Meds@HOME App to Support Medication Safety

University of Wisconsin (UW)

Status

Completed

Conditions

Medication Errors and Other Product Use Errors and Issues

Treatments

Other: Med@HOME Mobile App

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05816590

2022-1620

A536771 (Other Identifier)

Pediatric Hospitalist (Other Identifier)

Protocol Version 12/5/23 (Other Identifier)

R18HS028409 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

336 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Child with Medical Complexity):

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

Inclusion Criteria (Primary Caregiver):

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

Inclusion Criteria (Secondary Caregiver):

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

Inclusion Criteria (Other Caregivers - Treatment Group only):

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

Exclusion Criteria: