Tailored Messaging for CRC Screening

Study Overview
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Brief Summary
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This is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy.

Detailed Description
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The proposed study is a prospective, randomized trial. All eligible subjects (patients identified to be contacted to schedule screening colonoscopy) will be randomized to one of three study arms: usual scheduling process (control), a generic message arm, or a tailored message arm. Patients in the tailored message arm will receive a telephone call and be asked a series of questions that will be used to assign patients to one of four messaging cohorts. After these questions have been answered, the patient will then receive a tailored message corresponding to his or her respective messaging cohort, encouraging them to schedule a colonoscopy with a directed script. In the generic message arm, patients will receive a telephone call and be asked to answer the same series of questions as the tailored message group, then receive a single, standard script encouraging them to schedule a colonoscopy.

Official Title
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Patient-directed Messaging to Increase Colorectal Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Generic message
* Behavioral: Tailored message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment 50-75 years of age Due for CRC screening or surveillance (defined as no evidence of: colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, stool DNA test or Cologuard in the last 3 years) Exclusion Criteria: Age <50 or >75 Pregnant woman Evidence of prior colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, fecal DNA test or Cologuard in the last 3 years History of colorectal cancer History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis) History of colon surgery or resection History of symptoms concerning for colorectal cancer, such as lower GI bleeding, within the past 6 months Family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC) Current serious medical condition with estimated life expectancy of less than 6 months, such as incurable cancer, end-stage congestive heart failure, decompensated cirrhosis, end stage renal disease, etc. Dementia Does not speak English No telephone number listed in electronic medical record Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants in this arm will Usual scheduling process without any intervention | |
| Experimental: Generic Message<br>Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the study team member will ask the participant a series of 7 questions then receive a generic message encouraging colonoscopy scheduling. | Behavioral: Generic message<br>* Generic message<br>|
| Experimental: Tailored Message<br>Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the participant will answer a series of 7 questions then receive a tailored message encouraging colonoscopy scheduling, which will be determined by their responses to the preceding questions. | Behavioral: Tailored message<br>* Tailored message<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonoscopy completion rate | The ratio of the number of participants who complete a colonoscopy to the total number of enrolled participants | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonoscopy scheduling rate | The ratio of the number of participants who schedule a colonoscopy to the total number of enrolled participants | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer screening