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

NCT03590509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2020-10-14

No results posted yet for this 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

Interventions

OTHER

Telemedicine Program

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

OTHER

Usual Comprehensive Care

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

Sponsors & Collaborators

  • Texas Medical Center Health Policy Institute

    collaborator UNKNOWN
  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Elenir Avritscher · The University of Texas McGovern Medical School at Houston

  • Ricardo Mosquera, MD · The University of Texas McGovern Medical School at Houston

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2020-05-05
Completion
2020-05-05

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03590509 on ClinicalTrials.gov