Parental AdheRence of an Asynchronous Mobile hEalth Application for Children With Medical TEchnologies Using a Randomized Trial of Outpatient Nursing Care Models (PARAMETER)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 732
- 试验地点
- 2
- 主要终点
- All Cause Readmission
研究概览
简要总结
This is a single-site, stratified grouping parallel- randomized control trial design comparing 30-day all-cause readmission rates and parent experience with two groups of pediatric participants.
详细描述
This proposal's overall objective is to evaluate the effectiveness of an enterprise-level outpatient nursing care model with an asynchronous mobile health platform for parents of children with medical complexity (CMC) age 0-3 years to communicate with their child's healthcare team via remote patient monitoring (RPM).
The researchers will evaluate the efficacy of a proactive nursing care model on 30-day readmissions (Aim 1), parental experience and managing their child's care at home (Aim 2), and healthcare team engagement frequency with a proactive outpatient nursing care model necessary to achieve adoption into outpatient models of care (Aim 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-3 years 11 months with a parent/Legally authorized representative
- •Children with complex medical conditions with medical technologies (feeding, oxygen saturation monitor, and/or oxygen equipment) prescribed by the inpatient care team,
- •Discharging to a home setting with parents/legally authorized representatives (LAR's) who can read primarily English, Spanish, Somali, Burmese, Korean, Chinese-Simplified, German, French, Filipino, Arabic, and Vietnamese.
- •Availability to download a mobile application onto a parent/LAR-owned device
- •Additionally, adult participants will also be included and grouped as follows:
- •Adult Group 1: Parents/Legally authorized representatives of pediatric subject as part of a dyad.
- •Adult Group 2: Healthcare team users at Children's Mercy Kansas City.
排除标准
- •Inability to be discharged to care in the home setting.
- •Those not meeting the above inclusion criteria.
- •We will exclude a child who is followed solely by the Cardiac High Acuity Monitoring Program Heart Center outpatient team as randomization for this patient population would impact the study design (NCT0603439)
- •Those children with PICC lines as their only medical technology.
- •Equitable Selection: Parent/LAR that do not speak or read one of the 11 languages available in the CHAMP application will be excluded due to potential translation limits of the app.
- •Healthcare team users: Non-Employees of Children's Mercy.
结局指标
主要结局
All Cause Readmission
时间窗: 30 days
During the time period- 30 days after nearest discharge from study enrollment- Any Inpatient or observation encounters to a hospital setting
次要结局
- Home Monitoring Data Adherence(30 days)
- Length of Readmission(30 days)
- Parental Experience(30 days)
- Initiation Adherence(30 days)
- Discontinuation Adherence(30 days)
研究者
Lori Erickson
Director, Remote Health Solutions
Children's Mercy Hospital Kansas City