Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension

NCT04603560 | Completed Results DMC

• 2 other identifiers: 2020P002897P30AG064199
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Audit and Feedback

EXPERIMENTAL

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.

Behavioral: Audit and Feedback

Pharmacist E-Detailing

EXPERIMENTAL

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.

Behavioral: Pharmacist E-Detailing

Control

NO INTERVENTION

No intervention will be provided to physicians in the control arm.

Interventions

Audit and Feedback BEHAVIORAL

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.

Audit and Feedback

Pharmacist E-Detailing BEHAVIORAL

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.

Pharmacist E-Detailing

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• fewer than 100 patients on their primary care panel
• practice less than one session per week
• 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
• excluded from the hypertension registry
• currently pregnant or post-partum 6 months
• receiving hospice care

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Haff N, Sreedhara SK, Wood W, Yom-Tov E, Horn DM, Hoover M, Low G, Lauffenburger JC, Chaitoff A, Russo M, Hanken K, Crum KL, Fontanet CP, Choudhry NK. Testing interventions to reduce clinical inertia in the treatment of hypertension: rationale and design of a pragmatic randomized controlled trial. Am Heart J. 2024 Feb;268:18-28. doi: 10.1016/j.ahj.2023.11.005. Epub 2023 Nov 14.

  PMID: 37967641 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Nancy Haff, MD, MPH
• Organization: Brigham and Women's Hospital

nhaff@mgb.org

617-278-0930

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Epidemiologist, Division of Pharmacoepidemiology

Model 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. The number of participants listed below includes both patients and providers (466 patients and 45 providers).

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 27, 2020
• Study Start: October 26, 2021
• Primary Completion: August 8, 2022
• Study Completion: February 8, 2023
• Last Updated: August 21, 2024
• Results First Posted: December 28, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)