Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem

NCT06598436 | Recruiting

• 2 other identifiers: 23-40207R01MD019042
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (2)

• Change in Patient-Level Hemoglobin A1C

  Change in A1C (%) will be determined by subtracting month 3, 6, and 12 A1C values from baseline A1C

  Baseline, month 3, month 6, and month 12

• Change in Patient Portal Use

  The average number of patient portal log-ins per month will be obtained from the EHR

  Baseline, month 3, month 6, and month 12

Secondary Outcomes (11)

• 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

Study Arms (4)

Patient Intervention + Clinic Intervention

EXPERIMENTAL

Digital coach navigator + Clinic Intervention

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

Patient Usual Care + Clinic Usual Care

NO INTERVENTION

Usual Care (Patient-Level) + Clinic Usual Care

Patient Intervention + Clinic Usual Care

EXPERIMENTAL

Digital coach navigator + Clinic Usual Care

Other: Digital Health Coaching (Patient-Level Intervention)

Patient Usual Care + Clinic Intervention

EXPERIMENTAL

Usual Care (Patient-Level) + Clinic Intervention

Other: Practice Facilitation (Clinic-Level Intervention)

Interventions

Digital Health Coaching (Patient-Level Intervention) OTHER

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.

Patient Intervention + Clinic Intervention; Patient Intervention + Clinic Usual Care

Practice Facilitation (Clinic-Level Intervention) OTHER

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).

Patient Intervention + Clinic Intervention; Patient Usual Care + Clinic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Tech Council: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

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

San Francisco, California, 94110, United States

RECRUITING

Related Publications (23)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Ramirez V, Johnson E, Gonzalez C, Ramirez V, Rubino B, Rossetti G. Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics. JMIR Mhealth Uhealth. 2016 Apr 19;4(2):e41. doi: 10.2196/mhealth.4928.

  PMID: 27095507 BACKGROUND

• Schickedanz A, Huang D, Lopez A, Cheung E, Lyles CR, Bodenheimer T, Sarkar U. Access, interest, and attitudes toward electronic communication for health care among patients in the medical safety net. J Gen Intern Med. 2013 Jul;28(7):914-20. doi: 10.1007/s11606-012-2329-5. Epub 2013 Feb 20.

  PMID: 23423453 BACKGROUND

• Nishii A, Campos-Castillo C, Anthony D. Disparities in patient portal access by US adults before and during the COVID-19 pandemic. JAMIA Open. 2022 Dec 16;5(4):ooac104. doi: 10.1093/jamiaopen/ooac104. eCollection 2022 Dec.

  PMID: 36540762 BACKGROUND

• Barbosa W, Zhou K, Waddell E, Myers T, Dorsey ER. Improving Access to Care: Telemedicine Across Medical Domains. Annu Rev Public Health. 2021 Apr 1;42:463-481. doi: 10.1146/annurev-publhealth-090519-093711.

  PMID: 33798406 BACKGROUND

• Meng YY, Diamant A, Jones J, Lin W, Chen X, Wu SH, Pourat N, Roby D, Kominski GF. Racial and Ethnic Disparities in Diabetes Care and Impact of Vendor-Based Disease Management Programs. Diabetes Care. 2016 May;39(5):743-9. doi: 10.2337/dc15-1323. Epub 2016 Mar 10.

  PMID: 26965718 BACKGROUND

• Wisniewski H, Gorrindo T, Rauseo-Ricupero N, Hilty D, Torous J. The Role of Digital Navigators in Promoting Clinical Care and Technology Integration into Practice. Digit Biomark. 2020 Nov 26;4(Suppl 1):119-135. doi: 10.1159/000510144. eCollection 2020 Winter.

  PMID: 33442585 BACKGROUND

• Samuels-Kalow M, Jaffe T, Zachrison K. Digital disparities: designing telemedicine systems with a health equity aim. Emerg Med J. 2021 Jun;38(6):474-476. doi: 10.1136/emermed-2020-210896. Epub 2021 Mar 4.

  PMID: 33674277 BACKGROUND

• Uscher-Pines L, Sousa J, Jones M, Whaley C, Perrone C, McCullough C, Ober AJ. Telehealth Use Among Safety-Net Organizations in California During the COVID-19 Pandemic. JAMA. 2021 Mar 16;325(11):1106-1107. doi: 10.1001/jama.2021.0282.

  PMID: 33528494 BACKGROUND

• Jain V, Al Rifai M, Lee MT, Kalra A, Petersen LA, Vaughan EM, Wong ND, Ballantyne CM, Virani SS. Racial and Geographic Disparities in Internet Use in the U.S. Among Patients With Hypertension or Diabetes: Implications for Telehealth in the Era of COVID-19. Diabetes Care. 2021 Jan;44(1):e15-e17. doi: 10.2337/dc20-2016. Epub 2020 Nov 2. No abstract available.

  PMID: 33139408 BACKGROUND

• Alkureishi MA, Choo ZY, Rahman A, Ho K, Benning-Shorb J, Lenti G, Velazquez Sanchez I, Zhu M, Shah SD, Lee WW. Digitally Disconnected: Qualitative Study of Patient Perspectives on the Digital Divide and Potential Solutions. JMIR Hum Factors. 2021 Dec 15;8(4):e33364. doi: 10.2196/33364.

  PMID: 34705664 BACKGROUND

• Gaskin DJ, Hadley J. Population characteristics of markets of safety-net and non-safety-net hospitals. J Urban Health. 1999 Sep;76(3):351-70. doi: 10.1007/BF02345673.

  PMID: 12607901 BACKGROUND

• Khoong EC, Butler BA, Mesina O, Su G, DeFries TB, Nijagal M, Lyles CR. Patient interest in and barriers to telemedicine video visits in a multilingual urban safety-net system. J Am Med Inform Assoc. 2021 Feb 15;28(2):349-353. doi: 10.1093/jamia/ocaa234.

  PMID: 33164063 BACKGROUND

• Tieu L, Schillinger D, Sarkar U, Hoskote M, Hahn KJ, Ratanawongsa N, Ralston JD, Lyles CR. Online patient websites for electronic health record access among vulnerable populations: portals to nowhere? J Am Med Inform Assoc. 2017 Apr 1;24(e1):e47-e54. doi: 10.1093/jamia/ocw098.

  PMID: 27402138 BACKGROUND

• Tieu L, Sarkar U, Schillinger D, Ralston JD, Ratanawongsa N, Pasick R, Lyles CR. Barriers and Facilitators to Online Portal Use Among Patients and Caregivers in a Safety Net Health Care System: A Qualitative Study. J Med Internet Res. 2015 Dec 3;17(12):e275. doi: 10.2196/jmir.4847.

  PMID: 26681155 BACKGROUND

• Omomukuyo A, Ramirez A, Davis A, Velasquez A, Najmabadi AL, Kong M, Willard-Grace R, Brown W 3rd, Broderick A, Suomala K, McCulloch CE, Franco N, Sarkar U, Lyles C, Tran AS, Sharma AE, Tuot DS. Achieving Chronic Care Equity by Leveraging the Telehealth Ecosystem (ACCTIVATE): A Multilevel Randomized Controlled Trial Protocol. Med Res Arch. 2024 Nov;12(11):6087. doi: 10.18103/mra.v12i11.6087.

  PMID: 39679006 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Delphine Tuot, MD MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Ramirez, BS

CONTACT

415-562-4509; Andy.Ramirez@ucsf.edu

Alexandra Velasquez, MS

CONTACT

415-562-4509; ACCTIVATEStudy@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available as soon as possible or at the time of associated publication. The duration of preservation and sharing of the data will be a minimum of 5 years after the end of the funding period.
• Access Criteria: The investigators plan to provide access to the data via Dryad. Anyone can download a dataset via Dryad in the form of a zip file. Dryad will maintain storage and access of the data for as long as it maintains scientific utility.

Locations

US (1)