Hypertension
Conditions
Brief summary
This is a three-arm pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. Study investigators will use EHR data to identify providers of patients whose hypertension treatment was not intensified. Primary care physicians will then be randomized to one of three arms: pharmacist e-detailing, provider dashboards, or no intervention (control). After the intervention, the investigators will conduct virtual interviews with select providers from each arm. A predictive modeling approach will then be used to identify patient and provider characteristics that are associated with inertia and with responsiveness to each intervention.
Detailed description
We propose a pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. For Aim 1, we will use Electronic Health Record (EHR) data to identify physicians of patients whose hypertension treatment was not intensified despite their having persistently elevated blood pressure. We will then randomize primary care physicians to on of three arms: academic e-detailing, social norming, or no intervention (control). For Aim 2, we will conduct interviews with select physicians from each arm. We will then identify patient and physician characteristics that are associated with inertia and with responsiveness to each intervention.
Interventions
BEHAVIORALAudit and Feedback
A report of the provider's hypertension control rates compared to benchmark will be displayed using principles of social norming. We will present that provider's hypertension control rates compared to the 90th percentile of their peers.
BEHAVIORALPharmacist E-Detailing
A pharmacist will review the chart in advance and provide a personalized recommendation for how to intensify the specific patient's antihypertensive regimen based on current guidelines. For example, they might recommend adding an additional medication based on the patient's comorbid conditions and could suggest a starting dose and timeframe for dose escalation.
Sponsors
National Institute on Aging (NIA)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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. The number of participants listed below includes both patients and providers (466 patients and 45 providers).
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
Provider Inclusion Criteria: * Primary care physician * Practicing in primary care at Massachusetts General Hospital * Caring for at least 2 patients: (1) aged 18-79, (2) for whom the recent BP history in the last 18 months is above goal, (3) whose most recent BP at an outpatient visit was above goal, and (4) who did not have their hypertension treatment regimens intensified (dose increase, new medication, or medication exchange) at or since that time. The BP goal will be \<140/90 for all patients. To accommodate changes in care delivery that occurred during the COVID surge, outpatient visits will include in-office and virtual visits that had vitals recorded in the EHR the same day. Provider
Exclusion criteria
* fewer than 100 patients on their primary care panel * practice less than one session per week Patient Inclusion Criteria: * had a blood pressure greater than 140/90 mmHg at 2+ PCP visits in the past 12 months * treatment was not intensified at any of these visits Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Intensification | During the primary care office visit in which the provider-patient dyad received the intervention | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 173 |
| 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. | 143 |
| 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. | 150 |
| 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. | 16 |
| 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. | 15 |
| Control: Providers No intervention was provided to PCPs in the control arm. | 14 |
| Total | 511 |
Baseline characteristics
| Characteristic | Social Norming: Patients | Pharmacist E-Detailing: Patients | Control: Patients | Social Norming: Providers | Pharmacist E-Detailing: Providers | Control: Providers | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous Age | 64.35 years STANDARD_DEVIATION 11.69 | 64.91 years STANDARD_DEVIATION 10.72 | 64.11 years STANDARD_DEVIATION 12.83 | 53.56 years STANDARD_DEVIATION 10.38 | 51.33 years STANDARD_DEVIATION 11.1 | 51.71 years STANDARD_DEVIATION 13.15 | 64.45 years STANDARD_DEVIATION 11.76 |
| Diastolic blood pressure | 81.57 mmHg STANDARD_DEVIATION 9.34 | 81.75 mmHg STANDARD_DEVIATION 8.82 | 82.78 mmHg STANDARD_DEVIATION 8.89 | — | — | — | 82.01 mmHg STANDARD_DEVIATION 9.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 4 Participants | 20 Participants | 2 Participants | 0 Participants | 0 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 137 Participants | 129 Participants | 119 Participants | 14 Participants | 15 Participants | 14 Participants | 428 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants | 10 Participants | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 44 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 13 Participants | 10 Participants | 2 Participants | 4 Participants | 4 Participants | 39 Participants |
| Race/Ethnicity, Customized Black or African American | 20 Participants | 17 Participants | 15 Participants | 0 Participants | 1 Participants | 0 Participants | 53 Participants |
| Race/Ethnicity, Customized Other/Unknown/Not reported | 15 Participants | 8 Participants | 21 Participants | 0 Participants | 1 Participants | 0 Participants | 45 Participants |
| Race/Ethnicity, Customized White | 132 Participants | 105 Participants | 104 Participants | 14 Participants | 9 Participants | 10 Participants | 374 Participants |
| Sex: Female, Male Female | 71 Participants | 73 Participants | 75 Participants | 8 Participants | 11 Participants | 10 Participants | 248 Participants |
| Sex: Female, Male Male | 102 Participants | 70 Participants | 75 Participants | 8 Participants | 4 Participants | 4 Participants | 263 Participants |
| Systolic blood pressure | 148.97 mmHg STANDARD_DEVIATION 11.06 | 149.48 mmHg STANDARD_DEVIATION 9.02 | 148.13 mmHg STANDARD_DEVIATION 10.89 | — | — | — | 148.85 mmHg STANDARD_DEVIATION 10.41 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 173 | 0 / 143 | 0 / 150 |
| other Total, other adverse events | 0 / 173 | 0 / 143 | 0 / 150 |
| serious Total, serious adverse events | 0 / 173 | 0 / 143 | 0 / 150 |
Outcome results
Primary
Treatment Intensification
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
Time frame: During the primary care office visit in which the provider-patient dyad received the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Social Norming | Treatment Intensification | 21 Participants |
| Pharmacist E-Detailing | Treatment Intensification | 23 Participants |
| Control | Treatment Intensification | 19 Participants |
Comparison: Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size95% CI: [0.54, 1.66]
Comparison: Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size95% CI: [0.72, 2.29]
Comparison: Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size.95% CI: [0.74, 2.56]