Clinical trial NCT04603560: Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
Official title: Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-10-27
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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 Exclusion Criteria:

* excluded from the hypertension registry
* currently pregnant or post-partum 6 months
* receiving hospice care

Primary outcomes:
measure: Treatment Intensification
timeFrame: During the primary care office visit in which the provider-patient dyad received the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: