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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05349422
• Other study ID #: 21-00133
• Secondary ID: R01HL156355
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: November 16, 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1726
• Est. completion date: November 16, 2025
• Est. primary completion date: May 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Medication Adherence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mean Systolic Blood Pressure		Month 12
Secondary	Mean Systolic Blood Pressure		Month 18
Secondary	Mean Diastolic Blood Pressure		Month 12
Secondary	Mean Diastolic Blood Pressure		Month 18