Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
700 participants
INTERVENTIONAL
2020-12-01
2027-11-30
Brief Summary
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Detailed Description
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The ALTA intervention focuses on identifying Latinx patients with uncontrolled hypertension who are non-adherent to their antihypertensive medication, referring them to health coaches, coaching patients on medication adherence and self-management, care planning, and monitoring patients to improve patient outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Practice Faciliation
Will be supported by a practice facilitator
ALTA
The study will involve each site starting with the usual care phase, followed by a period of 6 months during which practice facilitators will conduct the pre-implementation evaluation (e.g., workflow analysis, environmental scan), refine the practice facilitation strategies that will be used in the implementation phase, and train staff in the Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA) intervention model. ALTA is an efficacious systems-level intervention designed to help patients improve their ability to take their high blood pressure medications and control their blood pressure. Practices and the Project ALTA team will work together to implement the ALTA model into routine care to improve blood pressure control and medication adherence in Latinx patients.
Usual Care
Using a stepped wedge design, all practice sites begin as part of the Usual Care (UC) control condition and will receive standard hypertension management that is part of the current clinic procedure. No practice facilitation will occur at this time.
No interventions assigned to this group
Interventions
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ALTA
The study will involve each site starting with the usual care phase, followed by a period of 6 months during which practice facilitators will conduct the pre-implementation evaluation (e.g., workflow analysis, environmental scan), refine the practice facilitation strategies that will be used in the implementation phase, and train staff in the Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA) intervention model. ALTA is an efficacious systems-level intervention designed to help patients improve their ability to take their high blood pressure medications and control their blood pressure. Practices and the Project ALTA team will work together to implement the ALTA model into routine care to improve blood pressure control and medication adherence in Latinx patients.
Eligibility Criteria
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Inclusion Criteria
* Be fluent in English or Spanish
* Be age 18 years or older
* Receiving care in a safety-net primary care practice
* Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)
* Have been prescribed at least one anti-hypertensive medication and be non- adherent to their medications, defined as adherence \<80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.
• Primary care provider (MD/DO, NP), Nurse, Medical Assistant, or administrative staff employed at the participating practices and (b) interacts with at least five patients with a diagnosis of hypertension.
Exclusion Criteria
* Participation in other hypertension-related clinical trials
* Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
* Plan to discontinue care at their practice within the next 12 months
• Refuse to participate
18 Years
90 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Antoinette Schoenthaler, EdD
Role: PRINCIPAL_INVESTIGATOR
NYUMC Langone
Locations
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NYUMC Langone
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Chervonski E, Pelegri E, De La Calle F, Mandal S, Graves CA, Colella D, Elmaleh-Sachs A, Nay J, Dapkins I, Schoenthaler A. Cardiovascular Health Markers With Remote Team-Based Hypertension Management in a Safety-Net Population. Am J Prev Med. 2025 Aug 5;69(5):108031. doi: 10.1016/j.amepre.2025.108031. Online ahead of print.
Schoenthaler A, De La Calle F, De Leon E, Garcia M, Colella D, Nay J, Dapkins I. Application of the FRAME-IS to a multifaceted implementation strategy. BMC Health Serv Res. 2024 Jun 1;24(1):695. doi: 10.1186/s12913-024-11139-0.
Gago C, De Leon E, Mandal S, de la Calle F, Garcia M, Colella D, Dapkins I, Schoenthaler A. "Hypertension is such a difficult disease to manage": federally qualified health center staff- and leadership-perceived readiness to implement a technology-facilitated team-based hypertension model. Implement Sci Commun. 2024 May 2;5(1):49. doi: 10.1186/s43058-024-00587-8.
Schoenthaler A, De La Calle F, Leon E, Garcia M, Colella D, Nay J, Dapkins I. Application of the FRAME-IS to a Multifaceted Implementation Strategy. Res Sq [Preprint]. 2024 Feb 12:rs.3.rs-3931349. doi: 10.21203/rs.3.rs-3931349/v1.
Schoenthaler A, De La Calle F, Soto A, Barrett D, Cruz J, Payano L, Rosado M, Adhikari S, Ogedegbe G, Rosal M. Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices. Implement Sci Commun. 2021 Feb 17;2(1):21. doi: 10.1186/s43058-021-00111-2.
Other Identifiers
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18-01290
Identifier Type: -
Identifier Source: org_study_id
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