- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05349422
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
Status
Completed
Conditions
Intervention / Treatment
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:
- 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.
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.
Sponsor
Collaborators
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.
General Publications
- Blecker S, Schoenthaler A, Martinez TR, Belli HM, Zhao Y, Wong C, Fitchett C, Bearnot HR, Mann D. Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 7;12:e47930. doi: 10.2196/47930.
- Kharmats AY, Martinez TR, Belli H, Zhao Y, Mann DM, Schoenthaler AM, Voils CI, Blecker S. Self-reported adherence and reasons for nonadherence among patients with low proportion of days covered for antihypertension medications. J Manag Care Spec Pharm. 2023 May;29(5):557-563. doi: 10.18553/jmcp.2023.29.5.557.
- Martinez TR, Schoenthaler AM, Mann DM, Belli H, Bearnot HR, Lustbader I, Blecker S. Healthcare Professionals' Perspectives on Addressing Patients' Medication Adherence in Primary Care Settings. J Eval Clin Pract. 2025 Dec;31(8):e70322. doi: 10.1111/jep.70322.
- Blecker S, Mann DM, Martinez TR, Belli HM, Zhao Y, Ahmed A, Fitchett C, Wong C, Bearnot HR, Voils CI, Schoenthaler AM. Medication Adherence in Hypertension: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2025 Sep 1;10(9):914-921. doi: 10.1001/jamacardio.2025.2155.
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
Additional Relevant MeSH Terms
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Medication Adherence
- Organization and Administration
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Records
- Medical Records Systems, Computerized
- Medical Records
- Electronic Health Records
Other Study ID Numbers
- 21-00133
- R01HL156355 (U.S. NIH Grant/Contract)
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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