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

NCT05349422 | Completed

• 2 other identifiers: 21-00133R01HL156355
• Study Type: interventional
• Target: 1,726
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Average Number of Days Covered (PDC) as a Measure of Medication Adherence

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Electronic Health Record (EHR) Enabled Teamlets

Usual Care Group

NO INTERVENTION

Usual Care Clinical Decision Support (CDS) Tools

Interventions

Electronic Health Record (EHR) Enabled Teamlets 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who decline to be observed.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (4)

• 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.

  PMID: 37418304 BACKGROUND

• 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.

  PMID: 37121253 BACKGROUND

• 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.

  PMID: 41308044 DERIVED

• 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.

  PMID: 40632527 DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Saul Blecker, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 27, 2022
• Study Start: October 6, 2022
• Primary Completion: November 11, 2024
• Study Completion: May 11, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)