Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
NCT ID: NCT06598436
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2024-11-04
2028-09-30
Brief Summary
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Detailed Description
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Aim 1: Assess the impact of the multi-level intervention on clinical outcomes at 3, 6, 12, and 24 months. Our working hypotheses are that patients randomized to receive digital coaching (vs. usual care) will experience a greater change in mean glycosylated hemoglobin A1C, both overall and among Black and Latinx patients. Clinics randomized to practice facilitation (vs. usual care) will experience a greater clinic-level change in mean glycosylated hemoglobin A1C, both overall and among their Black and Latinx populations.
Aim 2: Assess the impact of the multi-level intervention on process outcomes related to digital literacy, engagement in care, and health IT utilization at 3, 6, 12, and 24 months. The investigators hypothesize that randomization to digital coaching (vs. usual care) will increase patient portal use, digital literacy, and visit show rate, overall and among Black and Latinx patients. Randomization to practice facilitation (vs. usual care) will increase clinic-level use of telehealth video visits and patient-portal communication, overall and with Black and Latinx patients.
Aim 3: Conduct a mixed methods evaluation of intervention implementation outcomes. Quantitative engagement data, direct observations of intervention sessions, and stakeholder interviews will characterize implementation outcomes and factors necessary to integrate the multi-level intervention into clinical operations, applying the RE-AIM implementation science framework.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Patient Intervention + Clinic Intervention
Digital coach navigator + Clinic Intervention
Digital Health Coaching (Patient-Level Intervention)
The patient-level intervention combines the role of digital health navigator and chronic disease health coach to facilitate access to devices and broadband, offer digital skills training, and provide chronic disease health coaching focused on telehealth modalities.
Practice Facilitation (Clinic-Level Intervention)
The clinic-level intervention includes primary care clinic support through practice facilitation that empowers team members to address racial/ethnic disparities in telehealth use through consistent review of telehealth equity data and input from clinic-specific Patient Advisory Councils (PACs).
Patient Usual Care + Clinic Usual Care
Usual Care (Patient-Level) + Clinic Usual Care
No interventions assigned to this group
Patient Intervention + Clinic Usual Care
Digital coach navigator + Clinic Usual Care
Digital Health Coaching (Patient-Level Intervention)
The patient-level intervention combines the role of digital health navigator and chronic disease health coach to facilitate access to devices and broadband, offer digital skills training, and provide chronic disease health coaching focused on telehealth modalities.
Patient Usual Care + Clinic Intervention
Usual Care (Patient-Level) + Clinic Intervention
Practice Facilitation (Clinic-Level Intervention)
The clinic-level intervention includes primary care clinic support through practice facilitation that empowers team members to address racial/ethnic disparities in telehealth use through consistent review of telehealth equity data and input from clinic-specific Patient Advisory Councils (PACs).
Interventions
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Digital Health Coaching (Patient-Level Intervention)
The patient-level intervention combines the role of digital health navigator and chronic disease health coach to facilitate access to devices and broadband, offer digital skills training, and provide chronic disease health coaching focused on telehealth modalities.
Practice Facilitation (Clinic-Level Intervention)
The clinic-level intervention includes primary care clinic support through practice facilitation that empowers team members to address racial/ethnic disparities in telehealth use through consistent review of telehealth equity data and input from clinic-specific Patient Advisory Councils (PACs).
Eligibility Criteria
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Inclusion Criteria
* English or Spanish-Speaking
* Have uncontrolled diabetes defined as a listed diagnosis of diabetes with a recorded A1C ≥ 8.0% in the past two years or have uncontrolled HTN defined as a listed diagnosis of HTN and last recorded documented SBP \>140 mmHg
* At least 2 visits at a participating SFHN primary care site in the last 24 months
Exclusion Criteria
* Presence of co-morbid conditions that would make it inappropriate to focus on telehealth chronic disease management. Conditions may include: end-stage or terminal condition with limited life expectancy and severe mental illness.
* Lack of any working phone number
* Visual or hearing impairment that precludes use of telehealth for chronic disease management
* Cognitive impairment defined by the inability to restate study goals during the consent process
* Pregnant
18 Years
ALL
No
Sponsors
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San Francisco Tech Council
UNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Delphine Tuot, MD MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Zuckerberg San Francisco General Hospital (ZSFG) & SF Department of Public Health (DPH)
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Meng YY, Diamant A, Jones J, Lin W, Chen X, Wu SH, Pourat N, Roby D, Kominski GF. Racial and Ethnic Disparities in Diabetes Care and Impact of Vendor-Based Disease Management Programs. Diabetes Care. 2016 May;39(5):743-9. doi: 10.2337/dc15-1323. Epub 2016 Mar 10.
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Jain V, Al Rifai M, Lee MT, Kalra A, Petersen LA, Vaughan EM, Wong ND, Ballantyne CM, Virani SS. Racial and Geographic Disparities in Internet Use in the U.S. Among Patients With Hypertension or Diabetes: Implications for Telehealth in the Era of COVID-19. Diabetes Care. 2021 Jan;44(1):e15-e17. doi: 10.2337/dc20-2016. Epub 2020 Nov 2. No abstract available.
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Other Identifiers
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23-40207
Identifier Type: -
Identifier Source: org_study_id
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