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This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-Usual Care | No Intervention | Participants will receive a simple text message reminder | |
| Messaging Group A | Experimental | Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). |
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| Messaging Group B | Experimental | Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). |
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| Messaging Group C | Experimental | Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bundled messaging intervention | Behavioral | A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with scheduled or completed colorectal cancer screening. | Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization. | up to 3 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy. | Number of participants with abnormal stool-based test who complete a diagnostic colonoscopy within 90 days of intervention. | up to 90 days from intervention |
| Number of participants who complete screening. |
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Inclusion Criteria:
OR
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilana Richman, MD | Contact | 203 737 1024 | ilana.richman@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ilana Richman, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornell Scott Hill Health | Recruiting | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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The study will include adults who receive care at a local, multisite federally qualified health center, who have outstanding orders for colorectal cancer screening.
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Number of participants who complete screening (stool-based testing or colonoscopy) within 90 days of randomization. |
| up to 90 days from randomization |
| Number of participants who achieve the primary endpoint. | Number of participants who achieve the primary endpoint (screening or scheduling of screening) at 6 months post randomization. | 6 months post randomization |
| Number of participants who achieve the primary endpoint by message type. | Number of participants who achieve the primary endpoint (screening scheduling or completion rate at 90 days) by message type (message A/B/C). | up to 90 days from randomization |
| Number of participants who complete screening within 6 months of initial outreach. | Number of participants who complete screening within 6 months of initial outreach by text message type (message A/B/C). | up to 6 months from initial outreach |
| Number of participants who complete screening colonoscopy within 6 months of initial outreach. | Number of participants who complete screening colonoscopy within 6 months of initial outreach by text message type (message A/B/C). | up to 6 months from initial outreach |
| Number of participants who provide any response. | Number of participants who provide any response to text messages by message type (message A/B/C). | 7, 14, 21, and 90 days |
| Number of participants who achieve the primary outcome from among those who did and did not respond to any text message. | Number of participants who achieve the primary outcome from among those who did and did not respond to any text message. | 6 months post randomization |
| Number of providers who respond to reminders. | Number of providers who respond to provider reminders through MyChart message, phone call, or in-clinic discussion. | 6 months post randomization |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |