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

Telehealth Nursing Intervention for Children With Complex Health Care Needs

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.

Study Overview

• Status: Completed
• Conditions: Unplanned Use of Health Care Services
• Intervention / Treatment: Other: telehealth plus aprn triage

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

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: APRN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 year RCT follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years RCT follow-up
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	2 years RCT follow-up

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Stanley Finkelstein, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 25, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimate): April 4, 2011

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: triage; telehealth; advanced practice nurse; aprn; CCHCN; improve family quality of life; reduce unplanned use of health care services; telehealth triage intervention
• Other Study ID Numbers: 0908M70627