Not provided
Not provided
Not provided
Not provided
Study has been withdrawn/stopped as funding was not recieved. Therefore, study was never started (no participants enrolled).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proactive Nursing Care model using a mobile application and software platform | Experimental |
|
|
| Standard of care control arm | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHAMP App | Device | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lori Erickson, PhD | Children's Mercy Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38340352 | Background | 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. | |
| 27166202 | Background | 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. |
Not provided
Not provided
The study team will make the data dictionary available on request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 33591609 | Background | 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. |