Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in Patient-Level Hemoglobin A1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
Patient Usual Care + Clinic Usual Care
Usual Care (Patient-Level) + Clinic Usual Care
Patient Intervention + Clinic Intervention
Digital coach navigator + Clinic Intervention
干预措施: Digital Health Coaching (Patient-Level Intervention) (Other)
Patient Intervention + Clinic Intervention
Digital coach navigator + Clinic Intervention
干预措施: Practice Facilitation (Clinic-Level Intervention) (Other)
Patient Intervention + Clinic Usual Care
Digital coach navigator + Clinic Usual Care
干预措施: Digital Health Coaching (Patient-Level Intervention) (Other)
Patient Usual Care + Clinic Intervention
Usual Care (Patient-Level) + Clinic Intervention
干预措施: Practice Facilitation (Clinic-Level Intervention) (Other)
结局指标
主要结局
Change in Patient-Level Hemoglobin A1C
时间窗: 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
时间窗: Baseline, month 3, month 6, and month 12
The average number of patient portal log-ins per month will be obtained from the EHR
次要结局
- Digital Literacy(Baseline, month 3, month 6, and month 12)
- Medication Adherence(Baseline, month 3, month 6, and month 12)
- Patient Activation Measure (PAM)(Baseline, month 3, month 6, and month 12)
- Change in Clinic-Wide Blood Pressure (mmHg)(Baseline, month 3, month 6, month 12, and month 24)
- Change in Clinic-Wide Hemoglobin A1C (average)(Baseline, month 3, month 6, month 12, and month 24)
- Change in Patient-Level Systolic BP (mmHg)(Baseline, month 3, month 6, month 12)
- Proportion of Primary care Clinic Visits Completed by Video(Baseline, month 3, month 6, month 12 and month 24)
- Number of Patient Portal Communications Completed by Primary Care Team Members(Baseline, month 3, month 6, month 12, and month 24)
- Clinic-level Visit Show Rates(Baseline, month 3, month 6, month 12, and month 24)
- Change in Patient-Level urine microalbuminuria (mg/g) among individuals with hypertension and/or diabetes(Baseline, month 3, month 6, month 12)
- 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)