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Virtual and Physical Health Assessments and Treatment Plans (VHAT)

Primary Purpose

Vascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual visit
Sponsored by
CAMC Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vascular Diseases focused on measuring Vascular, Clinic visit, Tele-health

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Patients referred to and scheduled for an initial visit at our Vascular Center of Excellence (VCOE).

Exclusion Criteria:

  • Patients that are deemed urgent cases by the VCOE, and scheduled within two weeks for the initial clinic visit.
  • Patients who are scheduled to have the placement of an arteriovenous (AV) fistula at the time of the initial clinic visit.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Type of visit

    Arm Description

    Single arm, non-randomized crossover design. All patients will receive both types of visits virtual and physical, and after assessments are made, participants will be classified by physicians into low, moderate or high risk for intervention.

    Outcomes

    Primary Outcome Measures

    Categorization of physician treatment plans. (Physicians will classify treatment plans as low, moderate or high need for vascular intervention)
    Comparison of virtual visit treatment plans to physical treatment plans. After assessments, physicians will classify patients' treatment plans into low (treat medically), moderate (vascular intervention in the future, but not immediately) or high (needs immediately, within 2 weeks). The distribution of low, moderate and high among the two types of visits (Virtual and Physical) will be compared.

    Secondary Outcome Measures

    Patient satisfaction
    Comparison of patient satisfaction after virtual and physical visits. Satisfaction will be measured by two survey questions based on a 1 to 5 Likert scale.

    Full Information

    First Posted
    April 12, 2019
    Last Updated
    July 26, 2021
    Sponsor
    CAMC Health System
    Collaborators
    Sarah & Pauline Maier Foundation, Inc., WVCTSI
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03947905
    Brief Title
    Virtual and Physical Health Assessments and Treatment Plans
    Acronym
    VHAT
    Official Title
    Comparison of Virtual to Physical Health Assessments and Treatment Plans for Patients Presenting for Initial Vascular Clinic Visits
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CAMC Health System
    Collaborators
    Sarah & Pauline Maier Foundation, Inc., WVCTSI

    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
    The aim of the current study is to compare virtual clinic visits (i.e., real-time, face-to-face visits conducted over the internet with tablet devices) to actual physical clinic visits. After both types of visits (virtual versus physical) physicians will be asked to classify patients into low, moderate or high risk for a vascular intervention. It is hypothesized that there will be good agreement between classifications made after the virtual visits as compared to those made after physical visits. That is, virtual visit classifications will be as good as those made after physical visits.
    Detailed Description
    Patient dissatisfaction can increase because of the complexities associated with navigating modern health care systems. It is easy to speculate that some of this dissatisfaction is associated with travel, wait times and other issues that arise during routine clinic visits. The authors of recent studies have demonstrated that it is possible and feasible to conduct many routine visits remotely. It is our belief that virtual health assessments and treatment plans (VHAT) conducted remotely can be as effective, perhaps be more efficient and increase patient satisfaction when compared to regular physical health assessments and treatment plans (PHAT). Physicians want to provide optimal health care; however, in geographically isolated areas such as some locations in West Virginia that can be a challenge. It seems reasonable to believe that monitoring patients with telehealth technology, collecting on-going real time data and conducting VHAT can provide high quality health care for patients. It can also help to classify health risk, increase patient and medical staff satisfaction, decrease staff time for visits, while at the same time increase the efficiency of the follow-up process. The investigators plan to compare the physician assessments and future treatment plans made using VHAT to those made after PHAT. It is believed that VHAT assessments will be in agreement with those made with PHAT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vascular Diseases
    Keywords
    Vascular, Clinic visit, Tele-health

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single arm crossover design where all participants receive both types of visits (Virtual and Physical visits).
    Masking
    None (Open Label)
    Masking Description
    Open label
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Type of visit
    Arm Type
    Experimental
    Arm Description
    Single arm, non-randomized crossover design. All patients will receive both types of visits virtual and physical, and after assessments are made, participants will be classified by physicians into low, moderate or high risk for intervention.
    Intervention Type
    Procedure
    Intervention Name(s)
    Virtual visit
    Other Intervention Name(s)
    Physical visit
    Intervention Description
    Type of visit
    Primary Outcome Measure Information:
    Title
    Categorization of physician treatment plans. (Physicians will classify treatment plans as low, moderate or high need for vascular intervention)
    Description
    Comparison of virtual visit treatment plans to physical treatment plans. After assessments, physicians will classify patients' treatment plans into low (treat medically), moderate (vascular intervention in the future, but not immediately) or high (needs immediately, within 2 weeks). The distribution of low, moderate and high among the two types of visits (Virtual and Physical) will be compared.
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    Comparison of patient satisfaction after virtual and physical visits. Satisfaction will be measured by two survey questions based on a 1 to 5 Likert scale.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Patients referred to and scheduled for an initial visit at our Vascular Center of Excellence (VCOE). Exclusion Criteria: Patients that are deemed urgent cases by the VCOE, and scheduled within two weeks for the initial clinic visit. Patients who are scheduled to have the placement of an arteriovenous (AV) fistula at the time of the initial clinic visit.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Albeir Y Mousa, MD
    Phone
    3043884875
    Email
    amousa@hsc.wvu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mike Broce, BA
    Phone
    3043889923
    Email
    Mike.broce@camc.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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