Clinical trial NCT03978468: ICOLLAB FOR Children With Medical Complexity
Official title: Interagency Collaboration To Improve Home Care of Children With Medical Complexity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Medical Complexity
Keywords: Collaboration, Home Health Nurse, Providers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 96
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.).

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.

Primary outcomes:
measure: Rate of Hospitalization
timeFrame: 6 months
measure: Rate of ER visits
timeFrame: 6 months
measure: Days to readmission
timeFrame: 6 months
Secondary outcomes:
measure: Impact on Family Scale
timeFrame: 6 months
measure: Client Satisfaction Survey
timeFrame: 6 months
Other outcomes:
measure: Home health nurse retention
timeFrame: 6 months
measure: Home health nurse-healthcare provider collaborations, HHN PCP ICOLLAB Survey
timeFrame: 6 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Savithri Nageswaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.