Clinical trial NCT03713515: Bridging the Evidence-to-practice Gap
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped Wedge
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of implementation fidelity
timeFrame: 12 months
Secondary outcomes:
measure: Blood Pressure (BP) control
timeFrame: Baseline and 12 months
measure: Medication adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYUMC Langone
state: New York
Study officials:
affiliation: NYUMC Langone
name: Antoinette Schoenthaler, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.