Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients Implementation (E-VICTORS) (E-VICTORS)

August 9, 2023 updated by: Wake Forest University Health Sciences

Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients (E-VICTORS) Project

This pre-post study will evaluate the implementation of a cardiovascular telehealth platform, which will connect experts from the Wake Forest University Health Sciences (WFUHS) tertiary care center with Wilkes County Emergency Medical Services (WC-EMS) system, Wilkes Medical Center Emergency Department (ED), and The Wilkes County Health Department Public Health Community Clinic (PHCC) to improve cardiovascular care in this rural community.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This program aims to improve cardiovascular care for patients in Wilkes County by implementing a cardiovascular telehealth program designed to; a) assist WC- EMS paramedics with the early risk stratification (electrocardiogram (EKG) interpretation, vital signs, and risk scores), treatment, and transportation destination decisions in patients with acute chest pain or dyspnea, b) support Wilkes Medical Center (WMC) Emergency Department (ED) providers (physicians and advanced practice clinicians) in the evaluation, management, and disposition of patients with acute cardiovascular symptoms, and c) provide consultative expertise to the Primary Health Care Centers (PHCC) for patients seen following an EMS or ED encounter for cardiovascular symptoms.

Study Type

Observational

Enrollment (Estimated)

24000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Wilkesboro, North Carolina, United States, 28697
        • Not yet recruiting
        • Wilkes County Emergency Medical Services
        • Contact:
      • Wilkesboro, North Carolina, United States, 28697
        • Not yet recruiting
        • Wilkes County Public Health Community Clinic
        • Contact:
      • Wilkesboro, North Carolina, United States, 28697
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population is adult patients with cardiovascular symptoms. Therefore, adult patients (>18 years old) with acute chest pain or dyspnea concerning for acute cardiovascular disease will be eligible.

Description

Inclusion Criteria:

  • age > 18 years at time of index encounter
  • Cardiovascular symptoms (chest discomfort or dyspnea consistent with possible ACS) as indicated by the treating provider

Exclusion Criteria:

  • Age <18
  • Traumatic chest pain
  • Dyspnea that is clearly from a non-cardiac etiology
  • Patients with hemodynamic instability SBP < 90 mmHg, HR>160 or <40 bpm
  • Patients requiring intubation/mechanical ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Quality Surveillance Data
For this quality surveillance study, data will be collected retrospectively through electronic health record (EHR) queries for all eligible patients treated for acute cardiovascular symptoms by one of the study sites.
Other: Quality Surveillance Data Collection
Data will be retrospectively collected through EHR queries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Emergency Department (ED) utilization
Time Frame: baseline
ED utilization among patients with cardiovascular symptoms will be defined as the total number of cardiovascular-related ED admissions divided by the total number of unique individual patients receiving cardiovascular care during the project period.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cardiovascular hospitalizations
Time Frame: Baseline
Cardiovascular hospitalizations will be defined as an inpatient or observation admission for cardiovascular conditions or symptoms based on Current Procedures Terminology (CPT) and International Classification of Diseases (ICD) codes
Baseline
Number of Cardiovascular Inter-facility transfers
Time Frame: Baseline
Cardiovascular Inter-facility transfers will be defined based on patients with cardiovascular symptoms or conditions transferred from Wilkes Medical Center (WMC) to another hospital.
Baseline
Number of 30-day cardiovascular Emergency Department (ED) re-admissions
Time Frame: day 30
30-day cardiovascular ED re-admissions will be defined as any cardiovascular related ED admission occurring during the 30 days following their initial/index ED encounter.
day 30
Number of 30-day cardiovascular hospital re-admissions
Time Frame: day 30
30-day cardiovascular hospital re-admissions will be defined as any cardiovascular related hospital admission occurring during the 30 days following their index hospitalization.
day 30
Number of Adverse Events
Time Frame: day 30 and Month 12
Determine if telehealth implementation will result in improved sorting of cases for escalated and de-escalated care, reducing the number of adverse events.
day 30 and Month 12
Change in Cost - societal level
Time Frame: day 30 and Month 12
Evaluate whether spending on healthcare (i.e., insurance payments) changes during the 30-day follow-up period.
day 30 and Month 12
Change in Cost - provider level
Time Frame: day 30 and Month 12
Estimates will be obtained for the impact of the establishment of the telehealth program on the budget of the tertiary center.
day 30 and Month 12
Cost-effectiveness
Time Frame: Month 12 and Month 48
Cost-effectiveness: will be evaluated at the societal level to inform the relative changes in patient outcomes and costs resulting from the telehealth program.
Month 12 and Month 48
Cardiovascular telehealth consultation rate
Time Frame: Baseline
Cardiovascular telehealth consultation rate will be assessed by identifying the total number of patients that received cardiovascular telehealth consultations at each originating site divided by the total number of patients at each originating site with cardiovascular symptoms.
Baseline
Cardiovascular telehealth adoption rate
Time Frame: Month 12
Adoption rate will be defined by the cardiovascular telehealth consultation rate at each originating site during the first 12 months following implementation of the cardiovascular telehealth service.
Month 12
Cardiovascular telehealth sustainability rate
Time Frame: Month 24 - Month 48 post Intervention
Sustainability rate will be defined by the cardiovascular telehealth consultation rate at each site greater than 12 months after the availability of the cardiovascular telehealth service.
Month 24 - Month 48 post Intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
(ED) Emergency Department length of stay (LOS)
Time Frame: Baseline
ED LOS will be defined as the time from the patient's ED arrival to ED discharge, transfer, or admission
Baseline
Time to transfer
Time Frame: Baseline
Time to transfer will be defined by the time between a physician order for transfer and the patient leaving the ED
Baseline
Patient satisfaction Score
Time Frame: Day 30 and year 1
Patient satisfaction will be measured (telephone follow-ups) using a modified Short Assessment of Patient Satisfaction (SAPS) which is a validated 7 question instrument, which uses a 5-point Likert scale - scoring: 0 to 10 = Very dissatisfied; 11 to 18 = Dissatisfied; 19 to 26 = Satisfied; 27 to 28 = Very satisfied
Day 30 and year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Simon A Mahler, MD, MS, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00068612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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