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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care
- ClinicalTrials.gov ID
- NCT05349422
- Acronym / sponsor ID
- 21-00133
- Conditions
- Blood Pressure, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,842 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 May 2025 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization at 10 clinics.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Electronic Health Record (EHR) Enabled Teamlets |
| Usual Care Group | No intervention | –Usual Care Clinical Decision Support (CDS) Tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age>18 years
- Presence of Hypertension as defined by either:
- Outpatient clinic visit in the NYULH between 06/1/2022 and 12/31/2025
- A clinician from an NYULH ambulatory practice location.
- Adult patients during appointments with eligible clinicians
Key exclusion criteria (2 listed)
- Patients who decline to be observed.
- The study team has no specific exclusion criteria for patients in chart review.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record (EHR) Enabled TeamletsThe 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. | Behavioural | Intervention Group |
Primary outcome
Average Number of Days Covered (PDC) as a Measure of Medication Adherence
Time frame: Month 12
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
5 secondary outcomes
Average Number of Days Covered (PDC) as a Measure of Medication Adherence
Time frame: Month 18
Mean Systolic Blood Pressure
Time frame: Month 12
Mean Systolic Blood Pressure
Time frame: Month 18
Mean Diastolic Blood Pressure
Time frame: Month 12
Mean Diastolic Blood Pressure
Time frame: Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37418304Blecker 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.
- Background: PubMed 37121253Kharmats 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.
- Derived from this study: PubMed 41308044Martinez 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.
- Derived from this study: PubMed 40632527Blecker 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saul Blecker, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Number of Days Covered (PDC) as a Measure of Medication Adherence (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349422, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.