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

NCT ID: NCT05349422

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1726 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-06

Study Completion Date

2025-05-11

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization at 10 clinics.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

Electronic Health Record (EHR) Enabled Teamlets

Intervention Type BEHAVIORAL

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.

Usual Care Group

Usual Care Clinical Decision Support (CDS) Tools

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronic Health Record (EHR) Enabled Teamlets

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saul Blecker, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 37418304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37121253 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41308044 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40632527 (View on PubMed)

Other Identifiers

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R01HL156355

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-00133

Identifier Type: -

Identifier Source: org_study_id