Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT03713333
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2018-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementing Digital Health in a Learning Health System
Sponsor:
Scripps Health
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASE-INNOVATE
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 identiļ¬cation for precisely how new innovations merge into systems of care and are applied to various practice settings.
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 identiļ¬cation for precisely how new innovations merge into systems of care and are applied to various practice settings.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: