Bridging the Evidence-to-practice Gap

Phase 4

Recruiting

• Conditions: Hypertension
• Interventions: Behavioral: ALTA

• Registration Number: NCT03713515
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Study Start: 2020-12-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2027-06-01
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Practice Faciliation	ALTA	Will be supported by a practice facilitator

Primary Outcome Measures

Name	Time	Method
Level of implementation fidelity	12 months	Implementation fidelity will be defined as the degree to which ALTA was delivered, as intended. A mixed methods approach will be used to assess the five core domains of implementation fidelity: (1) adherence to the program protocol; (2) dose of the program delivered; (3) quality of program delivery; (4) participant responsiveness; and (5) program differentiation.

Secondary Outcome Measures

Name	Time	Method
Medication adherence	12 months	Will be assessed via pharmacy refills obtained from prescription orders in the clinic EHR using the proportion of days covered (PDC) metric, calculated as the total number of days covered by the medication.
Blood Pressure (BP) control	Baseline and 12 months	First, BP control, will be defined as SBP \<140 and DBP \<90 mmHg.121 BP control will be assessed using the mean of the last two measurements recorded in the electronic health record (EHR) during each of the pre-intervention and post-intervention study periods (baseline and 12 months). We will also examine the proportion of patients with BP control \<130/80 mmHg in exploratory analyses to provide preliminary data on BP control rates of hypertensive Latino patients when considering the new guidelines. We will also explore mean change in systolic and diastolic BP based on the mean of the last two recorded BP readings in the EHR during the pre- and post-intervention periods.

Trial Locations

Locations (1)

NYUMC Langone; 🇺🇸 New York, New York, United States