Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,220
- 试验地点
- 4
- 主要终点
- Text message engagement
研究概览
简要总结
The goal of this interventional study is to create and test a comprehensive and low burden text message program within existing Community Health Centers (CHC) electronic records system to encourage patients to complete at home colorectal cancer (CRC) screening and to make sure they get follow-up care if their results are abnormal.
First, the investigators will learn from clinic staff and patients what their needs and preferences are in terms of use of technology. This information will be used to design the text messages program.
- Clinic patients will participate in focus groups
- Clinic staff will participate in interviews
Second, the investigators will test a series of different message versions in two batches (experiments):
- Clinic patients with orders for an at-home colorectal cancer screening kit will receive the different message versions.
- In the first batch, the messages that get the most engagement from patients will be selected to be used in the second experiment.
- In the second batch, the investigators will test which messages lead to the most colorectal cancer screening completion.
- This will be rolled-out within the clinics existing electronic record system. The study team will not receive any information that will identify individual patients.
Lastly, the investigators will check again with clinic staff to learn how the program performed, and what would be needed to continue using the text message program in the long run.
-Clinic staff will participate in interviews and surveys.
详细描述
This trial is studying optimization of text messages and outreach approaches by community health centers to increase patients' completion of FIT colon cancer screening tests. Text message reminders are a low cost, scalable way to deliver patient reminders that are low burden for staff. The proposed work uses a creative, community-engaged, systems-level approach to improve completion of FIT testing and abnormal follow-up and program sustainment in CHCs.
The study design includes three parts. First, the text messages will be optimized to maximize patient engagement and outreach (Aims 1 & 2). The study will enroll patients from three partnering CHCs to participate in six focus groups to inform message design. The investigators will also conduct key informant interviews with 5-15 staff per CHC regarding the logistics of ensuring seamless integration into routine clinical operations and perspectives on the intervention activities. Then, a factorial experiment will be conducted, assigning 2,000 patients who have received a stool-based screening kit to different reminder messages. Engagement will be measured as replies or use of ≥1 links, to indicate interaction with the message. The experiment will compare: (1) personalization; (2) concern or negative emotions about screening; and (3) gain framing. In the factorial design patients will not be individually enrolled, this intervention will be tested within the workflows of usual practice. All data for the factorial experiment will be de-identified.
With those tools in place, the investigators will optimize outreach strategies for CRC screening completion. In a second factorial experiment with 5,100 patients, the investigators will optimize outreach strategy for primary screening outcomes of home-based stool screening test completion and screening completion by any guideline-recommended CRC screening test. Secondary outcomes include follow-up care for abnormal stool test results. In this factorial experiment, the investigators will test the impact of three outreach conditions on screening completion: increasing patient autonomy, providing information for accessing resources for impediments to care, and provision of live support. As in the first factorial test, for the second factorial test patients will not be individually enrolled, as the intervention will be tested within the workflows of usual practice. All data will be de-identified.
Finally, the study will assess implementation outcomes and sustainment of intervention components and effects. The investigators will conduct staff interviews and surveys to assess organizational capacity for sustaining the intervention elements being tested as well as the acceptability and feasibility of the text messages and screening tools. Sustainment of the text message outreach intervention elements will be assessed at post intervention and two 6-month intervals post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria for CHC Patients Cohorts
- •Inclusion Criteria (CHC Patients):
- •Adults 45-75 years old
- •Receive care in partner CHCs
- •Are of average risk for colorectal cancer
- •Received a stool-based testing order at their CHC
- •Have a mobile phone and can receive text messages (Aim 1 quantitative cohort only)
- •Fluent in English, Spanish, or another predominant language to be identified by the PI (applicable to patients focus groups cohort only)
排除标准
- •(CHC Patients):
- •Personal or family history of CRC or colorectal polyps
- •History of inflammatory bowel disease
- •Heritable conditions that put them at above average risk for colorectal cancer (e.g., familial adenomatous polyposis)
- •Eligibility Criteria for CHC Staff Cohorts Inclusion Criteria (CHC Staff)
- •Adult employees of participating CHCs
- •Job responsibilities include activities related to CRC screening
- •Exclusion Criteria (CHC Staff)
研究组 & 干预措施
Concern Message - No Gain Frame
No personalization, screening concerns/negative emotions, no gain-framed message.
干预措施: Screening Concerns Text Message (Behavioral)
Concern Message - Gain Frame
No personalization, screening concerns/negative emotions, gain-framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Standard Message - Gain Frame
No personalization, no concerns/negative emotion, gain-framed message.
干预措施: Message Framing Text Message (Behavioral)
Personalized Message - No Gain Frame
Personalization included, no screening concerns/negative emotions, no gain-framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Personalized - Concern Message - Gain Frame
Personalization and screening concerns/negative emotions, gain framed message.
干预措施: Screening Concerns Text Message (Behavioral)
Personalized Message - Gain Frame
Personalization included, no screening concerns/negative emotions, gain-framed message.
干预措施: Message Framing Text Message (Behavioral)
Personalized Message - Gain Frame
Personalization included, no screening concerns/negative emotions, gain-framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Personalized Message - No Gain Frame
Personalization included, no screening concerns/negative emotions, no gain-framed message.
干预措施: Personalized Text Message (Behavioral)
Personalized Message - No Gain Frame
Personalization included, no screening concerns/negative emotions, no gain-framed message.
干预措施: Message Framing Text Message (Behavioral)
Concern Message - No Gain Frame
No personalization, screening concerns/negative emotions, no gain-framed message.
干预措施: Message Framing Text Message (Behavioral)
Concern Message - No Gain Frame
No personalization, screening concerns/negative emotions, no gain-framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Standard Message - No Gain Frame
No personalization, no screening concerns/negative emotions, no gain-framed message.
干预措施: Message Framing Text Message (Behavioral)
Concern Message - Gain Frame
No personalization, screening concerns/negative emotions, gain-framed message.
干预措施: Message Framing Text Message (Behavioral)
Personalized Message - Gain Frame
Personalization included, no screening concerns/negative emotions, gain-framed message.
干预措施: Personalized Text Message (Behavioral)
Autonomy Outreach Support
Autonomy support included, no impediments or live support.
干预措施: Data Reporting and Visualization System Tools (Other)
Autonomy + Impediments Support
Autonomy and impediments support included. No live support included.
干预措施: Impediments Support Outreach (Behavioral)
Autonomy + Impediments + Live Support
Autonomy, impediments, and live support included.
干预措施: Impediments Support Outreach (Behavioral)
Autonomy + Live Support
Autonomy and live support with impediments support.
干预措施: Autonomy Support Outreach (Behavioral)
Autonomy + Live Support
Autonomy and live support with impediments support.
干预措施: Live Support Outreach (Behavioral)
Autonomy + Live Support
Autonomy and live support with impediments support.
干预措施: Data Reporting and Visualization System Tools (Other)
Standard Message - Gain Frame
No personalization, no concerns/negative emotion, gain-framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Outreach + Impediments + Live Support
No autonomy support. Impediment support and live support included.
干预措施: Impediments Support Outreach (Behavioral)
Outreach + Impediments + Live Support
No autonomy support. Impediment support and live support included.
干预措施: Live Support Outreach (Behavioral)
Personalized - Concern Message - Gain Frame
Personalization and screening concerns/negative emotions, gain framed message.
干预措施: Message Framing Text Message (Behavioral)
Personalized - Concern Message - Gain Frame
Personalization and screening concerns/negative emotions, gain framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Outreach + Impediments Support
No autonomy support, no live support. Impediment support.
干预措施: Impediments Support Outreach (Behavioral)
Outreach + Impediments Support
No autonomy support, no live support. Impediment support.
干预措施: Data Reporting and Visualization System Tools (Other)
Autonomy Outreach Support
Autonomy support included, no impediments or live support.
干预措施: Autonomy Support Outreach (Behavioral)
Standard Message - No Gain Frame
No personalization, no screening concerns/negative emotions, no gain-framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Personalized - Concern Message - No Gain Frame
Personalization and screening concerns/negative emotions, no gain-framed message.
干预措施: Screening Concerns Text Message (Behavioral)
Personalized - Concern Message - No Gain Frame
Personalization and screening concerns/negative emotions, no gain-framed message.
干预措施: Message Framing Text Message (Behavioral)
Personalized - Concern Message - No Gain Frame
Personalization and screening concerns/negative emotions, no gain-framed message.
干预措施: Data Reporting and Visualization System Tools (Other)
Basic Outreach Only
No autonomy support, no impediments support, no live support.
干预措施: Live Support Outreach (Behavioral)
Basic Outreach Only
No autonomy support, no impediments support, no live support.
干预措施: Data Reporting and Visualization System Tools (Other)
Outreach + Impediments + Live Support
No autonomy support. Impediment support and live support included.
干预措施: Data Reporting and Visualization System Tools (Other)
Outreach + Live Support
Live support included. No autonomy or impediments support.
干预措施: Live Support Outreach (Behavioral)
Outreach + Live Support
Live support included. No autonomy or impediments support.
干预措施: Data Reporting and Visualization System Tools (Other)
Autonomy + Impediments Support
Autonomy and impediments support included. No live support included.
干预措施: Autonomy Support Outreach (Behavioral)
Autonomy + Impediments Support
Autonomy and impediments support included. No live support included.
干预措施: Data Reporting and Visualization System Tools (Other)
Autonomy + Impediments + Live Support
Autonomy, impediments, and live support included.
干预措施: Autonomy Support Outreach (Behavioral)
Autonomy + Impediments + Live Support
Autonomy, impediments, and live support included.
干预措施: Live Support Outreach (Behavioral)
Autonomy + Impediments + Live Support
Autonomy, impediments, and live support included.
干预措施: Data Reporting and Visualization System Tools (Other)
Concern Message - Gain Frame
No personalization, screening concerns/negative emotions, gain-framed message.
干预措施: Screening Concerns Text Message (Behavioral)
结局指标
主要结局
Text message engagement
时间窗: 14 days after reminder message delivery
Proportion of message recipients who interact with CRC screening reminder messages by reply
Stool-based CRC screening completion
时间窗: 3 months after reminder message delivery
Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record
次要结局
- Time to follow-up care after abnormal stool-based screening test(3 months after date of abnormal result)
- Invalid test results(3 months after reminder message delivery)