Meds@HOME - Improving Medication Safety for Medically Complex Children With mHealth Across Caregiving Networks (R18 Aim 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Change in Percentage of Participants Demonstrating Medication Administration Accuracy
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •Failure to meet all inclusion criteria
- •Another child from the household is already enrolled in the study
研究组 & 干预措施
Meds@HOME Intervention
干预措施: Med@HOME Mobile App (Other)
Control Group
结局指标
主要结局
Change in Percentage of Participants Demonstrating Medication Administration Accuracy
时间窗: 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
次要结局
- Mean Number of Individual Components of Medication Adherence Correct(up to 6 months)
- Change in Percentage of Participants Demonstrating Medication Administration Accuracy among Secondary Caregivers(baseline (before randomization), 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)
- Count of hospital encounters and hospital days during study period(up to 6 months)
- Count of ED encounters during study period(up to 6 months)
- Mean FCAT (Family Caregiver Activation in Transition) Score for 5 medication-specific items(up to 6 months)
- Parent-Reported Medication Understanding(up to 6 months)
- Mean parent-reported medication adherence using the Adherence to Refills and Medications Scale (ARMS)(up to 6 months)
- Count of deaths during the study period(up to 6 months)
- Rate of Medication Adherence for Individual Components (indication, formulation, dose, frequency, and route)(up to 6 months)