PDF(Pubmed)
Abstract：
BACKGROUND: Persons with diabetes have 27% elevated risk of developing colorectal cancer (CRC) and are disproportionately from priority health disparities populations. Federally qualified health centers (FQHCs) struggle to implement CRC screening programs for average risk patients. Strategies to effectively prioritize and optimize CRC screening for patients with diabetes in the primary care safety-net are needed.
METHODS: Guided by the Exploration, Preparation, Implementation and Sustainment Framework, we conducted a stakeholder-engaged process to identify multi-level change objectives for implementing optimized CRC screening for patients with diabetes in FQHCs. To identify change objectives, an implementation planning group of stakeholders from FQHCs, safety-net screening programs, and policy implementers were assembled and met over a 7-month period. Depth interviews (n = 18-20) with key implementation actors were conducted to identify and refine the materials, methods and strategies needed to support an implementation plan across different FQHC contexts. The planning group endorsed the following multi-component implementation strategies: identifying clinic champions, development/distribution of patient educational materials, developing and implementing quality monitoring systems, and convening clinical meetings. To support clinic champions during the initial implementation phase, two learning collaboratives and bi-weekly virtual facilitation will be provided. In single group, hybrid type 2 effectiveness-implementation trial, we will implement and evaluate these strategies in a in six safety net clinics (n = 30 patients with diabetes per site). The primary clinical outcomes are: (1) clinic-level colonoscopy uptake and (2) overall CRC screening rates for patients with diabetes assessed at baseline and 12-months post-implementation. Implementation outcomes include provider and staff fidelity to the implementation plan, patient acceptability, and feasibility will be assessed at baseline and 12-months post-implementation.
CONCLUSIONS: Study findings are poised to inform development of evidence-based implementation strategies to be tested for scalability and sustainability in a future hybrid 2 effectiveness-implementation clinical trial. The research protocol can be adapted as a model to investigate the development of targeted cancer prevention strategies in additional chronically ill priority populations.
BACKGROUND: This study was registered in ClinicalTrials.gov (NCT05785780) on March 27, 2023 (last updated October 21, 2023).
METHODS: Guided by the Exploration, Preparation, Implementation and Sustainment Framework, we conducted a stakeholder-engaged process to identify multi-level change objectives for implementing optimized CRC screening for patients with diabetes in FQHCs. To identify change objectives, an implementation planning group of stakeholders from FQHCs, safety-net screening programs, and policy implementers were assembled and met over a 7-month period. Depth interviews (n = 18-20) with key implementation actors were conducted to identify and refine the materials, methods and strategies needed to support an implementation plan across different FQHC contexts. The planning group endorsed the following multi-component implementation strategies: identifying clinic champions, development/distribution of patient educational materials, developing and implementing quality monitoring systems, and convening clinical meetings. To support clinic champions during the initial implementation phase, two learning collaboratives and bi-weekly virtual facilitation will be provided. In single group, hybrid type 2 effectiveness-implementation trial, we will implement and evaluate these strategies in a in six safety net clinics (n = 30 patients with diabetes per site). The primary clinical outcomes are: (1) clinic-level colonoscopy uptake and (2) overall CRC screening rates for patients with diabetes assessed at baseline and 12-months post-implementation. Implementation outcomes include provider and staff fidelity to the implementation plan, patient acceptability, and feasibility will be assessed at baseline and 12-months post-implementation.
CONCLUSIONS: Study findings are poised to inform development of evidence-based implementation strategies to be tested for scalability and sustainability in a future hybrid 2 effectiveness-implementation clinical trial. The research protocol can be adapted as a model to investigate the development of targeted cancer prevention strategies in additional chronically ill priority populations.
BACKGROUND: This study was registered in ClinicalTrials.gov (NCT05785780) on March 27, 2023 (last updated October 21, 2023).
摘要：
背景：糖尿病患者患结肠直肠癌（CRC）的风险增加了27％，并且与优先健康差异人群不成比例。具有联邦资格的健康中心（FQHC）努力为平均风险患者实施CRC筛查计划。需要在初级护理安全网中有效优先考虑和优化糖尿病患者CRC筛查的策略。
方法：在探索的指导下，准备工作,实施和维持框架，我们进行了利益相关者参与的流程,以确定多水平变化目标,以便在FQHCs中为糖尿病患者实施优化的CRC筛查.要确定变更目标，由FQHC的利益相关者组成的实施计划小组，安全网筛查计划，政策实施者在7个月的时间里集合并会面。进行了与关键实施行为者的深度访谈（n=18-20），以确定和完善材料，在不同的FQHC环境中支持实施计划所需的方法和策略。规划小组批准了以下多部分实施策略：确定诊所冠军，开发/分发患者教育材料，开发和实施质量监控系统，召开临床会议。为了在初始实施阶段支持诊所冠军，将提供两次学习合作和每两周一次的虚拟便利。在单个组中，混合2型有效性实施试验，我们将在6个安全网诊所(每个中心n=30名糖尿病患者)实施和评估这些策略.主要临床结果是：（1）临床水平的结肠镜摄取和（2）在基线和实施后12个月评估的糖尿病患者的总体CRC筛查率。实施结果包括提供者和员工对实施计划的忠诚，患者可接受性,可行性将在基线和实施后12个月进行评估。
结论：研究结果准备为开发基于证据的实施策略提供信息，以在未来的混合2有效性实施临床试验中测试可扩展性和可持续性。研究方案可以作为模型进行调整，以研究其他慢性病优先人群中靶向癌症预防策略的发展。
背景：该研究于2023年3月27日在ClinicalTrials.gov（NCT05785780）中注册（最后更新于2023年10月21日）。
方法：在探索的指导下，准备工作,实施和维持框架，我们进行了利益相关者参与的流程,以确定多水平变化目标,以便在FQHCs中为糖尿病患者实施优化的CRC筛查.要确定变更目标，由FQHC的利益相关者组成的实施计划小组，安全网筛查计划，政策实施者在7个月的时间里集合并会面。进行了与关键实施行为者的深度访谈（n=18-20），以确定和完善材料，在不同的FQHC环境中支持实施计划所需的方法和策略。规划小组批准了以下多部分实施策略：确定诊所冠军，开发/分发患者教育材料，开发和实施质量监控系统，召开临床会议。为了在初始实施阶段支持诊所冠军，将提供两次学习合作和每两周一次的虚拟便利。在单个组中，混合2型有效性实施试验，我们将在6个安全网诊所(每个中心n=30名糖尿病患者)实施和评估这些策略.主要临床结果是：（1）临床水平的结肠镜摄取和（2）在基线和实施后12个月评估的糖尿病患者的总体CRC筛查率。实施结果包括提供者和员工对实施计划的忠诚，患者可接受性,可行性将在基线和实施后12个月进行评估。
结论：研究结果准备为开发基于证据的实施策略提供信息，以在未来的混合2有效性实施临床试验中测试可扩展性和可持续性。研究方案可以作为模型进行调整，以研究其他慢性病优先人群中靶向癌症预防策略的发展。
背景：该研究于2023年3月27日在ClinicalTrials.gov（NCT05785780）中注册（最后更新于2023年10月21日）。
