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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder, Asthma, Autism Spectrum Disorder, Depression, Epilepsy

Intervention / Treatment
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* Other: TriVox for clinical care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TriVox Active<br>Provider using TriVox for clinical care | Other: TriVox for clinical care<br>* Use TriVox disease modules to manage patients<br>|
| No Intervention: TriVox Delayed-start<br>Providers not using TriVox for clinical care | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic disease, patient portal, health information technology, patient provider communication, quality improvement