Meds@HOME App to Support Medication Safety
- Conditions
- Medication Errors and Other Product Use Errors and Issues
- Interventions
- Other: Med@HOME Mobile App
- Registration Number
- NCT05816590
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
Not provided
- Failure to meet all inclusion criteria
- Another child from the household is already enrolled in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meds@HOME Intervention Med@HOME Mobile App -
- Primary Outcome Measures
Name Time Method Change in Percentage of Participants Demonstrating Medication Administration Accuracy baseline (before randomization), 6 months 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
- Secondary Outcome Measures
Name Time Method Change in Percentage of Participants Demonstrating Medication Administration Accuracy among Secondary Caregivers baseline (before randomization), 6 months Rate of medication administration accuracy, measured as in the primary outcome, amongst secondary caregivers after 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 Parent-Reported Medication Confidence up to 6 months 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.
Count of hospital encounters and hospital days during study period up to 6 months Count of hospital encounters and hospital days during study period.
Count of ED encounters during study period up to 6 months Count of ED encounters during study period.
Mean Number of Individual Components of Medication Adherence Correct up to 6 months Mean number of individual components correct (from 0 components to all 5: indication, formulation, dose, frequency, route).
Mean FCAT (Family Caregiver Activation in Transition) Score for 5 medication-specific items up to 6 months 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.
Parent-Reported Medication Understanding up to 6 months 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.
Mean parent-reported medication adherence using the Adherence to Refills and Medications Scale (ARMS) up to 6 months ARMS is a 12-item instrument scored from 12 to 34, with lower scores indicating better adherence.
Count of deaths during the study period up to 6 months Count of deaths during the study period
Rate of Medication Adherence for Individual Components (indication, formulation, dose, frequency, and route) up to 6 months Rate of individual components each measured dichotomously (indication, formulation, dose, frequency, and route).
Trial Locations
- Locations (1)
University of Wisconsin-Madison, UW Health
🇺🇸Madison, Wisconsin, United States