Implementing Digital Health in a Learning Health System (ASE-INNOVATE)

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

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 on measures of healthcare efficiency. Handheld imaging and digital technologies provide a rapid diagnostic assessment at the time of a healthcare encounter. As such, the potential of such devices to improve healthcare efficiency is significant. Measures of healthcare efficiency directly related to digital health technologies 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 at the point-of-care. 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.

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

digital health, handheld ultrasound, smartphone ECG, mobile health, point of care genomics, big data, artificial intelligence, learning health system

Pragmatic, multisite, cluster randomized trial comparing technology-enabled healthcare visitations with digital health devices and handheld imaging to standard-care

Treating physicians and clinical practitioners will not be concealed to the randomized allocation of individual clinics or the patients that are seen in these encounters. Physicians in the interventional group will participate in conducting technology-enabled visitations before a patient encounter and therefore are not blinded to the assessment. For the standard care group handheld imaging and digital health screening will be performed after the patient-physician encounter. Principal investigators, outcome adjudicators, and statisticians are blinded to randomization, device findings, and treatment decisions.

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.

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)

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

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

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

Number of referrals for diagnostic imaging with transthoracic echocardiography between randomized arms

Percentage of patients presenting to the emergency department for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms

Percentage of patients hospitalized for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms

Percentage of patients presenting for a clinical visitation for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms

Percentage of patients initiating medical therapy for a cardiac condition including: heart failure, coronary artery disease, atrial fibrillation, and/or hypertension between randomized arms

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

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