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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05406336
Other study ID # K01HL151974
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date July 31, 2025

Study information

Verified date June 2024
Source Temple University
Contact Gabriel Tajeu, DrPH
Phone 2055312258
Email gabriel.tajeu@temple.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: practicing Temple University Health System primary care clinicians who see patients (i.e., internal medicine, family medicine, attending physicians, nurse practitioners) will be eligible to participate - Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Predicted uncontrolled BP status (yes/no) at follow up visit, derived using a machine learning algorithm
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Temple University

Outcome

Type Measure Description Time frame Safety issue
Primary Vignette #1 - antihypertensive medication treatment intensification 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
Primary Vignette #2 - antihypertensive medication treatment intensification 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
Primary Vignette #3 - antihypertensive medication treatment intensification 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
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