Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Digital 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.
• Другое Practice 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).

Первичные конечные точки

• Change in Patient-Level Hemoglobin A1C [Срок оценки: Baseline, month 3, month 6, and month 12]
• Change in Patient Portal Use [Срок оценки: Baseline, month 3, month 6, and month 12]

Вторичные конечные точки (11)

• Digital Literacy [Срок оценки: Baseline, month 3, month 6, and month 12]
• Medication Adherence [Срок оценки: Baseline, month 3, month 6, and month 12]
• Patient Activation Measure (PAM) [Срок оценки: Baseline, month 3, month 6, and month 12]
• Change in Clinic-Wide Blood Pressure (mmHg) [Срок оценки: Baseline, month 3, month 6, month 12, and month 24]
• Change in Clinic-Wide Hemoglobin A1C (average) [Срок оценки: Baseline, month 3, month 6, month 12, and month 24]
• Change in Patient-Level Systolic BP (mmHg) [Срок оценки: Baseline, month 3, month 6, month 12]
• Proportion of Primary care Clinic Visits Completed by Video [Срок оценки: Baseline, month 3, month 6, month 12 and month 24]
• Number of Patient Portal Communications Completed by Primary Care Team Members [Срок оценки: Baseline, month 3, month 6, month 12, and month 24]
• Clinic-level Visit Show Rates [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Baseline, month 3, month 6, month 12, and month 24]

Критерии участия

Критерии включения

• ≥ 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Zuckerberg San Francisco General Hospital (ZSFG) & SF Department of Public Health — San Francisco

Публикации

• Patrick K, Norman GJ, Davila EP, Calfas KJ, Raab F, Gottschalk M, Sallis JF, Godbole S, Covin JR. Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes. J Diabetes Sci Technol. 2013 May 1;7(3):759-70. doi: 10.1177/193229681300700322. PMID 23759410
• Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):855-870. doi: 10.1093/jamia/ocz023. PMID 30958532
• Irizarry T, Shoemake J, Nilsen ML, Czaja S, Beach S, DeVito Dabbs A. Patient Portals as a Tool for Health Care Engagement: A Mixed-Method Study of Older Adults With Varying Levels of Health Literacy and Prior Patient Portal Use. J Med Internet Res. 2017 Mar 30;19(3):e99. doi: 10.2196/jmir.7099. PMID 28360022
• Taha J, Sharit J, Czaja SJ. The impact of numeracy ability and technology skills on older adults' performance of health management tasks using a patient portal. J Appl Gerontol. 2014 Jun;33(4):416-36. doi: 10.1177/0733464812447283. Epub 2012 Jun 4. PMID 24781964
• Sarkar U, Karter AJ, Liu JY, Adler NE, Nguyen R, Lopez A, Schillinger D. Social disparities in internet patient portal use in diabetes: evidence that the digital divide extends beyond access. J Am Med Inform Assoc. 2011 May 1;18(3):318-21. doi: 10.1136/jamia.2010.006015. Epub 2011 Jan 24. PMID 21262921
• Wallace LS, Angier H, Huguet N, Gaudino JA, Krist A, Dearing M, Killerby M, Marino M, DeVoe JE. Patterns of Electronic Portal Use among Vulnerable Patients in a Nationwide Practice-based Research Network: From the OCHIN Practice-based Research Network (PBRN). J Am Board Fam Med. 2016 Sep-Oct;29(5):592-603. doi: 10.3122/jabfm.2016.05.160046. PMID 27613792
• Sarkar U, Karter AJ, Liu JY, Adler NE, Nguyen R, Lopez A, Schillinger D. The literacy divide: health literacy and the use of an internet-based patient portal in an integrated health system-results from the diabetes study of northern California (DISTANCE). J Health Commun. 2010;15 Suppl 2(Suppl 2):183-96. doi: 10.1080/10810730.2010.499988. PMID 20845203
• Lyles CR, Tieu L, Sarkar U, Kiyoi S, Sadasivaiah S, Hoskote M, Ratanawongsa N, Schillinger D. A Randomized Trial to Train Vulnerable Primary Care Patients to Use a Patient Portal. J Am Board Fam Med. 2019 Mar-Apr;32(2):248-258. doi: 10.3122/jabfm.2019.02.180263. PMID 30850461

Идентификаторы

NCT: NCT06598436 · 23-40207 · R01MD019042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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