Meds@HOME App to Support Medication Safety

NCT05816590 | Completed DMC

• 5 other identifiers: 2022-1620Protocol Version 12/5/23A536771Pediatric HospitalistR18HS028409
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Errors and Other Product Use Errors and Issues

Keywords

Children with Medical Complexity; Medication; Adverse Events

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of Participants Demonstrating Medication Administration Accuracy

  Rate of medication administration accuracy, measured dichotomously as correct identification of each of the following for a randomly selected high risk medication: indication, formulation, dose, frequency, and route after 6-months

  baseline (before randomization), 6 months

Secondary Outcomes (12)

• Change in Percentage of Participants Demonstrating Medication Administration Accuracy among Secondary Caregivers

  baseline (before randomization), 6 months

• Count of University of Wisconsin (UW) hospital encounters during study period with Adverse Drug Event (ADE) codes

  up to 6 months

• Count of UW Emergency Department (ED) encounters during study period with ADE codes

  up to 6 months

• Mean parent-reported medication adherence using the Adherence to Refills and Medications Scale (ARMS)

  up to 6 months

• Mean FCAT (Family Caregiver Activation in Transition) Score for 5 medication-specific items

  up to 6 months

Study Arms (2)

Meds@HOME Intervention

EXPERIMENTAL

Other: Med@HOME Mobile App

Control Group

NO INTERVENTION

Interventions

Med@HOME Mobile App OTHER

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.

Meds@HOME Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• less than or equal to 17 years of age at start of study
• In the last 12 months, child has had at least two or more encounters (in-person or telehealth clinic visit, ED visit, or hospital admission) in the UWHC/AFCH system
• Child has 2 or more different complex chronic conditions
• Child has at least 1 active, outpatient prescription for a scheduled high-risk medication
• Provided assent, if appropriate
• Provided written informed consent form as the child's parent or legal guardian
• Willing to comply with all study procedures and available for the duration of the study
• At least 18 years of age
• Comfortable speaking and reading in English
• Self-identifies as a primary caregiver of a study-eligible CMC
• Currently provides care on an ongoing basis to the study-eligible CMC. Child may not be housed in a skilled nursing facility, an acute care or transitional facility, a rehabilitative hospital, or in a medical group home
• Has iOS or Android mobile device (smartphone, tablet) with a phone plan that includes daily Wi-Fi service and data
• Has been identified as a "secondary caregiver" by the primary caregiver
• Provided informed consent
• Willing to comply with all study procedures and be available for the duration of the study

You may not qualify if:

• Another child from the household is already enrolled in the study

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Wisconsin-Madison, UW Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Werner NE, Morgen M, Kooiman S, Jolliff A, Warner G, Feinstein J, Chui M, Katz B, Storhoff B, Sodergren K, Coller R. Effectiveness of a Mobile App (Meds@HOME) to Improve Medication Safety for Children With Medical Complexity: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 9;13:e60621. doi: 10.2196/60621.

  PMID: 39250787 DERIVED

Study Officials

• Ryan Coller, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 18, 2023
• Study Start: December 11, 2023
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)