Blood Pressure, Medication Adherence
Conditions
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.
Interventions
BEHAVIORALElectronic 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.
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization at 10 clinics.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Days Covered (PDC) as a Measure of Medication Adherence | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Days Covered (PDC) as a Measure of Medication Adherence | Month 18 | 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 |
| Mean Systolic Blood Pressure | Month 12 | — |
| Mean Diastolic Blood Pressure | Month 12 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSaul Blecker, MD
NYU Langone Health
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 167 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1219 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 156 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 74 Participants |
| Race (NIH/OMB) Black or African American | 151 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 122 Participants |
| Race (NIH/OMB) White | 998 Participants |
| Region of Enrollment United States | 1726 participants |
| Sex: Female, Male Female | 887 Participants |
| Sex: Female, Male Male | 424 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 919 | 8 / 807 |
| other Total, other adverse events | 0 / 919 | 0 / 807 |
| serious Total, serious adverse events | 0 / 919 | 0 / 807 |
Outcome results
None listed