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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04617834

Collaborator

Health Resources and Services Administration (HRSA) (U.S. Fed)

24,000

Enrollment

Locations

Anticipated Duration (Months)

6000

Patients Per Site

143

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Acute Coronary Syndrome	Other: Quality Surveillance Data Collection

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 Design

Study Type:

Observational

Anticipated Enrollment :

24000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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 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 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.
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.
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.
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.
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.
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 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.
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.

Other Outcome Measures

(ED) Emergency Department length of stay (LOS) [Baseline]
ED LOS will be defined as the time from the patient's ED arrival to ED discharge, transfer, or admission
Time to transfer [Baseline]
Time to transfer will be defined by the time between a physician order for transfer and the patient leaving the ED
Patient satisfaction Score [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilkes County Emergency Medical Services	Wilkesboro	North Carolina	United States	28697
2	Wilkes County Public Health Community Clinic	Wilkesboro	North Carolina	United States	28697
3	Wilkes Medical Center	Wilkesboro	North Carolina	United States	28697
4	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157