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

December 29, 2025 updated by: NYU Langone Health
The study team will conduct a cluster randomized control trial in 10 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1726

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Individuals:

  1. Age>18 years
  2. Presence of Hypertension as defined by either:

    1. Blood pressure ≥140/90
    2. Hypertension diagnosis
    3. Prescription for at least one antihypertensive medication
  3. Outpatient clinic visit in the NYULH between 06/1/2022 and 12/31/2025

MAs, PCPs, LPNs, and RNs:

  1. A clinician from an NYULH ambulatory practice location.

    a. Eligible clinicians include physicians, medical assistants, licensed practical nurses, and registered nurses.

  2. Adult patients during appointments with eligible clinicians
  3. Age > 18 years

Exclusion Criteria:

  1. Patients who decline to be observed.
  2. The study team has no specific exclusion criteria for patients in chart review.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
No Intervention: Usual Care Group
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
Time Frame: Month 12
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
Time Frame: Month 18
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
Time Frame: Month 12
Month 12
Mean Systolic Blood Pressure
Time Frame: Month 18
Month 18
Mean Diastolic Blood Pressure
Time Frame: Month 12
Month 12
Mean Diastolic Blood Pressure
Time Frame: Month 18
Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Saul Blecker, MD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Actual)

November 11, 2024

Study Completion (Actual)

May 11, 2025

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Saul.Blecker@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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