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OpenTrials
Completed

NCT Number: NCT03713333

Implementing Digital Health in a Learning Health System

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.

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Key information

Conditions

Cardiovascular Diseases Arrhythmias, Cardiac Atrial Fibrillation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Disease Genetic Diseases, Inborn Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virgina University

Morgantown, West Virginia, 26506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Health Device Diagnostics

Diagnostic Test

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 outcomes

  1. Health Economic Outcomes

    Time frame: 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 outcomes

  1. Mobile Cardiac Telemetry

    Time frame: 180 days

    Number of referrals for mobile cardiac telemetry monitoring between randomized arms

  2. Health Economic Outcomes

    Time frame: 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

  3. Patient-Reported Outcome Measures

    Time frame: 30 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

  4. Patient-Reported Outcome Measures

    Time frame: 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

  5. Patient-Reported Experience Measures

    Time frame: 30 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

  6. Patient-Reported Experience Measures

    Time frame: 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

  7. Diagnostic Imaging

    Time frame: 180 days

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

  8. Heart Failure

    Time frame: 180 days

    Incidence of heart failure diagnosed between randomized arms

  9. Atrial Fibrillation

    Time frame: 180 days

    Incidence of atrial fibrillation diagnosed between randomized arms

  10. Emergency Department Visitations

    Time frame: 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

  11. Hospitalization

    Time frame: 180 days

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

  12. Clinic Visitations

    Time frame: 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

  13. Medical Therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Collaborators

  • West Virginia University

Registry information

Official study 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

Acronym: ASE-INNOVATE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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