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

NCT ID: NCT02097355

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

946 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder Asthma Autism Spectrum Disorder Depression Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TriVox Active

Provider using TriVox for clinical care

Group Type EXPERIMENTAL

TriVox for clinical care

Intervention Type OTHER

Use TriVox disease modules to manage patients

TriVox Delayed-start

Providers not using TriVox for clinical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TriVox for clinical care

Use TriVox disease modules to manage patients

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eugenia Chan

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eugenia Chan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Eric Fleegler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.youtube.com/watch?v=VR1vcbx0Ef4

ICISS: Collaborating Online to Improve Children's Health Care

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BCH PPQI 52012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

EndeavorOTC® Research Study in College Students
NCT06376032 ACTIVE_NOT_RECRUITING NA