Clinical trial NCT06598436: Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
Official title: Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: 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)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Tech Council
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-09-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The investigators propose a prospective, multilevel, nonblinded 2x2 randomized controlled trial to determine the effectiveness of a clinic-level intervention and a patient-level intervention, as well as the potential synergistic impact of both interventions on process outcomes and clinical measures of diabetes control. Five of the 11 participating clinics will be randomized to receive practice facilitation for 24 months. After implementing the clinic-level intervention, the investigators will begin recruiting/randomizing eligible patients in a 1:2 ratio to receive tailored digital coaching (n=200) or usual care (n=400) for 3 months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Patient-Level Hemoglobin A1C
timeFrame: Baseline, month 3, month 6, and month 12
measure: Change in Patient Portal Use
timeFrame: Baseline, month 3, month 6, and month 12
Secondary outcomes:
measure: Digital Literacy
timeFrame: Baseline, month 3, month 6, and month 12
measure: Medication Adherence
timeFrame: Baseline, month 3, month 6, and month 12
measure: Patient Activation Measure (PAM)
timeFrame: Baseline, month 3, month 6, and month 12
measure: Change in Clinic-Wide Blood Pressure (mmHg)
timeFrame: Baseline, month 3, month 6, month 12, and month 24
measure: Change in Clinic-Wide Hemoglobin A1C (average)
timeFrame: Baseline, month 3, month 6, month 12, and month 24
measure: Change in Patient-Level Systolic BP (mmHg)
timeFrame: Baseline, month 3, month 6, month 12
measure: Proportion of Primary care Clinic Visits Completed by Video
timeFrame: Baseline, month 3, month 6, month 12 and month 24
measure: Number of Patient Portal Communications Completed by Primary Care Team Members
timeFrame: Baseline, month 3, month 6, month 12, and month 24
measure: Clinic-level Visit Show Rates
timeFrame: Baseline, month 3, month 6, month 12, and month 24
measure: Change in Patient-Level urine microalbuminuria (mg/g) among individuals with hypertension and/or diabetes
timeFrame: Baseline, month 3, month 6, month 12
measure: Change in Clinic-Wide Urine Albumin-Creatinine Ratio UACR (mg/g) among individuals with hypertension and/or diabetes.
timeFrame: Baseline, month 3, month 6, month 12, and month 24
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital (ZSFG) &amp;amp; SF Department of Public Health (DPH)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Delphine Tuot, MD MAS
role: PRINCIPAL_INVESTIGATOR
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