Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care

Study Overview
=================
Brief Summary
-----------------
The study team will conduct a cluster randomized control trial in up to 22 NYU primary care practices to assess the effectiveness and implementation of the multicomponent intervention on medication adherence and blood pressure control for patients who are non-adherent to antihypertensive medications.

Official Title
-----------------
Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care

Conditions
-----------------
Blood Pressure, Medication Adherence

Intervention / Treatment
-----------------
* Behavioral: Electronic Health Record (EHR) Enabled Teamlets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals: Age>18 years Presence of Hypertension as defined by either: Blood pressure ≥140/90 Hypertension diagnosis Prescription for at least one antihypertensive medication Outpatient clinic visit in the NYULH between 06/1/2022 and 12/31/2025 MAs, PCPs, LPNs, and RNs: A clinician from an NYULH ambulatory practice location. a. Eligible clinicians include physicians, medical assistants, licensed practical nurses, and registered nurses. Adult patients during appointments with eligible clinicians Age > 18 years Exclusion Criteria: Patients who decline to be observed. The study team has no specific exclusion criteria for patients in chart review.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization of up to 22 clinics.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Behavioral: Electronic Health Record (EHR) Enabled Teamlets<br>* The intervention consist of four components: 1) patients with hypertension will be automatically screened for low medication adherence using linked EHR-pharmacy data at the time of a PCP encounter; 2) MAs will deliver a validated, rapid, survey of common causes of non-adherence; 3) MAs and/or RNs will address barriers to adherence tailored to survey response, including delivery of brief health coaching based on motivational interviewing; and 4) PCPs will address specific barriers to adherence based on survey response.<br>|
| No Intervention: Usual Care Group<br>Usual Care Clinical Decision Support (CDS) Tools | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Days Covered (PDC) as a Measure of Medication Adherence | The proportion of days covered (PDC) is used to estimate medication adherence by looking at the proportion of days in which a person has access to the medication, over a given period of interest | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Days Covered (PDC) as a Measure of Medication Adherence | The proportion of days covered (PDC) is used to estimate medication adherence by looking at the proportion of days in which a person has access to the medication, over a given period of interest | Month 18 | 
| Mean Systolic Blood Pressure |  | Month 12 | 
| Mean Systolic Blood Pressure |  | Month 18 | 
| Mean Diastolic Blood Pressure |  | Month 12 | 
| Mean Diastolic Blood Pressure |  | Month 18 |