Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Trials. 2023 Apr 14;24(1):274. doi: 10.1186/s13063-023-07273-5.
Screening for colorectal cancer (CRC) is widely recommended but underused, even though CRC is the third most diagnosed cancer and the second leading cause of cancer death in the USA. The mPATH™ program is an iPad-based application designed to identify patients due for CRC screening, educate them on the commonly used screening tests, and help them select their best option, with the goal of increasing CRC screening rates.
The mPATH™ program consists of questions asked of all adult patients at check-in (mPATH™-CheckIn), as well as a module specific for patients due for CRC screening (mPATH™-CRC). In this study, the mPATH™ program is evaluated through a Type III hybrid implementation-effectiveness design. Specifically, the study consists of three parts: (1) a cluster-randomized controlled trial of primary care clinics comparing a "high touch" evidence-based implementation strategy with a "low touch" implementation strategy; (2) a nested pragmatic study evaluating the effectiveness of mPATH-CRC™ on completion of CRC screening; and (3) a mixed-methods study evaluating factors that facilitate or impede the maintenance of interventions like mPATH-CRC™. The primary objective is to compare the proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH™-CRC in the 6th month following implementation between the "high touch" and "low touch" implementation strategies. Effectiveness of mPATH™-CRC is evaluated by comparing the proportion who complete CRC screening within 16 weeks of their visit to the clinic between a pre-implementation cohort (8 months before implementation) and a post-implementation cohort (8 months after implementation).
This study will provide data on both the implementation of the mPATH™ program and its effectiveness in improving screening rates for CRC. In addition, this work has the potential to have an even broader impact by identifying strategies to support the sustained use of other similar technology-based primary care interventions.
ClinicalTrials.gov NCT03843957. Registered on 18 February 2019.
在美国，结直肠癌（CRC）是第三大常见癌症，也是癌症死亡的第二大主要原因，但结直肠癌筛查的应用却并不广泛。mpath™ 计划是一款基于 iPad 的应用程序，旨在识别需要进行 CRC 筛查的患者，对他们进行常用筛查测试的教育，并帮助他们选择最佳选项，目的是提高 CRC 筛查率。
mpath™ 计划包括在所有成年患者就诊时询问的问题（mpath™-CheckIn），以及针对需要 CRC 筛查的患者的特定模块（mpath™-CRC）。在这项研究中，mpath™ 计划通过 III 型混合实施效果设计进行评估。具体来说，该研究由三部分组成：（1）对初级保健诊所进行的集群随机对照试验，比较了基于证据的“高接触”实施策略与“低接触”实施策略；（2）嵌套实用研究，评估 mpath-CRC™ 对 CRC 筛查完成情况的有效性；（3）混合方法研究，评估有助于或阻碍 mpath-CRC™ 等干预措施维持的因素。主要目标是比较“高接触”和“低接触”实施策略下，实施后第 6 个月符合 CRC 筛查条件的 50-74 岁患者中完成 mpath-CRC 的比例。通过比较实施前队列（实施前 8 个月）和实施后队列（实施后 8 个月）中在就诊后 16 周内完成 CRC 筛查的比例，评估 mpath-CRC 的有效性。
本研究将提供有关 mpath™ 计划实施情况及其提高 CRC 筛查率效果的数据。此外，这项工作有可能通过确定支持持续使用其他类似基于技术的初级保健干预措施的策略，产生更广泛的影响。
ClinicalTrials.gov NCT03843957。注册于 2019 年 2 月 18 日。
