Attention Deficit Hyperactivity DisorderTriVoxHealthNCT02097355
Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions
A study testing TriVox for clinical care in people with Attention Deficit Hyperactivity Disorder and Asthma, run by Boston Children's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Asthma, Autism Spectrum Disorder
- What is being tested?
- TriVox for clinical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 946 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Asthma, Autism Spectrum Disorder, Depression, Epilepsy
- Being tested
- TriVox for clinical care
- Keywords
- chronic disease, patient portal, health information technology, patient provider communication, quality improvement
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Asthma, Autism Spectrum Disorder, Depression, Epilepsy, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriVox for clinical careOther
Use TriVox disease modules to manage patients
| Study group | Role | What they receive |
|---|---|---|
| TriVox Active | Experimental | Provider using TriVox for clinical care Receives: Other: TriVox for clinical care |
| TriVox Delayed-start | No intervention | Providers not using TriVox for clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 12 months
Secondary outcomes (3)
Number of patients with "red flag" alerts
Number of patients whose responses to clinical questionnaires trigger a "red flag" alert in ICISS
Measured: 1 month
Change in caregiver-rated global functioning
Caregiver ratings on modified Clinical Global Assessment Scale
Measured: Baseline to 12 months
Experience of care
Participant ratings on Post-Visit Experience of Care Survey
Measured: Baseline and after every ambulatory visit for up to 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 946 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugenia Chan, Boston Children's Hospital
- Investigators
- Eugenia Chan, MD, MPH, Principal investigator, Boston Children's HospitalEric Fleegler, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097355
- Sponsor's protocol ID
- BCH PPQI 52012
- Acronym
- TriVoxHealth
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2014
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02097355
- Acronym / sponsor ID
- TriVoxHealth / BCH PPQI 52012
- Conditions
- Attention Deficit Hyperactivity Disorder, Asthma, Autism Spectrum Disorder, Depression, Epilepsy
- Keywords
- chronic disease, patient portal, health information technology, patient provider communication, quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TriVox Active | Experimental | Other: TriVox for clinical careProvider using TriVox for clinical care |
| TriVox Delayed-start | No intervention | –Providers not using TriVox for clinical care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriVox for clinical careUse TriVox disease modules to manage patients | Other | TriVox Active |
Primary outcome
Change in caregiver-rated disease-specific symptoms
Time frame: Baseline to 12 months
Caregiver-reported ratings on disease-specific symptom rating scale. For example, Vanderbilt ADHD Parent Rating Scale for ADHD; Asthma Control Test for asthma
3 secondary outcomes
Number of patients with "red flag" alerts
Time frame: 1 month
Change in caregiver-rated global functioning
Time frame: Baseline to 12 months
Experience of care
Time frame: Baseline and after every ambulatory visit for up to 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- ICISS: Collaborating Online to Improve Children's Health CareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenia Chan, MD, MPH principal investigator
Boston Children's Hospital
Eric Fleegler, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriVox for clinical care in people with Attention Deficit Hyperactivity Disorder and Asthma, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caregiver-rated disease-specific symptoms (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.