Chao Chun R, Cannizzaro Nancy T, Hahn Erin E, Tewari Devansu, Ngo-Metzger Quyen, Hsu Chunyi, Shen Ernest, Wride Patricia, Hodeib Melissa, Gould Michael, Mittman Brian S
Department of Research and Evaluation, Kaiser Permanente, 100 S. Los Robles Ave, Pasadena, CA 91101, USA.
Department of Obstetrics and Gynecology, Kaiser Permanente, Irvine, Gynecologic Oncology Division, KPSC - Orange County Women's Health Services, 6650 Alton Pkwy, Irvine, CA 92618, USA.
Contemp Clin Trials. 2023 Jan;124:106994. doi: 10.1016/j.cct.2022.106994. Epub 2022 Nov 4.
Limited guidance exists regarding implementation strategies that best facilitate cancer screening practice substitution and achieve optimal stakeholder-centered outcomes. Here we describe the protocol for a randomized pragmatic trial comparing two implementation strategies to facilitate substitution of primary HPV screening for Pap and HPV co-testing to perform routine cervical cancer screening of women aged 30-65 years at Kaiser Permanente Southern California (KPSC).
Twelve service areas within KPSC will be randomized to a "centrally-administered system-wide implementation + local-tailored implementation" strategy or a "centrally-administered system-wide implementation only" strategy. The centrally-administered strategy comprises clinician and staff educational activities. Sites in the local-tailored arm will then conduct a structured local needs assessment followed by site-specific selection and deployment of implementation interventions. Surveys and interviews will be conducted among women and providers from the primary care and ob/gyn departments prior to the system-wide transition, shortly after the transition, and after the completion of local-tailored interventions. A stakeholder advisory committee will assist with study design, defining stakeholder-centered outcomes, and developing data collection tools.
The primary outcome of interest is uptake of primary HPV screening. Secondary provider-centered outcomes include provider knowledge, delivery of patient education, satisfaction with the practice substitution process, and resistance to primary HPV screening. Secondary patient-centered outcomes include patient knowledge, stigma, and satisfaction with the screening process. Intervention fidelity will also be measured via surveys.
Findings from this study will help inform future use of a local-tailored implementation strategy for adopting primary HPV screening at large health care systems. Findings may also be applicable to other types of practice substitution.
关于哪种实施策略最有助于癌症筛查实践替代并实现以利益相关者为中心的最佳结果，目前的指导有限。在此，我们描述了一项随机实用试验的方案，该试验比较两种实施策略，以促进用原发性人乳头瘤病毒（HPV）筛查替代巴氏涂片和HPV联合检测，对南加州凯撒医疗集团（KPSC）30至65岁女性进行常规宫颈癌筛查。
KPSC内的12个服务区将被随机分配到“集中管理的全系统实施+本地定制实施”策略或“仅集中管理的全系统实施”策略。集中管理策略包括临床医生和工作人员的教育活动。然后，本地定制组的站点将进行结构化的本地需求评估，随后进行针对特定站点的实施干预措施的选择和部署。在全系统过渡前、过渡后不久以及本地定制干预措施完成后，将对初级保健和妇产科部门的女性和提供者进行调查和访谈。一个利益相关者咨询委员会将协助研究设计、确定以利益相关者为中心的结果以及开发数据收集工具。
感兴趣的主要结果是原发性HPV筛查的采用情况。以提供者为中心的次要结果包括提供者知识、患者教育的提供、对实践替代过程的满意度以及对原发性HPV筛查的抵触情绪。以患者为中心的次要结果包括患者知识、耻辱感以及对筛查过程的满意度。干预保真度也将通过调查来衡量。
本研究的结果将有助于为未来在大型医疗系统中采用原发性HPV筛查的本地定制实施策略提供参考。研究结果也可能适用于其他类型的实践替代。
