Clinical trial NCT05349422: Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care
Official title: Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Pressure
Medication Adherence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-04-27
Enrollment: 1726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization at 10 clinics.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Average Number of Days Covered (PDC) as a Measure of Medication Adherence
timeFrame: Month 12
Secondary outcomes:
measure: Average Number of Days Covered (PDC) as a Measure of Medication Adherence
timeFrame: Month 18
measure: Mean Systolic Blood Pressure
timeFrame: Month 12
measure: Mean Systolic Blood Pressure
timeFrame: Month 18
measure: Mean Diastolic Blood Pressure
timeFrame: Month 12
measure: Mean Diastolic Blood Pressure
timeFrame: Month 18
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Saul Blecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.