1. A study protocol for a cluster randomized pragmatic trial for comparing strategies for implementing primary HPV testing for routine cervical cancer screening in a large health care system.
- Author
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Chao, Chun R., Cannizzaro, Nancy T., Hahn, Erin E., Tewari, Devansu, Ngo-Metzger, Quyen, Hsu, Chunyi, Shen, Ernest, Wride, Patricia, Hodeib, Melissa, Gould, Michael, and Mittman, Brian S.
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PAPILLOMAVIRUSES , *CLUSTER randomized controlled trials , *EARLY detection of cancer , *MEDICAL screening , *CERVICAL cancer , *MEDICAL care - Abstract
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. • Protocol of a study comparing implementation strategies for facilitating practice change. • A randomized pragmatic trial that evaluates strategies in implementing primary HPV screening. • The implementation strategies are "local-tailored" approach and the "prescribed" approach. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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