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

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

Study Overview

• Status: Completed
• Conditions: Depression; Epilepsy; Asthma; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: TriVox for clinical care

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 Type: Interventional
• Enrollment (Actual): 946
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with "red flag" alerts	Number of patients whose responses to clinical questionnaires trigger a "red flag" alert in ICISS	1 month
Change in caregiver-rated global functioning	Caregiver ratings on modified Clinical Global Assessment Scale	Baseline to 12 months
Experience of care	Participant ratings on Post-Visit Experience of Care Survey	Baseline and after every ambulatory visit for up to 84 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization	inpatient and ambulatory visits within healthcare system directly related to patient's medical or mental health condition	12 months
Direct out of pocket expenditures	Out of pocket expenditures directly related to care for child's medical or mental health condition, e.g. co-pays, prescription costs	12 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Eugenia Chan, MD, MPH, Boston Children's Hospital; Principal Investigator: Eric Fleegler, MD, MPH, Boston Children's Hospital

Publications and helpful links

Helpful Links

• ICISS: Collaborating Online to Improve Children's Health Care

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: chronic disease; quality improvement; health information technology; patient portal; patient provider communication
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
• Other Study ID Numbers: BCH PPQI 52012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO