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.
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
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
- Conditions
- Unplanned Use of Health Care Services
- 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 group | Role | What they receive |
|---|---|---|
| control group | No intervention | Control group arm follows usual care |
| Intervention group arm 1 | Experimental | Intervention group arm 1 receives aprn/telephone care coordination Receives: Other: telehealth plus aprn triage |
| Intervention group arm 2 | Experimental | Intervention 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.
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)
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
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.
- First posted4 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unplanned Use of Health Care ServicesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley Finkelstein, PhD, Principal investigator, University of Minnesota
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Nursing Intervention for Children With Complex Health Care Needs
- ClinicalTrials.gov ID
- NCT01328353
- Acronym / sponsor ID
- 0908M70627
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Control group arm follows usual care |
| Intervention group arm 1 | Experimental | Other: telehealth plus aprn triageIntervention group arm 1 receives aprn/telephone care coordination |
| Intervention group arm 2 | Experimental | Other: telehealth plus aprn triageIntervention group arm 2 receives aprn/telephone/video care coordination |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with complex health care needs, in the patient population of the Special Needs Clinic, St Paul Children's Hospital
Key exclusion criteria (2 listed)
- Healthy children
- CCHCN children not seen in the Special Needs Clinic at St Paul Children's Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telehealth plus aprn triageAlso: APRNaprn using either telephone or telephone plus video conferencing will provide triage for CCHCN | Other | Intervention group arm 1, Intervention group arm 2 |
Primary outcome
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 secondary outcomes
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
To measure the deficit between help needed and help received using the Discrepancy Visual Analog scale
Time frame: 2 years RCT follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley Finkelstein, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
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.