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
About this trial
This is an interventional health services research trial for Vascular Diseases focused on measuring Vascular, Clinic visit, Tele-health
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.
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
NCT ID
NCT03947905
First Posted
April 12, 2019
Last Updated
July 26, 2021
Sponsor
CAMC Health System
Collaborators
Sarah & Pauline Maier Foundation, Inc., WVCTSI
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
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Virtual and Physical Health Assessments and Treatment Plans
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