NCT06672042WithdrawnNot Applicable
Parental AdheRence of an Asynchronous Mobile hEalth Application for Children With Medical TEchnologies Using a Randomized Trial of Outpatient Nursing Care Models (PARAMETER)
Children's Mercy Hospital Kansas City1 site in 1 country732 target enrollmentStarted: August 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 732
- Locations
- 1
- Primary Endpoint
- All Cause Readmission
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Proactive Nursing Care model using a mobile application and software platform
Experimental
- Includes weekly data monitoring by the study team clinical nurse coordinators with communication through phone, email, or patient portal with documentation in the EMR
- Email delivery of data summary reports on each child's data to their outpatient providers, Unrestricted research team approved healthcare team provider access to this data through the CHAMP App PARAMETER web portal,
- Follow-up communications from providers to parents at provider discretion, and initiation of Health interventions by providers as deemed clinically appropriate from their review of the data collected and their knowledge of the participant.
- Parents will enter home monitoring data daily into the CHAMP App as fitting with their discharge regimen: This may include Feeding, oxygen saturation, heart rate, videos, weight (home scale), or a combination of these.
Intervention: CHAMP App (Device)
Standard of care control arm
No Intervention
- No proactive monitoring or communication from the research coordinators
- Follow-up communications from providers to parents at their general healthcare providers discretion, and Initiation of health interventions by providers as deemed clinically appropriate from their review of the data collected and reported by parents via patient portal, phone, and in-person communications and their knowledge of the participant.
- Parents will be provided a paper log that they will utilize for recording their child's home monitoring data and turn in at the end of the month
- Parents will write down the home monitoring data fitting with their child's discharge regimen: This may include Feeding, oxygen saturation, heart rate, videos, weight (home scale), or a combination of these.
- Optional: Parents can utilize the App if they allocate to Arm 2 (Paper) at first, with a combined weekly check-in with the research coordinators. The parents will get a chance to fill out SUS after month of use
Outcomes
Primary Outcomes
All Cause Readmission
Time Frame: 30 days
During the time period- 30 days after nearest discharge from study enrollment- Any Inpatient or observation encounters to a hospital setting
Secondary Outcomes
- Home Monitoring Data Adherence(30 days)
- Length of Readmission(30 days)
- Parental Experience(30 days)
- Initiation Adherence(30 days)
- Discontinuation Adherence(30 days)
Investigators
Lori Erickson
Director, Remote Health Solutions
Children's Mercy Hospital Kansas City
Study Sites (1)
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