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

NCT03590509 | Completed

• 1 other identifier: 02-25769000-33200-12
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Disease

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (1)

• Days of care outside the home

  Days of care in the hospital, ER, or clinic \[excluding well-child checks\]

  Up to 24 months

Secondary Outcomes (8)

• Rate of serious illness

  Up to 24 months

• Number of admissions

  Up to 24 months

• Number of PICU admissions

  Up to 24 months

• Number of ER visits

  Up to 24 months

• Number of 30-day hospital readmissions

  Up to 30 days following a discharge from a hospital

Study Arms (2)

Telemedicine Program*

EXPERIMENTAL

Integrated Telemedicine-Home Visitation\* Program. \*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: Telemedicine Program

Control

ACTIVE COMPARATOR

Usual Comprehensive Care

Other: Usual Comprehensive Care

Interventions

Telemedicine Program OTHER

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

Also known as: Integrated Telemedicine-Home Visitation* Program

Telemedicine Program*

Usual Comprehensive Care OTHER

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

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children attending the High-Risk Children's Clinic
• or more chronic conditions
• High healthcare utilization in the year prior to enrollment (of ≥3 ED visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions)
• \>50% estimated risk of hospitalization in the year after enrollment (as judged by Program's Director \[Dr. R. Mosquera\] based on patient's diagnosis, clinical course, and socioeconomic risk factor).

You may not qualify if:

• Unrepaired congenital heart disease
• Mitochondrial disorders
• Active cancer
• Do-Not-Resuscitate (DNR) order
• Patients receiving compassionate care
• No Internet access

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Texas Medical Center Health Policy Institute: collaborator

Study Sites (1)

The University of Texas Health Science, Houston

Houston, Texas, 77030, United States

Location

Related Publications (16)

• Simon TD, Berry J, Feudtner C, Stone BL, Sheng X, Bratton SL, Dean JM, Srivastava R. Children with complex chronic conditions in inpatient hospital settings in the United States. Pediatrics. 2010 Oct;126(4):647-55. doi: 10.1542/peds.2009-3266. Epub 2010 Sep 20.

  PMID: 20855394 BACKGROUND

• Mosquera RA, Avritscher EB, Samuels CL, Harris TS, Pedroza C, Evans P, Navarro F, Wootton SH, Pacheco S, Clifton G, Moody S, Franzini L, Zupancic J, Tyson JE. Effect of an enhanced medical home on serious illness and cost of care among high-risk children with chronic illness: a randomized clinical trial. JAMA. 2014 Dec 24-31;312(24):2640-8. doi: 10.1001/jama.2014.16419.

  PMID: 25536255 BACKGROUND

• Avritscher EBC, Mosquera RA, Samuels CL, et al. An Enhanced Medical Home for High-Risk Chronically Ill Children: Are Benefits Identified During a Clinical Trial Sustained in Practice? Under Review.

  BACKGROUND

• McLean S, Chandler D, Nurmatov U, Liu J, Pagliari C, Car J, Sheikh A. Telehealthcare for asthma. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD007717. doi: 10.1002/14651858.CD007717.pub2.

  PMID: 20927763 BACKGROUND

• Looman WS, Antolick M, Cady RG, Lunos SA, Garwick AE, Finkelstein SM. Effects of a Telehealth Care Coordination Intervention on Perceptions of Health Care by Caregivers of Children With Medical Complexity: A Randomized Controlled Trial. J Pediatr Health Care. 2015 Jul-Aug;29(4):352-63. doi: 10.1016/j.pedhc.2015.01.007. Epub 2015 Mar 5.

  PMID: 25747391 BACKGROUND

• Simmonds B, Turner N, Thomas L, Campbell J, Lewis G, Wiles N, Turner K. Patients' experiences of participating in a large-scale trial of cognitive behavioural therapy for depression: a mixed methods study. Fam Pract. 2013 Dec;30(6):705-11. doi: 10.1093/fampra/cmt028. Epub 2013 Jul 12.

  PMID: 23851972 BACKGROUND

• Kuo DZ, Cohen E, Agrawal R, Berry JG, Casey PH. A national profile of caregiver challenges among more medically complex children with special health care needs. Arch Pediatr Adolesc Med. 2011 Nov;165(11):1020-6. doi: 10.1001/archpediatrics.2011.172.

  PMID: 22065182 BACKGROUND

• Cohen E, Berry JG, Camacho X, Anderson G, Wodchis W, Guttmann A. Patterns and costs of health care use of children with medical complexity. Pediatrics. 2012 Dec;130(6):e1463-70. doi: 10.1542/peds.2012-0175. Epub 2012 Nov 26.

  PMID: 23184117 BACKGROUND

• Homer CJ, Klatka K, Romm D, Kuhlthau K, Bloom S, Newacheck P, Van Cleave J, Perrin JM. A review of the evidence for the medical home for children with special health care needs. Pediatrics. 2008 Oct;122(4):e922-37. doi: 10.1542/peds.2007-3762.

  PMID: 18829788 BACKGROUND

• Hoffman A, Emanuel EJ. Reengineering US health care. JAMA. 2013 Feb 20;309(7):661-2. doi: 10.1001/jama.2012.214571. No abstract available.

  PMID: 23423408 BACKGROUND

• Totten AM, Womack DM, Eden KB, McDonagh MS, Griffin JC, Grusing S, Hersh WR. Telehealth: Mapping the Evidence for Patient Outcomes From Systematic Reviews [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Jun. Report No.: 16-EHC034-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK379320/

  PMID: 27536752 BACKGROUND

• Wells S, O'Neill M, Rogers J, Blaine K, Hoffman A, McBride S, Tschudy MM, Shumskiy I, Mauskar S, Berry JG. Nursing-led Home Visits Post-hospitalization for Children with Medical Complexity. J Pediatr Nurs. 2017 May-Jun;34:10-16. doi: 10.1016/j.pedn.2017.03.003. Epub 2017 Mar 23.

  PMID: 28342694 BACKGROUND

• Peacock S, Konrad S, Watson E, Nickel D, Muhajarine N. Effectiveness of home visiting programs on child outcomes: a systematic review. BMC Public Health. 2013 Jan 9;13:17. doi: 10.1186/1471-2458-13-17.

  PMID: 23302300 BACKGROUND

• Parab CS, Cooper C, Woolfenden S, Piper SM. Specialist home-based nursing services for children with acute and chronic illnesses. Cochrane Database Syst Rev. 2013 Jun 15;2013(6):CD004383. doi: 10.1002/14651858.CD004383.pub3.

  PMID: 23771694 BACKGROUND

• Cooper C, Wheeler DM, Woolfenden SR, Boss T, Piper S. Specialist home-based nursing services for children with acute and chronic illnesses. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004383. doi: 10.1002/14651858.CD004383.pub2.

  PMID: 17054202 BACKGROUND

• Mosquera RA, Avritscher EBC, Pedroza C, Lee KH, Ramanathan S, Harris TS, Eapen JC, Yadav A, Caldas-Vasquez M, Poe M, Martinez Castillo DJ, Harting MT, Ottosen MJ, Gonzalez T, Tyson JE. Telemedicine for Children With Medical Complexity: A Randomized Clinical Trial. Pediatrics. 2021 Sep;148(3):e2021050400. doi: 10.1542/peds.2021-050400.

  PMID: 34462343 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elenir Avritscher

  The University of Texas McGovern Medical School at Houston

  PRINCIPAL INVESTIGATOR

• Ricardo Mosquera, MD

  The University of Texas McGovern Medical School at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: While the families and HRCC staff cannot be blinded, the healthcare economist and the statistician will remain blinded to treatment group when performing the analyses.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Quality-Improvement Trial

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 18, 2018
• Study Start: August 23, 2018
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)