Medication Errors and Other Product Use Errors and IssuesNCT05816590
Meds@HOME App to Support Medication Safety
A study testing Med@HOME Mobile App in people with Medication Errors and Other Product Use Errors and Issues, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Errors and Other Product Use Errors and Issues
- What is being tested?
- Med@HOME Mobile App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 6 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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
- 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
Who cannot join
- Failure to meet all inclusion criteria
- Another child from the household is already enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison, UW Health
Madison, Wisconsin, 53792
About this study
Official title: Meds@HOME - Improving Medication Safety for Medically Complex Children With mHealth Across Caregiving Networks (R18 Aim 2)
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.
Read the 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
- Being tested
- Med@HOME Mobile App
- Keywords
- Children with Medical Complexity, Medication, Adverse Events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Med@HOME Mobile AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Meds@HOME Intervention | Experimental | Not described Receives: Other: Med@HOME Mobile App |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline (before randomization), 6 months
Secondary outcomes (12)
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
Measured: baseline (before randomization), 6 months
Count of University of Wisconsin (UW) hospital encounters during study period with Adverse Drug Event (ADE) codes
Measured: up to 6 months
Count of UW Emergency Department (ED) encounters during study period with ADE codes
Measured: 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.
Measured: 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.
Measured: up to 6 months
Parent-Reported Medication Confidence
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.
Measured: 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.
Measured: up to 6 months
Count of hospital encounters and hospital days during study period
Count of hospital encounters and hospital days during study period.
Measured: up to 6 months
Count of ED encounters during study period
Count of ED encounters during study period.
Measured: up to 6 months
Count of deaths during the study period
Count of deaths during the study period
Measured: 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).
Measured: 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).
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 Dec 2023
- Primary completion6 May 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication Errors and Other Product Use Errors and IssuesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Ryan Coller, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816590
- Sponsor's protocol ID
- 2022-1620
- Other IDs
- Protocol Version 12/5/23, A536771, Pediatric Hospitalist, R18HS028409
- Status last verified
- May 2025
- First submitted
- 16 Mar 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Hare C, Werner N, Morgen M, Kooiman S, Feinstein J, Chui MA, Warner G, Jolliff A, Storhoff B, Sondegren K, Gerber D, Eickhoff J, Coller RJ. Medication Management and Caregiving Stress or Benefit in Children with Medical Complexity. J Pediatr Clin Pract. 2026 Aug 17;22:200235. doi: 10.1016/j.jpedcp.2026.200235. eCollection 2026 Dec.
PubMed 42824059Werner NE, Morgen M, Kooiman S, Jolliff A, Warner G, Feinstein J, Chui M, Katz B, Storhoff B, Sodergren K, Coller R. Effectiveness of a Mobile App (Meds@HOME) to Improve Medication Safety for Children With Medical Complexity: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 9;13:e60621. doi: 10.2196/60621.
PubMed 39250787
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meds@HOME - Improving Medication Safety for Medically Complex Children With mHealth Across Caregiving Networks (R18 Aim 2)
- ClinicalTrials.gov ID
- NCT05816590
- Acronym / sponsor ID
- 2022-1620
- Keywords
- Children with Medical Complexity, Medication, Adverse Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meds@HOME Intervention | Experimental | Other: Med@HOME Mobile App |
| Control Group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (2 listed)
- Failure to meet all inclusion criteria
- Another child from the household is already enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Med@HOME Mobile AppMeds@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. | Other | Meds@HOME Intervention |
Primary outcome
Change in Percentage of Participants Demonstrating Medication Administration Accuracy
Time frame: 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
12 secondary outcomes
Change in Percentage of Participants Demonstrating Medication Administration Accuracy among Secondary Caregivers
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)
Time frame: up to 6 months
Mean FCAT (Family Caregiver Activation in Transition) Score for 5 medication-specific items
Time frame: up to 6 months
Parent-Reported Medication Confidence
Time frame: up to 6 months
Parent-Reported Medication Understanding
Time frame: up to 6 months
Count of hospital encounters and hospital days during study period
Time frame: up to 6 months
Count of ED encounters during study period
Time frame: up to 6 months
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)
Time frame: up to 6 months
Mean Number of Individual Components of Medication Adherence Correct
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 42824059O'Hare C, Werner N, Morgen M, Kooiman S, Feinstein J, Chui MA, Warner G, Jolliff A, Storhoff B, Sondegren K, Gerber D, Eickhoff J, Coller RJ. Medication Management and Caregiving Stress or Benefit in Children with Medical Complexity. J Pediatr Clin Pract. 2026 Aug 17;22:200235. doi: 10.1016/j.jpedcp.2026.200235. eCollection 2026 Dec.
- Derived from this study: PubMed 39250787Werner NE, Morgen M, Kooiman S, Jolliff A, Warner G, Feinstein J, Chui M, Katz B, Storhoff B, Sodergren K, Coller R. Effectiveness of a Mobile App (Meds@HOME) to Improve Medication Safety for Children With Medical Complexity: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 9;13:e60621. doi: 10.2196/60621.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Coller, MD, MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Med@HOME Mobile App in people with Medication Errors and Other Product Use Errors and Issues, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of Participants Demonstrating Medication Administration Accuracy (time frame: baseline (before randomization), 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816590, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.