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

Primary Purpose

Cardiovascular Diseases, Hypertension, Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Digital Health Device Diagnostics
Sponsored by
Scripps Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cardiovascular Diseases focused on measuring digital health, handheld ultrasound, smartphone ECG, mobile health, point of care genomics, big data, artificial intelligence, learning health system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Technology-Enabled Visitations

    Standard-Care Visitations

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 15, 2018
    Last Updated
    October 17, 2018
    Sponsor
    Scripps Health
    Collaborators
    West Virginia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03713333
    Brief Title
    Implementing Digital Health in a Learning Health System
    Acronym
    ASE-INNOVATE
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2018 (Anticipated)
    Primary Completion Date
    October 20, 2019 (Anticipated)
    Study Completion Date
    October 20, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Scripps Health
    Collaborators
    West Virginia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Hypertension, Heart Failure, Atrial Fibrillation, Metabolic Syndrome, Genetic Disease
    Keywords
    digital health, handheld ultrasound, smartphone ECG, mobile health, point of care genomics, big data, artificial intelligence, learning health system

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Pragmatic, multisite, cluster randomized trial comparing technology-enabled healthcare visitations with digital health devices and handheld imaging to standard-care
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Technology-Enabled Visitations
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard-Care Visitations
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Digital Health Device Diagnostics
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Patient-Reported Outcome Measures
    Description
    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
    Title
    Patient-Reported Experience Measures
    Description
    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
    Title
    Health Economic Outcomes
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Mobile Cardiac Telemetry
    Description
    Number of referrals for mobile cardiac telemetry monitoring between randomized arms
    Time Frame
    180 days
    Title
    Diagnostic Imaging
    Description
    Number of referrals for diagnostic imaging with transthoracic echocardiography between randomized arms
    Time Frame
    180 days
    Title
    Heart Failure
    Description
    Incidence of heart failure diagnosed between randomized arms
    Time Frame
    180 days
    Title
    Atrial Fibrillation
    Description
    Incidence of atrial fibrillation diagnosed between randomized arms
    Time Frame
    180 days
    Title
    Emergency Department Visitations
    Description
    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
    Title
    Hospitalization
    Description
    Percentage of patients hospitalized for a cardiac condition (example; myocardial infarction, heart failure, atrial fibrillation, and stroke) between randomized arms
    Time Frame
    180 days
    Title
    Clinic Visitations
    Description
    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
    Title
    Medical Therapy
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Partho P Sengupta, MD
    Phone
    304-598-4478
    Email
    partho.sengupta@hsc.wvu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lan Hu
    Phone
    304-598-4478
    Email
    lan.hu@wvumedicine.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Partho Sengupta, MD
    Organizational Affiliation
    West Virginia University Heart and Vascular Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sanjeev Bhavnani, MD
    Organizational Affiliation
    Scripps Clinic
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Implementing Digital Health in a Learning Health System

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