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Interagency Collaboration (ICollab) for Children With Medical Complexity (ICOLLAB Trial)

N/A
Waitlist Available
Led By Savithri Nageswaran, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.).
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

ICOLLAB Trial Summary

This trial will test whether home health nurses working with Brenner Children's Hospital can improve the health of children with complex chronic medical conditions.

ICOLLAB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ICOLLAB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Days to readmission
Rate of ER visits
Rate of Hospitalization
Secondary outcome measures
Client Satisfaction Survey
Impact on Family Scale
Other outcome measures
Home health nurse retention
Home health nurse-healthcare provider collaborations, HHN PCP ICOLLAB Survey

ICOLLAB Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interagency Collaboration (ICollab Group)Experimental Treatment2 Interventions
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)
Group II: Usual Care GroupActive Control1 Intervention
Children will receive usual care.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,111 Total Patients Enrolled
Savithri Nageswaran, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
909 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Contemporary Clinical Trials CommunicationsJournal
Randomized Controlled Trial Evaluating a Collaborative Model of Care for Transitioning Children with Medical Complexity from Hospital to Home Healthcare: Study Protocol
Nageswaran, Savithri, Douglas Easterling, Cobi W. Ingram, Jamie E. Skaar, Anna Miller-Fitzwater, and Edward H. Ip. 2020. “Randomized Controlled Trial Evaluating a Collaborative Model of Care for Transitioning Children with Medical Complexity from Hospital to Home Healthcare: Study Protocol”. Contemporary Clinical Trials Communications. Elsevier BV. doi:10.1016/j.conctc.2020.100652.
clinicaltrials.govStudy
ICOLLAB FOR Children With Medical Complexity
2019. "ICOLLAB FOR Children With Medical Complexity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03978468.
~18 spots leftby Apr 2025
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