Clinical trial NCT01328353: Telehealth Nursing Intervention for Children With Complex Health Care Needs (CCHCN)
Official title: Telehealth Nursing Intervention for Children With Complex Health Care Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2011-04-04
Enrollment: 163
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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
timeFrame: 2 year RCT follow-up
Secondary outcomes:
measure: 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.
timeFrame: 2 years RCT follow-up
measure: To measure the deficit between help needed and help received using the Discrepancy Visual Analog scale
timeFrame: 2 years RCT follow-up
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Univ Minnesota and St Paul Childrens Hospital and Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Stanley Finkelstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: