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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD019042 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| San Francisco Tech Council | UNKNOWN |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Intervention + Clinic Intervention | Experimental | Digital coach navigator + Clinic Intervention |
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| 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 |
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| Patient Usual Care + Clinic Intervention | Experimental | Usual Care (Patient-Level) + Clinic Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Digital Literacy | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andy Ramirez, BS | Contact | 415-562-4509 | Andy.Ramirez@ucsf.edu | |
| Alexandra Velasquez, MS | Contact | 415-562-4509 | ACCTIVATEStudy@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Delphine Tuot, MD MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital (ZSFG) & SF Department of Public Health (DPH) | Recruiting | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23759410 | Background | 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. | |
| 30958532 | 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. |
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The proposed research will include data from approximately 690 participants recruited from primary care clinics in the San Francisco Health Network with uncontrolled diabetes (defined as glycosylated A1c greater than or equal to 8.0%). The final dataset will include self-reported demographic, telehealth engagement, and chronic disease self-management data from self-report, and additional demographic, clinical outcome, and telehealth utilization data from the electronic medical record. The data will be made available in a de-identified format in a .csv or .dta file. In addition to the IPD data set, the ACCTIVATE study team will share the data set, data dictionary, statistical analysis plan, analytic code, and final protocol with amendments
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.
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.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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.
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| 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). |
|
| Baseline, month 3, month 6, and month 12 |
| Medication Adherence | 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. | Baseline, month 3, month 6, and month 12 |
| Patient Activation Measure (PAM) | 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. | Baseline, month 3, month 6, and month 12 |
| Change in Clinic-Wide Blood Pressure (mmHg) | BP readings will be obtained from the EHR | Baseline, month 3, month 6, month 12, and month 24 |
| Change in Clinic-Wide Hemoglobin A1C (average) | Hemoglobin A1C readings will be obtained from the EHR | Baseline, month 3, month 6, month 12, and month 24 |
| Change in Patient-Level Systolic BP (mmHg) | Changes in mean SBP from baseline, using values from the electronic health record. | Baseline, month 3, month 6, month 12 |
| Proportion of Primary care Clinic Visits Completed by Video | This proportion will be ascertained from the electronic health record. | Baseline, month 3, month 6, month 12 and month 24 |
| Number of Patient Portal Communications Completed by Primary Care Team Members | The number of patient portal communications will be ascertained from the EHR | Baseline, month 3, month 6, month 12, and month 24 |
| Clinic-level Visit Show Rates | Visit show rates for in-person, phone, or telehealth video as obtained from the EHR | 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 | Urine microalbuminuria (mg/g) will be obtained from the electronic health record. | 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. | Microalbuminuria values among individuals with hypertension and/or diabetes will be obtained from the EHR. | Baseline, month 3, month 6, month 12, and month 24 |
| 28360022 | 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. |
| 24781964 | 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. |
| 21262921 | 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. |
| 27613792 | 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. |
| 20845203 | 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. |
| 30850461 | 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. |
| 27095507 | 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. |
| 23423453 | 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. |
| 36540762 | 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. |
| 33798406 | 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. |
| 26965718 | 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. |
| 33442585 | 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. |
| 33674277 | 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. |
| 33528494 | 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. |
| 33139408 | 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. |
| 34705664 | 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. |
| 12607901 | 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. |
| 33164063 | 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. |
| 27402138 | 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. |
| 26681155 | 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. |
| 39679006 | Derived | 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. |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |