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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL156355 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental |
| |
| Usual Care Group | No Intervention | Usual Care Clinical Decision Support (CDS) Tools |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 18 |
| Mean Systolic Blood Pressure |
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Inclusion Criteria:
Individuals:
Age>18 years
Presence of Hypertension as defined by either:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saul Blecker, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37418304 | Background | 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. | |
| 37121253 | 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. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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In Phase 1, 25 clinicians were recruited for qualitative interviews and usability testing sessions. In Phase 2, 1,726 patients (and 91 clinicians) were recruited and enrolled in the randomized control trial.
| ID | Title | Description |
|---|---|---|
| FG000 | (Phase I) Experimental - Clinicians | Clinicians participated in qualitative interviews and usability testing sessions. |
| FG001 | (Phase II) Experimental | 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. |
| FG002 | (Phase II) Usual Care Group | Usual Care Clinical Decision Support (CDS) Tools |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristic data were collected from patient participants in Phase 2 only; no baseline characteristic data were collected from clinician participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2: Intervention Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 among patient participants in Phase 2 only. | Posted | Mean | Standard Deviation | percentage of days | Month 12 |
|
12 months
Assessed among patients who participated in Phase 2 only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2: Intervention Group (Patients) | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saul Blecker, MD | NYU Langone Health | 646-501 2513 | Saul.Blecker@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2025 | Mar 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D057286 | Electronic Health Records |
| ID | Term |
|---|---|
| D016347 | Medical Records Systems, Computerized |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
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The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization at 10 clinics.
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|
| Month 12 |
| Mean Systolic Blood Pressure | Month 18 |
| Mean Diastolic Blood Pressure | Month 12 |
| Mean Diastolic Blood Pressure | Month 18 |
| 41308044 | Derived | 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. |
| 40632527 | 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. |
| BG001 | Phase 2: Usual Care Group | Usual Care Clinical Decision Support (CDS) Tools |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Phase 2: Usual Care Group (Patients) | Usual Care Clinical Decision Support (CDS) Tools |
|
|
| Secondary | 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 among patient participants in Phase 2 only. | Posted | Mean | Standard Deviation | percentage of days | Month 18 |
|
|
|
| Secondary | Mean Systolic Blood Pressure | Measured among patient participants in Phase 2 only. | Posted | Mean | Standard Deviation | mm Hg | Month 12 |
|
|
|
| Secondary | Mean Systolic Blood Pressure | Measured among patient participants in Phase 2 only. | Posted | Mean | Standard Deviation | mm Hg | Month 18 |
|
|
|
| Secondary | Mean Diastolic Blood Pressure | Measured among patient participants in Phase 2 only. | Posted | Mean | Standard Deviation | mm Hg | Month 12 |
|
|
|
| Secondary | Mean Diastolic Blood Pressure | Measured among patient participants in Phase 2 only. | Posted | Mean | Standard Deviation | mm Hg | Month 18 |
|
|
|
| 7 |
| 919 |
| 0 |
| 919 |
| 0 |
| 919 |
| EG001 | Phase 2: Usual Care Group (Patients) | Usual Care Clinical Decision Support (CDS) Tools | 8 | 807 | 0 | 807 | 0 | 807 |
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| D001519 | Behavior |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |