- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406336
Machine Learning to Reduce Hypertension Treatment Clinical Inertia
April 7, 2025 updated by: Temple University
Among individuals with an uncontrolled BP at the current visit, the objective of this study is to compare clinical management of hypertension with and without information from a machine learning algorithm on whether a patient will have uncontrolled blood pressure at their next follow up visit through a case-vignette study.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Among adults with uncontrolled blood pressure (BP) at a clinic visit, clinical inertia is common.
Clinical inertia is defined as a failure of providers to initiate or intensify treatment (i.e., adding medication or increasing dosage) when guidelines indicate doing so.
Prior studies report that clinicians intensify antihypertensive medication treatment in less than 20% of visits where intensification would have been clinically recommended.
Thus, patients who have uncontrolled BP may not receive timely therapy to control their BP.
To address this issue, the investigators will use a randomized design to test the hypothesis that clinicians will be more likely to intensify the hypertensive regimen and/or assess nonadherence for patients with uncontrolled BP at the current visit when presented with information that a patient is predicted to have uncontrolled BP at the next visit by a machine learning algorithm.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriel Tajeu, DrPH
- Phone Number: 2055312258
- Email: gtajeu@uab.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria: practicing primary care clinicians who see patients (i.e., internal medicine, family medicine, attending physicians, nurse practitioners) will be eligible to participate -
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Information from Machine Learning Algorithm
The investigators will create case vignettes to assess clinician hypertension management behavior, specifically antihypertensive medication intensification among individuals with uncontrolled blood pressure (BP).
This arm will not include information from a machine learning algorithm designed to predict uncontrolled BP at a follow up visit.
|
|
|
Experimental: Information from Machine Learning Algorithm
The investigators will create case vignettes to assess clinician hypertension management behavior, specifically antihypertensive medication intensification among individuals with uncontrolled blood pressure (BP).
This arm will include information from a machine learning algorithm designed to predict uncontrolled BP at a follow up visit about whether the algorithm predicts that the patient will have uncontrolled BP at the next visit.
|
The investigators have created a machine learning algorithm to predict uncontrolled blood pressure (BP) status (yes/no) at a follow up visit among adults with uncontrolled BP at their current visit.
The investigators will determine whether adding this information to a vignette describing a patient will increase the likelihood that a clinician will intensify antihypertensive medication treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vignette #1 - antihypertensive medication treatment intensification
Time Frame: Immediately after clinical vignette
|
A clinical vignette of a patient with uncontrolled blood pressure will be presented to clinicians.
They will then be asked to assess wether they would intensify antihypertensive medication treatment.
This will be assessed using a 5-point Likert scale with scores ranging from 1 ("Strongly disagree") to 5 ("Strongly agree").
Likert scale scores will be compared between clinicians in the control and intervention group.
|
Immediately after clinical vignette
|
|
Vignette #2 - antihypertensive medication treatment intensification
Time Frame: Immediately after clinical vignette
|
A second clinical vignette of a patient with uncontrolled blood pressure will be presented to clinicians.
They will then be asked to assess wether they would intensify antihypertensive medication treatment.
This will be assessed using a 5-point Likert scale with scores ranging from 1 ("Strongly disagree") to 5 ("Strongly agree").
Likert scale scores will be compared between clinicians in the control and intervention group.
|
Immediately after clinical vignette
|
|
Vignette #3 - antihypertensive medication treatment intensification
Time Frame: Immediately after clinical vignette
|
A third clinical vignette of a patient with uncontrolled blood pressure will be presented to clinicians.
They will then be asked to assess wether they would intensify antihypertensive medication treatment.
This will be assessed using a 5-point Likert scale with scores ranging from 1 ("Strongly disagree") to 5 ("Strongly agree").
Likert scale scores will be compared between clinicians in the control and intervention group.
|
Immediately after clinical vignette
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gabriel Tajeu, DrPH, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 25, 2025
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
July 31, 2025
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01HL151974 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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