Bridging the Evidence-to-practice Gap

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713515
• Other study ID #: 18-01290
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: Jocelyn Cruz, MPH
• Phone: 6465013474
• Email: Jocelyn.Acosta[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• ALTA
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.

Locations

Country	Name	City	State
United States	NYUMC Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of implementation fidelity	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.	12 months
Secondary	Blood Pressure (BP) control	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.	Baseline and 12 months
Secondary	Medication adherence	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.	12 months