Department of Family Medicine and Community Health, Research Division, Rutgers Robert Wood Johnson Medical School, 303 George Street, Rm 309, New Brunswick, NJ, USA.
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
BMC Prim Care. 2024 Jul 5;25(1):242. doi: 10.1186/s12875-024-02496-0.
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.
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.
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.
This study was registered in ClinicalTrials.gov (NCT05785780) on March 27, 2023 (last updated October 21, 2023).
糖尿病患者罹患结直肠癌（CRC）的风险增加 27%，且主要来自优先卫生差异人群。合格的联邦医疗保险初级保健中心（FQHC）在为一般风险患者实施 CRC 筛查项目方面面临困难。需要制定策略，以有效地为初级保健保障网中的糖尿病患者确定和优化 CRC 筛查的优先级。
在探索、准备、实施和维持框架的指导下，我们开展了一项利益相关者参与的流程，以确定在 FQHC 中为糖尿病患者实施优化 CRC 筛查的多层次变更目标。为了确定变更目标，从 FQHC、安全网筛查计划和政策执行者中召集了一个实施计划小组的利益相关者，并在 7 个月的时间里举行了会议。对关键实施者进行了深度访谈（n=18-20），以确定和完善在不同 FQHC 环境下支持实施计划所需的材料、方法和策略。规划小组认可了以下多组分实施策略：确定诊所拥护者、患者教育材料的开发/分发、开发和实施质量监测系统，以及召开临床会议。为了在初始实施阶段为诊所拥护者提供支持，将提供两个学习合作组织和两周一次的虚拟促进。在单一小组、混合 2 型有效性-实施试验中，我们将在六家安全网诊所（每个站点 30 名糖尿病患者）中实施和评估这些策略。主要临床结果包括：（1）诊所层面结肠镜检查的采用率和（2）基线和实施后 12 个月时糖尿病患者的总体 CRC 筛查率。实施结果包括提供者和工作人员对实施计划的忠实程度、患者可接受性和可行性，将在基线和实施后 12 个月进行评估。
研究结果有望为开发基于证据的实施策略提供信息，以便在未来的混合 2 型有效性-实施临床试验中进行可扩展性和可持续性测试。研究方案可以作为模型进行调整，以在其他慢性疾病优先人群中研究有针对性的癌症预防策略的制定。
该研究于 2023 年 3 月 27 日在 ClinicalTrials.gov（NCT05785780）注册（最后更新于 2023 年 10 月 21 日）。
