NCT03590509

An Integrated Telemedicine-Home Visitation Program to Increase Outcomes for Children With Medical Complexity

Completed NA Last updated 14 October 2020

What this trial tests

NA trial testing Telemedicine Program in Chronic Disease in 422 participants. Completed in 5 May 2020.

Timeline

23 August 2018

Primary endpoint
5 May 2020

5 May 2020

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	422
Start date	23 August 2018
Primary completion	5 May 2020
Estimated completion	5 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Telemedicine Program
• Usual Comprehensive Care

Conditions studied

• Chronic Disease — all drugs for Chronic Disease →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Eligibility, any sex, with Chronic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of negative binomial and zero-inflated negative binomial models for the analysis of zero-inflated count data: application to the telemedicine for children with medical complexity trial.
   Lee KH, Pedroza C, Avritscher EBC, Mosquera RA, et al · · 2023 · cited 12× · PMID 37752579 · DOI 10.1186/s13063-023-07648-8
2. The Effect of Adding Telemedicine to Comprehensive Care for Children with Medical Complexity: A Randomized Quality Improvement Trial
   Ricardo M, Avritscher E, Pedroza C, Lee K, et al · · 2021
3. Optimizing Health Outcomes Among Newly Dual Eligibility Beneficiaries in Managed Care: Patient‐Provider Language, Race and Technology Discordance
   Banerjee S, Ma L, Lee C, Schmittdiel J, et al · · 2021