Clinical trial NCT04617834: Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients Implementation (E-VICTORS)
Official title: Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients (E-VICTORS) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Keywords: acute chest pain
telehealth
implementation science
rural health
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2020-11-05
Enrollment: 24000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Emergency Department (ED) utilization
timeFrame: baseline
Secondary outcomes:
measure: Number of Cardiovascular hospitalizations
timeFrame: Baseline
measure: Number of Cardiovascular Inter-facility transfers
timeFrame: Baseline
measure: Number of 30-day cardiovascular Emergency Department (ED) re-admissions
timeFrame: day 30
measure: Number of 30-day cardiovascular hospital re-admissions
timeFrame: day 30
measure: Number of Adverse Events
timeFrame: day 30 and Month 12
measure: Change in Cost - societal level
timeFrame: day 30 and Month 12
measure: Change in Cost - provider level
timeFrame: day 30 and Month 12
measure: Cost-effectiveness
timeFrame: Month 12 and Month 48
measure: Cardiovascular telehealth consultation rate
timeFrame: Baseline
measure: Cardiovascular telehealth adoption rate
timeFrame: Month 12
measure: Cardiovascular telehealth sustainability rate
timeFrame: Month 24 - Month 48 post Intervention
Other outcomes:
measure: (ED) Emergency Department length of stay (LOS)
timeFrame: Baseline
measure: Time to transfer
timeFrame: Baseline
measure: Patient satisfaction Score
timeFrame: Day 30 and year 1
Locations:
city: Wilkesboro
country: United States
facility: Wilkes County Emergency Medical Services
state: North Carolina
city: Wilkesboro
country: United States
facility: Wilkes County Public Health Community Clinic
state: North Carolina
city: Wilkesboro
country: United States
facility: Wilkes Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Simon A Mahler, MD, MS
role: PRINCIPAL_INVESTIGATOR
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