Implementing Digital Health in a Learning Health System
- Conditions
- Genetic DiseaseHypertensionMetabolic SyndromeCardiovascular DiseasesHeart FailureAtrial Fibrillation
- Interventions
- Diagnostic Test: Digital Health Device Diagnostics
- Registration Number
- NCT03713333
- Lead Sponsor
- Scripps Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 374
- All participants of the ASE 2018 Outreach Event who are at least 18 years old who are referred for a cardiac evaluation
- Those not willing to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Technology-Enabled Visitations 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.
- Primary Outcome Measures
Name Time Method Health Economic Outcomes 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 Outcome Measures
Name Time Method Heart Failure 180 days Incidence of heart failure diagnosed between randomized arms
Patient-Reported Experience Measures 180 days Agency for Healthcare Research and Quality Consumer Assessment of Healthcare Providers and Systems (average scores and difference between randomized arms) where higher scores are associated with greater patient satisfaction and patient experience
Mobile Cardiac Telemetry 180 days Number of referrals for mobile cardiac telemetry monitoring between randomized arms
Patient-Reported Outcome Measures 180 days Veterans Research and Development Corporation-12 Patient Reported Outcomes (mean total score 50 +/- 10) where higher values are associated with greater mental and physical debility
Health Economic Outcomes 30 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
Atrial Fibrillation 180 days Incidence of atrial fibrillation diagnosed between randomized arms
Diagnostic Imaging 180 days Number of referrals for diagnostic imaging with transthoracic echocardiography between randomized arms
Emergency Department Visitations 180 days Percentage of patients presenting to the emergency department for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms
Hospitalization 180 days Percentage of patients hospitalized for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms
Clinic Visitations 180 days Percentage of patients presenting for a clinical visitation for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms
Medical Therapy 180 days Percentage of patients initiating medical therapy for a cardiac condition including: heart failure, coronary artery disease, atrial fibrillation, and/or hypertension between randomized arms
Trial Locations
- Locations (1)
West Virgina University
šŗšøMorgantown, West Virginia, United States