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

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ClinicalTrials.gov Identifier: NCT03713333
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
West Virginia University
Information provided by (Responsible Party):
Sanjeev Bhavnani MD, Scripps Health

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date October 19, 2018
Estimated Study Start Date  ICMJE October 20, 2018
Estimated Primary Completion Date October 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Mobile Cardiac Telemetry [ Time Frame: 180 days ]
    Number of referrals for mobile cardiac telemetry monitoring between randomized arms
  • Diagnostic Imaging [ Time Frame: 180 days ]
    Number of referrals for diagnostic imaging with transthoracic echocardiography between randomized arms
  • Heart Failure [ Time Frame: 180 days ]
    Incidence of heart failure diagnosed between randomized arms
  • Atrial Fibrillation [ Time Frame: 180 days ]
    Incidence of atrial fibrillation diagnosed between randomized arms
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementing Digital Health in a Learning Health System
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Pragmatic, multisite, cluster randomized trial comparing technology-enabled healthcare visitations with digital health devices and handheld imaging to standard-care
Masking: Triple (Care Provider, Investigator, Outcomes 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.
Primary Purpose: Screening
Condition  ICMJE
  • Cardiovascular Diseases
  • Hypertension
  • Heart Failure
  • Atrial Fibrillation
  • Metabolic Syndrome
  • Genetic Disease
Intervention  ICMJE Diagnostic Test: Digital Health Device Diagnostics

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)
Study Arms  ICMJE
  • Experimental: Technology-Enabled Visitations
    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.
    Intervention: Diagnostic Test: Digital Health Device Diagnostics
  • No Intervention: Standard-Care Visitations
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 20, 2019
Estimated Primary Completion Date October 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Partho P Sengupta, MD 304-598-4478 partho.sengupta@hsc.wvu.edu
Contact: Lan Hu 304-598-4478 lan.hu@wvumedicine.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713333
Other Study ID Numbers  ICMJE Pro00029622
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sanjeev Bhavnani MD, Scripps Health
Study Sponsor  ICMJE Scripps Health
Collaborators  ICMJE West Virginia University
Investigators  ICMJE
Principal Investigator: Partho Sengupta, MD West Virginia University Heart and Vascular Institute
Study Director: Sanjeev Bhavnani, MD Scripps Clinic
PRS Account Scripps Health
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP