跳至主要内容
临床试验/NCT03978468
NCT03978468已完成不适用

Interagency Collaboration To Improve Home Care of Children With Medical Complexity.

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年11月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Rate of Hospitalization

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.).

排除标准

  • •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.

研究组 & 干预措施

Usual Care Group

Active Comparator

Children will receive usual care.

干预措施: Usual Care (Other)

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)

干预措施: Interagency Collaboration (ICollab) (Other)

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)

干预措施: Usual Care (Other)

结局指标

主要结局

Rate of Hospitalization

时间窗: 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

时间窗: 6 months

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

Days to readmission

时间窗: 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.

次要结局

  • Client Satisfaction Survey(6 months)
  • Impact on Family Scale(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验