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CompletedNCT01328353Updated Nov 1, 2019

Telehealth Nursing Intervention for Children With Complex Health Care Needs (CCHCN)

A Phase 3 interventional study of telehealth plus aprn triage in Unplanned Use of Health Care Services, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2019-11-01.

Sponsored by University of Minnesota · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
2 Years to 15 Years
Sex
All
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Study summary

The overall objective of this study is to evaluate the effectiveness of a telehealth care coordination and case management nursing intervention for children with complex special health care needs.

Read the detailed description

Children with complex special health care needs are those children who have multiple, complex, chronic health conditions who require health and related services of a type or amount beyond that required by children generally. When these children are hospitalized, they receive services as part of an integrated system that provides centralized record keeping and care orders, clearly identified roles and methods of communication for health professionals involved in their care, an established method to obtain equipment and supplies, and regular monitoring of the child's condition. However, when the same child is cared for at home, services are often fragmented, and rarely accessed and delivered in a coordinated system. The task of coordinating services and sharing information between providers almost always becomes the responsibility of the parent or guardian. Families report that their greatest challenges are the stress of coordinating multiple providers, and the disconnect and lack of communication between services and providers. This study will address these issues, using an advanced practice nurse (APN) program of telehealth care coordination and case management in support of these families. Either the telephone or telephone plus interactive video are used by an advanced practice nurse to provide care coordination and case management. Goals of the program are to (1) reduce the number of crisis or unplanned uses of health care services and increase the number of non-crisis or planned health care service usage, (2) improve the QL (quality of life) for these children and their families, and (3) reduce the deficit between help needed and help received for the families in caring for these children. The study objective will be accomplished using a three armed randomized controlled trial. Children will be randomized into a control group receiving usual care that includes LPN (Licensed practical nurse)-delivered care coordination and RN (registered nurse)-delivered telephone triage, an intervention group receiving APN-delivered telephone care coordination and case management, and another intervention group receiving APN-delivered telephone + video care coordination and case management services. It is hypothesized that as the level of telehealth use in coordination and management increases the utilization of unplanned, or crisis, health care service utilization will decrease, that families will receive more of their needed care, and quality of life for the children and their families will improve

02

Conditions studied

  • Unplanned Use of Health Care Services

Keywords

  • triage
  • aprn
  • telehealth
  • CCHCN
  • advanced practice nurse
  • improve family quality of life
  • reduce unplanned use of health care services
  • telehealth triage intervention
03

In context

Lead sponsor

University of Minnesota is the lead sponsor of 1,210 studies on the registry; 194 are open to participants now.

Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children with complex health care needs, in the patient population of the Special Needs Clinic, St Paul Children's Hospital

Exclusion criteria

Exclusion Criteria:

  • Healthy children
  • CCHCN children not seen in the Special Needs Clinic at St Paul Children's Hospital
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
163 participants (actual)

Study arms

  • No intervention
    control group

    Control group arm follows usual care

  • Experimental
    Intervention group arm 1

    Intervention group arm 1 receives aprn/telephone care coordination

    Other: telehealth plus aprn triage

  • Experimental
    Intervention group arm 2

    Intervention group arm 2 receives aprn/telephone/video care coordination

    Other: telehealth plus aprn triage

Interventions

  • Othertelehealth plus aprn triage

    aprn using either telephone or telephone plus video conferencing will provide triage for CCHCN

    Also known as: APRN

06

What researchers measure

Primary outcomes

  1. To determine the number of crisis or unplanned uses of health care services by enrolled subject, based on data collected in the Health Care Service Utilization calendar maintained by study subjects, and from the subjects' EMR

    This measure will show if the intervention can shift the number of crisis and unplanned health care services utilized to planned service utilization, based on data collected from the subjects' Health Care Service Utilization calendars and their EMR

    Time frame: 2 year RCT follow-up

Secondary outcomes

  1. To measure changes in quality of life for CCHCN and their families over the study period, using scores from the PedsQL and PedsQL Family Impact Module instruments.

    These measures will determine the effectiveness of the intervention on improving the quality of life for CCHCN subjects and their families, based on scores from the Peds QL and PedsQL Family Module survey instruments

    Time frame: 2 years RCT follow-up

  2. To measure the deficit between help needed and help received using the Discrepancy Visual Analog scale

    To measure the effectiveness of the intervention on reducing the discrepancy between parents' reported need for help from others and their reported receipt of help from others using the Discrepancy Visual Analog scale

    Time frame: 2 years RCT follow-up

07

Study locations

1 site
  • Univ Minnesota and St Paul Childrens Hospital and Clinic
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01328353
Responsible party
Sponsor
First posted
Apr 4, 2011
Start date
Sep 2009
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Nov 1, 2019

Study contacts

Stanley Finkelstein, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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