Parental Adherence of a Mobile Application (PARAMETER)

Parental AdheRence of an Asynchronous Mobile hEalth Application for Children With Medical TEchnologies Using a Randomized Trial of Outpatient Nursing Care Models (PARAMETER)

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.

Study Overview

• Status: Withdrawn
• Conditions: Pediatrics; Nursing; Children With Medical Complexity (CMC); Medically Complex
• Intervention / Treatment: Device: CHAMP App

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proactive Nursing Care model using a mobile application and software platform; 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.	Device: CHAMP App; CHAMP® App is a proprietary, downloadable, mobile Software Application and software platform designed and developed by the Children's Mercy Hospital of Kansas City (CMH), that permits parents and caregivers to transmit to the care team data to permit remote monitoring of the patient's condition. The parent or caregiver enters into the CHAMP App data including vital signs, intake and output, video, and images of patients (collectively, "CHAMP® Data"), which operates on computers, mobile devices, and handheld computers. The CHAMP® App is intended to be used in the clinical care of pediatric patients in the home setting that are followed by specialty health care teams to improve patient self-management through the use of asynchronous data. Videos and data related to the patient are entered by the parent and sent electronically to the Clinical Care Team as recommended by the clinical team.
No Intervention: Standard of care control arm; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cause Readmission	During the time period- 30 days after nearest discharge from study enrollment- Any Inpatient or observation encounters to a hospital setting	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Monitoring Data Adherence	From study enrollment to 30 days after discharge- Remote health monitoring adherence (both arms) to daily data entry	30 days
Length of Readmission	Time measured in days of hospital readmission from admission to discharge, Any time of readmission during 30-day monitoring period	30 days
Parental Experience	At enrollment and 30 days after discharge: Parental Experience of discharge home after a hospitalization measured by the PACT-M tool at two-time points (enrollment at initial discharge and at 30 days). Along with the data for Aim 1, for the PACT-M tool 35. The PACT-M tool is a 9 item, reliable, validated tool with 5-point Likert answers (Appendix) (Strongly disagree to Agree Strongly). System usability survey questions will also be utilized for Arm 1 CHAMP App participants.	30 days
Initiation Adherence	First day of data documentation after discharge	30 days
Discontinuation Adherence	Last day of data documentation after discharge before end of study period	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Team Engagement	Healthcare team engagement frequency with proactive outpatient nursing care model necessary to achieve adoption into outpatient models of care	30 days

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Lori Erickson, PhD, Children's Mercy Kansas City

Publications and helpful links

General Publications

• Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.
• Hall M, Berry JG, Hall M, Goodwin EJ, Margaret Wright S, Bettenhausen J, Colvin JD. Changes in hospitalization populations by level of complexity at children's hospitals. J Hosp Med. 2024 May;19(5):399-402. doi: 10.1002/jhm.13292. Epub 2024 Feb 10.
• Elliott M, Erickson L, Russell CL, Chrisman M, Gross Toalson J, Emerson A. Defining a new normal: A qualitative exploration of the parent experience during the single ventricle congenital heart disease interstage period. J Adv Nurs. 2021 May;77(5):2437-2446. doi: 10.1111/jan.14785. Epub 2021 Feb 16.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: mHealth; remote patient monitoring; Software Platform
• Other Study ID Numbers: STUDY00003221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will make the data dictionary available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No