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An Integrated Telemedicine-Home Visitation Program to Increase Outcomes for Children With Medical Complexity
NCT03590509 · View on ClinicalTrials.gov ↗
Study Summary
Children with medical complexity (CMC) account for \<1% of all children but approximately 40% of all pediatric deaths and inpatient care spending in the U.S.1 Optimizing their outcomes requires a comprehensive approach to augmenting care in all settings: clinic, hospital, and home. The clinic component of the comprehensive care (CC) program provides 24/7 access to an experienced team of primary care providers and subspecialists and reduced their serious illnesses and hospital and ICU days by 47-69% and health-system costs by \>$10,000 per child-year.2,3 The hospital component (inpatient consultation service) is further improving outcomes. Having improved both inpatient and outpatient care, the investigators now propose to complete a 360 degree approach by developing and rigorously assessing an integrated telemedicine-home-visitation program (THVP) to augment care for CMC in their homes to reduce the need for clinic visits as well hospitalizations. Building on prior experience in using telemedicine for children at UTH and evidence of benefits in other populations, 4,5 the providers will use a convenient, inexpensive, HIPAA-compliant telemedicine platform to make observations in the home to augment care, help address acute problems remotely at any hour, better coordinate care with healthcare personnel, and thereby reduce clinic visits, ED visits, and hospitalizations. Home visits will be conducted by a nurse home visitor whenever considered likely to be beneficial for any of the CMC and at least once by the primary care providers (PCPs) immediately following enrollment of children with chronic respiratory failure requiring mechanical ventilation at home. To promote reimbursements and further grant funding, the investigators will test the integrated THVP in a randomized quality improvement (QI) pilot study to verify its effectiveness in reducing total days of care outside the home.
Conditions Studied
Interventions
- OTHER Telemedicine Program
- OTHER Usual Comprehensive Care
Study Locations (1)
Texas
- The University of Texas Health Science, Houston — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2018-08-23 |
| Est. Completion | 2020-05-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03590509
The ClinicalTrials.gov registry entry for NCT03590509 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 422 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 811 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Disease appearing as the primary indexed condition, and to 2 interventions — of which Telemedicine Program is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03590509 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03590509 about?
NCT03590509 is a clinical study titled "An Integrated Telemedicine-Home Visitation Program to Increase Outcomes for Children With Medical Complexity". Children with medical complexity (CMC) account for \<1% of all children but approximately 40% of all pediatric deaths and inpatient care spending in the U.S.1 Optimizing their outcomes requires a comprehensive approach to augmenting care in all settings: clinic, hospital, and home. The clinic compon...
What is the current status of trial NCT03590509?
This trial is currently completed. It is a NA study. The enrollment target is 422 participants. The study started on 2018-08-23. Estimated completion is 2020-05-05.
What conditions does trial NCT03590509 study?
This clinical trial studies the following conditions: Chronic Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03590509?
The interventions under investigation include: Telemedicine Program (OTHER), Usual Comprehensive Care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03590509?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 811 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03590509 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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