FQHC Intervention for CGM Uptake in Hispanic Adults with T1D

FQHC 对患有 T1D 的西班牙裔成人 CGM 摄取的干预

• 批准号: 10709635
• 负责人: Veena Channamesetty
• 金额: $ 42.99万
• 依托单位: UNIVERSITY OF CONNECTICUT STORRS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-24 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709635
• 关键词: Acute; Adherence; Adult; Aptitude; Behavioral; Blood Glucose Self-Monitoring; Caring; Certification; Cessation of life; Characteristics; Clinical; Collaborations; Communities; Community Healthcare; Connecticut; Continuous Glucose Monitor; Data; Data Collection; Diabetes Mellitus; Dose; Education; Emergency department visit; Endocrinologist; Endocrinology; Enrollment; Equity; Family; Family member; Feasibility Studies; Federally Qualified Health Center; Focus Groups; Fostering; Funding; Future; Glucose; Goals; Group Interviews; Health Personnel; Healthcare; Hispanic; Hispanic Populations; Hospitalization; Hypoglycemia; Incidence; Income; Individual; Inequity; Insulin; Insulin-Dependent Diabetes Mellitus; Insurance; Insurance Coverage; Intervention; Knowledge; Life; Low income; Measures; Medicaid; Methods; Modeling; Motivation; Not Hispanic or Latino; Outcome; Participant; Perception; Phase; Physicians; Physiological; Pilot Projects; Poverty; Preparation; Procedures; Process; Protocols documentation; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Schedule; Signal Transduction; Site; Social Network; Social support; Specialist; Target Populations; Technology; Testing; Time; Titrations; Training; Trust; Uninsured; Visit; care outcomes; community based participatory research; cultural competence; design; diabetes education; diabetes management; dosage; empowerment; experience; family support; health care model; health data; health inequalities; implementation intervention; improved; intervention delivery; intervention participants; intervention refinement; medical specialties; novel; patient engagement; peer; peer support; phase 1 study; phase 2 study; pilot test; prevent; primary care provider; programs; psychosocial; randomized, clinical trials; recruit; skill acquisition; skills; social health determinants; uptake

Abstract Low-income Hispanic adults with type 1 diabetes (T1D) experience a disproportionate burden of life-threatening, acute complications, both hypoglycemia and diabetes ketoacidosis, with high rates of related emergency department visits, hospitalizations, and death. Use of continuous glucose monitoring (CGM) may mitigate these inequities. Yet, Hispanics with T1D have exceptionally low levels of CGM use. This reflects social determinants of health (SODH), as framed by the multiple levels of the Socio-Ecological Model (SEM). The SEM’s healthcare provider level is a main driver in Hispanic disenfranchisement from CGM. With a severe shortage of endocrinologists, primary care providers are increasingly managing T1D although a high majority report inadequate confidence in titrating insulin and using CGM. With limited access to endocrinology, low-income, Hispanic adults with T1D thus often receive diabetes management in federally qualified health centers (FQHCs) with scant or no access to CGM. Hence, to foster equitable uptake of CGM in the most vulnerable Hispanic adults with T1D, a 4-year, mixed-methods, feasibility study with a pilot randomized controlled trial (RCT) is proposed to primarily assess the feasibility of the SEM-guided intervention (targeting the individual, family/social networks, and healthcare provider levels). The individual level of the intervention fosters essential acquisition of information, motivation, and behavioral skills for CGM uptake through two approaches: (1) 4-week, personalized, CGM sessions with a RN certified in diabetes education; and (2) followed by peer education visits between data collection points. The family/social networks level leverages the core Hispanic values of familismo and collectivismo to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement with a peer educator during scheduled visits, respectively. The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO. In study phase 1 (Aim 1), the intervention, informed by stakeholder qualitative findings, will be refined and RCT deployment will be planned with 4 FQHC sites randomized to deliver the intervention (n=2) or control (n=2) conditions with a total enrollment goal of 30 Hispanics with T1D (sites having roughly equivalent enrollment rates). Project ECHO: CGM & T1D Care will also be delivered to intervention site providers. In phase 2 (Aim 2), the feasibility of the study protocol (e.g., recruitment and retention yields, data collection procedures, intervention implementation, and intervention acceptability, among others) will be routinely assessed. In phase 2 (Aim 3), significant intervention signals in terms of physiological (e.g., A1C and time within, above, and below range), psychosocial (e.g., quality of life, family support, physician trust), and behavioral (CGM adherence) outcomes from baseline to 3- and 6- months postbaseline will be assessed. The long-term goal of this study is to inform a large, multi-site RCT, and with successful results, provide a model for CGM uptake in Hispanic adults with T1D for FQHCs nationally

抽象的 患有 1 型糖尿病 (T1D) 的低收入西班牙裔成年人承受着不成比例的危及生命的负担， 急性并发症，包括低血糖和糖尿病酮症酸中毒，相关紧急情况发生率很高 科室就诊、住院和死亡。使用连续血糖监测 (CGM) 可以缓解这些问题 不平等。然而，患有 T1D 的西班牙裔人群 CGM 的使用水平却极低。这反映了社会决定因素 健康（SODH），由社会生态模型（SEM）的多个层面构成。 SEM 的医疗保健 提供者水平是西班牙裔被剥夺 CGM 权利的主要驱动因素。在严重短缺的情况下 内分泌学家、初级保健提供者越来越多地治疗 T1D，尽管大多数报告 对滴定胰岛素和使用 CGM 信心不足。由于获得内分泌学的机会有限，低收入、 因此，患有 T1D 的西班牙裔成年人经常在联邦合格的健康中心 (FQHC) 接受糖尿病治疗 很少或根本无法使用 CGM。因此，为了促进最脆弱的西班牙裔美国人公平地接受 CGM 针对患有 T1D 的成人，一项为期 4 年的混合方法可行性研究，其中包括试点随机对照试验 (RCT) 建议初步评估 SEM 引导干预措施的可行性（针对个人、家庭/社会） 网络和医疗保健提供者级别）。干预的个人水平促进了基本的获得 通过两种方法采用 CGM 的信息、动机和行为技能：(1) 4 周、个性化、 与获得糖尿病教育认证的注册护士进行连续血糖监测 (CGM) 课程； (2) 随后在数据之间进行同伴教育访问 收集点。家庭/社交网络层面利用了西班牙裔家庭主义的核心价值观和 集体主义促进对 CGM 吸收的关键支持，并由家庭成员共同参加为期 4 周的课程 以及参与者在预定访问期间分别与同伴教育者的接触。的提供商级别 干预旨在促进增强干预实施中的文化能力，并提供临床 通过 ECHO 项目对 T1D 管理和 CGM 进行严格培训，为 CGM 提供支持。正在学习阶段 1（目标 1），根据利益相关者的定性调查结果，干预措施将得到完善，RCT 部署将 规划 4 个 FQHC 站点，随机提供干预 (n=2) 或对照 (n=2) 条件，总计 30 名患有 T1D 的西班牙裔美国人的入学目标（入学率大致相当的网站）。 ECHO 项目：CGM & T1D 护理也将提供给干预现场提供者。在第二阶段（目标 2），研究的可行性 协议（例如，招聘和保留率、数据收集程序、干预实施以及 干预的可接受性等）将被定期评估。在第 2 阶段（目标 3），进行重大干预 生理信号（例如 A1C 以及在范围内、高于和低于范围内的时间）、心理社会信号（例如，质量 从基线到 3- 和 6- 的生活、家庭支持、医生信任）和行为（CGM 依从性）结果 将评估基线后几个月。这项研究的长期目标是为大型多中心随机对照试验提供信息，并且 取得成功的结果，为全国 FQHC 的 1 型糖尿病西班牙裔成年人采用 CGM 提供了一个模型