Trial Outcomes & Findings for Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension (NCT NCT04603560)
NCT ID: NCT04603560
Last Updated: 2024-08-21
Results Overview
The primary outcome was whether physicians intensified treatment at the target visit. Intensification was defined as adding a new antihypertensive medication or increasing the total daily dose of an existing one. This was measured by identifying all prescriptions for anti-hypertensive medications in the electronic health record (EHR) on the day of the target visit and comparing the medication name and total daily dose to anti-hypertensive medications prescribed prior to the target visit date, following the same procedure used to identify intensification during the eligibility assessment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
511 participants
Primary outcome timeframe
During the primary care office visit in which the provider-patient dyad received the intervention
Results posted on
2024-08-21
Participant Flow
This was a cluster-randomized trial randomized at the provider level. Primary care providers were invited to participate and consented into the study. Patients accrued into the study were study-eligible patients cared for by each enrolled primary care provider.
Participant milestones
| Measure |
Social Norming: Patients
In this arm, patients received care at visits as directed by their primary care providers (PCPs). PCPs received reports that displayed the physician's hypertension control rates compared to their peers.
|
Pharmacist E-Detailing: Patients
In this arm, patients received care at visits as directed by their primary care providers (PCPs). PCPs received individual feedback and recommendations generated by a clinical pharmacist delivered as a message through the EHR in advance of eligible patient visits.
|
Control: Patients
In this arm, patients received care at visits as directed by their primary care providers (PCPs). No intervention was provided to PCPs in the control arm.
|
Social Norming: Providers
In this arm, rates of blood pressure control across all patients with hypertension cared for by each PCP were obtained from a system-wide performance dashboard, and reports were generated that displayed the physician's hypertension control rates compared to their peers. To ensure PCPs were compared to targets that they could reasonably attain, a different comparison was used based on the PCP's current rate of hypertension control. If the PCP's rates were below the practice average, the practice average was used for comparison. If the PCP's rate was above the practice average, the rate of the top performer in the practice was used.
|
Pharmacist E-Detailing: Providers
In this arm, PCPs received individual feedback and recommendations generated by a clinical pharmacist delivered as a message through the EHR. Eligible patients with an upcoming (target) visit with their PCP were identified using EHR data, as above. A clinical pharmacist reviewed each patient's chart and generated a personalized recommendation for how to modify the specific patient's antihypertensive regimen based on clinical practice guidelines.
|
Control: Providers
No intervention was provided to PCPs in the control arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
173
|
143
|
150
|
16
|
15
|
14
|
|
Overall Study
COMPLETED
|
173
|
143
|
150
|
16
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline measurement for patients only. Blood pressures were not obtained for Providers.
Baseline characteristics by cohort
| Measure |
Social Norming: Patients
n=173 Participants
In this arm, patients received care at visits as directed by their primary care providers (PCPs). PCPs received reports that displayed the physician's hypertension control rates compared to their peers.
|
Pharmacist E-Detailing: Patients
n=143 Participants
In this arm, patients received care at visits as directed by their primary care providers (PCPs). PCPs received individual feedback and recommendations generated by a clinical pharmacist delivered as a message through the EHR in advance of eligible patient visits.
|
Control: Patients
n=150 Participants
In this arm, patients received care at visits as directed by their primary care providers (PCPs). No intervention was provided to PCPs in the control arm.
|
Social Norming: Providers
n=16 Participants
In this arm, rates of blood pressure control across all patients with hypertension cared for by each PCP were obtained from a system-wide performance dashboard, and reports were generated that displayed the physician's hypertension control rates compared to their peers. To ensure PCPs were compared to targets that they could reasonably attain, a different comparison was used based on the PCP's current rate of hypertension control. If the PCP's rates were below the practice average, the practice average was used for comparison. If the PCP's rate was above the practice average, the rate of the top performer in the practice was used.
|
Pharmacist E-Detailing: Providers
n=15 Participants
In this arm, PCPs received individual feedback and recommendations generated by a clinical pharmacist delivered as a message through the EHR. Eligible patients with an upcoming (target) visit with their PCP were identified using EHR data, as above. A clinical pharmacist reviewed each patient's chart and generated a personalized recommendation for how to modify the specific patient's antihypertensive regimen based on clinical practice guidelines.
|
Control: Providers
n=14 Participants
No intervention was provided to PCPs in the control arm.
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age
|
64.35 years
STANDARD_DEVIATION 11.69 • n=173 Participants
|
64.91 years
STANDARD_DEVIATION 10.72 • n=143 Participants
|
64.11 years
STANDARD_DEVIATION 12.83 • n=150 Participants
|
53.56 years
STANDARD_DEVIATION 10.38 • n=16 Participants
|
51.33 years
STANDARD_DEVIATION 11.1 • n=15 Participants
|
51.71 years
STANDARD_DEVIATION 13.15 • n=14 Participants
|
64.45 years
STANDARD_DEVIATION 11.76 • n=511 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=173 Participants
|
73 Participants
n=143 Participants
|
75 Participants
n=150 Participants
|
8 Participants
n=16 Participants
|
11 Participants
n=15 Participants
|
10 Participants
n=14 Participants
|
248 Participants
n=511 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=173 Participants
|
70 Participants
n=143 Participants
|
75 Participants
n=150 Participants
|
8 Participants
n=16 Participants
|
4 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
263 Participants
n=511 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=173 Participants
|
4 Participants
n=143 Participants
|
20 Participants
n=150 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
39 Participants
n=511 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=173 Participants
|
129 Participants
n=143 Participants
|
119 Participants
n=150 Participants
|
14 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
428 Participants
n=511 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=173 Participants
|
10 Participants
n=143 Participants
|
11 Participants
n=150 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
44 Participants
n=511 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=173 Participants
|
13 Participants
n=143 Participants
|
10 Participants
n=150 Participants
|
2 Participants
n=16 Participants
|
4 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
39 Participants
n=511 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=173 Participants
|
17 Participants
n=143 Participants
|
15 Participants
n=150 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
53 Participants
n=511 Participants
|
|
Race/Ethnicity, Customized
White
|
132 Participants
n=173 Participants
|
105 Participants
n=143 Participants
|
104 Participants
n=150 Participants
|
14 Participants
n=16 Participants
|
9 Participants
n=15 Participants
|
10 Participants
n=14 Participants
|
374 Participants
n=511 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown/Not reported
|
15 Participants
n=173 Participants
|
8 Participants
n=143 Participants
|
21 Participants
n=150 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
45 Participants
n=511 Participants
|
|
Systolic blood pressure
|
148.97 mmHg
STANDARD_DEVIATION 11.06 • n=173 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
149.48 mmHg
STANDARD_DEVIATION 9.02 • n=143 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
148.13 mmHg
STANDARD_DEVIATION 10.89 • n=150 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
—
|
—
|
—
|
148.85 mmHg
STANDARD_DEVIATION 10.41 • n=466 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
|
Diastolic blood pressure
|
81.57 mmHg
STANDARD_DEVIATION 9.34 • n=173 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
81.75 mmHg
STANDARD_DEVIATION 8.82 • n=143 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
82.78 mmHg
STANDARD_DEVIATION 8.89 • n=150 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
—
|
—
|
—
|
82.01 mmHg
STANDARD_DEVIATION 9.04 • n=466 Participants • Baseline measurement for patients only. Blood pressures were not obtained for Providers.
|
PRIMARY outcome
Timeframe: During the primary care office visit in which the provider-patient dyad received the interventionThe primary outcome was whether physicians intensified treatment at the target visit. Intensification was defined as adding a new antihypertensive medication or increasing the total daily dose of an existing one. This was measured by identifying all prescriptions for anti-hypertensive medications in the electronic health record (EHR) on the day of the target visit and comparing the medication name and total daily dose to anti-hypertensive medications prescribed prior to the target visit date, following the same procedure used to identify intensification during the eligibility assessment
Outcome measures
| Measure |
Social Norming
n=173 Participants
In this arm, rates of blood pressure control across all patients with hypertension cared for by each PCP were obtained from a system-wide performance dashboard, and reports were generated that displayed the physician's hypertension control rates compared to their peers. To ensure PCPs were compared to targets that they could reasonably attain, a different comparison was used based on the PCP's current rate of hypertension control. If the PCP's rates were below the practice average, the practice average was used for comparison. If the PCP's rate was above the practice average, the rate of the top performer in the practice was used .
|
Pharmacist E-Detailing
n=143 Participants
In this arm, PCPs received individual feedback and recommendations generated by a clinical pharmacist delivered as a message through the EHR. Eligible patients with an upcoming (target) visit with their PCP were identified using EHR data, as above. A clinical pharmacist reviewed each patient's chart and generated a personalized recommendation for how to modify the specific patient's antihypertensive regimen based on clinical practice guidelines.
|
Control
n=150 Participants
No intervention will be provided to physicians in the control arm.
|
|---|---|---|---|
|
Treatment Intensification
|
21 Participants
|
23 Participants
|
19 Participants
|
Adverse Events
Social Norming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pharmacist E-Detailing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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