Blood PressureNCT05349422
Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care
A study testing Electronic Health Record (EHR) Enabled Teamlets in people with Blood Pressure and Medication Adherence, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Medication Adherence
- What is being tested?
- Electronic Health Record (EHR) Enabled Teamlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,842 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 11 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals:
- Age>18 years
- Presence of Hypertension as defined by either:
- Blood pressure ≥140/90
- Hypertension diagnosis
- Prescription for at least one antihypertensive medication
Show all 12Show fewer
- 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.
- Eligible clinicians include physicians, medical assistants, licensed practical nurses, and registered nurses.
- Adult patients during appointments with eligible clinicians
- Age > 18 years
Who cannot join
- Patients who decline to be observed.
- The study team has no specific exclusion criteria for patients in chart review.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Electronic Health Record (EHR) Enabled Teamlets
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record (EHR) Enabled TeamletsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Electronic Health Record (EHR) Enabled Teamlets |
| Usual Care Group | No intervention | Usual Care Clinical Decision Support (CDS) Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Days Covered (PDC) as a Measure of Medication Adherence
The percentage of days covered (PDC) is used to estimate medication adherence by looking at the percentage of days in which a person has access to the medication, over a given period of interest
Measured: Month 12
Secondary outcomes (5)
Average Number of Days Covered (PDC) as a Measure of Medication Adherence
The percentage of days covered (PDC) is used to estimate medication adherence by looking at the percentage of days in which a person has access to the medication, over a given period of interest
Measured: Month 18
Mean Systolic Blood Pressure
Measured: Month 12
Mean Systolic Blood Pressure
Measured: Month 18
Mean Diastolic Blood Pressure
Measured: Month 12
Mean Diastolic Blood Pressure
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start6 Oct 2022
- Primary completion11 Nov 2024
- Study completion11 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization at 10 clinics.
- Masking
- None (open label)
- Enrolment
- 1,842 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Saul Blecker, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349422
- Sponsor's protocol ID
- 21-00133
- Other IDs
- R01HL156355
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2022
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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.
PubMed 37418304Kharmats 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.
PubMed 37121253Martinez 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.
PubMed 41308044Blecker 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.
PubMed 40632527