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Colorectal Cancer Screening Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (CRC PROACTIVE)

2026年7月30日 更新者:Shivan J Mehta、University of Pennsylvania

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. A substantial portion of the United States population remains overdue for screening, despite availability and insurance coverage of preventive health services. Barriers for completion and remaining up to date with screening include patients not remaining actively engaged with their care team, time constraints during office visits, and operational strain. This project aims to implement and evaluate a primary care visit-based outreach program that improves patient follow through on completion of overdue CRC screening.

This will be a 6 month, stepped-wedge, pragmatic trial conducted at Penn Medicine.

研究概览

地位

邀请报名

详细说明

A substantial portion of the United States population remains overdue for preventive care screenings, despite availability of health services. This gap in care persists due to both patient and clinician facing barriers. Patients may not always remain actively engaged with their care team, while clinicians are impacted by time constraints and the complexity of managing multiple care tasks during visits. One population health strategy to address these barriers is visit-based nudges, which are anchored around office visits and use methods such as post-visit texting to patients. One study aimed at improving colorectal cancer screening rates uses visit-based outreach, in addition to direct outreach, to offer patients colonoscopy and fecal immunochemical tests (FIT), which are top tier tests for CRC screening. Another prior study, aimed at improving mammogram completion, utilized pended orders and post-visit texting to increase screening rates by 5 percentage points at six months for intervention patients. Both studies have highlighted the need to create a scalable program for a cohesive patient experience. Building upon our prior and current work and in collaboration with primary care, we propose to develop and evaluate an integrated visit-based preventive health program with nudges to patients using a stepped wedge design, with the goal of implementing this system across primary care practices. This trial will run concurrently with another trial, PROACTIVE (IRB #589571), evaluating pre-visit and post-visit nudges to clinicians and patients to increase screening completion for multiple care gaps identified as high priority by primary care. Because this trial only utilizes post-visit text messaging to the patient and no clinician nudge, it will be a distinct analysis and considered a separate trial.

研究类型

介入性

注册 (估计的)

3888

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania Health System

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

All patients must meet the following criteria to be eligible:

  1. Age 18 years or older
  2. A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
  3. Overdue for colorectal cancer screening by health maintenance
  4. Ordered for FIT or Colonoscopy at the eligible visit

Exclusion Criteria:

As this trial is integrated with routine clinical operations, there will be no exclusion criteria other than already having an eligible visit at some point during the trial duration with an order for FIT or Colonoscopy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预:Control Condition
During the control condition, clinics will receive standard of care.
实验性的:Active Intervention
During the active intervention, clinics will receive patient facing nudges. Patient nudges will be post-visit text message reminders about their overdue CRC screening.
All patients who complete their primary care visit and whose provider signed a colonoscopy or FIT order at their office visit will be sent post-visit text messages 7 and 14 days after visit completion, if they have not yet scheduled or completed their overdue CRC screening. The messages delivered at 7 and 14 days will remind patients that appointments for their colonoscopy are available for them and provide phone number(s) to call for scheduling, or the messages will remind patients to return their FIT kit in the mail. We will translate patient text messages into Spanish for patients who require an interpreter according to their language preferences in the EHR. Patients will also have the option to engage with a bi-directional support menu via text message.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Colonoscopy Completion (6 months)
大体时间:Within 6 months after first eligible primary care visit.
The primary outcome is completion of a colonoscopy within 6 months of the first eligible primary care visit at which a colonoscopy was ordered by the PCP.
Within 6 months after first eligible primary care visit.

次要结果测量

结果测量
措施说明
大体时间
Colonoscopy Completion (12 months)
大体时间:Within 12 months after the first eligible primary care visit.
The secondary outcome is completion of a colonoscopy within 12 months of the first eligible primary care visit with an order for colonoscopy.
Within 12 months after the first eligible primary care visit.
FIT Completion (6 months)
大体时间:Within 6 months after the first eligible primary care visit.
The secondary outcome is completion of a fecal immunochemical test (FIT) within 6 months of the first eligible primary care visit with an order for a FIT.
Within 6 months after the first eligible primary care visit.
FIT Completion (12 months)
大体时间:Within 12 months after the first eligible primary care visit.
The secondary outcome is completion of FIT within 12 months of the first eligible primary care visit with an order for a FIT.
Within 12 months after the first eligible primary care visit.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Shivan Mehta、University of Pennsylvania

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月28日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 26-6819

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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