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

Cardiovascular Diseases Clinical Trial

— E-VICTORS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617834
• Other study ID #: IRB00068612
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: Lauren Koehler, MS
• Phone: 336-716-4646
• Email: lekoehle[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24000
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases

Intervention

Other:
• Quality Surveillance Data Collection
Data will be retrospectively collected through EHR queries

Locations

Country	Name	City	State
United States	Wilkes County Emergency Medical Services	Wilkesboro	North Carolina
United States	Wilkes County Public Health Community Clinic	Wilkesboro	North Carolina
United States	Wilkes Medical Center	Wilkesboro	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

References & Publications (36)

Abrams TE, Vaughan-Sarrazin M, Kaboli PJ. Mortality and revascularization following admission for acute myocardial infarction: implication for rural veterans. J Rural Health. 2010 Fall;26(4):310-7. doi: 10.1111/j.1748-0361.2010.00318.x. Epub 2010 Aug 17. — View Citation

American College of Emergency Physicians Clinical Policies Subcommittee (Writing Committee) on Suspected Non-ST-Elevation Acute Coronary Syndromes:; Tomaszewski CA, Nestler D, Shah KH, Sudhir A, Brown MD. Clinical Policy: Critical Issues in the Evaluation and Management of Emergency Department Patients With Suspected Non-ST-Elevation Acute Coronary Syndromes. Ann Emerg Med. 2018 Nov;72(5):e65-e106. doi: 10.1016/j.annemergmed.2018.07.045. — View Citation

Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196. — View Citation

Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available. Erratum In: Circulation. 2020 Jan 14;141(2):e33. — View Citation

Brunetti ND, Dellegrottaglie G, Lopriore C, Di Giuseppe G, De Gennaro L, Lanzone S, Di Biase M. Prehospital telemedicine electrocardiogram triage for a regional public emergency medical service: is it worth it? A preliminary cost analysis. Clin Cardiol. 2014 Mar;37(3):140-5. doi: 10.1002/clc.22234. Epub 2014 Jan 22. — View Citation

Chit A, Becker DL, DiazGranados CA, Maschio M, Yau E, Drummond M. Cost-effectiveness of high-dose versus standard-dose inactivated influenza vaccine in adults aged 65 years and older: an economic evaluation of data from a randomised controlled trial. Lancet Infect Dis. 2015 Dec;15(12):1459-66. doi: 10.1016/S1473-3099(15)00249-2. Epub 2015 Sep 8. — View Citation

Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. — View Citation

Dauerman HL, Bates ER, Kontos MC, Li S, Garvey JL, Henry TD, Manoukian SV, Roe MT. Nationwide Analysis of Patients With ST-Segment-Elevation Myocardial Infarction Transferred for Primary Percutaneous Intervention: Findings From the American Heart Association Mission: Lifeline Program. Circ Cardiovasc Interv. 2015 May;8(5):e002450. doi: 10.1161/CIRCINTERVENTIONS.114.002450. — View Citation

Erhardt L, Herlitz J, Bossaert L, Halinen M, Keltai M, Koster R, Marcassa C, Quinn T, van Weert H; Task Force on the management of chest pain. Task force on the management of chest pain. Eur Heart J. 2002 Aug;23(15):1153-76. doi: 10.1053/euhj.2002.3194. No abstract available. — View Citation

Gesell SB, Golden SL, Limkakeng AT Jr, Carr CM, Matuskowitz A, Smith LM, Mahler SA. Implementation of the HEART Pathway: Using the Consolidated Framework for Implementation Research. Crit Pathw Cardiol. 2018 Dec;17(4):191-200. doi: 10.1097/HPC.0000000000000154. — View Citation

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. No abstract available. — View Citation

Harrington RA, Califf RM, Balamurugan A, Brown N, Benjamin RM, Braund WE, Hipp J, Konig M, Sanchez E, Joynt Maddox KE. Call to Action: Rural Health: A Presidential Advisory From the American Heart Association and American Stroke Association. Circulation. 2020 Mar 10;141(10):e615-e644. doi: 10.1161/CIR.0000000000000753. Epub 2020 Feb 10. — View Citation

Hawthorne G, Sansoni J, Hayes L, Marosszeky N, Sansoni E. Measuring patient satisfaction with health care treatment using the Short Assessment of Patient Satisfaction measure delivered superior and robust satisfaction estimates. J Clin Epidemiol. 2014 May;67(5):527-37. doi: 10.1016/j.jclinepi.2013.12.010. — View Citation

James CV, Moonesinghe R, Wilson-Frederick SM, Hall JE, Penman-Aguilar A, Bouye K. Racial/Ethnic Health Disparities Among Rural Adults-United States, 2012-2015: MMWR Surveillance Summaries / November 17, 2017 / 66(23);1-9. J Health Care Poor Underserved. 2018;29(1):19-34. doi: 10.1353/hpu.2018.0003. — View Citation

Jollis JG, Al-Khalidi HR, Roettig ML, Berger PB, Corbett CC, Doerfler SM, Fordyce CB, Henry TD, Hollowell L, Magdon-Ismail Z, Kochar A, McCarthy JJ, Monk L, O'Brien P, Rea TD, Shavadia J, Tamis-Holland J, Wilson BH, Ziada KM, Granger CB. Impact of Regionalization of ST-Segment-Elevation Myocardial Infarction Care on Treatment Times and Outcomes for Emergency Medical Services-Transported Patients Presenting to Hospitals With Percutaneous Coronary Intervention: Mission: Lifeline Accelerator-2. Circulation. 2018 Jan 23;137(4):376-387. doi: 10.1161/CIRCULATIONAHA.117.032446. Epub 2017 Nov 14. — View Citation

Kerr D, Holden D, Smith J, Kelly AM, Bunker S. Predictors of ambulance use in patients with acute myocardial infarction in Australia. Emerg Med J. 2006 Dec;23(12):948-52. doi: 10.1136/emj.2006.038414. — View Citation

Lambert L, Brown K, Segal E, Brophy J, Rodes-Cabau J, Bogaty P. Association between timeliness of reperfusion therapy and clinical outcomes in ST-elevation myocardial infarction. JAMA. 2010 Jun 2;303(21):2148-55. doi: 10.1001/jama.2010.712. — View Citation

Langabeer JR 2nd, Champagne-Langabeer T, Alqusairi D, Kim J, Jackson A, Persse D, Gonzalez M. Cost-benefit analysis of telehealth in pre-hospital care. J Telemed Telecare. 2017 Sep;23(8):747-751. doi: 10.1177/1357633X16680541. Epub 2016 Dec 5. — View Citation

Langabeer JR 2nd, Prasad S, Seo M, Smith DT, Segrest W, Owan T, Gerard D, Eisenhauer MD. The effect of interhospital transfers, emergency medical services, and distance on ischemic time in a rural ST-elevation myocardial infarction system of care. Am J Emerg Med. 2015 Jul;33(7):913-6. doi: 10.1016/j.ajem.2015.04.009. Epub 2015 Apr 10. — View Citation

Larson DM, Menssen KM, Sharkey SW, Duval S, Schwartz RS, Harris J, Meland JT, Unger BT, Henry TD. "False-positive" cardiac catheterization laboratory activation among patients with suspected ST-segment elevation myocardial infarction. JAMA. 2007 Dec 19;298(23):2754-60. doi: 10.1001/jama.298.23.2754. — View Citation

Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e259. — View Citation

Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD. Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85. — View Citation

Mahler SA, Lenoir KM, Wells BJ, Burke GL, Duncan PW, Case LD, Herrington DM, Diaz-Garelli JF, Futrell WM, Hiestand BC, Miller CD. Safely Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge. Circulation. 2018 Nov 27;138(22):2456-2468. doi: 10.1161/CIRCULATIONAHA.118.036528. — View Citation

Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3. — View Citation

Mohr NM, Young T, Harland KK, Skow B, Wittrock A, Bell A, Ward MM. Emergency Department Telemedicine Shortens Rural Time-To-Provider and Emergency Department Transfer Times. Telemed J E Health. 2018 Aug;24(8):582-593. doi: 10.1089/tmj.2017.0262. Epub 2018 Jan 2. — View Citation

O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available. — View Citation

Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1. — View Citation

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. — View Citation

Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139. — View Citation

Psaty BM, Delaney JA, Arnold AM, Curtis LH, Fitzpatrick AL, Heckbert SR, McKnight B, Ives D, Gottdiener JS, Kuller LH, Longstreth WT Jr. Study of Cardiovascular Health Outcomes in the Era of Claims Data: The Cardiovascular Health Study. Circulation. 2016 Jan 12;133(2):156-64. doi: 10.1161/CIRCULATIONAHA.115.018610. Epub 2015 Nov 4. — View Citation

Rhudy JP Jr, Alexandrov AW, Hyrkas KE, Jablonski-Jaudon RA, Pryor ER, Wang HE, Bakitas MA. Geographic access to interventional cardiology services in one rural state. Heart Lung. 2016 Sep-Oct;45(5):434-40. doi: 10.1016/j.hrtlng.2016.07.002. Epub 2016 Aug 1. — View Citation

Stopyra J, Snavely AC, Hiestand B, Wells BJ, Lenoir KM, Herrington D, Hendley N, Ashburn NP, Miller CD, Mahler SA. Comparison of accelerated diagnostic pathways for acute chest pain risk stratification. Heart. 2020 Jul;106(13):977-984. doi: 10.1136/heartjnl-2019-316426. Epub 2020 Apr 8. — View Citation

Stopyra JP, Harper WS, Higgins TJ, Prokesova JV, Winslow JE, Nelson RD, Alson RL, Davis CA, Russell GB, Miller CD, Mahler SA. Prehospital Modified HEART Score Predictive of 30-Day Adverse Cardiac Events. Prehosp Disaster Med. 2018 Feb;33(1):58-62. doi: 10.1017/S1049023X17007154. Epub 2018 Jan 10. — View Citation

Stopyra JP, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD, Mahler SA. The HEART Pathway Randomized Controlled Trial One-year Outcomes. Acad Emerg Med. 2019 Jan;26(1):41-50. doi: 10.1111/acem.13504. Epub 2018 Jul 19. — View Citation

Stopyra JP, Snavely AC, Scheidler JF, Smith LM, Nelson RD, Winslow JE, Pomper GJ, Ashburn NP, Hendley NW, Riley RF, Koehler LE, Miller CD, Mahler SA. Point-of-Care Troponin Testing during Ambulance Transport to Detect Acute Myocardial Infarction. Prehosp Emerg Care. 2020 Nov-Dec;24(6):751-759. doi: 10.1080/10903127.2020.1721740. Epub 2020 Mar 3. — View Citation

Tanguay A, Dallaire R, Hebert D, Begin F, Fleet R. Rural Patient Access to Primary Percutaneous Coronary Intervention Centers is Improved by a Novel Integrated Telemedicine Prehospital System. J Emerg Med. 2015 Nov;49(5):657-64. doi: 10.1016/j.jemermed.2015.05.009. Epub 2015 Jul 26. — View Citation

* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	(ED) Emergency Department length of stay (LOS)	ED LOS will be defined as the time from the patient's ED arrival to ED discharge, transfer, or admission	Baseline
Other	Time to transfer	Time to transfer will be defined by the time between a physician order for transfer and the patient leaving the ED	Baseline
Other	Patient satisfaction Score	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
Primary	Number of Emergency Department (ED) utilization	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	Number of Cardiovascular hospitalizations	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
Secondary	Number of Cardiovascular Inter-facility transfers	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
Secondary	Number of 30-day cardiovascular Emergency Department (ED) re-admissions	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
Secondary	Number of 30-day cardiovascular hospital re-admissions	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
Secondary	Number of Adverse Events	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
Secondary	Change in Cost - societal level	Evaluate whether spending on healthcare (i.e., insurance payments) changes during the 30-day follow-up period.	day 30 and Month 12
Secondary	Change in Cost - provider level	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
Secondary	Cost-effectiveness	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
Secondary	Cardiovascular telehealth consultation rate	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
Secondary	Cardiovascular telehealth adoption rate	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
Secondary	Cardiovascular telehealth sustainability rate	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

External Links

•   Access NC Community Demographics Search. Accessed May 12, 2020.
•   Bureau USC. American Community Survey (ACS).
•   Bureau USC. Type of Health Insurance Coverage by State: 2013, 2017, and 2018.
•   Bureau USC. United States Census Bureau QuickFacts. 2020
•   CMS Rural Health Strategy, Accessed 8/27/2018
•   Health Insurance Coverage in the United States: 2018: United States Census Bureau
•   HPSA Find
•   Local Area Unemployment Statistics Information and Analysis
•   Medicare Fee-For-Service Payment
•   MUA Find