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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01328353
First received: March 25, 2011
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Unplanned Use of Health Care Services
Other: telehealth plus aprn triage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telehealth Nursing Intervention for Children With Complex Health Care Needs

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 year RCT follow-up ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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. [ Time Frame: 2 years RCT follow-up ] [ Designated as safety issue: No ]
    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

  • To measure the deficit between help needed and help received using the Discrepancy Visual Analog scale [ Time Frame: 2 years RCT follow-up ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 198
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
aprn using either telephone or telephone plus video conferencing will provide triage for CCHCN
Other Name: APRN
Experimental: Intervention group arm 2
Intervention group arm 2 receives aprn/telephone/video care coordination
Other: telehealth plus aprn triage
aprn using either telephone or telephone plus video conferencing will provide triage for CCHCN
Other Name: APRN

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

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Healthy children
  • CCHCN children not seen in the Special Needs Clinic at St Paul Children's Hospital
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328353

Locations
United States, Minnesota
Univ Minnesota and St Paul Childrens Hospital and Clinic
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Stanley Finkelstein, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01328353     History of Changes
Other Study ID Numbers: TeleFamilies
Study First Received: March 25, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
triage
aprn
telehealth
CCHCN
advanced practice nurse
improve family quality of life
reduce unplanned use of health care services
telehealth triage intervention

ClinicalTrials.gov processed this record on August 21, 2014