Skip to main content
Clinical Trials/NCT07569250
NCT07569250Not yet recruitingNot Applicable

Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization

University of Colorado, Denver4 sites in 1 country7,220 target enrollmentStarted: December 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
7,220
Locations
4
Primary Endpoint
Text message engagement

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
45 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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)

Exclusion Criteria

  • (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)

Arms & Interventions

Concern Message - No Gain Frame

Experimental

No personalization, screening concerns/negative emotions, no gain-framed message.

Intervention: Screening Concerns Text Message (Behavioral)

Concern Message - Gain Frame

Experimental

No personalization, screening concerns/negative emotions, gain-framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Standard Message - Gain Frame

Experimental

No personalization, no concerns/negative emotion, gain-framed message.

Intervention: Message Framing Text Message (Behavioral)

Personalized Message - No Gain Frame

Experimental

Personalization included, no screening concerns/negative emotions, no gain-framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Personalized - Concern Message - Gain Frame

Experimental

Personalization and screening concerns/negative emotions, gain framed message.

Intervention: Screening Concerns Text Message (Behavioral)

Personalized Message - Gain Frame

Experimental

Personalization included, no screening concerns/negative emotions, gain-framed message.

Intervention: Message Framing Text Message (Behavioral)

Personalized Message - Gain Frame

Experimental

Personalization included, no screening concerns/negative emotions, gain-framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Personalized Message - No Gain Frame

Experimental

Personalization included, no screening concerns/negative emotions, no gain-framed message.

Intervention: Personalized Text Message (Behavioral)

Personalized Message - No Gain Frame

Experimental

Personalization included, no screening concerns/negative emotions, no gain-framed message.

Intervention: Message Framing Text Message (Behavioral)

Concern Message - No Gain Frame

Experimental

No personalization, screening concerns/negative emotions, no gain-framed message.

Intervention: Message Framing Text Message (Behavioral)

Concern Message - No Gain Frame

Experimental

No personalization, screening concerns/negative emotions, no gain-framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Standard Message - No Gain Frame

Experimental

No personalization, no screening concerns/negative emotions, no gain-framed message.

Intervention: Message Framing Text Message (Behavioral)

Concern Message - Gain Frame

Experimental

No personalization, screening concerns/negative emotions, gain-framed message.

Intervention: Message Framing Text Message (Behavioral)

Personalized Message - Gain Frame

Experimental

Personalization included, no screening concerns/negative emotions, gain-framed message.

Intervention: Personalized Text Message (Behavioral)

Autonomy Outreach Support

Experimental

Autonomy support included, no impediments or live support.

Intervention: Data Reporting and Visualization System Tools (Other)

Autonomy + Impediments Support

Experimental

Autonomy and impediments support included. No live support included.

Intervention: Impediments Support Outreach (Behavioral)

Autonomy + Impediments + Live Support

Experimental

Autonomy, impediments, and live support included.

Intervention: Impediments Support Outreach (Behavioral)

Autonomy + Live Support

Experimental

Autonomy and live support with impediments support.

Intervention: Autonomy Support Outreach (Behavioral)

Autonomy + Live Support

Experimental

Autonomy and live support with impediments support.

Intervention: Live Support Outreach (Behavioral)

Autonomy + Live Support

Experimental

Autonomy and live support with impediments support.

Intervention: Data Reporting and Visualization System Tools (Other)

Standard Message - Gain Frame

Experimental

No personalization, no concerns/negative emotion, gain-framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Outreach + Impediments + Live Support

Experimental

No autonomy support. Impediment support and live support included.

Intervention: Impediments Support Outreach (Behavioral)

Outreach + Impediments + Live Support

Experimental

No autonomy support. Impediment support and live support included.

Intervention: Live Support Outreach (Behavioral)

Personalized - Concern Message - Gain Frame

Experimental

Personalization and screening concerns/negative emotions, gain framed message.

Intervention: Message Framing Text Message (Behavioral)

Personalized - Concern Message - Gain Frame

Experimental

Personalization and screening concerns/negative emotions, gain framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Outreach + Impediments Support

Experimental

No autonomy support, no live support. Impediment support.

Intervention: Impediments Support Outreach (Behavioral)

Outreach + Impediments Support

Experimental

No autonomy support, no live support. Impediment support.

Intervention: Data Reporting and Visualization System Tools (Other)

Autonomy Outreach Support

Experimental

Autonomy support included, no impediments or live support.

Intervention: Autonomy Support Outreach (Behavioral)

Standard Message - No Gain Frame

Experimental

No personalization, no screening concerns/negative emotions, no gain-framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Personalized - Concern Message - No Gain Frame

Experimental

Personalization and screening concerns/negative emotions, no gain-framed message.

Intervention: Screening Concerns Text Message (Behavioral)

Personalized - Concern Message - No Gain Frame

Experimental

Personalization and screening concerns/negative emotions, no gain-framed message.

Intervention: Message Framing Text Message (Behavioral)

Personalized - Concern Message - No Gain Frame

Experimental

Personalization and screening concerns/negative emotions, no gain-framed message.

Intervention: Data Reporting and Visualization System Tools (Other)

Basic Outreach Only

Experimental

No autonomy support, no impediments support, no live support.

Intervention: Live Support Outreach (Behavioral)

Basic Outreach Only

Experimental

No autonomy support, no impediments support, no live support.

Intervention: Data Reporting and Visualization System Tools (Other)

Outreach + Impediments + Live Support

Experimental

No autonomy support. Impediment support and live support included.

Intervention: Data Reporting and Visualization System Tools (Other)

Outreach + Live Support

Experimental

Live support included. No autonomy or impediments support.

Intervention: Live Support Outreach (Behavioral)

Outreach + Live Support

Experimental

Live support included. No autonomy or impediments support.

Intervention: Data Reporting and Visualization System Tools (Other)

Autonomy + Impediments Support

Experimental

Autonomy and impediments support included. No live support included.

Intervention: Autonomy Support Outreach (Behavioral)

Autonomy + Impediments Support

Experimental

Autonomy and impediments support included. No live support included.

Intervention: Data Reporting and Visualization System Tools (Other)

Autonomy + Impediments + Live Support

Experimental

Autonomy, impediments, and live support included.

Intervention: Autonomy Support Outreach (Behavioral)

Autonomy + Impediments + Live Support

Experimental

Autonomy, impediments, and live support included.

Intervention: Live Support Outreach (Behavioral)

Autonomy + Impediments + Live Support

Experimental

Autonomy, impediments, and live support included.

Intervention: Data Reporting and Visualization System Tools (Other)

Concern Message - Gain Frame

Experimental

No personalization, screening concerns/negative emotions, gain-framed message.

Intervention: Screening Concerns Text Message (Behavioral)

Outcomes

Primary Outcomes

Text message engagement

Time Frame: 14 days after reminder message delivery

Proportion of message recipients who interact with CRC screening reminder messages by reply

Stool-based CRC screening completion

Time Frame: 3 months after reminder message delivery

Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Increasing CRC Screening in Community... | Clinical Trial