Bridging the Evidence-to-practice Gap

NCT03713515 | Completed Phase 4 Results

• 1 other identifier: 18-01290
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Change in Blood Pressure (BP) Control

  Baseline, Post Intervention (Months 24-36)

• Change in Medication Adherence

  Baseline, Post Intervention (Months 24-36)

Study Arms (2)

Practice Faciliation

EXPERIMENTAL

Will be supported by a practice facilitator

Behavioral: ALTA

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.

Interventions

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.

Practice Faciliation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as Latino
• 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.

You may not qualify if:

• Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYUMC Langone

New York, New York, 10016, United States

Location

Related Publications (6)

• 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.

  PMID: 42223807 DERIVED

• 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.

  PMID: 40763829 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.

  PMID: 38822342 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.

  PMID: 38698497 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.

  PMID: 38410454 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.

  PMID: 33597041 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jocelyn Cruz, MPH
• Organization: NYU Langone Health

Jocelyn.Acosta@nyulangone.org

6465013474

Study Officials

• Antoinette Schoenthaler, EdD

  NYUMC Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped Wedge

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: December 1, 2020
• Primary Completion: May 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 10, 2026
• Results First Posted: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: 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

Locations

US (1)