Implementing Digital Health in a Learning Health System

Study 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 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.

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

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

Intervention / Treatment
-----------------
* Diagnostic Test: Digital Health Device Diagnostics


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pragmatic, multisite, cluster randomized trial comparing technology-enabled healthcare visitations with digital health devices and handheld imaging to standard-care
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology-Enabled Visitations<br>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<br>* 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)<br>|
| No Intervention: Standard-Care Visitations<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 30 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 | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobile Cardiac Telemetry | Number of referrals for mobile cardiac telemetry monitoring between randomized arms | 180 days | 
| Diagnostic Imaging | Number of referrals for diagnostic imaging with transthoracic echocardiography between randomized arms | 180 days | 
| Heart Failure | Incidence of heart failure diagnosed between randomized arms | 180 days | 
| Atrial Fibrillation | Incidence of atrial fibrillation diagnosed between randomized arms | 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 | 180 days | 
| Hospitalization | Percentage of patients hospitalized for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms | 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 | 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 | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mobile health, point of care genomics, big data, artificial intelligence, digital health, handheld ultrasound, smartphone ECG, learning health system