NCT03713333

Implementing Digital Health in a Learning Health System

Implementation of High Definition Screening Using Handheld Imaging and Digital Health Technologies Within a Learning Health System to Identify Cardiovascular Disease at the Point-of-care: The ASE-INNOVATE Program

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objective #1: Determine the effectiveness of handheld imaging and digital health devices on long term health and patient-reported outcomes through pragmatic and randomized clinical trial designs. Objective #2: Assess the impact of digital health devices and remote patient monitoring (RPM) on measures of healthcare efficiency. Measures of healthcare efficiency directly related to digital health technologies and RPM include: identify which interventions can improve care; define the variations in care and; demonstrate within which patient populations digital health technologies are most effective. Objective #3: Apply integration methods for handheld imaging and digital health devices used for clinical decisions. Achieving integration and interoperability-the ability of different information technology systems and software applications to communicate and exchange data with each other-requires identification for precisely how new innovations merge into systems of care and are applied to various practice settings.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-10-20
• Primary completion: 2019-12-20
• Completion: 2020-03-20
• First posted: 2018-10-19
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study