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Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. A substantial portion of the United States population remains overdue for screening, despite availability and insurance coverage of preventive health services. Barriers for completion and remaining up to date with screening include patients not remaining actively engaged with their care team, time constraints during office visits, and operational strain. This project aims to implement and evaluate a primary care visit-based outreach program that improves patient follow through on completion of overdue CRC screening.
This will be a 6 month, stepped-wedge, pragmatic trial conducted at Penn Medicine.
A substantial portion of the United States population remains overdue for preventive care screenings, despite availability of health services. This gap in care persists due to both patient and clinician facing barriers. Patients may not always remain actively engaged with their care team, while clinicians are impacted by time constraints and the complexity of managing multiple care tasks during visits. One population health strategy to address these barriers is visit-based nudges, which are anchored around office visits and use methods such as post-visit texting to patients. One study aimed at improving colorectal cancer screening rates uses visit-based outreach, in addition to direct outreach, to offer patients colonoscopy and fecal immunochemical tests (FIT), which are top tier tests for CRC screening. Another prior study, aimed at improving mammogram completion, utilized pended orders and post-visit texting to increase screening rates by 5 percentage points at six months for intervention patients. Both studies have highlighted the need to create a scalable program for a cohesive patient experience. Building upon our prior and current work and in collaboration with primary care, we propose to develop and evaluate an integrated visit-based preventive health program with nudges to patients using a stepped wedge design, with the goal of implementing this system across primary care practices. This trial will run concurrently with another trial, PROACTIVE (IRB #589571), evaluating pre-visit and post-visit nudges to clinicians and patients to increase screening completion for multiple care gaps identified as high priority by primary care. Because this trial only utilizes post-visit text messaging to the patient and no clinician nudge, it will be a distinct analysis and considered a separate trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Condition | No Intervention | During the control condition, clinics will receive standard of care. | |
| Active Intervention | Experimental | During the active intervention, clinics will receive patient facing nudges. Patient nudges will be post-visit text message reminders about their overdue CRC screening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-visit patient messaging | Behavioral | All patients who complete their primary care visit and whose provider signed a colonoscopy or FIT order at their office visit will be sent post-visit text messages 7 and 14 days after visit completion, if they have not yet scheduled or completed their overdue CRC screening. The messages delivered at 7 and 14 days will remind patients that appointments for their colonoscopy are available for them and provide phone number(s) to call for scheduling, or the messages will remind patients to return their FIT kit in the mail. We will translate patient text messages into Spanish for patients who require an interpreter according to their language preferences in the EHR. Patients will also have the option to engage with a bi-directional support menu via text message. |
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopy Completion (6 months) | The primary outcome is completion of a colonoscopy within 6 months of the first eligible primary care visit at which a colonoscopy was ordered by the PCP. | Within 6 months after first eligible primary care visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopy Completion (12 months) | The secondary outcome is completion of a colonoscopy within 12 months of the first eligible primary care visit with an order for colonoscopy. | Within 12 months after the first eligible primary care visit. |
| FIT Completion (6 months) |
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Inclusion Criteria:
All patients must meet the following criteria to be eligible:
Exclusion Criteria:
As this trial is integrated with routine clinical operations, there will be no exclusion criteria other than already having an eligible visit at some point during the trial duration with an order for FIT or Colonoscopy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shivan Mehta | Contact | 215-898-9807 | shivan.mehta@pennmedicine.upenn.edu | |
| Caitlin Brophy | Contact | Caitlin.Brophy@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shivan Mehta | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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In a cluster randomized stepped wedge design, units (e.g., clinics) are randomized to a particular time period at which to switch from the control condition to the active intervention. After the intervention is activated by a unit, it remains active throughout the remainder of the trial. The first period serves as a baseline with all clinics following the control condition. In the last period of the trial, all clinics are implementing the active intervention. PROACTIVE CRC will consist of six 4-week periods including the baseline period, where all clinics will practice the current standard of care (i.e., the control condition). Prior to study launch, 24 participating clinics will be randomized to activate the patient nudges at the start of one of the remaining five periods (i.e., periods 2 through 6). The randomization will be stratified by clinic type, defined as community (employed by health system) or academic (part of medical school department).
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The secondary outcome is completion of a fecal immunochemical test (FIT) within 6 months of the first eligible primary care visit with an order for a FIT. |
| Within 6 months after the first eligible primary care visit. |
| FIT Completion (12 months) | The secondary outcome is completion of FIT within 12 months of the first eligible primary care visit with an order for a FIT. | Within 12 months after the first eligible primary care visit. |