Nair Monika, Lundgren Lina E, Soliman Amira, Dryselius Petra, Fogelberg Ebba, Petersson Marcus, Hamed Omar, Triantafyllou Miltiadis, Nygren Jens
School of Health and Welfare, Halmstad University, Halmstad, Sweden.
School of Business, Innovation and Sustainability, Halmstad University, Halmstad, Sweden.
JMIR Res Protoc. 2024 Mar 11;13:e52744. doi: 10.2196/52744.
Care for patients with heart failure (HF) causes a substantial load on health care systems where a prominent challenge is the elevated rate of readmissions within 30 days following initial discharge. Clinical professionals face high levels of uncertainty and subjectivity in the decision-making process on the optimal timing of discharge. Unwanted hospital stays generate costs and cause stress to patients and potentially have an impact on care outcomes. Recent studies have aimed to mitigate the uncertainty by developing and testing risk assessment tools and predictive models to identify patients at risk of readmission, often using novel methods such as machine learning (ML).
This study aims to investigate how a developed clinical decision support (CDS) tool alters the decision-making processes of health care professionals in the specific context of discharging patients with HF, and if so, in which ways. Additionally, the aim is to capture the experiences of health care practitioners as they engage with the system's outputs to analyze usability aspects and obtain insights related to future implementation.
A quasi-experimental design with randomized crossover assessment will be conducted with health care professionals on HF patients' scenarios in a region located in the South of Sweden. In total, 12 physicians and nurses will be randomized into control and test groups. The groups shall be provided with 20 scenarios of purposefully sampled patients. The clinicians will be asked to take decisions on the next action regarding a patient. The test group will be provided with the 10 scenarios containing patient data from electronic health records and an outcome from an ML-based CDS model on the risk level for readmission of the same patients. The control group will have 10 other scenarios without the CDS model output and containing only the patients' data from electronic medical records. The groups will switch roles for the next 10 scenarios. This study will collect data through interviews and observations. The key outcome measures are decision consistency, decision quality, work efficiency, perceived benefits of using the CDS model, reliability, validity, and confidence in the CDS model outcome, integrability in the routine workflow, ease of use, and intention to use. This study will be carried out in collaboration with Cambio Healthcare Systems.
The project is part of the Center for Applied Intelligent Systems Research Health research profile, funded by the Knowledge Foundation (2021-2028). Ethical approval for this study was granted by the Swedish ethical review authority (2022-07287-02). The recruitment process of the clinicians and the patient scenario selection will start in September 2023 and last till March 2024.
This study protocol will contribute to the development of future formative evaluation studies to test ML models with clinical professionals.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52744.
心力衰竭(HF)患者的护理给医疗保健系统带来了巨大负担,其中一个突出挑战是初次出院后30天内再入院率升高。临床专业人员在决定最佳出院时机的过程中面临高度的不确定性和主观性。不必要的住院会产生成本,并给患者带来压力,还可能对护理结果产生影响。最近的研究旨在通过开发和测试风险评估工具及预测模型来识别有再入院风险的患者,以减轻这种不确定性,这些研究通常采用机器学习(ML)等新方法。
本研究旨在调查一种已开发的临床决策支持(CDS)工具如何改变医疗保健专业人员在HF患者出院这一特定背景下的决策过程,若有改变,是通过哪些方式。此外,目的是了解医疗保健从业者在与系统输出交互时的体验,以分析可用性方面,并获得与未来实施相关的见解。
将对瑞典南部一个地区的医疗保健专业人员就HF患者的情况进行随机交叉评估的准实验设计。总共12名医生和护士将被随机分为对照组和测试组。将为两组提供20个经过有目的抽样的患者场景。临床医生将被要求就患者的下一步行动做出决策。测试组将获得10个包含电子健康记录中的患者数据以及基于ML的CDS模型对同一患者再入院风险水平的预测结果的场景。对照组将有另外10个没有CDS模型输出且仅包含电子病历中患者数据的场景。两组将在接下来的10个场景中互换角色。本研究将通过访谈和观察收集数据。关键结果指标包括决策一致性、决策质量、工作效率、使用CDS模型的感知益处、可靠性、有效性、对CDS模型结果的信心、在常规工作流程中的可集成性、易用性以及使用意愿。本研究将与Cambio Healthcare Systems合作开展。
该项目是应用智能系统研究中心健康研究项目的一部分,由知识基金会资助(2021 - 2028年)。本研究已获得瑞典伦理审查机构的伦理批准(2022 - 07287 - 02)。临床医生的招募过程和患者场景选择将于2023年9月开始,持续至2024年3月。
本研究方案将有助于未来开展形成性评估研究,以与临床专业人员一起测试ML模型。
国际注册报告标识符(IRRID):PRR1 - 10.2196/52744。