Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study.

Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study.
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DOI:
10.1186/s12875-023-02186-3
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发表时间:
2023-11-09
期刊:
BMC primary care
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其他
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乳腺癌检测和治疗的进步导致管理显着的晚期和长期治疗效果的个人数量增加。初级保健在照顾有癌症病史的患者方面发挥着重要作用,但关于如何有效地将生存护理证据应用到初级保健服务中的指导却很少。该方案描述了一个多阶段、混合方法、由研究者驱动的研究过程,该过程优先考虑可操作的、基于证据的初级保健改进,通过整合实施和初级保健转型框架:探索、准备、实施和维持(EPIS)框架和实践变革模型(PCM)来增强乳腺癌生存护理。通过深度访谈和四轮德尔菲小组与来自初级保健和肿瘤学的不同利益相关者的信息,我们将在26个初级保健实践中实施和评估混合1型有效性实施群集随机设计的迭代临床干预。多组成部分的执行战略将包括促进、审计和反馈以及学习协作。将进行持续的数据收集和分析,以优化干预措施的采用。测试有效性的主要临床结果是全面的乳腺癌随访护理。将使用混合方法评估实施情况,以探索组织和背景变量如何影响实施后6个月和12个月提供后续护理、症状和风险管理活动的采用、实施和早期可持续性。研究结果有望为可扩展的,高影响力的干预过程的发展提供信息,以加强对初级保健中有乳腺癌病史的患者的长期随访护理。如果成功,下一步将包括与一个基于国家初级保健实践的研究网络合作,实施一项全国传播研究。所确定的可采取行动的活动和过程也可以应用于其他癌症部位后续护理的组织和护理提供干预措施的发展。于2022年6月2日在ClinicalTrials.gov注册:NCT 05400941。在线版本包含补充材料,可通过10.1186/s12875-023-02186-3获得。
Advances in detection and treatment for breast cancer have led to an increase in the number of individuals managing significant late and long-term treatment effects. Primary care has a role in caring for patients with a history of cancer, yet there is little guidance on how to effectively implement survivorship care evidence into primary care delivery. This protocol describes a multi-phase, mixed methods, stakeholder-driven research process that prioritizes actionable, evidence-based primary care improvements to enhance breast cancer survivorship care by integrating implementation and primary care transformation frameworks: the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework and the Practice Change Model (PCM). Informed by depth interviews and a four round Delphi panel with diverse stakeholders from primary care and oncology, we will implement and evaluate an iterative clinical intervention in a hybrid type 1 effectiveness-implementation cluster randomized design in twenty-six primary care practices. Multi-component implementation strategies will include facilitation, audit and feedback, and learning collaboratives. Ongoing data collection and analysis will be performed to optimize adoption of the intervention. The primary clinical outcome to test effectiveness is comprehensive breast cancer follow-up care. Implementation will be assessed using mixed methods to explore how organizational and contextual variables affect adoption, implementation, and early sustainability for provision of follow-up care, symptom, and risk management activities at six- and 12-months post implementation. Study findings are poised to inform development of scalable, high impact intervention processes to enhance long-term follow-up care for patients with a history of breast cancer in primary care. If successful, next steps would include working with a national primary care practice-based research network to implement a national dissemination study. Actionable activities and processes identified could also be applied to development of organizational and care delivery interventions for follow-up care for other cancer sites. Registered with ClinicalTrials.gov on June 2, 2022: NCT05400941. The online version contains supplementary material available at 10.1186/s12875-023-02186-3.
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