Clinical trial NCT05816590: Meds@HOME App to Support Medication Safety
Official title: Meds@HOME - Improving Medication Safety for Medically Complex Children With mHealth Across Caregiving Networks (R18 Aim 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Errors and Other Product Use Errors and Issues
Keywords: Children with Medical Complexity
Medication
Adverse Events
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-04-18
Enrollment: 336
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility 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:

* Failure to meet all inclusion criteria
* Another child from the household is already enrolled in the study

Primary outcomes:
measure: Change in Percentage of Participants Demonstrating Medication Administration Accuracy
timeFrame: baseline (before randomization), 6 months
Secondary outcomes:
measure: Change in Percentage of Participants Demonstrating Medication Administration Accuracy among Secondary Caregivers
timeFrame: baseline (before randomization), 6 months
measure: Count of University of Wisconsin (UW) hospital encounters during study period with Adverse Drug Event (ADE) codes
timeFrame: up to 6 months
measure: Count of UW Emergency Department (ED) encounters during study period with ADE codes
timeFrame: up to 6 months
measure: Mean parent-reported medication adherence using the Adherence to Refills and Medications Scale (ARMS)
timeFrame: up to 6 months
measure: Mean FCAT (Family Caregiver Activation in Transition) Score for 5 medication-specific items
timeFrame: up to 6 months
measure: Parent-Reported Medication Confidence
timeFrame: up to 6 months
measure: Parent-Reported Medication Understanding
timeFrame: up to 6 months
measure: Count of hospital encounters and hospital days during study period
timeFrame: up to 6 months
measure: Count of ED encounters during study period
timeFrame: up to 6 months
measure: Count of deaths during the study period
timeFrame: up to 6 months
measure: Rate of Medication Adherence for Individual Components (indication, formulation, dose, frequency, and route)
timeFrame: up to 6 months
measure: Mean Number of Individual Components of Medication Adherence Correct
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison, UW Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan Coller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: