Hypertension
Conditions
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.
Interventions
BEHAVIORALALTA
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped Wedge
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementation Fidelity - Adherence: Screening | Up to Month 12 | Defined as the percentage of eligible participants who were screened. |
| Implementation Fidelity - Adherence: Referrals | Up to Month 12 | Defined as the percentage of screened participants who were referred. |
| Implementation Fidelity - Adherence: Enrollment | Up to Month 12 | Defined as the percentage of referred participants who were enrolled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure (BP) Control | Baseline, Post Intervention (Months 24-36) | Assessed as the change in percentage of participants with blood pressure (BP) control, defined as systolic BP (SBP) \<140 and diastolyic BP (DBP) \<90 mmHg. |
| Change in Medication Adherence | Baseline, Post Intervention (Months 24-36) | Assessed via pharmacy refills obtained from prescription orders in the clinic EHR using the proportion of days covered (PDC) metric; medication adherence defined as PDC ≥ 80; this outcome will be measured as the change in percentage of participants who meet medication adherence. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAntoinette Schoenthaler, EdD
NYUMC Langone
Participant flow
Pre-assignment details
Clinics were assigned to a Cohort which specified the timing of the Usual Care, Pre-Imp, and Intervention Periods. Participants were enrolled only during the Intervention Periods. No participants dropped out during the course of the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 232 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 340 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 39 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 652 |
| other Total, other adverse events | 0 / 652 |
| serious Total, serious adverse events | 50 / 652 |
Outcome results
None listed