- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160012
Peer Comparison Feedback to Providers to Improve Hypertension Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypertension (HTN) affects about 30% of US adults, and effective treatment that reduces long-term risk of subsequent cardiovascular disease is widely available; however, only about half of adults maintain good control. HTN control requires diagnosis, initiation of treatment, adherence to medications, and titration of medications. The investigators' prior work from Way2Text and SupportBP showed that there is significant clinical inertia in escalating medications for HTN through increasing dosage or adding new medications.
Prior studies have shown that providing feedback to providers with peer comparison data can leverage social norms to improve evidence-based practices in antibiotic and statin prescribing. Penn Medicine Lancaster General Primary Care is rolling out a Hypertension Control Implementation Plan (HCIP) as an initiative to improve hypertension control through creation of a clinic-based pathway to identify patients with hypertension, appropriately measure blood pressure, and prescribe medications to reduce blood pressure. Busy PCPs have competing demands of care, so there is an opportunity to leverage peer comparison to nudge providers to adhere to the HCIP and intensify medications.
The study design is a stratified parallel-group cluster-randomized trial. PCPs will be randomized in a 1:1 ratio, stratified by practice, to either: 1) Control: Usual Care- This will include the standard HCIP roll-out, and PCPs can access their HTN control rates using the existing EPIC dashboard.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Lancaster, Pennsylvania, United States, 17602
- Lancaster General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary Care Providers who have at =>30 patients hypertension as determined by the HTN quality metric
- Patients aged 18-85 with hypertension in their encounter diagnosis within the last 2 years (office visits, ED/Urgent Care, Hospital, Hospital Encounter, and Prenatal Visit)
- Patients will be counted in the denominator of the quality metric if they have both systolic and diastolic BP measures from an encounter with their PCP department within the last year (including office visits, well child, prenatal visit, consult visit, confidential, e-visit, nursing only, home/offsite visit, and telemedicine) that is >140 for systolic BP and >90 diastolic BP
Exclusion Criteria:
- Primary Care Providers includes providers with <30 patients in the HTN quality metric
- Patients will be excluded if they are 66 and older with a frailty diagnosis and those with an advanced illness diagnosis within the past year; 81 and older with frailty diagnosis within the past year
- It also excludes patients with end stage renal disease (indicated by evaluation of the GFR, diagnosis of end stage renal disease in last year, dialysis received in last year, or renal transplant) and patients with a pregnancy diagnosis in the last 9 months
- It also excludes patients with an end of life indicator (comfort care encounter in last year, comfort care noted in problem list in last year, and comfort care/palliative care procedures in last year)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
This group will not receive peer comparison messages and will continue with usual care.
|
|
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Experimental: Intervention
This group will receive peer comparison messages.
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In addition to usual care, PCPs will receive a monthly report as an EPIC in basket message describing what category they are in:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in new hypertensive medication prescriptions or an increased dose of hypertensive medication
Time Frame: 6 months
|
Change in new hypertensive medication prescriptions or an increased dose of hypertensive medication from baseline to the follow up period, as measured by the proportion of patients with a new prescription or dose placed for hypertensive medications in the electronic health record (EHR) from baseline to follow-up
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in hypertension control percentage
Time Frame: 6 months
|
Change in hypertension control percentage from baseline to follow up period, as measured by percentage increases in a hypertension quality improvement report that is provided to physicians in the electronic health record (EHR) and reflects rate of hypertension control across all patients under the care of that physician.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shivan Mehta, MD,MBA,MSHP, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 849584
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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