Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The proposed project will address this evidence-to-practice gap by evaluating the effect of practice facilitation (PF) of the intervention implementation fidelity (primary outcome) and clinical measures at 12 months (secondary outcomes).
Advancing Medication Adherence for Latinx with Hypertension through a Team-based Care Approach (ALTA) evaluates the effectiveness of using a quality improvement method called practice facilitation (PF) to implement our evidence-based systems-level intervention for improving medication adherence and blood pressure control.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practice Faciliation | Experimental | Will be supported by a practice facilitator |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTA | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation Fidelity - Adherence: Screening | Defined as the percentage of eligible participants who were screened. | Up to Month 12 |
| Implementation Fidelity - Adherence: Referrals | Defined as the percentage of screened participants who were referred. | Up to Month 12 |
| Implementation Fidelity - Adherence: Enrollment | Defined as the percentage of referred participants who were enrolled. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure (BP) Control | Assessed as the change in percentage of participants with blood pressure (BP) control, defined as systolic BP (SBP) <140 and diastolyic BP (DBP) <90 mmHg. | Baseline, Post Intervention (Months 24-36) |
| Change in Medication Adherence |
Not provided
Inclusion Criteria:
Clinic and nonclinical staff inclusion criteria:
• 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:
Clinic and nonclinical staff exclusion criteria:
• Refuse to participate
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antoinette Schoenthaler, EdD | NYUMC Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYUMC Langone | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42223807 | Derived | De Leon E, De La Calle F, Mandal S, Rosal MC, Nay J, Colella D, Dapkins I, Schoenthaler A. Understanding Implementation of a Technology-Facilitated Hypertension Model in Federally Qualified Health Centers: A Realist Evaluation of Staff Experiences. J Gen Intern Med. 2026 Jun 1. doi: 10.1007/s11606-026-10505-4. Online ahead of print. | |
| 40763829 |
Not provided
Not provided
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Access will be granted to Researchers who provide a methodologically sound proposal.
Beginning 3 months and ending 5 years following article publication.
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided). NYU Data Catalog
Not provided
Clinics were assigned to a Cohort which specified the timing of the Usual Care, Pre-Imp, and Intervention Periods. Participants were enrolled only during the Intervention Periods. No participants dropped out during the course of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Usual Care for Months 0-3; Pre-Imp for Months 4-8; Intervention for Months 9-12 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months. |
| FG001 | Sequence 2: Usual Care for Months 2-5; Pre-Imp for Months 6-8; Intervention for Months 9-12 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months. |
| FG002 | Sequence 3: Usual Care for Months 3-6; Pre-Imp for Months 7-9; Intervention for Months 10-13 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months. |
| FG003 | Sequence 4: Usual Care for Months 1-4, Pre-Imp for Months 5-9; Intervention for Months 10-13 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months. |
| FG004 | Sequence 5: Usual Care for Months 2-4; Pre-Imp for Months 5-11; Intervention for Months 12-15 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months. |
| FG005 | Sequence 6: Usual Care for Months 9-12; Pre-Imp for Months 13-15; Intervention for Months 15-18. | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Usual Care: Months 0-3 |
| |||||||||||||
| Usual Care: Months 1-4 |
| |||||||||||||
| Usual Care: Months 2-4 |
| |||||||||||||
| Usual Care: Months 2-5 |
| |||||||||||||
| Usual Care: Months 3-6 |
| |||||||||||||
| Usual Care: Months 9-12 |
| |||||||||||||
| Pre-Implementation: Months 4-8 |
| |||||||||||||
| Pre-Implementation: Months 5-9 |
| |||||||||||||
| Pre-Implementation: Months 5-11 |
| |||||||||||||
| Pre-Implementation: Months 6-8 |
| |||||||||||||
| Pre-Implementation: Months 7-9 |
| |||||||||||||
| Pre-Implementation: Months 13-15 |
| |||||||||||||
| Intervention for Months 9-12 |
| |||||||||||||
| Intervention for Months 10-13 |
| |||||||||||||
| Intervention for Months 12-15 |
| |||||||||||||
| Intervention for Months 15-18 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Implementation Fidelity - Adherence: Screening | Defined as the percentage of eligible participants who were screened. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
12 Months
Systematic assessment. Hospitalizations were systematically ascertained through structured extraction of electronic health record (EHR) data by the study team. For each hospitalization, the specific event, date of occurrence, and duration of stay were collected. Data were obtained following completion of the 12-month intervention phase according to prespecified study procedures.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Participants | All participants enrolled. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure related hospitalization | Cardiac disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jocelyn Cruz, MPH | NYU Langone Health | 6465013474 | Jocelyn.Acosta@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2025 | Feb 25, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Stepped Wedge
Not provided
Not provided
Not provided
|
Assessed via pharmacy refills obtained from prescription orders in the clinic EHR using the proportion of days covered (PDC) metric; medication adherence defined as PDC ≥ 80; this outcome will be measured as the change in percentage of participants who meet medication adherence. |
| Baseline, Post Intervention (Months 24-36) |
| 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 Nov;69(5):108031. doi: 10.1016/j.amepre.2025.108031. Epub 2025 Aug 5. |
| 38822342 | Derived | 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. |
| 38698497 | Derived | 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. |
| 38410454 | Derived | 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. |
| 33597041 | Derived | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Sequence 2 |
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months |
| BG002 | Sequence 3 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months |
| BG003 | Sequence 4 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months |
| BG004 | Sequence 5 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months |
| BG005 | Sequence 6 | During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Implementation Fidelity - Adherence: Referrals | Defined as the percentage of screened participants who were referred. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Primary | Implementation Fidelity - Adherence: Enrollment | Defined as the percentage of referred participants who were enrolled. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Secondary | Change in Blood Pressure (BP) Control | Assessed as the change in percentage of participants with blood pressure (BP) control, defined as systolic BP (SBP) <140 and diastolyic BP (DBP) <90 mmHg. | Defined as participants who were eligible to receive the intervention who ALSO had available BP measurements - only 387 participants met this criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Post Intervention (Months 24-36) |
|
|
|
| Secondary | Change in Medication Adherence | Assessed via pharmacy refills obtained from prescription orders in the clinic EHR using the proportion of days covered (PDC) metric; medication adherence defined as PDC ≥ 80; this outcome will be measured as the change in percentage of participants who meet medication adherence. | Defined as participants who were eligible to receive the intervention with available medication data - only 333 participants met this criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Post Intervention (Months 24-36) |
|
|
|
| 652 |
| 50 |
| 652 |
| 0 |
| 652 |
Not provided
Not provided
Not provided