Trial Outcomes & Findings for Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care (NCT NCT05349422)
NCT ID: NCT05349422
Last Updated: 2026-06-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1842 participants
Primary outcome timeframe
Month 12
Results posted on
2026-06-30
Participant Flow
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.
Unit of analysis: Primary Care Practices
Participant milestones
| Measure |
(Phase I) Experimental - Clinicians
Clinicians participated in qualitative interviews and usability testing sessions.
|
(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.
|
(Phase II) Usual Care Group
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|---|
|
Overall Study
STARTED
|
25 0
|
967 5
|
850 5
|
|
Overall Study
Clinicians Started
|
25 0
|
48 5
|
43 5
|
|
Overall Study
Clinicians Completed
|
25 0
|
48 5
|
43 5
|
|
Overall Study
COMPLETED
|
25 0
|
952 5
|
825 5
|
|
Overall Study
NOT COMPLETED
|
0 0
|
15 0
|
25 0
|
Reasons for withdrawal
| Measure |
(Phase I) Experimental - Clinicians
Clinicians participated in qualitative interviews and usability testing sessions.
|
(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.
|
(Phase II) Usual Care Group
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
7
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
8
|
17
|
Baseline Characteristics
Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care
Baseline characteristics by cohort
| Measure |
Phase 2: Intervention Group
n=919 Participants
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.
|
Phase 2: Usual Care Group
n=807 Participants
Usual Care Clinical Decision Support (CDS) Tools
|
Total
n=1726 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 14.3 • n=20 Participants
|
66.6 years
STANDARD_DEVIATION 13.5 • n=20 Participants
|
67.2 years
STANDARD_DEVIATION 13.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
495 Participants
n=20 Participants
|
392 Participants
n=20 Participants
|
887 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
424 Participants
n=20 Participants
|
415 Participants
n=20 Participants
|
839 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=20 Participants
|
67 Participants
n=20 Participants
|
167 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
635 Participants
n=20 Participants
|
584 Participants
n=20 Participants
|
1219 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
184 Participants
n=20 Participants
|
156 Participants
n=20 Participants
|
340 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
227 Participants
n=20 Participants
|
151 Participants
n=20 Participants
|
378 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
501 Participants
n=20 Participants
|
497 Participants
n=20 Participants
|
998 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
151 Participants
n=20 Participants
|
122 Participants
n=20 Participants
|
273 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
919 participants
n=20 Participants
|
807 participants
n=20 Participants
|
1726 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Measured among patient participants in Phase 2 only.
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
Outcome measures
| Measure |
Phase 2: Intervention Group (Patients)
n=904 Participants
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.
|
Phase 2: Usual Care Group (Patients)
n=782 Participants
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|
|
Average Number of Days Covered (PDC) as a Measure of Medication Adherence
|
51.1 percentage of days
Standard Deviation 39.5
|
53.1 percentage of days
Standard Deviation 39.6
|
SECONDARY outcome
Timeframe: Month 18Population: Measured among patient participants in Phase 2 only.
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
Outcome measures
| Measure |
Phase 2: Intervention Group (Patients)
n=904 Participants
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.
|
Phase 2: Usual Care Group (Patients)
n=782 Participants
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|
|
Average Number of Days Covered (PDC) as a Measure of Medication Adherence
|
50.5 percentage of days
Standard Deviation 40.7
|
52.3 percentage of days
Standard Deviation 40.6
|
SECONDARY outcome
Timeframe: Month 12Population: Measured among patient participants in Phase 2 only.
Outcome measures
| Measure |
Phase 2: Intervention Group (Patients)
n=904 Participants
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.
|
Phase 2: Usual Care Group (Patients)
n=782 Participants
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|
|
Mean Systolic Blood Pressure
|
138 mm Hg
Standard Deviation 14.3
|
136 mm Hg
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Month 18Population: Measured among patient participants in Phase 2 only.
Outcome measures
| Measure |
Phase 2: Intervention Group (Patients)
n=904 Participants
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.
|
Phase 2: Usual Care Group (Patients)
n=782 Participants
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|
|
Mean Systolic Blood Pressure
|
138 mm Hg
Standard Deviation 14.4
|
135 mm Hg
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Month 12Population: Measured among patient participants in Phase 2 only.
Outcome measures
| Measure |
Phase 2: Intervention Group (Patients)
n=904 Participants
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.
|
Phase 2: Usual Care Group (Patients)
n=782 Participants
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|
|
Mean Diastolic Blood Pressure
|
79.1 mm Hg
Standard Deviation 9.7
|
78.5 mm Hg
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Month 18Population: Measured among patient participants in Phase 2 only.
Outcome measures
| Measure |
Phase 2: Intervention Group (Patients)
n=904 Participants
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.
|
Phase 2: Usual Care Group (Patients)
n=782 Participants
Usual Care Clinical Decision Support (CDS) Tools
|
|---|---|---|
|
Mean Diastolic Blood Pressure
|
78.7 mm Hg
Standard Deviation 9.7
|
78.5 mm Hg
Standard Deviation 9.0
|
Adverse Events
Phase 2: Intervention Group (Patients)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Phase 2: Usual Care Group (Patients)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place