ICOLLAB FOR Children With Medical Complexity

NCT03978468 | Completed

• 2 other identifiers: IRB0005814410359
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Children With Medical Complexity

Keywords

Collaboration, Home Health Nurse, Providers

Outcome Measures

Primary Outcomes (3)

• 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

  6 months

• Rate of ER visits

  Rate of ER visits will be calculated as follows: \[Number of ER visits/ observation period in years\]\*100

  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.

  6 months

Secondary Outcomes (2)

• Impact on Family Scale

  6 months

• Client Satisfaction Survey

  6 months

Other Outcomes (2)

• Home health nurse retention

  6 months

• Home health nurse-healthcare provider collaborations, HHN PCP ICOLLAB Survey

  6 months

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

Children will receive usual care.

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)

Other: Interagency Collaboration (ICollab); Other: Usual Care

Interventions

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.

Interagency Collaboration (ICollab Group)

Usual Care OTHER

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.

Interagency Collaboration (ICollab Group); Usual Care Group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 32964166 DERIVED

Study Officials

• Savithri Nageswaran, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: November 8, 2019
• Primary Completion: February 15, 2023
• Study Completion: March 15, 2023
• Last Updated: June 5, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)