This study is not yet accepting patients

Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem

a study on Diabetes

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Delphine Tuot, MD MAS
Headshot of Delphine Tuot
Delphine Tuot

Description

Summary

This study examines the impact of a multi-level intervention aiming to improve telehealth access for low-income patients managing chronic health conditions, such as hypertension and diabetes. The multi-level intervention includes clinic-level practice facilitation and patient-level digital health coaching.

Details

ACCTIVATE is a multi-level intervention (including practice facilitation and patient digital coaching) that aims to tackle patient-level and clinic-level barriers to increase the equitable use of telehealth tools for chronic disease management. Direct patient support via digital coaching can meet the needs of patients who have been left behind in the digital divide. For those with reduced digital literacy and low access to smartphones and broadband, this resource can increase their confidence in using digital technologies and engaging in virtual care. Additionally, primary care clinic support through practice facilitation can empower team members to address racial/ethnic disparities in telehealth use through equitable screening/offering of digital technologies, resources to prepare patients for virtual chronic disease management, and consistent review of telehealth equity data. The investigators hypothesize that this multi-level intervention will improve patient control of chronic health conditions (i.e., glycosylated hemoglobin) as well as digital literacy, while also increasing patient and clinician engagement with patient portals, telehealth video visits and remote monitoring.

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.

Keywords

Diabetes, Adverse Event, Blood Pressure, Community Advisory Board (CAB), Chronic Kidney Disease (CKD), Clinic-level Intervention, Clinical Research Coordinator (CRC), Cardiovascular Disease, Digital Coach Navigator, Federally Qualified Health Center (FQHC), Good Clinical Practice, Health Care Systems, Health Insurance Portability and Accountability Act of 1996, Hemoglobin A1C, Informed Consent Form (ICF), Institutional Review Board (IRB), Library, National Institutes of Health (NIH), Randomized Control Trial (RCT), National Institute of Minority Health and Health Disparities (NIHMD), Patient Advisory Council (PAC), Patient-level Intervention, Principal Investigator (PI), Socioeconomic Status, San Francisco Health Network (SFHN), Systolic Blood Pressure (SBP), Telehealth, Telemedicine, University of California, San Francisco (UCSF), Zuckerberg San Francisco General Hospital (ZSFG), Digital Health Coaching (Patient-Level Intervention), Practice Facilitation (Clinic-Level Intervention)

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥ 18 years of age
  • English or Spanish-Speaking
  • Have diabetes with a last A1C ≥ 8.0%
  • At least 1 visit at a participating SFHN primary care site in the last 24 months

You CAN'T join if...

  • Higher than average digital literacy, defined as an Digital Healthcare Literacy Scale (DHLS) score greater than 10, as determined prior to the baseline study visit; these patients may not benefit from a digital coaching intervention.
  • 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

Location

  • Zuckerberg San Francisco General Hospital (ZSFG) & SF Department of Public Health (DPH)
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Delphine Tuot, MD MAS
    College: Stanford University, BS Medical School: McGill University Faculty of Medicine, MDCM Other graduate training: University of California, San Francisco, MAS Internal Medicine residency: University of California, San Francisco Nephrology fellowship: University of California, San Francisco Dr. Tuot is a Professor of Medicine, Interim Division Chief of Nephrology at ZSFG, A…

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06598436
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated