A non-randomized controlled stepped wedge trial to evaluate the effectiveness of a multi-level mammography intervention in improving appointment adherence in underserved women
A non-randomized controlled stepped wedge trial to evaluate the effectiveness of a multi-level mammography intervention in improving appointment adherence in underserved women
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DOI：
10.1186/s13012-015-0334-x
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发表时间：
2015-10-14
影响因子：
7.2
通讯作者：
Bartholomew, L. K.
中科院分区：
文献类型：
--
作者：
Highfield, L.;Rajan, S. S.;Bartholomew, L. K.
背景：乳腺癌存在相当大的种族和社会经济差异。尽管存在大量旨在减少服务不足的乳腺癌筛查障碍的循证干预措施 (EBI)，但社区和临床环境中对 EBI 的采用缺乏或未达到最佳采用。本研究评估了一种基于理论、系统设计的实施策略，以支持采用和实施基于患者导航的干预措施，称为安心计划 (PMP)，旨在改善服务不足的女性的乳腺癌筛查。方法/设计：PMP 将使用非随机阶梯楔形设计提供给大休斯顿地区符合联邦资格的健康中心和慈善诊所。由于现实世界中实施和采用的实际限制，将不会使用开始时间的随机化和盲法。任何潜在的混杂或偏差都将在分析中得到控制。将评估诸如预约依从性、患者转诊诊断、诊断转诊时间、患者转诊治疗、治疗转诊时间以及干预的预算影响等结果。实施研究综合框架 (CFIR) 的构建评估将在实施期间和每个参与诊所的研究结束时（维持）进行评估。将使用描述性统计（卡方检验）和广义估计方程 (GEE) 来分析数据。 讨论：虽然平行组随机对照试验 (RCT) 被认为是评估 EBI 疗效的黄金标准，但在实践中保留有效的 EBI 可能既不道德又/或不切实际。阶梯式楔形设计解决了这个问题，使所有诊所最终都能在研究期间收到 EBI，并允许每个诊所作为自己的对照，同时保持强大的内部有效性。我们预计，PMP 将被证明是一项可行且成功的策略，可减少服务不足的女性的预约缺席情况。
Background: Considerable racial and socio-economic disparities exist in breast cancer. In spite of the existence of numerous evidence-based interventions (EBIs) aimed at reducing breast cancer screening barriers among the underserved, there is a lack of uptake or sub-optimal uptake of EBIs in community and clinical settings. This study evaluates a theoretically based, systematically designed implementation strategy to support adoption and implementation of a patient navigation-based intervention, called Peace of Mind Program (PMP), aimed at improving breast cancer screening among underserved women.Methods/design: The PMP will be offered to federally qualified health centers and charity clinics in the Greater Houston area using a non-randomized stepped wedge design. Due to practical constraints of implementing and adopting in the real-world, randomization of start times and blinding will not be used. Any potential confounding or bias will be controlled in the analysis. Outcomes such as appointment adherence, patient referral to diagnostics, time to diagnostic referral, patient referral to treatment, time to treatment referral, and budget impact of the intervention will be assessed. Assessment of constructs from the consolidated framework for implementation research (CFIR) will be assessed during implementation and at the end of the study (sustainment) from each participating clinic. Data will be analyzed using descriptive statistics (chi-square tests) and generalized estimating equations (GEE).Discussion: While parallel group randomized controlled trials (RCT) are considered the gold standard for evaluating EBI efficacy, withholding an effective EBI in practice can be both unethical and/or impractical. The stepped wedge design addresses this issue by enabling all clinics to eventually receive the EBI during the study and allowing each clinic to serve as its own control, while maintaining strong internal validity. We expect that the PMP will prove to be a feasible and successful strategy for reducing appointment no-shows in underserved women.