Virtual and Physical Health Assessments and Treatment Plans (VHAT)

Comparison of Virtual to Physical Health Assessments and Treatment Plans for Patients Presenting for Initial Vascular Clinic Visits

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Diseases
• Intervention / Treatment: Procedure: Virtual visit

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Albeir Y Mousa, MD; Phone Number: 3043884875; Email: amousa@hsc.wvu.edu
• Study Contact Backup: Name: Mike Broce, BA; Phone Number: 3043889923; Email: Mike.broce@camc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type of visit; 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.	Procedure: Virtual visit; Type of visit; Other Names: Physical visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Collaborators and Investigators

• Sponsor: CAMC Health System
• Collaborators: Sarah & Pauline Maier Foundation, Inc.; WVCTSI

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Vascular; Tele-health; Clinic visit
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 19-558

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