Evaluating the impact of Basic needs Assessment and Support to Improve Colposcopy Show rate: The BASICS Trial

评估基本需求评估和支持对提高阴道镜检查显示率的影响：BASICS 试验

基本信息

批准号：
10657708
负责人：
Lindsay M Kuroki
金额：
$ 7.78万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10657708
关键词：
Address Adherence Adoption Age Appointment Black Populations Brief Alcohol Screening and Intervention for College Students Caring Cervical Cervical Cancer Screening Cessation of life Clinic Clinical Clothing Cohort Studies Colposcopy Community Health Aides Data Diagnosis Disease Distress Effectiveness Eligibility Determination Enrollment Equity Ethnic Origin Food Geographic Locations Goals Health Personnel Housing Illinois Implementation readiness Incidence Individual Inequity Intervention Lesion Low income Maintenance Malignant neoplasm of cervix uteri Medicaid Medical Needs Assessment Newly Diagnosed Patient Self-Report Patients Prevalence Race Randomized Randomized, Controlled Trials Reach, Effectiveness, Adoption, Implementation, and Maintenance Recommendation Reduce health disparities Reporting Resources Rural Safety Screening Result Shelter facility Site System Telephone Testing Therapeutic Intervention Time Transportation Uninsured Universities Washington Work adherence rate arm black patient caregiving cervical cancer prevention community clinic community setting cost effective disparity reduction effectiveness testing efficacy evaluation follow-up food insecurity health care service organization health care settings implementation evaluation improved medical schools mortality neighborhood safety patient population patient screening patient subsets premalignant prevent prevention service primary outcome programs racial disparity recruit satisfaction secondary outcome social social disparities social health determinants socioeconomic disparity treatment as usual usability usual care arm

项目摘要

PROJECT SUMMARY/ABSTRACT Each year, approximately 3.5 million individuals have an abnormal cervical screening result and are recommended for medical follow-up, most commonly colposcopy. Colposcopy allows health providers to detect pre-cancers and offer therapeutic interventions that may prevent cervical cancer. Unfortunately, between 37% and 77% of patients are lost to follow-up after their abnormal screen and never receive appropriate care. Low adherence to colposcopy is especially prevalent among Black patients, those with low income, and individuals who are uninsured or have Medicaid, leading to socioeconomic disparities in cervical cancer incidence and mortality. Our preliminary data from two university-based colposcopy clinics that provide care to these underserved patients, show that colposcopy adherence improved from 50% to 83% after implementation of a tailored phone call intervention reminding patients of their appointment and offering navigator assistance with unmet social needs (e.g. utilities, transportation, food, shelter, clothing, safety). These pilot data suggest that a social needs navigator program improves colposcopy adherence, but the lack of randomization limits the strength of our conclusions. In this proposal, our objective is to test, and assess the readiness for implementation of a colposcopy clinic-based social needs navigator program focused on five social determinants of health: housing/shelter, food insecurity, personal and neighborhood safety, financial needs, and distress. This project will test the hypothesis that this equity-focused, social needs navigator program can improve colposcopy adherence among underserved patients. We will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. They will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36). In the navigator arm, a community health worker will provide four months of assistance tailored to their needs. In the enhanced usual care arm, patients will be offered information and referral to United Way 2-1-1, a free, 24-hr national helpline that connects callers with local resources. In specific Aim 1 we will determine the efficacy of our social needs navigator program to improve colposcopy adherence. Aim 2 will assess the ability of our navigator program to reduce unmet social needs and distress. Aim 3 will use the RE-AIM framework to evaluate metrics of implementation and potential for dissemination. The proposed work will provide key data to launch a large, pragmatic, multisite randomized controlled trial to rigorously test the effectiveness, implementation, and maintenance of our social needs navigator program across different patient populations, community settings, and healthcare organizations. If such a trial shows that our navigator program is effective, cost-effective, feasible, and acceptable, it can be widely implemented to improve colposcopy adherence and equity in cervical cancer prevention, incidence, and mortality.

项目概要/摘要每年，大约有 350 万人的宫颈筛查结果异常，需要接受治疗建议进行医疗随访，最常见的是阴道镜检查。阴道镜检查可以让医疗保健提供者发现癌症前期并提供可能预防宫颈癌的治疗干预措施。不幸的是，37% 77% 的患者在筛查异常后失去随访，并且从未得到适当的护理。低的坚持阴道镜检查在黑人患者、低收入人群和个人中尤其普遍没有保险或有医疗补助，导致宫颈癌发病率的社会经济差异死亡。我们的初步数据来自两家为这些人提供护理的大学阴道镜诊所服务不足的患者表明，实施阴道镜检查后，阴道镜检查依从性从 50% 提高到 83% 量身定制的电话干预提醒患者预约并提供导航帮助未满足的社会需求（例如公用事业、交通、食物、住所、衣服、安全）。这些试点数据表明社会需求导航计划提高了阴道镜检查的依从性，但缺乏随机性限制了强度我们的结论。在本提案中，我们的目标是测试和评估实施的准备情况基于阴道镜检查的临床社会需求导航计划重点关注健康的五个社会决定因素：住房/庇护所、粮食不安全、个人和邻里安全、财务需求和困境。这个项目将检验这个以公平为中心的社会需求导航计划可以改善阴道镜检查的假设服务不足的患者的依从性。我们将进行一项随机对照试验，其中 72 名符合条件的人被转介到华盛顿大学进行阴道镜检查的患者（低收入、无保险或享受医疗补助）医学院入学，然后筛选未满足的社会需求和困扰。那时他们将是以 1:1 的比例随机分为接受社会需求导航计划 (n=36) 或加强常规护理 (n=36)。在导航器部门的一名社区卫生工作者将根据他们的需求提供为期四个月的援助。在在增强型常规护理部门，将为患者提供信息并转介至 United Way 2-1-1，这是一个免费的 24 小时服务将呼叫者与当地资源联系起来的国家求助热线。在具体目标 1 中，我们将确定我们的功效社会需求导航计划，以提高阴道镜检查的依从性。目标 2 将评估我们导航员的能力旨在减少未满足的社会需求和痛苦的计划。目标 3 将使用 RE-AIM 框架来评估指标实施情况和传播潜力。拟议的工作将为启动大型、务实的多中心随机对照试验，严格测试有效性、实施情况和维护我们在不同患者群体、社区环境中的社会需求导航计划，和医疗保健组织。如果这样的试验表明我们的导航器方案是有效的、具有成本效益的、可行的，且可接受，可以广泛实施，以提高宫颈癌阴道镜检查的依从性和公平性预防、发病率和死亡率。