ICOLLAB FOR Children With Medical Complexity

Not Applicable

Completed

• Conditions: Children With Medical Complexity
• Interventions: Other: Usual Care; Other: Interagency Collaboration (ICollab)

• Registration Number: NCT03978468
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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. 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 Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-07
• Study Start: 2019-11-08
• Status Verified: 2022-06
• Primary Completion: 2023-02-15
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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.).

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Group	Usual Care	Children will receive usual care.
Interagency Collaboration (ICollab Group)	Interagency Collaboration (ICollab)	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)
Interagency Collaboration (ICollab Group)	Usual Care	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)

Primary Outcome Measures

Name	Time	Method
Rate of Hospitalization	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	6 months	Rate of ER visits will be calculated as follows: \[Number of ER visits/ observation period in years\]\*100
Days to readmission	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.

Secondary Outcome Measures

Name	Time	Method
Impact on Family Scale	6 months	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.
Client Satisfaction Survey	6 months	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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States