Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension

Hypertension Clinical Trial

Official title:

Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603560
• Other study ID #: 2020P002897
• Secondary ID: P30AG064199
• Status: Completed
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: February 8, 2023

Study information

• Verified date: December 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: February 8, 2023
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Audit 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.
• Pharmacist 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	During the primary care office visit in which the provider-patient dyad received the intervention