CHAMP App for Medically Complex Children

(PARAMETER Trial)

Overseen By Ryan Thompson

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Cardiac program, PICC lines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lori Erickson, PhD

Principal Investigator

Children's Mercy Kansas City

Eligibility Criteria

This trial is for children aged 0-3 years with complex medical conditions who are discharging to a home setting. Parents or legal representatives must be able to read English, Spanish, Somali, Burmese, Korean, Chinese-Simplified, German, French, Filipino, Arabic or Vietnamese and download an app.

Inclusion Criteria

Adult Group 2: Healthcare team users at Children's Mercy Kansas City

I am under 4 years old and have a guardian.

I will be discharged to a home where caregivers understand English, Spanish, Somali, Burmese, Korean, Chinese-Simplified, German, French, Filipino, Arabic, or Vietnamese.

Exclusion Criteria

My child only uses a PICC line for medical treatment.

Not meeting the above inclusion criteria

Child followed solely by the Cardiac High Acuity Monitoring Program Heart Center outpatient team

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a mobile health application for remote patient monitoring and communication with healthcare providers

30 days

Weekly data monitoring by clinical nurse coordinators

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CHAMP App

Trial Overview The CHAMP mobile application's effectiveness in reducing hospital readmission rates and improving parent experience is being tested. The study randomly assigns participants into two groups to compare outcomes within a month after discharge.

Participant Groups

Group I: Proactive Nursing Care model using a mobile application and software platform Experimental Treatment 1 Intervention

* 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.

Group II: Standard of care control arm Active Control 1 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

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+