Children With Medical ComplexityICOLLABNCT03978468
ICOLLAB FOR Children With Medical Complexity
A study testing Interagency Collaboration (ICollab) in people with Children With Medical Complexity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Background: Children with medical complexity (CMC) have higher hospitalizations and readmissions compared to children without medical complexity. While CMC were institutionalized in the past, increasingly CMCs are now cared for at home. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Children With Medical Complexity
- What is being tested?
- Interagency Collaboration (ICollab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2019to 15 Mar 2023
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The Nurse Clinician will screen children for eligibility for the study (see Eligibility Form). Only children with medical complexity (CMC) who are discharged home with private-duty nursing (PDN) services will be included. CMC will be identified as (1) child <18 years of age; and (2) presence of a chronic condition, defined as a health condition expected to last ≥ 12 months; and (3) complexity of the condition, defined as needing ongoing care with ≥ 5 sub-specialists/ services, or dependent on ≥ 2 technologies (e.g. gastrostomy, oxygen, tracheostomy, ventilator, etc.).
Who cannot join
- Children who might turn 18 during the intervention period will be excluded to avoid having to re-consent with adult informed consent form (ICF). Children who receive skilled nursing visits or personal care services only, those discharged to a long-term care facility or to a foster home, or whose caregivers do not speak English/Spanish, will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Interagency Collaboration To Improve Home Care of Children With Medical Complexity.
Background: Children with medical complexity (CMC) have higher hospitalizations and readmissions compared to children without medical complexity. While CMC were institutionalized in the past, increasingly CMCs are now cared for at home. Caring for individuals with disabilities at home, and not congregate care settings is a Healthy People 2020 Objective. Home health nursing, especially good-quality care, is important for CMC. The purpose of this research is to test whether collaboration between home health nurses, primary-care doctors, and the complex care team (a special team at Brenner Children's Hospital that provides care for children with complex chronic medical conditions (CCMC)) can improve the health of these children.
Read the detailed description
The specific aims of this study are to: develop and implement a model of care, Interagency Collaboration (ICollab) in which communication with Home Health Nurse (HHN) and Primary Care Provider (PCP) is maintained and clinical support is provided to HHN; evaluate whether ICollab is effective in reducing healthcare utilization of Children with medical complexity (CMC) and caregiver burden; and assess caregiver satisfaction in home health care, HHN retention, and collaboration with other healthcare providers.
Methods: Investigators will develop and implement an intervention model (ICollab) that includes: (1) maintaining communication with HHN and PCP about clinical information about CMC, and (2) providing clinical support to HHN. Investigators will create an interdisciplinary intervention team in our children s hospital consisting of a pediatrician and a nurse. The intervention team will ensure communication with HHN and PCP by communicating clinical information (recommendations from clinic visits and emergency room (ER) visits, and discharge summary). The team will provide clinical support to HHN via collaborative meetings and availability as a resource for clinical problem-solving with HHN. Investigators will recruit 110 CMC discharged home on private-duty nursing services into this randomized trial. The intervention group (n=55) will receive the ICollab intervention for 6 months post-discharge from the hospital, in addition to usual care. Children in the control group (n=55) will receive only usual care. Outcome measures will include healthcare utilization metrics (hospitalization rates, ER visit rates, and days to readmission), caregiver burden and caregiver satisfaction with home health care, HHN retention, and HHN collaboration with other healthcare providers. Investigators hypothesize that ICollab will reduce healthcare utilization and caregiver burden, and improve caregiver satisfaction with home health care, increase HHN retention, and increase HHN collaboration with other healthcare providers. Investigators will perform a systematic process evaluation of the implementation of the intervention and standardize the ICollab model.
Implications: How healthcare delivery of CMC can be structured to avoid fragmentation especially surrounding transition across clinical settings is an understudied area. Our results will address this gap by providing a critically needed evidence-base for interventions to improve the quality of healthcare delivery for CMC
- Conditions
- Children With Medical Complexity
- Being tested
- Interagency Collaboration (ICollab), Usual Care
- Keywords
- Collaboration, Home Health Nurse, Providers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interagency Collaboration (ICollab)Other
The intervention has the following components: 1) ICollab Component 1: The Nurse Clinician will review clinic and emergency room (ER) visit notes for clinicians' recommendations and communicate these to the home health nurse (HHN). 2) ICollab Component 2a: The intervention team will meet weekly by phone with HHNs (6 times/ child). The Nurse Clinician will document meeting notes for each child in the ER, communicate this information with the HHN, and share it with the primary care provider (PCP) by routing the note through the ER or faxing the note. 3) ICollab Component 2b: The Nurse Clinician will be available as a resource for the HHN during regular work hours for clinical problem-solving. 4) ICollab Component 2c: the intervention team physician will offer her contact information for clinical problem-solving about the child to the PCP. The Nurse Clinician will communicate with the PCP about the plan developed in the meetings, and changes to plan of care.
Usual CareOther
The primary medical team identifies the need for home health nursing services for Children with Medical Complexity(CMC), and the hospital care coordinators help caregivers choose a home health agency. Hospital-based physicians write home health orders that are communicated to the home health agency. The clinic manager of the home health agency uses these orders to develop the home health plan of care, Centers for Medicare \& Medicaid Services(Form CMS-485) and communicates the plan to the agencies' HHNs. PCPs oversee the home health plan of care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | Children will receive usual care. Receives: Other: Usual Care |
| Interagency Collaboration (ICollab Group) | Experimental | Subjects of this arm will receive ICollab intervention in addition to usual care which consists of communication with Home Health Nurse (HHN) , Collaborative meetings, and communication with Primary Care Physician (PCP) Receives: Other: Interagency Collaboration (ICollab); Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hospitalization
Using data obtained from the Translational Data Warehouse, the number of hospitalizations will be calculated for each child..compare the rate of hospitalizations/ 100-child years in the 2 groups. Number of hospitalizations during the observation period will be counted and the rate will be calculated as:
[Number of hospitalizations/ observation period in years] *100
Measured: 6 months
Rate of ER visits
Rate of ER visits will be calculated as follows: [Number of ER visits/ observation period in years]*100
Measured: 6 months
Days to readmission
Days to readmission will be calculated as the duration between the time of index hospitalization (time of enrollment) and the date of admission for the subsequent hospitalization.
Measured: 6 months
Secondary outcomes (2)
Impact on Family Scale
Change in caregiver burden will be measured using the 15- item Impact on Family Scale - Revised, which has 4 domains - financial, family/ social, personal strain, and mastery. Scores range from 15 to 60; the lower the score, the greater the impact.
Measured: 6 months
Client Satisfaction Survey
Caregiver satisfaction with home care will be compared between the 2 groups and measured by the Client Satisfaction Survey. It has 35 items with 4 subscales. Total Score: Minimum 1 and Maximum 5; lower the score the better
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start8 Nov 2019
- Primary completion15 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children With Medical ComplexityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Savithri Nageswaran, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978468
- Sponsor's protocol ID
- IRB00058144
- Other IDs
- 10359
- Acronym
- ICOLLAB
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2019
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nageswaran S, Easterling D, Ingram CW, Skaar JE, Miller-Fitzwater A, Ip EH. Randomized controlled trial evaluating a collaborative model of care for transitioning children with medical complexity from hospital to home healthcare: Study protocol. Contemp Clin Trials Commun. 2020 Dec;20:100652. doi: 10.1016/j.conctc.2020.100652. Epub 2020 Sep 18.
PubMed 32964166
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interagency Collaboration To Improve Home Care of Children With Medical Complexity.
- ClinicalTrials.gov ID
- NCT03978468
- Acronym / sponsor ID
- ICOLLAB / IRB00058144
- Conditions
- Children With Medical Complexity
- Keywords
- Collaboration, Home Health Nurse, Providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 7 Jun 2019 (actual)
- 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.
Background: Children with medical complexity (CMC) have higher hospitalizations and readmissions compared to children without medical complexity. While CMC were institutionalized in the past, increasingly CMCs are now cared for at home. Caring for individuals with disabilities at home, and not congregate care settings is a Healthy People 2020 Objective. Home health nursing, especially good-quality care, is important for CMC. The purpose of this research is to test whether collaboration between home health nurses, primary-care doctors, and the complex care team (a special team at Brenner Children's Hospital that provides care for children with complex chronic medical conditions (CCMC)) can improve the health of these children.
Detailed description
The specific aims of this study are to: develop and implement a model of care, Interagency Collaboration (ICollab) in which communication with Home Health Nurse (HHN) and Primary Care Provider (PCP) is maintained and clinical support is provided to HHN; evaluate whether ICollab is effective in reducing healthcare utilization of Children with medical complexity (CMC) and caregiver burden; and assess caregiver satisfaction in home health care, HHN retention, and collaboration with other healthcare providers.
Methods: Investigators will develop and implement an intervention model (ICollab) that includes: (1) maintaining communication with HHN and PCP about clinical information about CMC, and (2) providing clinical support to HHN. Investigators will create an interdisciplinary intervention team in our children s hospital consisting of a pediatrician and a nurse. The intervention team will ensure communication with HHN and PCP by communicating clinical information (recommendations from clinic visits and emergency room (ER) visits, and discharge summary). The team will provide clinical support to HHN via collaborative meetings and availability as a resource for clinical problem-solving with HHN. Investigators will recruit 110 CMC discharged home on private-duty nursing services into this randomized trial. The intervention group (n=55) will receive the ICollab intervention for 6 months post-discharge from the hospital, in addition to usual care. Children in the control group (n=55) will receive only usual care. Outcome measures will include healthcare utilization metrics (hospitalization rates, ER visit rates, and days to readmission), caregiver burden and caregiver satisfaction with home health care, HHN retention, and HHN collaboration with other healthcare providers. Investigators hypothesize that ICollab will reduce healthcare utilization and caregiver burden, and improve caregiver satisfaction with home health care, increase HHN retention, and increase HHN collaboration with other healthcare providers. Investigators will perform a systematic process evaluation of the implementation of the intervention and standardize the ICollab model.
Implications: How healthcare delivery of CMC can be structured to avoid fragmentation especially surrounding transition across clinical settings is an understudied area. Our results will address this gap by providing a critically needed evidence-base for interventions to improve the quality of healthcare delivery for CMC
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Other: Usual CareChildren will receive usual care. |
| Interagency Collaboration (ICollab Group) | Experimental | Other: Interagency Collaboration (ICollab), Other: Usual CareSubjects of this arm will receive ICollab intervention in addition to usual care which consists of communication with Home Health Nurse (HHN) , Collaborative meetings, and communication with Primary Care Physician (PCP) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The Nurse Clinician will screen children for eligibility for the study (see Eligibility Form). Only children with medical complexity (CMC) who are discharged home with private-duty nursing (PDN) services will be included. CMC will be identified as (1) child <18 years of age; and (2) presence of a chronic condition, defined as a health condition expected to last ≥ 12 months; and (3) complexity of the condition, defined as needing ongoing care with ≥ 5 sub-specialists/ services, or dependent on ≥ 2 technologies (e.g. gastrostomy, oxygen, tracheostomy, ventilator, etc.).
Key exclusion criteria (1 listed)
- Children who might turn 18 during the intervention period will be excluded to avoid having to re-consent with adult informed consent form (ICF). Children who receive skilled nursing visits or personal care services only, those discharged to a long-term care facility or to a foster home, or whose caregivers do not speak English/Spanish, will be excluded.
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 |
|---|---|---|
| Interagency Collaboration (ICollab)The intervention has the following components: 1) ICollab Component 1: The Nurse Clinician will review clinic and emergency room (ER) visit notes for clinicians' recommendations and communicate these to the home health nurse (HHN). 2) ICollab Component 2a: The intervention team will meet weekly by phone with HHNs (6 times/ child). The Nurse Clinician will document meeting notes for each child in the ER, communicate this information with the HHN, and share it with the primary care provider (PCP) by routing the note through the ER or faxing the note. 3) ICollab Component 2b: The Nurse Clinician will be available as a resource for the HHN during regular work hours for clinical problem-solving. 4) ICollab Component 2c: the intervention team physician will offer her contact information for clinical problem-solving about the child to the PCP. The Nurse Clinician will communicate with the PCP about the plan developed in the meetings, and changes to plan of care. | Other | Interagency Collaboration (ICollab Group) |
| Usual CareThe primary medical team identifies the need for home health nursing services for Children with Medical Complexity(CMC), and the hospital care coordinators help caregivers choose a home health agency. Hospital-based physicians write home health orders that are communicated to the home health agency. The clinic manager of the home health agency uses these orders to develop the home health plan of care, Centers for Medicare \& Medicaid Services(Form CMS-485) and communicates the plan to the agencies' HHNs. PCPs oversee the home health plan of care. | Other | Interagency Collaboration (ICollab Group), Usual Care Group |
Primary outcome
Rate of Hospitalization
Time frame: 6 months
Using data obtained from the Translational Data Warehouse, the number of hospitalizations will be calculated for each child..compare the rate of hospitalizations/ 100-child years in the 2 groups. Number of hospitalizations during the observation period will be counted and the rate will be calculated as: [Number of hospitalizations/ observation period in years] *100
Rate of ER visits
Time frame: 6 months
Rate of ER visits will be calculated as follows: [Number of ER visits/ observation period in years]*100
Days to readmission
Time frame: 6 months
Days to readmission will be calculated as the duration between the time of index hospitalization (time of enrollment) and the date of admission for the subsequent hospitalization.
2 secondary outcomes
Impact on Family Scale
Time frame: 6 months
Client Satisfaction Survey
Time frame: 6 months
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 5 Jun 2023.
- Derived from this study: PubMed 32964166Nageswaran S, Easterling D, Ingram CW, Skaar JE, Miller-Fitzwater A, Ip EH. Randomized controlled trial evaluating a collaborative model of care for transitioning children with medical complexity from hospital to home healthcare: Study protocol. Contemp Clin Trials Commun. 2020 Dec;20:100652. doi: 10.1016/j.conctc.2020.100652. Epub 2020 Sep 18.
- Individual participant dataSharing planned: No
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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.
Savithri Nageswaran, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interagency Collaboration (ICollab) in people with Children With Medical Complexity, run by Wake Forest University Health Sciences 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 1 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 5 Jun 2023. 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.
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?
Rate of Hospitalization (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978468, which also lists 1 linked publication.
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 5 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.