Tremblay Dominique, Joly-Mischlich Thomas, Dufour Annick, Battista Marie-Claude, Berbiche Djamal, Côté José, Décelles Marco, Forget Catherine, Guérin Brigitte, Larivière Manon, Lemay Frédéric, Lemonde Manon, Maillet Éric, Moreau Nathalie, Pavic Michel, Soldera Sara, Wilhelmy Catherine
Nursing School, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada.
Department of Pharmacy, Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
JMIR Res Protoc. 2025 Jan 20;14:e63099. doi: 10.2196/63099.
Telehomecare monitoring (TM) in patients with cancer is a complex intervention. Research shows variations in the benefits and challenges TM brings to equitable access to care, the therapeutic relationship, self-management, and practice transformation. Further investigation into these variations factors will improve implementation processes and produce effective outcomes.
This study aims to concurrently analyze implementation and evaluate the effectiveness of TM for patients receiving anticancer oral therapy. The objectives are to (1) contextualize how and why TM is implemented according to (a) site characteristics, (b) team characteristics, and (c) characteristics of patients receiving anticancer oral therapy; (2) assess TM effectiveness for recording electronic patient-reported outcome measures (ePROMs) and patient-reported experience measures (ePREMs) according to the site, implementation process, and patient characteristics; (3) describe the acceptability and feasibility of TM from the perspectives of the people directly or indirectly involved and provide evidence-based actionable guidance in anticipation of provincewide implementation.
This type II hybrid effectiveness-implementation study uses a concurrent mixed methods design. Evaluability assessment is integrated into an emerging practice in 3 participating sites to enable the evaluation of implementation strategies on TM clinical outcomes. Quantitative data for ePROMs and ePREMs will be collected using validated oncology questionnaire. Descriptive statistics and repeated measures using multiple linear mixed models and generalized estimating equations analyses will be undertaken alongside interpretive descriptive coding of qualitative data. Qualitative data will be gathered from key informants guided by the RE-AIM (reach, efficacy, adoption, implementation, maintenance) framework and its extension, PRISM (practical robust implementation and sustainability model). The concurrent approach allows results at multiple stages of this study to be integrated iteratively. The methodological choice aims to provide real-world data that are rigorous, rapidly usable in practice, and transferable to other settings.
Questionnaires were pretested and the technological platform was codeveloped with members of the cancer care team and patients. Preparatory work was carried out to configure the TM platform and activate coordinating mechanisms between members of the cancer care team, patients, information technology experts, and the research team. A steering committee with 3 working groups was established to oversee the technological, clinical, and evaluation aspects of this study. Recruitment of patients for ePROMs started in February 2024, and data collection is expected to continue until March 2025. Interviews with members of the cancer care team began in November 2024. Full analysis should be completed by September 2025.
This study will clarify how, why, for whom, and under what conditions TM can complement current care models. Our evaluability assessment will help to address implementation complexities and better understand intervention-to-practice operationalization so that implementation might be adapted to contextual factors without potentially harmful or inequitable impacts on patients.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63099.
癌症患者的远程居家监测(TM)是一项复杂的干预措施。研究表明,TM在公平获得护理、治疗关系、自我管理和实践转变方面带来的益处和挑战存在差异。对这些差异因素进行进一步调查将改善实施过程并产生有效的结果。
本研究旨在同时分析TM在接受抗癌口服治疗患者中的实施情况并评估其有效性。目标是:(1)根据(a)机构特征、(b)团队特征和(c)接受抗癌口服治疗患者的特征,将TM的实施方式及原因置于具体情境中;(2)根据机构、实施过程和患者特征,评估TM在记录电子患者报告结局指标(ePROMs)和患者报告体验指标(ePREMs)方面的有效性;(3)从直接或间接参与人员的角度描述TM的可接受性和可行性,并在预期全省范围内实施之前提供基于证据的可操作指导。
这项II型混合有效性 - 实施研究采用同步混合方法设计。可评估性评估被整合到3个参与机构的一项新兴实践中,以评估TM临床结局的实施策略。将使用经过验证的肿瘤学问卷收集ePROMs和ePREMs的定量数据。将进行描述性统计以及使用多重线性混合模型和广义估计方程分析的重复测量,并对定性数据进行解释性描述编码。定性数据将在RE - AIM(覆盖范围、疗效、采用、实施、维持)框架及其扩展PRISM(实用稳健实施和可持续性模型)的指导下,从关键信息提供者处收集。同步方法允许在本研究的多个阶段迭代整合结果。方法选择旨在提供严谨、在实践中可快速使用且可转移到其他环境的真实世界数据。
问卷进行了预测试,技术平台与癌症护理团队成员和患者共同开发。开展了准备工作,以配置TM平台并激活癌症护理团队成员、患者、信息技术专家和研究团队之间的协调机制。成立了一个由3个工作组组成的指导委员会,以监督本研究的技术、临床和评估方面。2024年2月开始招募患者进行ePROMs数据收集,预计数据收集将持续到2025年3月。2024年11月开始对癌症护理团队成员进行访谈。完整分析应在2025年9月完成。
本研究将阐明TM如何、为何、针对何人以及在何种条件下可以补充当前的护理模式。我们的可评估性评估将有助于解决实施复杂性问题,并更好地理解干预到实践的操作化,以便实施能够适应情境因素,而不会对患者产生潜在有害或不公平的影响。
国际注册报告标识符(IRRID):DERR1 - 10.2196/63099