An interventional study of Digital Health Device Diagnostics in Cardiovascular Diseases, Hypertension and Heart Failure, sponsored by Scripps Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Scripps Health · Not applicable, Interventional, and Screening
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.
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 374 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Scripps Health is the lead sponsor of 48 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
Diagnostic Test: Digital Health Device Diagnostics
Standard-care is defined as the range of services available during usual patient care. Handheld Imaging and digital health screening will be performed in the control group after the patient-physician encounter. As such, patients and physicians will be blinded to the diagnostic findings unless an abnormal finding is detected that requires physician review and triage for further care.
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)
Health Economic Outcomes
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
Time frame: 180 days
Mobile Cardiac Telemetry
Number of referrals for mobile cardiac telemetry monitoring between randomized arms
Time frame: 180 days
Health Economic Outcomes
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
Time frame: 30 days
Patient-Reported Outcome Measures
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
Time frame: 30 days
Patient-Reported Outcome Measures
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
Time frame: 180 days
Patient-Reported Experience Measures
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
Time frame: 30 days
Patient-Reported Experience Measures
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
Time frame: 180 days
Diagnostic Imaging
Number of referrals for diagnostic imaging with transthoracic echocardiography between randomized arms
Time frame: 180 days
Heart Failure
Incidence of heart failure diagnosed between randomized arms
Time frame: 180 days
Atrial Fibrillation
Incidence of atrial fibrillation diagnosed between randomized arms
Time frame: 180 days
Emergency Department Visitations
Percentage of patients presenting to the emergency department for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms
Time frame: 180 days
Hospitalization
Percentage of patients hospitalized for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms
Time frame: 180 days
Clinic Visitations
Percentage of patients presenting for a clinical visitation for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms
Time frame: 180 days
Medical Therapy
Percentage of patients initiating medical therapy for a cardiac condition including: heart failure, coronary artery disease, atrial fibrillation, and/or hypertension between randomized arms
Time frame: 180 days
Plan to share: Undecided
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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