Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04603560
Collaborator
(none)
545
1
3
19.1
28.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Audit and Feedback
  • Behavioral: Pharmacist E-Detailing
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
545 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
Actual Study Start Date :
Oct 26, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Experimental: 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.

Behavioral: 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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Treatment intensification [During the primary care office visit in which the provider-patient dyad received the intervention]

    Intensification of treatment will include an increase in dose of an existing antihypertensive medication, adding an additional medication, or rotation of one medication to another that is stronger or more appropriate for the patient (e.g. changing hydrochlorothiazide to furosemide for a patient with chronic kidney disease). These will be measured using prescribing information from the EHR on the day of the patient's visit.

Secondary Outcome Measures

  1. Change in systolic blood pressure [Up to 6 months following the intervention date]

    The initial value will be the systolic blood pressure at the time of the visit targeted by the intervention. The follow-up blood pressure will be the last blood pressure available in the EHR within 6 months after the visit targeted by the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Provider Inclusion Criteria:
  • Primary care physician

  • Practicing in primary care at Massachusetts General Hospital

  • Caring for at least 10 patients: (1) aged 18-79, (2) for whom the average of their most recent 3 blood pressure measurements 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 patients aged 18-59 and <150/90 for patients aged 60-79, consistent with MGH population health metrics.

Provider Exclusion Criteria:

-None

Patient Inclusion Criteria:
  • had a blood pressure greater than 140/900 mmHg at 2+ PCP visits in the past 12 months

  • treatment was not intensified at any of these visits

Patient Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nancy Haff, MD, MPH, Associate Epidemiologist, Division of Pharmacoepidemiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04603560
Other Study ID Numbers:
  • 2020P002897
First Posted:
Oct 27, 2020
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022