背景:这项研究将对移动应用程序进行试点测试,用药安全@HOME-Meds@HOME干预,以提高用药准确性,减少可预防的不良药物事件,并最终改善医疗复杂性(CMC)儿童的慢性护理管理。Meds@HOME应用程序是与CMC家族共同设计的,二级护理人员(SCG),和卫生专业人员支持CMC的主要护理人员(PCGs)和SCGs的药物管理。我们假设Meds@HOME将提高护理人员的用药准确性,减少可预防的不良药物事件,并最终改善慢性病护理管理。
目的:本研究旨在评估Meds@HOME对PCGs和SCGs用药准确性的有效性。
方法:本研究将招募多达152个PCGs和304个SCGs的CMC,他们至少开了1种预定的高危药物,并在威斯康星大学美国家庭儿童医院接受治疗。PCG将被随机分配,为期6个月的审判,对照组(不试验药物@HOME)或干预组(试验药物@HOME),比例为1:1。Meds@HOME应用程序允许护理人员创建儿童档案,储存药物和护理说明,并收到有关即将到来和逾期护理程序和药物补充的提醒。在试验措施开始和结束时完成的调查人口统计学,用药知识,对CMC护理网络的信心,和舒适的医疗信息。单变量和多变量广义估计方程将用于主要统计分析。主要结果是PCG的药物给药准确度,测量为对随机选择的高风险药物的以下各项的正确识别:适应症,配方,剂量,频率,和路线在基线和6个月后。次要结果包括SCG用药准确性(适应症,配方,剂量,频率,和路线),威斯康星大学医院和急诊科的计数,PCG报告的药物依从性,死亡人数,和PCG药物的信心和理解。
结果:这项研究的招募于2023年11月29日开始。截至2024年5月15日,我们已注册94/152(62%)PCGs。我们预计招聘将于2024年8月1日结束,最终参与者将于2025年1月28日完成研究,届时我们将开始分析完整的回答。我们预计在2025年底公布结果。
结论:Meds@HOME移动应用程序为服用高风险药物的CMC提供了改善PCG药物安全性的有希望的策略。此外,该协议强调了招募CMCSCG的新程序。在未来,该应用程序可以在不同的护理网络中更广泛地使用,以导航复杂的药物例程并促进药物安全。
背景:ClinicalTrials.govNCT05816590;https://clinicaltrials.gov/study/NCT05816590。
■DERR1-10.2196/60621。
BACKGROUND: This study will pilot-test the mobile app, Medication Safety @HOME-Meds@HOME intervention to improve medication administration accuracy, reduce preventable adverse drug events, and ultimately improve chronic care management for children with medical complexity (CMC). The Meds@HOME app was co-designed with CMC families, secondary caregivers (SCGs), and health professionals to support medication management for primary caregivers (PCGs) and SCGs of CMC. We hypothesize that Meds@HOME will improve caregivers\' medication administration accuracy, reduce preventable adverse drug events, and ultimately improve chronic care management.
OBJECTIVE: This study aims to evaluate the effectiveness of Meds@HOME on medication administration accuracy for PCGs and SCGs.
METHODS: This study will recruit up to 152 PCGs and 304 SCGs of CMC who are prescribed at least 1 scheduled high-risk medication and receive care at the University of Wisconsin American Family Children\'s Hospital. PCGs will be randomly assigned, for the 6-month trial, to either the control group (not trialing Meds@HOME) or the intervention group (trialing Meds@HOME) using 1:1 ratio. The Meds@HOME app allows caregivers to create a child profile, store medication and care instructions, and receive reminders for upcoming and overdue care routines and medication refills. Surveys completed both at the start and end of the trial measure demographics, medication delivery knowledge, confidence in the CMC\'s caregiving network, and comfort with medical information. Univariate and multivariate generalized estimation equations will be used for primary statistical analysis. The primary outcome is the PCG\'s rate of medication administration accuracy measured as correct identification of each of the following for a randomly selected high-risk medication: indication, formulation, dose, frequency, and route at baseline and after 6 months. Secondary outcomes include SCG medication administration accuracy (indication, formulation, dose, frequency, and route), count of University of Wisconsin hospital and emergency department encounters, PCG-reported medication adherence, count of deaths, and PCG medication confidence and understanding.
RESULTS: Recruitment for this study began on November 29, 2023. As of May 15, 2024, we have enrolled 94/152 (62%) PCGs. We expect recruitment to end by August 1, 2024, and the final participant will complete the study by January 28, 2025, at which point we will start analyzing the complete responses. We expect publication of results at the end of 2025.
CONCLUSIONS: The Meds@HOME mobile app provides a promising strategy for improving PCG medication safety for CMC who take high-risk medications. In addition, this protocol highlights novel procedures for recruiting SCGs of CMC. In the future, this app could be used more broadly across diverse caregiving networks to navigate complex medication routines and promote medication safety.
BACKGROUND: ClinicalTrials.gov NCT05816590; https://clinicaltrials.gov/study/NCT05816590.
UNASSIGNED: DERR1-10.2196/60621.