Clinical trial NCT06672042: Parental Adherence of a Mobile Application
Official title: Parental AdheRence of an Asynchronous Mobile hEalth Application for Children With Medical TEchnologies Using a Randomized Trial of Outpatient Nursing Care Models (PARAMETER)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pediatrics
Medically Complex
Children With Medical Complexity (CMC)
Nursing
Keywords: mHealth
Software Platform
remote patient monitoring
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: All Cause Readmission
timeFrame: 30 days
Secondary outcomes:
measure: Home Monitoring Data Adherence
timeFrame: 30 days
measure: Length of Readmission
timeFrame: 30 days
measure: Parental Experience
timeFrame: 30 days
measure: Initiation Adherence
timeFrame: 30 days
measure: Discontinuation Adherence
timeFrame: 30 days
Other outcomes:
measure: Healthcare Team Engagement
timeFrame: 30 days
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Lori Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.