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

NCT ID: NCT01328353

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-09-30

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

Conditions

Unplanned Use of Health Care Services

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

Control group arm follows usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group arm 1

Intervention group arm 1 receives aprn/telephone care coordination

Group Type: EXPERIMENTAL

telehealth plus aprn triage

Intervention Type: OTHER

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

Intervention group arm 2

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

Group Type: EXPERIMENTAL

telehealth plus aprn triage

Intervention Type: OTHER

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

Interventions

telehealth plus aprn triage

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

Intervention Type: OTHER

Other Intervention Names

APRN

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley Finkelstein, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Univ Minnesota and St Paul Childrens Hospital and Clinic

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0908M70627

Identifier Type: -

Identifier Source: org_study_id