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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
336
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.
University of Wisconsin-Madison, UW Health
Madison, Wisconsin, United States
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
Time frame: baseline (before randomization), 6 months
Change in Percentage of Participants Demonstrating Medication Administration Accuracy among Secondary Caregivers
Rate of medication administration accuracy, measured as in the primary outcome, amongst secondary caregivers after 6-months
Time frame: baseline (before randomization), 6 months
Count of University of Wisconsin (UW) hospital encounters during study period with Adverse Drug Event (ADE) codes
Time frame: up to 6 months
Count of UW Emergency Department (ED) encounters during study period with ADE codes
Time frame: up to 6 months
Mean parent-reported medication adherence using the Adherence to Refills and Medications Scale (ARMS)
ARMS is a 12-item instrument scored from 12 to 34, with lower scores indicating better adherence.
Time frame: up to 6 months
Mean FCAT (Family Caregiver Activation in Transition) Score for 5 medication-specific items
FCAT Score for 5 medication-specific items - composite and individual items will be reported after 6-months. Scoring is from 1-5 with higher scores indicating fewer challenges to care.
Time frame: up to 6 months
Parent-Reported Medication Confidence
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To evaluate Meds@HOME's effect on parent-reported medication confidence. Mean composite score after 6-months. Medication Confidence is measured on a 7-item survey scored on a 5 point likert scale for a total possible range of scores from 7-35 where lower scores indicate increased medication confidence.
Time frame: up to 6 months
Parent-Reported Medication Understanding
To evaluate Meds@HOME's effect on parent-reported medication understanding. Mean composite score after 6-months. Medication Understanding is measured on a 5-item survey scored on a 5 point likert scale for a total possible range of scores from 5-25 where lower scores indicate increased medication understanding.
Time frame: up to 6 months
Count of hospital encounters and hospital days during study period
Count of hospital encounters and hospital days during study period.
Time frame: up to 6 months
Count of ED encounters during study period
Count of ED encounters during study period.
Time frame: up to 6 months
Count of deaths during the study period
Count of deaths during the study period
Time frame: up to 6 months
Rate of Medication Adherence for Individual Components (indication, formulation, dose, frequency, and route)
Rate of individual components each measured dichotomously (indication, formulation, dose, frequency, and route).
Time frame: up to 6 months
Mean Number of Individual Components of Medication Adherence Correct
Mean number of individual components correct (from 0 components to all 5: indication, formulation, dose, frequency, route).
Time frame: up to 6 months