Back to resultsPersonalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
Primary Purpose
Hypertension
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit and Feedback
Pharmacist E-Detailing
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Audit and Feedback
Pharmacist E-Detailing
Control
Arm Description
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.
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 will be provided to physicians in the control arm.
Outcomes
Primary Outcome Measures
Treatment intensification
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
Change in systolic blood pressure
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.
Full Information
NCT ID
NCT04603560
First Posted
October 8, 2020
Last Updated
June 27, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04603560
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
505 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Audit and Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Pharmacist E-Detailing
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be provided to physicians in the control arm.
Intervention Type
Behavioral
Intervention Name(s)
Audit and Feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist E-Detailing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment intensification
Description
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.
Time Frame
During the primary care office visit in which the provider-patient dyad received the intervention
Secondary Outcome Measure Information:
Title
Change in systolic blood pressure
Description
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.
Time Frame
Up to 6 months following the intervention date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
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