Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA293501 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
| Massachusetts League of Community Health Centers | OTHER |
| Dana-Farber Cancer Institute |
Not provided
Not provided
Not provided
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.
Second, the investigators will test a series of different message versions in two batches (experiments):
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Message - Gain Frame | Experimental | No personalization, no concerns/negative emotion, gain-framed message. |
|
| Concern Message - Gain Frame | Experimental | No personalization, screening concerns/negative emotions, gain-framed message. |
|
| Concern Message - No Gain Frame | Experimental | No personalization, screening concerns/negative emotions, no gain-framed message. |
|
| Standard Message - No Gain Frame | Experimental | No personalization, no screening concerns/negative emotions, no gain-framed message. |
|
| Personalized Message - Gain Frame | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Text Message | Behavioral | Message includes personalized content. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Text message engagement | Proportion of message recipients who interact with CRC screening reminder messages by reply | 14 days after reminder message delivery |
| Stool-based CRC screening completion | Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record | 3 months after reminder message delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to follow-up care after abnormal stool-based screening test | Time (days) to follow-up care after abnormal stool-based screening test | 3 months after date of abnormal result |
| Invalid test results |
Not provided
Eligibility Criteria for CHC Patients Cohorts
Inclusion Criteria (CHC Patients):
Exclusion Criteria (CHC Patients):
Eligibility Criteria for CHC Staff Cohorts Inclusion Criteria (CHC Staff)
Exclusion Criteria (CHC Staff)
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yamila Sierra | Contact | 303-724-4811 | yamila.sierra@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gina Kruse, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Massachusetts League of Community Health Center, Inc. | Boston | Massachusetts | 02108 | United States |
All EHR derived data or data on text message intervention interactions, and any descriptive quality improvement data that we receive from the CHCs are de-identified. If qualitative data is shared, transcripts would be stripped of all identifiers.
The data will be available when the project is complete. The data will be maintained for 7 years on our servers, per our standard practice.
The primary restriction will be approval of data use requests by the participating community health centers' leadership. We will share the data with potential users who have a legitimate and appropriate use for data of this nature. Because the data is owned by the participating health centers, data use requests will be reviewed and approved by the health centers' leadership committee. Since the data is owned by the participating community health centers, a data use agreement will be created to allow for use and analysis by the collaborating researchers. All data use requests will be made to Dr. Kruse, who will discuss them with the study team and with CHC leadership, before any data use agreements are made and data is released.
Not provided
Not provided
| OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Massachusetts General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Personalization included, no screening concerns/negative emotions, gain-framed message.
|
| Personalized Message - No Gain Frame | Experimental | Personalization included, no screening concerns/negative emotions, no gain-framed message. |
|
| Personalized - Concern Message - Gain Frame | Experimental | Personalization and screening concerns/negative emotions, gain framed message. |
|
| Personalized - Concern Message - No Gain Frame | Experimental | Personalization and screening concerns/negative emotions, no gain-framed message. |
|
| Basic Outreach Only | Experimental | No autonomy support, no impediments support, no live support. |
|
| Outreach + Impediments Support | Experimental | No autonomy support, no live support. Impediment support. |
|
| Outreach + Impediments + Live Support | Experimental | No autonomy support. Impediment support and live support included. |
|
| Outreach + Live Support | Experimental | Live support included. No autonomy or impediments support. |
|
| Autonomy Outreach Support | Experimental | Autonomy support included, no impediments or live support. |
|
| Autonomy + Live Support | Experimental | Autonomy and live support with impediments support. |
|
| Autonomy + Impediments Support | Experimental | Autonomy and impediments support included. No live support included. |
|
| Autonomy + Impediments + Live Support | Experimental | Autonomy, impediments, and live support included. |
|
| Screening Concerns Text Message | Behavioral | Emotional concerns or barriers related to CRC screening. |
|
| Message Framing Text Message | Behavioral | Use gain-framed language to influence motivation. |
|
| Autonomy Support Outreach | Behavioral | Provide patients with choices or options to increase sense of control. |
|
| Impediments Support Outreach | Behavioral | Include information or resources to help overcome barriers to care. |
|
| Live Support Outreach | Behavioral | Offer access to live assistance. |
|
| Data Reporting and Visualization System Tools | Other | Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results. |
|
Proportion of message recipients with invalid stool-based screening test result
| 3 months after reminder message delivery |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012107 | Research Design |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided