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

• 批准号: 10512593
• 负责人: Lindsay M Kuroki
• 金额: $ 7.88万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 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/10512593
• 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; Enrollment; Ethnic Origin; Food; Geographic Locations; Goals; Health Personnel; Illinois; Implementation readiness; Incidence; Individual; Intervention; Lesion; Low income; Maintenance; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Medicaid; Medical; Needs Assessment; Newly Diagnosed; Patient Self-Report; Patients; Plant Roots; Prevalence; Race; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Reduce health disparities; Reporting; Resources; Rural; Safety; Screening Result; Shelter facility; System; Telephone; Testing; Therapeutic Intervention; Time; Transportation; Uninsured; Universities; Washington; Work; adherence rate; arm; base; black patient; cervical cancer prevention; community clinic; community setting; cost effective; disparity reduction; effectiveness testing; follow-up; food insecurity; health care service organization; health care settings; health disparity; implementation evaluation; improved; medical schools; mortality; neighborhood safety; patient population; patient screening; patient subsets; prevent; prevention service; primary outcome; programs; racial disparity; recruit; rural healthcare; satisfaction; secondary outcome; social; social disparities; social health determinants; socioeconomic disparity; treatment as usual; usability; usual care arm

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.

项目总结/摘要 每年约有350万人的宫颈筛查结果异常， 建议进行医学随访，最常见的是阴道镜检查。阴道镜检查允许健康提供者检测 癌症前的疾病，并提供可能预防宫颈癌的治疗干预措施。不幸的是，37%的 77%的患者在筛查异常后失访，从未得到适当的护理。低 坚持阴道镜检查在黑人患者、低收入者和个人中尤其普遍。 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， mortality.我们的初步数据来自两所大学的阴道镜诊所，为这些患者提供护理。 服务不足的患者，显示阴道镜检查依从性从50%提高到83%后，实施了一项 量身定制的电话干预，提醒患者他们的预约，并提供导航协助， 未得到满足的社会需求（如公用事业、交通、食物、住所、衣服、安全）。这些试验数据表明， 社会需求导航计划提高了阴道镜检查的依从性，但缺乏随机化限制了其强度 我们的结论。在本建议中，我们的目标是测试和评估实施 阴道镜检查诊所为基础的社会需求导航程序，重点是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 我将测试这个以公平为中心的社会需求导航程序可以改善阴道镜检查的假设 在服务不足的患者中坚持治疗。我们将进行一项随机对照试验， 转诊到华盛顿大学进行阴道镜检查的患者（低收入、无保险或接受医疗补助） 医学院，注册，然后筛选未满足的社会需求和痛苦。于其后向业主悉数 按1：1随机分为接受社会需求导航程序（n=36）或加强常规护理（n=36）。在 “领航员”是一名社区卫生工作者，将根据他们的需要提供为期四个月的援助。在 加强常规护理臂，病人将提供信息和转介到联合之路2-1-1，免费，24小时 将呼叫者与本地资源连接起来的全国性网络。在具体目标1中，我们将确定我们的 社会需要导航程序，以提高阴道镜检查的依从性。目标2将评估我们的领航员 减少未满足的社会需求和痛苦的方案。目标3将使用RE-AIM框架来评估指标 执行情况和传播潜力。拟议的工作将提供关键数据， 务实，多中心随机对照试验，严格测试的有效性，实施， 在不同的患者人群，社区环境， 和医疗保健组织。如果这样的试验表明，我们的导航程序是有效的，成本效益，可行的， 并且可以接受，它可以广泛实施，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。