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: 10584250
• 负责人: Veena Channamesetty
• 金额: $ 32.92万
• 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/10584250
• 关键词: Acute; Adherence; Adult; Aptitude; Behavioral; Blood Glucose Self-Monitoring; Caring; Cessation of life; Characteristics; Clinical; Communities; Community Healthcare; Connecticut; Data; Data Collection; Diabetes Mellitus; Dose; Education; Emergency department visit; Endocrinologist; Endocrinology; Enrollment; 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; 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 Clinical Trials; 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; care providers; community based participatory research; community intervention; cultural competence; design; diabetes education; diabetes management; dosage; experience; family support; glucose monitor; health care model; health data; health inequalities; healthcare community; 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; programs; psychosocial; 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

摘要 患有1型糖尿病（T1 D）的低收入西班牙裔成年人经历了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，相关急诊发生率高 部门访问、住院和死亡。使用动态血糖监测（CGM）可缓解这些问题 不平等。然而，患有T1 D的西班牙裔人使用CGM的水平非常低。这反映了社会决定因素 社会生态模型（SEM）的多层次框架下的健康（SODH）。SEM的医疗保健 供应商层面是西班牙裔被剥夺CGM权利的主要驱动力。由于严重缺乏 内分泌学家，初级保健提供者越来越多地管理T1 D，尽管大多数报告 对滴定胰岛素和使用CGM的信心不足。由于获得内分泌治疗的机会有限，低收入， 因此，患有T1 D的西班牙裔成年人经常在联邦合格的健康中心（CAHCs）接受糖尿病管理 很少或根本无法接触到CGM因此，为了促进最脆弱的西班牙裔人公平地接受CGM， 一项为期4年的混合方法可行性研究，包括一项试点随机对照试验（RCT）， 建议主要评估SEM引导的干预（针对个人、家庭/社会）的可行性 网络和医疗保健提供者级别）。个人层面的干预促进了基本的获得， 通过两种方法获得CGM摄取的信息、动机和行为技能：（1）4周，个性化， 与糖尿病教育认证的RN进行CGM会议;（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， 集体主义，以促进CGM摄取的关键支持，家庭成员共同参加为期4周的会议 和参与者在预定访问期间与同伴教育者的互动。类的提供程序级别 干预的目的是促进提高文化能力的干预交付和提供临床 通过T1 D管理和CGM项目ECHO的严格培训，为CGM提供支持。研究阶段 1（目标1），将根据利益相关者的定性结果对干预措施进行改进，并将 计划在4个随机分配的研究中心实施干预（n=2）或对照（n=2）治疗， 入组目标为30例T1 D西班牙裔患者（临床试验机构的入组率大致相当）。ECHO项目：CGM & T1 D护理也将提供给干预现场提供者。在第2阶段（目标2），研究的可行性 协议（例如，招聘和保留收益，数据收集程序，干预措施的实施，以及 干预的可接受性等）进行常规评估。在第2阶段（目标3）， 生理方面的信号（例如，A1 C和时间在范围内，高于和低于范围），心理社会（例如，质量 从基线到3- 6年的生活、家庭支持、医生信任）和行为（CGM依从性）结局 将评估基线后3个月。本研究的长期目标是为大型多中心RCT提供信息， 成功的结果，为全国T1 D西班牙裔成人的CGM摄取提供了一个模型