Children With Medical Complexity (CMC), Medically Complex, Nursing, Pediatrics
Conditions
Keywords
mHealth, Software Platform, remote patient monitoring
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).
Interventions
DEVICECHAMP 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.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Readmission | 30 days | During the time period- 30 days after nearest discharge from study enrollment- Any Inpatient or observation encounters to a hospital setting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Home Monitoring Data Adherence | 30 days | From study enrollment to 30 days after discharge- Remote health monitoring adherence (both arms) to daily data entry |
| Length of Readmission | 30 days | Time measured in days of hospital readmission from admission to discharge, Any time of readmission during 30-day monitoring period |
| Initiation Adherence | 30 days | First day of data documentation after discharge |
| Discontinuation Adherence | 30 days | Last day of data documentation after discharge before end of study period |
| Parental Experience | 30 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Team Engagement | 30 days | Healthcare team engagement frequency with proactive outpatient nursing care model necessary to achieve adoption into outpatient models of care |
Countries
United States
Outcome results
None listed