Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem (ACCTiVATE)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Diabetes

Treatments: Other: Practice Facilitation (Clinic-Level Intervention); Other: Digital Health Coaching (Patient-Level Intervention)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06598436

R01MD019042 (U.S. NIH Grant/Contract)

23-40207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age
• 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

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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600 participants in 4 patient groups

Patient Intervention + Clinic Intervention

Experimental group

Description:

Digital coach navigator + Clinic Intervention

Treatment:

Other: Digital Health Coaching (Patient-Level Intervention)

Other: Practice Facilitation (Clinic-Level Intervention)

Patient Usual Care + Clinic Usual Care

No Intervention group

Description:

Usual Care (Patient-Level) + Clinic Usual Care

Patient Intervention + Clinic Usual Care

Experimental group

Description:

Digital coach navigator + Clinic Usual Care

Treatment:

Other: Digital Health Coaching (Patient-Level Intervention)

Patient Usual Care + Clinic Intervention

Experimental group

Description:

Usual Care (Patient-Level) + Clinic Intervention

Treatment:

Other: Practice Facilitation (Clinic-Level Intervention)