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Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions (TriVoxHealth)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097355
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Eugenia Chan, Boston Children's Hospital

Study Description
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Brief Summary:
TriVox Health is an online system designed to make it easy for healthcare providers to monitor patients' disease symptoms and functioning over time and in between in-person visits (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and randomized clinical trial methods, we will evaluate the impact of TriVox on the health outcomes, patient/family experience of care, and healthcare utilization for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism, depression, and epilepsy.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Asthma Autism Spectrum Disorder Depression Epilepsy Other: TriVox for clinical care Not Applicable

Detailed Description:

TriVox Health is a web-based patient management and monitoring system designed to track patients' disease symptoms and response to therapy over time. TriVox Health enables clinics to use electronic surveys to gather data remotely from multiple responders, including patients, parents/guardians, school personnel and ancillary providers, and view the responses in a timely manner via graphical, tabular, and narrative summary formats.

This quality improvement (QI) initiative will implement TriVox as the standard of care for all patients who receive care for ADHD, asthma, autism, depression, and epilepsy within seven ambulatory specialties at Boston Children's Hospital. Patients and families will use TriVox to report on patient health status and will complete clinically-reTriVoxlevant questionnaires at routine intervals. Providers will use the information collected through TriVox to inform their clinical care of the patient/family.

To evaluate the effectiveness of TriVox, we will conduct a 24-month phased, cluster randomized controlled trial (RCT) where we randomize providers to "active" vs. "delayed-start" to TriVox use, with patients clustered by provider (within specialties) for analytic purposes. Delayed-start providers will crossover to active TriVox use after 12 months. Patients/families will complete additional surveys in order to assess the system's actual or potential effects on patient/family-provider interactions, healthcare utilization and costs.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 946 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrated Clinical Information Sharing System: Implementation and Mixed-Methods Evaluation of a Web-based Monitoring and Management System for Patients With Chronic Conditions
Actual Study Start Date : December 2014
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TriVox Active
Provider using TriVox for clinical care
 Other: TriVox for clinical care
Use TriVox disease modules to manage patients
No Intervention: TriVox Delayed-start
Providers not using TriVox for clinical care


Outcome Measures
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Primary Outcome Measures :
  1. Change in caregiver-rated disease-specific symptoms [ Time Frame: Baseline to 12 months ]
    Caregiver-reported ratings on disease-specific symptom rating scale. For example, Vanderbilt ADHD Parent Rating Scale for ADHD; Asthma Control Test for asthma


Secondary Outcome Measures :
  1. Number of patients with "red flag" alerts [ Time Frame: 1 month ]
    Number of patients whose responses to clinical questionnaires trigger a "red flag" alert in ICISS

  2. Change in caregiver-rated global functioning [ Time Frame: Baseline to 12 months ]
    Caregiver ratings on modified Clinical Global Assessment Scale

  3. Experience of care [ Time Frame: Baseline and after every ambulatory visit for up to 84 months ]
    Participant ratings on Post-Visit Experience of Care Survey


Other Outcome Measures:
  1. Healthcare utilization [ Time Frame: 12 months ]
    inpatient and ambulatory visits within healthcare system directly related to patient's medical or mental health condition

  2. Direct out of pocket expenditures [ Time Frame: 12 months ]
    Out of pocket expenditures directly related to care for child's medical or mental health condition, e.g. co-pays, prescription costs


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients with clinical diagnosis of ADHD, asthma, autism, depression, and/or epilepsy
  • Patient receives care for these diagnoses from providers in participating ambulatory clinics (Primary Care, Adolescent Medicine, Developmental Medicine, Neurology, Psychiatry)
  • Patient's primary caregiver enrolled in TriVox

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097355


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Eugenia Chan, MD, MPH Boston Children's Hospital
Principal Investigator: Eric Fleegler, MD, MPH Boston Children's Hospital
More Information
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Additional Information:

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Responsible Party: Eugenia Chan, Attending Physician, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02097355    
Other Study ID Numbers: BCH PPQI 52012
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eugenia Chan, Boston Children's Hospital:
chronic disease
patient portal
health information technology
patient provider communication
quality improvement
Additional relevant MeSH terms:
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Disease
Chronic Disease
Attention Deficit Disorder with Hyperactivity
Autism Spectrum Disorder
Pathologic Processes
 Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Child Development Disorders, Pervasive
Disease Attributes