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Completed

NCT Number: NCT03713515

Bridging the Evidence-to-practice Gap

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYUMC Langone

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

  • 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

Clinic and nonclinical staff exclusion criteria:

  • Refuse to participate

Treatment and study plan

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.

Primary outcomes

  1. Implementation Fidelity - Adherence: Screening

    Time frame: Up to Month 12

    Defined as the percentage of eligible participants who were screened.

  2. Implementation Fidelity - Adherence: Referrals

    Time frame: Up to Month 12

    Defined as the percentage of screened participants who were referred.

  3. Implementation Fidelity - Adherence: Enrollment

    Time frame: Up to Month 12

    Defined as the percentage of referred participants who were enrolled.

Secondary outcomes

  1. Change in Blood Pressure (BP) Control

    Time frame: Baseline, Post Intervention (Months 24-36)

    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.

  2. Change in Medication Adherence

    Time frame: Baseline, Post Intervention (Months 24-36)

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Bridging the Evidence-to-practice Gap: Evaluating Practice Facilitation as a Strategy to Accelerate Translation of a Systems-level Adherence Intervention Into Safety Net Practices

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2018
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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