Bridging the Evidence-to-practice Gap

NYU Langone Health

Status and phase: Enrolling; Phase 4

Conditions: Hypertension

Treatments: Behavioral: ALTA

Study type: Interventional

Funder types: Other

Identifiers

NCT03713515

18-01290

Details and patient eligibility

About

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).

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Practice Faciliation

Experimental group

Description:

Will be supported by a practice facilitator

Treatment:

Behavioral: ALTA

Usual Care

No Intervention group

Description:

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.