Community Services Navigation to Advance Health Equity in Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,450
- 试验地点
- 2
- 主要终点
- Change in Social Needs
研究概览
简要总结
The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.
详细描述
Disparities in breast cancer outcomes are persistent. In the United States, breast cancer is the most common, and second most deadly, cancer in women, with an estimated 281,550 new invasive breast cancer diagnoses and 43,600 breast cancer deaths in 2021. Underserved women, those who do not have adequate access to medical care, are represented disproportionately in those deaths, having lower incidence rates but higher mortality rates. While U.S. breast cancer mortality rates have decreased approximately 2% per year since 1990, socially and economically disadvantaged women have experienced increasing breast cancer mortality over that time. Rural women are more likely to experience diagnostic delays and are up to 1.5 times more likely to be diagnosed with advanced stages of disease compared with urban women.
Leveraging existing social systems for community navigation to facilitate breast screening follow-up. Our research has demonstrated that linkages between social needs screening in clinical settings and United Way 211's community referral service is possible using existing, low cost software solutions that can be adapted to clinical workflows. Specifically, the SINCERE 10-item social needs screener was combined with community services navigation and tested in a randomized controlled trial. That trial showed efficacy of the efficacy of this low cost, widely available solution to address the needs of vulnerable and underserved patients; namely, 211 active outreach v. passive information to address reported social needs. However, that trial was conducted in an Emergency Department, and has not been tested in other clinical settings. Building off of (collective) decades of work in breast cancer screening, the multiple PIs have formed an interdisciplinary team that has piloted an adaptation of the SINCERE social services screener (dubbed "B-SINCERE") in mammography clinics. This study will test the real-world efficacy (NIH stage 3) of the B-SINCERE community navigation intervention on increasing breast cancer screening episode completion. If efficacious, this intervention will be scalable with statewide community service providers and existing health information technology. Thus, the promise to make a real impact on early detection and improve breast cancer outcomes for underserved women with abnormal mammograms is the overarching driver of this work
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English and Spanish speakers
- •Received an abnormal result of a screening mammogram
- •Self-reports at least one social need on the B-SINCERE Screener
排除标准
- •Patients who are currently in treatment for breast cancer
- •Patients with a normal screening result.
- •Patients who do not exhibit at least 1 social need according to their SINCERE screening result.
- •Patients who don't speak English or Spanish
- •Cognitive limitations that impede informed consent
- •Patients living outside of Utah
结局指标
主要结局
Change in Social Needs
时间窗: up to 18 months after baseline assessment
Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener. To Test whether the use of a community services navigation intervention in conjunction with social service referrals decreases social needs compared to the referrals alone (usual care). B-SINCERE, reported on a 0-10 point scale, with 0=No Social Needs present, and 1-10=Social Needs present, anything greater than 0 indicates social needs and eligibility for the study.
Episode Completion (EC).
时间窗: up to 18 months after baseline assessment
EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed. Impact of the community services navigation intervention on breast cancer screening episode completion and preventive care utilization among women with self-reported social needs. Preventive Care Utilization is a descriptive measure that is not reporting a score on a scale.
次要结局
- Area deprivation index (ADI)(up to 18 months after baseline assessment)
- General Health Status(up to 18 months after baseline assessment)
- Rural Urban Commuting Area (RUCA)(up to 18 months after baseline assessment)
- Self-Report Generated Charlson Comorbidity Index(up to 18 months after baseline assessment)
- Social Service Utilization(up to 18 months after baseline assessment)
- Health Care Access(up to 18 months after baseline assessment)
- Breast cancer risk (Tyrer-Cuzick)(up to 18 months after baseline assessment)
- Preventive services visits(from baseline assessment, up to 18 months)
- PROMIS Global Health(up to 18 months after baseline assessment)
- PROMIS Depression(up to 18 months after baseline assessment)