Outreach and Reminder Strategies for Colorectal Cancer Screening

CR
EC
Overseen ByEvelyn C Okorie, MBS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests various strategies to remind and encourage people to complete overdue colorectal cancer screenings. It examines direct outreach methods, such as texts or letters, and doctor-initiated reminders during visits to determine which is most effective. Participants will be divided into groups to receive different types of reminders or none at all. Individuals aged 50 to 72 who have visited a Penn Medicine primary care doctor in the last two years and are behind on colorectal cancer screening may qualify for this trial. As an unphased trial, this study provides a unique opportunity to contribute to enhancing public health strategies for cancer screening reminders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these outreach and reminder strategies are safe for colorectal cancer screening?

Research shows that directly reaching out to patients for colorectal cancer screening, such as sending test kits to their homes, is generally safe and well-received. A study in a health system supporting low-income patients found that inviting individuals to complete both fecal immunochemical tests (FIT) and colonoscopies increased screening rates without significant side effects. This indicates that these outreach methods are safe.

For the method where patients choose their screening method, studies have shown that sending FIT kits directly to patients increases screening rates. No reports of serious safety issues have emerged with this approach.

Reminders from doctors, like text messages, have been studied for encouraging cancer screening. Evidence shows these digital reminders effectively promote screening without causing harm. They focus on gentle prompts rather than medical procedures, ensuring safety.

Overall, the strategies being tested involve outreach and reminders, not medical procedures, making them safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to boost colorectal cancer screening rates. Unlike the standard approach, which typically relies on patients scheduling screenings themselves, these strategies involve direct outreach and reminders through texts and mail, making it easier for patients to follow through. Some strategies even include real-time prompts from primary care physicians during visits, ensuring that patients are reminded at multiple touchpoints. By testing these different outreach methods, researchers hope to identify the most effective way to encourage timely cancer screenings, potentially leading to earlier detection and better health outcomes.

What evidence suggests that this trial's strategies could be effective for increasing colorectal cancer screening?

This trial will evaluate different outreach and reminder strategies to increase colorectal cancer (CRC) screening rates. Research has shown that direct patient outreach can significantly boost CRC screening numbers. Sending information by mail raised CRC screening rates by 7.3% compared to standard methods. In this trial, some participants will receive direct patient outreach, while others will not. Studies also reveal that offering a choice between different screening options, sequentially, leads to higher completion rates. For instance, providing a choice of methods resulted in a 17.1% screening rate, compared to 14.4% when only a colonoscopy was offered. Additionally, some participants will receive gentle reminders during doctor visits, which have proven effective in encouraging patients to complete their screenings. These strategies, tested in various arms of this trial, can significantly boost participation in CRC screening, potentially saving lives through early detection.16789

Who Is on the Research Team?

Shivan Mehta, MD, MSHP - Penn LDI

Shivan Mehta, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for patients aged 50-72 who are overdue for colorectal cancer screening, have seen a participating primary care physician in the last two years, and aren't up to date with their screenings. It's not for those on hospice or palliative care, uninsured/self-pay individuals, scheduled for colon procedures, at high risk of dying within three years, or with certain gastrointestinal conditions.

Inclusion Criteria

Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
I am between 50 and 72 years old.
I am not current with my colorectal cancer screenings.

Exclusion Criteria

Uninsured or self-pay patients
I have had my entire colon removed, have dementia, or cancer that has spread.
Elevated chance of mortality within 3 years according to mortality risk algorithm
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive direct outreach and clinician-directed nudges to encourage CRC screening completion

3 years
Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for CRC screening completion and effectiveness of interventions

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Direct Patient Outreach: Colonoscopy Only
  • Direct Patient Outreach: Sequential Choice
  • No Direct Patient Outreach
  • No Nudge/Text
  • Visit-Based Nudge/Text
Trial Overview The study tests if direct patient outreach programs and clinician nudges via electronic health records plus follow-up texts increase colorectal cancer screening rates over three years. Patients will be randomly assigned to receive different types of reminders or no reminder about CRC screening.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Arm 3B: Sequential Choice and Visit-Based Nudge/TextExperimental Treatment2 Interventions
Group II: Arm 3A: Sequential Choice and No Nudge/TextExperimental Treatment2 Interventions
Group III: Arm 2B: Colonoscopy Only and Visit-Based Nudge/TextExperimental Treatment2 Interventions
Group IV: Arm 2A: Colonoscopy Only and No Nudge/TextExperimental Treatment2 Interventions
Group V: Arm 1A: Usual CareExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials
360
Recruited
108,000+

Published Research Related to This Trial

A study involving over 220,000 adults showed that combining provider nudges with text message reminders significantly improved the completion rate of the herpes zoster vaccine series, with completion rates of 88.3% for those receiving both nudges compared to 85.3% for those who did not receive text messages.
Patients who received text message reminders not only completed their vaccine series at a higher rate but also received their second dose an average of 8.6 days sooner, highlighting the effectiveness of patient-focused nudges in enhancing vaccination adherence.
Impact of patient and provider nudges on addressing herpes zoster vaccine series completion.Gatwood, J., Brookhart, A., Kinney, O., et al.[2023]

Citations

Mailed Outreach and Patient Navigation for Colorectal ...A mailed FIT outreach and patient navigation program led to a significant 7.3–percentage point increase in colorectal cancer (CRC) screening over usual care.
A randomized controlled trial in a safety net health systemUsing intention-to-screen analysis, screening participation rates were higher for FIT outreach (58.8%) and colonoscopy outreach (42.4%) than usual care (29.6%) ...
A Randomized Trial of Choice Architecture and Mailed ...Compared with colonoscopy only, there was a significant increase in screening in active choice (absolute difference, 7.1%; 95% CI, 2.0–12.2; P = .006) and FIT ...
Study Details | NCT05693649 | Behavioral Economic ...This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges ...
Outreach invitations for FIT and colonoscopy improve ...Screening participation rates were 58.8% for patients in the FIT outreach arm (1410 of 2400 patients), 42.4% for patients in the colonoscopy ...
Findings from the Accelerating Colorectal Cancer Screening ...Offering delivery of screening kits directly to patients' homes created a way to overcome mail delivery barriers in remote or rural areas, as ...
Epidemiology of Colon Cancer Screening in a Safety-Net ...The registry was designed to capture data on demographics, clinic appointments, fecal occult blood tests and results, and to generate a daily ...
Colorectal Cancer Screening After Sequential Outreach ...This cohort study examines colorectal cancer (CRC) screening completion by race and ethnicity, age, and sex in an integrated health care ...
A Comprehensive and Coordinated Colorectal Cancer ...When a screening colonoscopy is ordered, Direct Access Screening is promoted, eliminating the need for patients who meet eligibility criteria to ...
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