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OpenTrials
Completed

NCT Number: NCT02097355

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Asthma Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Behavior Behavioral Symptoms Brain Diseases Bronchial Diseases Central Nervous System Diseases Child Development Disorders, Pervasive Chronic Disease Depression Disease Attributes Epilepsy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TriVox for clinical care

Other

Use TriVox disease modules to manage patients

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Integrated Clinical Information Sharing System: Implementation and Mixed-Methods Evaluation of a Web-based Monitoring and Management System for Patients With Chronic Conditions

Acronym: TriVoxHealth

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2014
Registry last updated
Jul 14, 2020

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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