Diabetes
Conditions
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)
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.
Interventions
OTHERDigital 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.
OTHERPractice 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).
Sponsors
San Francisco Tech Council
National Institute on Minority Health and Health Disparities (NIMHD)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Level Hemoglobin A1C | Baseline, month 3, month 6, and month 12 | Change in A1C (%) will be determined by subtracting month 3, 6, and 12 A1C values from baseline A1C |
| Change in Patient Portal Use | Baseline, month 3, month 6, and month 12 | The average number of patient portal log-ins per month will be obtained from the EHR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM) | Baseline, month 3, month 6, and month 12 | Patient activation will be measured by the Patient Activation Measure (PAM). The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree, 0 = undecided). Item scores are summed to a raw score resulting in theoretical values between 13 and 52, with higher scores indicating higher patient activation. |
| Change in Clinic-Wide Blood Pressure (mmHg) | Baseline, month 3, month 6, month 12, and month 24 | BP readings will be obtained from the EHR |
| Change in Clinic-Wide Hemoglobin A1C (average) | Baseline, month 3, month 6, month 12, and month 24 | Hemoglobin A1C readings will be obtained from the EHR |
| Change in Patient-Level Systolic BP (mmHg) | Baseline, month 3, month 6, month 12 | Changes in mean SBP from baseline, using values from the electronic health record. |
| Digital Literacy | Baseline, month 3, month 6, and month 12 | Digital literacy will be ascertained with the Digital Healthcare Literacy Scale (DHLS). The DHLS is an 3-item scale that uses a 5-point Likert scale. Scores range from 0 to 12, with higher scores indicating higher digital health care literacy. Ongoing digital literacy will be ascertained with the Digital Equity Screening Tool Scale (DEST). The DEST is an 5-item scale that uses a 5-point Likert scale. |
| Number of Patient Portal Communications Completed by Primary Care Team Members | Baseline, month 3, month 6, month 12, and month 24 | The number of patient portal communications will be ascertained from the EHR |
| Clinic-level Visit Show Rates | Baseline, month 3, month 6, month 12, and month 24 | Visit show rates for in-person, phone, or telehealth video as obtained from the EHR |
| Change in Patient-Level urine microalbuminuria (mg/g) among individuals with hypertension and/or diabetes | Baseline, month 3, month 6, month 12 | Urine microalbuminuria (mg/g) will be obtained from the electronic health record. |
| Change in Clinic-Wide Urine Albumin-Creatinine Ratio UACR (mg/g) among individuals with hypertension and/or diabetes. | Baseline, month 3, month 6, month 12, and month 24 | Microalbuminuria values among individuals with hypertension and/or diabetes will be obtained from the EHR. |
| Proportion of Primary care Clinic Visits Completed by Video | Baseline, month 3, month 6, month 12 and month 24 | This proportion will be ascertained from the electronic health record. |
| Medication Adherence | Baseline, month 3, month 6, and month 12 | Medication adherence will be ascertained by the eight-item Morisky Medication Adherence Scale (MMAS-8). The scales score ranges from 0 to 8, with higher scores indicating greater medication adherence. High adherence: A score of 8 Medium adherence: A score of 6-8 Low adherence: A score of 6 and below. |
Countries
United States
Contacts
Primary ContactAndy Ramirez, BS
Backup ContactAlexandra Velasquez, MS
Outcome results
None listed