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

October 30, 2019 updated by: University of Minnesota

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 2 year RCT follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 2 years RCT follow-up
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
Time Frame: 2 years RCT follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stanley Finkelstein, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0908M70627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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