CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 422 enrolled
Drug / intervention
Telemedicine Program +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03590509
NCT03590509N/ACompleted

An Integrated Telemedicine-Home Visitation Program to Increase Outcomes for Children With Medical Complexity: A Quality Improvement (QI) Pilot Trial

The University of Texas Health Science Center, Houston·interventional·Posted Jul 18, 2018·Updated Oct 14, 2020

In Brief

A clinical study evaluating Telemedicine Program and Usual Comprehensive Care for Chronic Disease. Completed, enrolled 422 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Disease
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 18, 2018
Enrollment StartAug 23, 2018
Primary CompletionMay 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.0 years ago

Interventions

Telemedicine Programother

A telemedicine platform (Zoom) will be added to comprehensive care (CC) to be used by the CC providers 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 assigned CC provider immediately following enrollment of children with chronic respiratory failure requiring mechanical ventilation at home. \*After the approval of the study protocol, the home-visitation component of the integrated intervention was deemed not to be feasible with the available resources and personnel and has was not implemented

Usual Comprehensive Careother

Comprehensive care (CC) provided in an enhanced medical home to assure effective care at any hour for or children with medical complexity