with risk for delay in breast cancer care. Massachusetts (MA) Cancer Registry data identified the following characteristics of Boston residents with greatest delays in breast cancer treatment: Black, Hispanic, non-English speaking, and public health insurance. Five health care institutions care for >90% of these women:
- Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
- Boston Medical Center (PI: Tracy Battaglia MD, MPH)
- Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
- Massachusetts General Hospital (site PI: Beverly Moy, MD)
- Tufts Medical Center (PI: Karen Freund MD, MPH)
University of Massachusetts Medical Center (PI: Stephenie Lemon, PhD) will play an integral role in the planning and implementation of the TRIP intervention but is not a clinical site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •are an adult female 18 years of age or older;
- •reside within 25 miles of the City of Boston;
- •have any of the following risk factors for delays in care: are Black and/or Hispanic ethnicity, do not speak English as their primary language, and/or have only public insurance or are uninsured at the time of diagnosis.
排除标准
- •cancer diagnosis made > 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited;
- •presence of a cognitive impairment such as dementia or delirium from any cause (e.g. metabolic, medication or drug induced), given the unique challenges to their treatment decision making/ adherence and the fact that the intervention would not include the patient directly, but rather the family;
- •home residence is outside of the city of Boston, Massachusetts.
研究组 & 干预措施
Control- Usual Care
This study will be utilizing electronic health record data to identify patients that match the TRIP eligibility criteria and received patient navigation prior to study rollout. These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.
TRIP Patient Navigation Intervention
This study will be enhancing current patient navigation at the participating 5 hospitals with the 3 components of the TRIP intervention (a shared patient registry, a social determinants of health platform, and additional training and support for Patient Navigators). All patients that are identified as TRIP eligible will receive these intervention benefits and will be categorized into the experimental arm of the study.
干预措施: TRIP Patient Navigation Intervention (Other)
结局指标
主要结局
Time-to-treatment Post-diagnosis
时间窗: Within 365 days of enrollment
The receipt of care will be defined as initiation of care within 365 days. This will be a continuous outcome defined as the number of days from definitive tissue biopsy (Time 0) to treatment initiation (Time 1). Treatment initiation is defined as the date of first cancer treatment: surgical, radiation, or systemic therapy (including chemotherapy, immunotherapy, targeted therapy, hormonal therapy). Time to treatment initiation can take any value from 0 days to 365 days (study period). The clinical outcome will be derived from data in the patient's medical record.
次要结局
未报告次要终点