Outreach and Reminder Strategies for Colorectal Cancer Screening

Overseen By Evelyn C Okorie, MBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: CRC history, Polyps, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Direct Patient Outreach: Colonoscopy Only, Direct Patient Outreach: Sequential Choice, No Direct Patient Outreach, No Nudge/Text, Visit-Based Nudge/Text for colorectal cancer screening?

Research shows that using behavioral economic strategies, like financial incentives and personalized messages, can increase participation in colorectal cancer screening. For example, offering a financial incentive led to higher screening rates compared to just providing information, and personalized messages increased participation among those who previously did not respond. ^{1 2 3 4 5}

Is the outreach and reminder strategy for colorectal cancer screening safe for humans?

The research articles provided do not contain specific safety data related to the outreach and reminder strategies for colorectal cancer screening. These strategies focus on increasing participation in screening programs rather than introducing new medical treatments or procedures. ^{1 2 4 6 7}

How does the treatment in the colorectal cancer screening trial differ from other treatments?

This treatment is unique because it focuses on outreach and reminder strategies, such as behavioral economic approaches and personalized messaging, to increase participation in colorectal cancer screening, rather than using a medical or pharmaceutical intervention. ^{1 2 4 8 9}

Research Team

Shivan Mehta, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Arm 3B: Sequential Choice and Visit-Based Nudge/Text Experimental Treatment 2 Interventions

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.

Group II: Arm 3A: Sequential Choice and No Nudge/Text Experimental Treatment 2 Interventions

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.

Group III: Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text Experimental Treatment 2 Interventions

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.

Group IV: Arm 2A: Colonoscopy Only and No Nudge/Text Experimental Treatment 2 Interventions

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.

Group V: Arm 1A: Usual Care Experimental Treatment 2 Interventions

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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient and provider nudges on addressing herpes zoster vaccine series completion. Gatwood, J., Brookhart, A., Kinney, O., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Active Choice and Financial Incentives to Increase Rates of Screening Colonoscopy-A Randomized Controlled Trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Testing behavioral economics messages to increase non-responders' participation in organized colorectal cancer-screening programs: A randomized controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Financial Incentives for Promoting Colorectal Cancer Screening: A Randomized, Comparative Effectiveness Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Behavioral Economic Incentives for Colorectal Cancer Screening in a Randomized Trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of patient and provider nudges on addressing herpes zoster vaccine series completion. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Hospital doctors' attitudes to brief educational messages that aim to modify diagnostic test requests: a qualitative study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Use of a GP-endorsed non-participant reminder letter to promote uptake of bowel scope screening: A randomised controlled trial in a hard-to-reach population. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A qualitative study of patient preferences for prompts and reminders for a direct-mail fecal testing program. [2021]