Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions (TriVoxHealth)
Primary Purpose
Attention Deficit Hyperactivity Disorder, Asthma, Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TriVox for clinical care
Sponsored by
About this trial
This is an interventional health services research trial for Attention Deficit Hyperactivity Disorder focused on measuring chronic disease, patient portal, health information technology, patient provider communication, quality improvement
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
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TriVox Active
TriVox Delayed-start
Arm Description
Provider using TriVox for clinical care
Providers not using TriVox for clinical care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of patients with "red flag" alerts
Number of patients whose responses to clinical questionnaires trigger a "red flag" alert in ICISS
Change in caregiver-rated global functioning
Caregiver ratings on modified Clinical Global Assessment Scale
Experience of care
Participant ratings on Post-Visit Experience of Care Survey
Full Information
NCT ID
NCT02097355
First Posted
March 21, 2014
Last Updated
July 13, 2020
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02097355
Brief Title
Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Asthma, Autism Spectrum Disorder, Depression, Epilepsy
Keywords
chronic disease, patient portal, health information technology, patient provider communication, quality improvement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
946 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TriVox Active
Arm Type
Experimental
Arm Description
Provider using TriVox for clinical care
Arm Title
TriVox Delayed-start
Arm Type
No Intervention
Arm Description
Providers not using TriVox for clinical care
Intervention Type
Other
Intervention Name(s)
TriVox for clinical care
Intervention Description
Use TriVox disease modules to manage patients
Primary Outcome Measure Information:
Title
Change in caregiver-rated disease-specific symptoms
Description
Caregiver-reported ratings on disease-specific symptom rating scale. For example, Vanderbilt ADHD Parent Rating Scale for ADHD; Asthma Control Test for asthma
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Number of patients with "red flag" alerts
Description
Number of patients whose responses to clinical questionnaires trigger a "red flag" alert in ICISS
Time Frame
1 month
Title
Change in caregiver-rated global functioning
Description
Caregiver ratings on modified Clinical Global Assessment Scale
Time Frame
Baseline to 12 months
Title
Experience of care
Description
Participant ratings on Post-Visit Experience of Care Survey
Time Frame
Baseline and after every ambulatory visit for up to 84 months
Other Pre-specified Outcome Measures:
Title
Healthcare utilization
Description
inpatient and ambulatory visits within healthcare system directly related to patient's medical or mental health condition
Time Frame
12 months
Title
Direct out of pocket expenditures
Description
Out of pocket expenditures directly related to care for child's medical or mental health condition, e.g. co-pays, prescription costs
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenia Chan, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Fleegler, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.youtube.com/watch?v=VR1vcbx0Ef4
Description
ICISS: Collaborating Online to Improve Children's Health Care
Learn more about this trial
Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions
We'll reach out to this number within 24 hrs