Implementing Digital Health in a Learning Health System

NCT03713333 | Completed DMC FDA Device

• 1 other identifier: Pro00029622
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

The need for new models of integrated care that can improve the efficiency of healthcare and reduce the costs are key priorities for health systems across the United States. Treatment costs for patients with at least one chronic medical or cardiovascular condition make up over 4-trillion dollars in spending on healthcare, with estimations of a population prevalence of 100-million affected individuals within the next decade. Therefore, the management of chronic conditions requires innovative and new implementation methods that improve outcomes, reduce costs, and increase healthcare efficiencies. Digital health, the use of mobile computing and communication technologies as an integral new models of care is seen as one potential solution. Despite the potential applications, there is limited data to support that new technologies improve healthcare outcomes. To do so requires; 1) robust methods to determine the impact of new technologies on healthcare outcomes and costs; and 2) evaluative mechanisms for how new devices are integrated into patient care. In this regard, the proposed clinical trial aims to advance the investigator's knowledge and to demonstrate the pragmatic utilization of new technologies within a learning healthcare system providing services to high-risk patient populations.

Conditions

Cardiovascular Diseases; Hypertension; Heart Failure; Atrial Fibrillation; Metabolic Syndrome; Genetic Disease

Keywords

digital health; handheld ultrasound; smartphone ECG; mobile health; point of care genomics; big data; artificial intelligence; learning health system

Outcome Measures

Primary Outcomes (1)

• Health Economic Outcomes

  Economic difference between the total costs of care between randomized arms including; clinic visitations, hospitalizations, emergency room visitations, and diagnostic testing. Collected as cumulative diagnosis-related group (DRG) and current procedural terminology (CPT) amounts in United States Dollars

  180 days

Secondary Outcomes (13)

• Mobile Cardiac Telemetry

  180 days

• Health Economic Outcomes

  30 days

• Patient-Reported Outcome Measures

  30 days

• Patient-Reported Outcome Measures

  180 days

• Patient-Reported Experience Measures

  30 days

Study Arms (2)

Technology-Enabled Visitations

EXPERIMENTAL

Technology-enabled visitations with digital health will include the following devices used at the time of a patient-physician encounter. These findings will be available to the treating physician at the time the visitation and to be used for clinical decisions.

Diagnostic Test: Digital Health Device Diagnostics

Standard-Care Visitations

NO INTERVENTION

Standard-care is defined as the range of services available during usual patient care. Handheld Imaging and digital health screening will be performed in the control group after the patient-physician encounter. As such, patients and physicians will be blinded to the diagnostic findings unless an abnormal finding is detected that requires physician review and triage for further care.

Interventions

Digital Health Device Diagnostics DIAGNOSTIC_TEST

Technology-enabled visitations with digital health will include the following devices used at the time of a patient-physician encounter. These findings will be available to the treating physician at the time the visitation and to be used for clinical decisions. * Handheld imaging - focused echocardiographic examination (Butterfly IQ) * Smartphone iECG for cardiac rhythm assessments (Alivecor) * Blood Pressure (CloudDX) * Oxygen Saturation (CloudDX) * Weight (CloudDX) * Point-of-Care Genetic Testing (Phosphorous)

Technology-Enabled Visitations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants of the ASE 2018 Outreach Event who are at least 18 years old who are referred for a cardiac evaluation

You may not qualify if:

• Those not willing to consent

Sponsors & Collaborators

• Scripps Health: lead
• West Virginia University: collaborator

Study Sites (1)

West Virgina University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (28)

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  PMID: 28914267 BACKGROUND

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  PMID: 28917688 RESULT

• Bhavnani SP, Narula J, Sengupta PP. Mobile technology and the digitization of healthcare. Eur Heart J. 2016 May 7;37(18):1428-38. doi: 10.1093/eurheartj/ehv770. Epub 2016 Feb 11.

  PMID: 26873093 RESULT

• Bansal M, Singh S, Maheshwari P, Adams D, McCulloch ML, Dada T, Sengupta SP, Kasliwal RR, Pellikka PA, Sengupta PP; VISION-in-Tele-Echo Study Investigators. Value of interactive scanning for improving the outcome of new-learners in transcontinental tele-echocardiography (VISION-in-Tele-Echo) study. J Am Soc Echocardiogr. 2015 Jan;28(1):75-87. doi: 10.1016/j.echo.2014.09.001. Epub 2014 Oct 8.

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Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Heart Failure; Atrial Fibrillation; Metabolic Syndrome; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Vascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Partho Sengupta, MD

  West Virginia University Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

• Sanjeev Bhavnani, MD

  Scripps Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treating physicians and clinical practitioners will not be concealed to the randomized allocation of individual clinics or the patients that are seen in these encounters. Physicians in the interventional group will participate in conducting technology-enabled visitations before and after a patient encounter and therefore are not blinded to the assessment. For the standard care group handheld imaging and remote patient monitoring will not be performed after the patient-physician encounter. Principal investigators, outcome adjudicators, and statisticians are blinded to randomization, device findings, and treatment decisions.
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Healthcare Innovation

Model Details: Pragmatic, multisite, cluster randomized trial comparing point of care and remote patient monitoring with digital health devices and handheld imaging to standard-care

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 19, 2018
• Study Start: October 20, 2018
• Primary Completion: December 20, 2019
• Study Completion: March 20, 2020
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (1)