Evaluating telementoring to initiate a multidimensional diabetes program for Latino(a)s in community clinics: A Randomized Clinical Trial

评估远程指导以在社区诊所为拉丁裔启动多维糖尿病计划：一项随机临床试验

• 批准号: 10477420
• 负责人: Elizabeth M Vaughan
• 金额: --
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2022-08-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477420
• 关键词: Address; Adherence; Adult; Albumins; American; Appointment; Blood Pressure; Body mass index; COVID-19; COVID-19 pandemic; Caring; Cholesterol; Clinic; Clinical; Communication; Communities; Community Health Aides; Complex; Data; Development; Diabetes Mellitus; Diagnosis; Education; Ethnic Origin; Evaluation; Expenditure; Face; Fright; Frontline worker; Glycosylated hemoglobin A; Guidelines; Health Expenditures; Health Services Accessibility; Healthcare; Healthcare Systems; Human Resources; Income; Individual; Inequality; International; Intervention; Investigation; Knowledge; Latino; Left; Logistics; Low income; Measures; Medical; Mentors; Minority; Minority Groups; Modality; Non-Insulin-Dependent Diabetes Mellitus; Ophthalmic examination and evaluation; Outcome; Participant; Patient Care; Patients; Pharmaceutical Preparations; Poverty; Prevalence; Program Acceptability; Program Evaluation; Provider; Public Health; Randomized; Randomized Clinical Trials; Research; Research Proposals; Sampling; Structure; Supervision; Testing; Texas; Training; Training Support; Videoconferencing; Visit; Vulnerable Populations; Work; arm; barrier to care; clinical efficacy; community clinic; comparison intervention; cost effective; diabetes education; disorder risk; disparity reduction; efficacy evaluation; foot; glycemic control; improved; influenza virus vaccine; innovation; interest; intervention participants; intervention program; literacy; mHealth; member; minority healthcare; multidisciplinary; pandemic disease; pragmatic implementation; primary outcome; programs; public health relevance; telehealth; treatment as usual; urinary

PROJECT SUMMARY/ABSTRACT Diabetes is a major public health problem in Latino(a)s. There are escalating numbers of Latino(a)s diagnosed with diabetes and at disproportionate rates compared to other ethnicities. Numerous interventions have been initiated to improve minority healthcare including diabetes group visits, which have been valuable in improving education and glycemic control. In our group visit investigations, we initiated Community Health Workers (CHWs)—local community members who serve as culturally-sensitive patient liaisons to the healthcare system—as part of the multidisciplinary team. We demonstrated that CHWs are vital team members and particularly helpful in identifying medication-access barriers. However, CHWs are frontline workers and often left unsupported and poorly supervised. We used these data to pioneer the combination of four diabetes interventions in our TIME trial (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education). The TIME trial showed that individuals randomized to TIME significantly improved glycemic control, blood pressure and adherence to American Diabetes Association standards compared to usual care. The study also showed that telehealth (mobile health (mHealth) and ZOOM video conferencing) was instrumental in supporting CHWs in their work and enhancing their communication with patients. The COVID-19 pandemic has highlighted the expansive use of telehealth and its ability to improve healthcare. It has also underscored the pressing need to improve care for low-income minorities. Though diabetes programs are valuable in improving education and clinical outcomes, they are often difficult to initiate in low-income settings. Pragmatic implementation using telehealth to mentor local clinic teams of providers and CHWs is promising to address these barriers. We have pilot data showing the feasibility of telementoring a local clinic to initiate TIME that has resulted in improved HbA1c levels but we now need to test it within a larger sample. In the proposed study we will evaluate this approach in a randomized clinical trial (N=250; intervention=125) of low-income, adult Latino(a)s with type 2 diabetes randomized to TIME (intervention) versus usual care enhanced with education (EUC). Our research group will provide telementoring to local clinic teams to initiate TIME into their clinics. To evaluate efficacy, we will compare TIME versus EUC clinical changes including HbA1c (primary outcome), blood pressure, cholesterol, and body mass index from baseline to 12-months (AIM 1). To compare longitudinal data of study arms, we will follow these clinical measures until 36 months (AIM 2). We will also provide TIME program acceptability and evaluation data for participants and clinic teams from baseline to 12- months (AIM 3). We hypothesize that TIME participants will have superior and more sustainable clinical outcomes compared to EUC individuals and that the intervention will have high levels of acceptability and evaluation data. We anticipate that the proposed study will provide justification of telementoring to initiate TIME and strong evidence to improve the longitudinal care of low-income Latino(a)s with diabetes.

项目总结/文摘