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This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges facilitated by the electronic health record (EHR) with follow-up text messaging on the uptake of CRC screening. The primary outcome is CRC screening completion at 3 years. Patient and clinician factors impacting the experience and effectiveness of the intervention will be explored through surveys and qualitative interviews.
Despite effective strategies for prevention, early detection, and treatment, colorectal cancer (CRC) remains the second leading cause of cancer death in the United States (US). While there have been considerable policy and system-level efforts to increase CRC screening rates, uptake remains well below national goals of 80% participation. Members of racial and ethnic minorities are even further behind. Approaches to increase population-based screening can consider [1] how screening is encouraged by targeting the clinicians who typically order or recommend the procedure or the patient who completes it; and [2] the kind of screening offered (e.g., colonoscopy or fecal immunochemical testing [FIT]). This project simultaneously tests interventions along both of these dimensions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1A: Usual Care | Experimental | Patients assigned to the Usual Care arm will receive current usual care and will not receive direct patient outreach or any visit-based interventions from this trial. |
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| Arm 2A: Colonoscopy Only and No Nudge/Text | Experimental | Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm will not receive visit-based interventions. |
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| Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text | Experimental | Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion. |
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| Arm 3A: Sequential Choice and No Nudge/Text | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Direct Patient Outreach | Behavioral | Patient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening. |
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| Measure | Description | Time Frame |
|---|---|---|
| CRC screening completion at 3 years | CRC screening completion at 3 years, which could be satisfied by any one of the following: colonoscopy completion at any time, negative FIT completed 2 times, or positive FIT followed by diagnostic colonoscopy within 1 year. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| CRC screening rate | CRC screening completion at 3 years by any modality | 3 years |
| Choice of test | The proportion of patients who complete CRC screening by screening type |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivan Mehta, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41412475 | Derived | Mehta SJ, Shaw PA, Reitz C, Brophy C, Okorie E, Williams K, Segura A, Tao J, Snider CK, Wollack C, Friday S, Rendle KA, Klaiman T, Glanz K, Rhodes C, Asch DA. Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial. Contemp Clin Trials. 2026 Feb;161:108188. doi: 10.1016/j.cct.2025.108188. Epub 2025 Dec 16. |
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Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm will not receive visit-based interventions. |
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| Arm 3B: Sequential Choice and Visit-Based Nudge/Text | Experimental | Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion. |
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| Direct Patient Outreach: Colonoscopy Only | Behavioral | Patient will receive direct outreach including an order to schedule and complete colonoscopy. |
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| Direct Patient Outreach: Sequential Choice | Behavioral | Patient will receive direct outreach including an order to schedule and complete colonoscopy then an at-home fecal immunochemical test (FIT) if colonoscopy is not completed. |
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| Visit-Based Nudge/Text | Behavioral | Patient's clinician will receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will also receive a text message 3 days after visit reminding them to complete colorectal cancer screening. |
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| No Nudge/Text | Behavioral | Patient's clinician will not receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will not receive a text message 3 days after visit reminding them to complete colorectal cancer screening. |
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| 3 years |
| 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 |
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