Clinical trial NCT02097355: Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Asthma
Autism Spectrum Disorder
Depression
Epilepsy
Keywords: chronic disease
patient portal
health information technology
patient provider communication
quality improvement
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 946
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in caregiver-rated disease-specific symptoms
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Number of patients with "red flag" alerts
timeFrame: 1 month
measure: Change in caregiver-rated global functioning
timeFrame: Baseline to 12 months
measure: Experience of care
timeFrame: Baseline and after every ambulatory visit for up to 84 months
Other outcomes:
measure: Healthcare utilization
timeFrame: 12 months
measure: Direct out of pocket expenditures
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Eugenia Chan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Eric Fleegler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: