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Clinical Trials/NCT03713515
NCT03713515
Recruiting
Phase 4

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

NYU Langone Health1 site in 1 country700 target enrollmentDecember 1, 2020
ConditionsHypertension

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Hypertension
Sponsor
NYU Langone Health
Enrollment
700
Locations
1
Primary Endpoint
Level of implementation fidelity
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
November 30, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Level of implementation fidelity

Time Frame: 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 Outcomes

  • Medication adherence(12 months)
  • Blood Pressure (BP) control(Baseline and 12 months)

Study Sites (1)

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