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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Scripps Health
- Enrollment
- 374
- Locations
- 1
- Primary Endpoint
- Health Economic Outcomes
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Sanjeev Bhavnani MD
Principal Investigator - Healthcare Innovation
Scripps Health
Eligibility Criteria
Inclusion Criteria
- •All participants of the ASE 2018 Outreach Event who are at least 18 years old who are referred for a cardiac evaluation
Exclusion Criteria
- •Those not willing to consent
Outcomes
Primary Outcomes
Health Economic Outcomes
Time Frame: 180 days
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
Secondary Outcomes
- Patient-Reported Experience Measures(180 days)
- Mobile Cardiac Telemetry(180 days)
- Patient-Reported Outcome Measures(180 days)
- Health Economic Outcomes(30 days)
- Heart Failure(180 days)
- Atrial Fibrillation(180 days)
- Diagnostic Imaging(180 days)
- Emergency Department Visitations(180 days)
- Hospitalization(180 days)
- Clinic Visitations(180 days)
- Medical Therapy(180 days)