Evaluating Telementoring for CHW-centered Diabetes Initiatives

Study Overview
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Brief Summary
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Diabetes care is complex and requires a multidimensional approach, but interventional programs are difficult to initiate in low-income and minority populations. In the proposed study, investigators will mentor local clinics via telehealth to initiate our diabetes program, TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education), into their clinics. Mentoring local clinics to initiate TIME is a promising strategy to enhance sustainable diabetes care and reduce disparities in vulnerable minority populations.

Detailed Description
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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, investigators 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. Investigators 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. Investigators 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. Investigators have pilot data showing the feasibility of telementoring a local clinic to initiate TIME that has resulted in improved HbA1c levels but it needs to be tested within a larger sample. In the proposed study investigators 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, investigators 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, investigators will follow these clinical measures until 36 months (AIM 2). Investigators will also provide TIME program acceptability and evaluation data for participants and clinic teams from baseline to 12-months (AIM 3). Investigators 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. Investigators 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.

Official Title
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Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-identified Latino(a) Spanish-speaking >/=18 years type 2 diabetes (T2D), e.g., HbA1c >/=6.5%, provider documented T2D, on oral anti-hyperglycemic uninsured, <150% federal poverty level Exclusion Criteria: no show to all group visits condition that may alter HbA1c levels, e.g., recent blood transfusion patients at high-risk or not appropriate for care in a group setting e.g., pregnancy, severe cognitive impairment, frequent clinic appointments for labile glucose/medication titration e.g., insulin.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention individuals will receive the 12-month diabetes TIME program | Other: Intervention<br>* In the proposed study, we will conduct a randomized clinical trial of low-income, adult Latino(a)s with type 2 diabetes randomized at the individual level to TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education) (intervention) versus usual care enhanced with education (EUC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month TIME program into their clinics.<br>|
| Other: Enhanced Usual Care (EUC)<br>We will define EUC as usual clinical care, which consists of diabetes management provider encounters (mean quarterly) plus monthly individual appointments with a pharm-Ds or nutritionists as clinically indicated. In addition, clinics offer multiple other individual and group opportunities. In addition for the EUC arm, we will provide three quarterly, 1-hour classes (nutrition medications, exercise). The classes will be led by a research-staff trained, bilingual healthcare professional e.g., nurse. EUC individuals will not have contact with CHWs. | Other: Intervention<br>* In the proposed study, we will conduct a randomized clinical trial of low-income, adult Latino(a)s with type 2 diabetes randomized at the individual level to TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education) (intervention) versus usual care enhanced with education (EUC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month TIME program into their clinics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Compare TIME versus EUC HbA1c levels | Baseline to 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Compare TIME versus blood pressure levels (systolic and diastolic) | Baseline to 12-months | 
| Body Mass Index (BMI) | Compare TIME versus EUC BMI levels | Baseline to 12-months | 
| Cholesterol | Compare TIME versus EUC cholesterol levels | Baseline to 12-months | 
| American Diabetes Association (ADA) adherence measures: Diabetes foot exam | Compare TIME versus EUC adherence to diabetes foot exams | Baseline to 12-months | 
| ADA adherence measures: B12 screening | Compare TIME versus EUC adherence to B12 screening | Baseline to 12-months | 
| ADA adherence measures: Diabetes eye exam | Compare TIME versus EUC adherence to diabetes eye exams | Baseline to 12-months | 
| ADA adherence measures: urine microalbumin screening | Compare TIME versus EUC adherence to urine microalbumin screening | Baseline to 12-months | 
| ADA adherence measures: flu vaccination | Compare TIME versus EUC adherence to flu vaccination | Baseline to 12-months | 
| ADA adherence measures: statin therapy | Compare TIME versus EUC adherence to statin therapy | Baseline to 12-months | 
| Sustainable clinical outcomes: HbA1c | Compared to EUC, TIME will have more sustainable HbA1c levels | baseline to 36-months | 
| Sustainable clinical outcomes: Blood pressure | Compared to EUC, TIME will have more sustainable blood pressure levels (systolic and diastolic) | baseline to 36-months | 
| Sustainable clinical outcomes: BMI | Compared to EUC, TIME will have more sustainable BMI levels | baseline to 36-months | 
| TIME satisfaction | Anticipate >/=80% patient satisfaction as demonstrated by our 12-question satisfaction survey questions (on Likert scales of 1 to 10 (n=5 questions) where 10 is very satisfied and 1 is not at all satisfied and from 1-4 (n=3 questions) where 4 is very satisfied and 1 is not satisfied). There are three open-ended questions. | 12-months | 
| Attrition | Rate of attrition for TIME participants | baseline to 12-months | 
| Community Health Worker (CHW) knowledge | At 12-months; Knowledge as measured the CHW posttest, which includes 24-questions from the Star Education Study diabetes knowledge test, which has shown validity and reliability in English and Spanish and our TIME 25-question diabetes medication test that has been previously published. Tests are multiple choice with 4 possible answers. | 12-months | 
| Telehealth Acceptability | Acceptability as measured by the Telehealth Usability Questionnaire, a 21-question survey of telehealth acceptability. Items are ranked on a 5-item scale (1 not acceptable, 5 very acceptable) and divided into six subsections that have shown good to excellent internal consistency. | 12-months |