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Clinical Trials/NCT04603560
NCT04603560
Completed
Not Applicable

Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension

Brigham and Women's Hospital1 site in 1 country511 target enrollmentOctober 26, 2021
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Brigham and Women's Hospital
Enrollment
511
Locations
1
Primary Endpoint
Treatment Intensification
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 26, 2021
End Date
February 8, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nancy Haff, MD, MPH

Associate Epidemiologist, Division of Pharmacoepidemiology

Brigham and Women's Hospital

Eligibility Criteria

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.

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

Outcomes

Primary Outcomes

Treatment Intensification

Time Frame: 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

Study Sites (1)

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