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

Recruiting

• Conditions: Acute Coronary Syndrome; Cardiovascular Diseases
• Interventions: Other: Quality Surveillance Data Collection

• Registration Number: NCT04617834
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-05
• Study Start: 2021-02-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24000

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Quality Surveillance Data	Quality Surveillance Data Collection	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.

Primary Outcome Measures

Name	Time	Method
Number of Emergency Department (ED) utilization	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.

Secondary Outcome Measures

Name	Time	Method
Change in Cost - provider level	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.
Cardiovascular telehealth adoption rate	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.
Number of Cardiovascular Inter-facility transfers	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.
Number of 30-day cardiovascular hospital re-admissions	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.
Number of Adverse Events	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.
Number of Cardiovascular hospitalizations	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
Number of 30-day cardiovascular Emergency Department (ED) re-admissions	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.
Cost-effectiveness	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.
Change in Cost - societal level	day 30 and Month 12	Evaluate whether spending on healthcare (i.e., insurance payments) changes during the 30-day follow-up period.
Cardiovascular telehealth consultation rate	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.
Cardiovascular telehealth sustainability rate	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.

Trial Locations

Locations (4)

Wilkes County Public Health Community Clinic; 🇺🇸 Wilkesboro, North Carolina, United States

Wilkes County Emergency Medical Services; 🇺🇸 Wilkesboro, North Carolina, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Wilkes Medical Center; 🇺🇸 Wilkesboro, North Carolina, United States