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Implementing Digital Health in a Learning Health System

NCT03713333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2024-04-18

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Digital Health Device Diagnostics

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)

Sponsors & Collaborators

  • West Virginia University

    collaborator OTHER

  • Scripps Health

    lead OTHER

Principal Investigators

  • Partho Sengupta, MD · West Virginia University Heart and Vascular Institute

  • Sanjeev Bhavnani, MD · Scripps Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-20
Primary Completion
2019-12-20
Completion
2020-03-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03713333 on ClinicalTrials.gov