Meds@HOME App to Support Medication Safety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2025-05-06

Brief Summary

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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.

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Detailed Description

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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

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Medication Errors and Other Product Use Errors and Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Meds@HOME Intervention

Group Type EXPERIMENTAL

Med@HOME Mobile App

Intervention Type 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.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
* At least 18 years of age
* Comfortable speaking and reading in English
* Currently provides care on an ongoing basis to the study-eligible CMC
* Administers medications to the study-eligible CMC
* Has an iOS or Android mobile device (smartphone) with a phone plan that includes daily Wi-Fi service and data

* Has been identified by a primary caregiver assigned to the intervention group as a person providing care to the child
* Has been invited by the primary caregiver to use the app (i.e., sent email invitation via Meds@HOMEapp)
* Signed up to become a Meds@HOME user by clicking on link in email invitation and completing user registration
* Is not participating in study survey data collection as a secondary caregiver

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No