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

Depression Clinical Trial

— TriVoxHealth  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097355
• Other study ID #: BCH PPQI 52012
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2019

Study information

• Verified date: July 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Depression
• Disease
• Epilepsy

Intervention

Other:
• TriVox for clinical care
Use TriVox disease modules to manage patients

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare utilization	inpatient and ambulatory visits within healthcare system directly related to patient's medical or mental health condition	12 months
Other	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
Primary	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	Number of patients with "red flag" alerts	Number of patients whose responses to clinical questionnaires trigger a "red flag" alert in ICISS	1 month
Secondary	Change in caregiver-rated global functioning	Caregiver ratings on modified Clinical Global Assessment Scale	Baseline to 12 months
Secondary	Experience of care	Participant ratings on Post-Visit Experience of Care Survey	Baseline and after every ambulatory visit for up to 84 months

External Links

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