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Unplanned Use of Health Care ServicesPhase 3NCT01328353

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

A Phase 3 study testing telehealth plus aprn triage in people with Unplanned Use of Health Care Services, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 15 years
Conditions the study is for
Unplanned Use of Health Care Services
What is being tested?
telehealth plus aprn triage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
1 siteUnited States
Study dates
Sep 2009to Sep 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • Healthy children
  • CCHCN children not seen in the Special Needs Clinic at St Paul Children's Hospital

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Univ Minnesota and St Paul Childrens Hospital and Clinic

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: 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.

Read the 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

Being tested
telehealth plus aprn triage
Keywords
triage, aprn, telehealth, CCHCN, advanced practice nurse, improve family quality of life, reduce unplanned use of health care services, telehealth triage intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telehealth plus aprn triageOther

    Also called APRN

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

Study groups in NCT01328353
Study groupRoleWhat they receive
control groupNo interventionControl group arm follows usual care
Intervention group arm 1ExperimentalIntervention group arm 1 receives aprn/telephone care coordination
Receives: Other: telehealth plus aprn triage
Intervention group arm 2ExperimentalIntervention group arm 2 receives aprn/telephone/video care coordination
Receives: Other: telehealth plus aprn triage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 year RCT follow-up

Secondary outcomes (2)
  1. 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

    Measured: 2 years RCT follow-up

  2. 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

    Measured: 2 years RCT follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2011 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328353
Sponsor's protocol ID
0908M70627
Status last verified
Oct 2019
First submitted
25 Mar 2011
Last updated
1 Nov 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing telehealth plus aprn triage in people with Unplanned Use of Health Care Services, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 2 year RCT follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.

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