Chui Michelle A, Berbakov Maria E, Gilson Aaron M, Stone Jamie A, Lehnbom Elin C, Hoffins Emily L, Moore Katherine G, Ford Ii James H
Chui SAMS (Systems Approach to Medication Safety) Lab, School of Nursing, University of Wisconsin-Madison, Madison, WI, United States.
Sonderegger Research Center, School of Pharmacy, University of Wisconsin-Madison, Madison, WI, United States.
JMIR Res Protoc. 2025 Sep 11;14:e69011. doi: 10.2196/69011.
The increase in people with complex chronic health conditions is stressing the US health care delivery system. Community pharmacies play a role in ensuring patients' safe medication use for chronic care management (CCM), but their efforts are undermined by volatile work demands and other system barriers. Medication safety in community pharmacies is a multidimensional issue shaped by the work system and interactions among pharmacists, primary care providers, and patients.
The objective is to create and evaluate a system of CCM that supports safe medication use. The CCM system design will focus on creating and evaluating a Medication Safety Map (MedSafeMap) for patients with complex chronic health conditions. This study has three aims: (1) identify and define community pharmacy work system design requirements for safe medication practices, enabling resilient performance; (2) design and develop MedSafeMap, a feasible and sustainable solution, to facilitate safe medication practices through resilient performance; and (3) implement MedSafeMap in community pharmacies and pilot-test its impact on pharmacy staff attitudes, behaviors, and performance.
This study will leverage participatory design and human factors engineering methods throughout the 3 aims. For aim 1, four rounds of qualitative observations within 6 pharmacy sites will be conducted to parse areas MedSafeMap could address. Two rounds of interviews with pharmacists and technicians from each of the sites will be used to expand upon areas of interest identified during the observations. Observational and interview data will be used to construct functional resonance analysis method models and resilience narratives to map both risks and best practices within the system based on daily workplace factors. For aim 2, focus groups with pharmacist and technician stakeholders will be guided by participatory stakeholder engagement to inform prototyping for MedSafeMap. Simulation-based research involving standardized patients in CCM scenarios will be used to test and refine MedSafeMap components. Finally, for aim 3, MedSafeMap will be implemented in pharmacies. Observations using the work observation method by activity timing (WOMBAT) for the time and motion study will aid in understanding how MedSafeMap impacts pharmacy staff workflow. We will assess adoption challenges and resilience-focused attitudes, behaviors, and performance to support CCM.
As of August 2025, all 6 pharmacy sites have been recruited. Three of the 4 rounds of observations, 2 rounds of interviews with 12 pharmacists and 12 technicians from the study sites, and the 6 focus groups have been conducted. Preparations for the simulations are ongoing.
MedSafeMap is an innovative approach that will guide pharmacists and technicians in safely providing care to patients with complex chronic health conditions. It will help them navigate the complex tasks and communications between the pharmacy, patient, and primary care provider arising with this type of complex care.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/69011.
患有复杂慢性健康问题的人数不断增加，给美国医疗保健系统带来了压力。社区药房在确保患者安全用药以进行慢性病管理（CCM）方面发挥着作用，但其努力受到工作需求波动和其他系统障碍的影响。社区药房的用药安全是一个多维度问题，受工作系统以及药剂师、初级保健提供者和患者之间的相互作用影响。
创建并评估一个支持安全用药的CCM系统。CCM系统设计将专注于为患有复杂慢性健康问题的患者创建并评估一份用药安全地图（MedSafeMap）。本研究有三个目标：（1）识别并定义社区药房工作系统设计中安全用药实践的要求，以实现弹性绩效；（2）设计并开发MedSafeMap，这是一个可行且可持续的解决方案，通过弹性绩效促进安全用药实践；（3）在社区药房实施MedSafeMap，并对其对药房工作人员态度、行为和绩效的影响进行试点测试。
本研究将在三个目标中充分利用参与式设计和人因工程方法。对于目标1，将在6个药房站点进行四轮定性观察，以剖析MedSafeMap可以解决的领域。对每个站点的药剂师和技术人员进行两轮访谈，以扩展观察期间确定的感兴趣领域。观察和访谈数据将用于构建功能共振分析方法模型和弹性叙述，以根据日常工作场所因素绘制系统内的风险和最佳实践。对于目标2，由参与式利益相关者参与指导药剂师和技术人员利益相关者的焦点小组，为MedSafeMap的原型设计提供信息。涉及CCM场景中标准化患者的基于模拟的研究将用于测试和完善MedSafeMap组件。最后，对于目标3，将在药房实施MedSafeMap。使用活动时间工作观察方法（WOMBAT）进行时间和动作研究的观察将有助于了解MedSafeMap如何影响药房工作人员的工作流程。我们将评估采用挑战以及以弹性为重点的态度、行为和绩效，以支持CCM。
截至2025年8月，已招募了所有6个药房站点。已进行了四轮观察中的三轮、对研究站点的12名药剂师和12名技术人员进行了两轮访谈以及6个焦点小组。模拟准备工作正在进行中。
MedSafeMap是一种创新方法，将指导药剂师和技术人员为患有复杂慢性健康问题的患者安全提供护理。它将帮助他们应对药房、患者和初级保健提供者之间因这种复杂护理而产生的复杂任务和沟通。
国际注册报告标识符（IRRID）：DERR1-10.2196/69011。
