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Machine Learning to Reduce Hypertension Treatment Clinical Inertia

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Predicted uncontrolled BP status (yes/no) at follow up visit, derived using a machine learning algorithm
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Uncontrolled blood pressure, Antihypertensive medication, Hypertension treatment, Clinical inertia, Machine learning

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    No Information from Machine Learning Algorithm

    Information from Machine Learning Algorithm

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2022
    Last Updated
    June 1, 2022
    Sponsor
    Temple University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05406336
    Brief Title
    Machine Learning to Reduce Hypertension Treatment Clinical Inertia
    Official Title
    Machine Learning to Reduce Hypertension Treatment Clinical Inertia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Temple University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Uncontrolled blood pressure, Antihypertensive medication, Hypertension treatment, Clinical inertia, Machine learning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No Information from Machine Learning Algorithm
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Information from Machine Learning Algorithm
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Predicted uncontrolled BP status (yes/no) at follow up visit, derived using a machine learning algorithm
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Vignette #1 - antihypertensive medication treatment intensification
    Description
    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.
    Time Frame
    Immediately after clinical vignette
    Title
    Vignette #2 - antihypertensive medication treatment intensification
    Description
    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.
    Time Frame
    Immediately after clinical vignette
    Title
    Vignette #3 - antihypertensive medication treatment intensification
    Description
    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.
    Time Frame
    Immediately after clinical vignette

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriel Tajeu, DrPH
    Phone
    2055312258
    Email
    gabriel.tajeu@temple.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gabriel Tajeu, DrPH
    Organizational Affiliation
    Temple University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Machine Learning to Reduce Hypertension Treatment Clinical Inertia

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