NCT05816590

Meds@HOME App to Support Medication Safety

Meds@HOME - Improving Medication Safety for Medically Complex Children With mHealth Across Caregiving Networks (R18 Aim 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study determines whether the mHealth intervention, Meds@HOME, helps caregivers improve medication administration to Children with Medical Complexity (CMC) who use high-risk medications. A total of 152 primary caregivers, 152 children, and up to 304 secondary caregivers will be recruited and can expect to be on study for up to 6 months.

Detailed description

The investigators will test the hypothesis that Meds@HOME use improves medication administration accuracy for caregivers by conducting a 6-month randomized controlled trial with caregivers of CMC. The study population will consist of 1) CMC who are prescribed at least one scheduled high-risk medication and receive care at UW Health, and 2) their caregivers. The study distinguishes between three types of caregivers: 1) primary caregivers (child's parent or legal guardian), 2) secondary caregivers (up to 2 individuals who regularly provide care for the child and who complete study surveys), and 3) other caregivers (invited to use the app but not complete study surveys). CMC and their primary caregiver participants will be randomized into intervention (Meds@HOME, "I") or control ("C") groups. Assessments at baseline and 6 months post-enrollment will assess the primary endpoint (medication administration accuracy), secondary outcomes, and Meds@HOME use by primary and secondary caregivers. Participant accrual will occur over 12 months at one site and participants can expect to be on study for 6 months. The primary study objective is to evaluate the effectiveness of Meds@HOME on primary caregiver medication administration accuracy. The secondary objectives are to evaluate Meds@HOME's: * effectiveness on secondary caregiver medication administration accuracy * effect on adverse drug event (ADE) hospital use * effect on adverse drug event ED use * effect on parent-reported medication adherence * effect on parent-reported medication activation * effect on parent-reported medication confidence * effect on parent-reported medication understanding * effect on all-cause hospital use * effect on all-cause ED use * effect on mortality * effect on the primary outcome measured as 5 individual components

Conditions

• Medication Errors and Other Product Use Errors and Issues

Interventions

Type	Name	Description
OTHER	Med@HOME Mobile App	Meds@HOME is a software application designed for use on a personal mobile device. The app allows primary caregiver to create routines where they can detail how to perform the routine, start date and time, and frequency (daily, weekly, monthly). Optional push notifications can be set so that users are alerted to an upcoming routine. Only primary caregivers can create, edit, and delete routines. All caregivers can check off on routines and receive notifications. Caregivers can also post notes related to routines or events. App enables an inventory of caregiver troubleshooting strategies and inventory reminders.

Timeline

• Start date: 2023-12-11
• Primary completion: 2025-05-06
• Completion: 2025-05-06
• First posted: 2023-04-18
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States