Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: No Direct Patient Outreach; Behavioral: No Nudge/Text; Behavioral: Direct Patient Outreach: Colonoscopy Only; Behavioral: Visit-Based Nudge/Text; Behavioral: Direct Patient Outreach: Sequential Choice

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ages 50-72
• Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
• Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, MT-sDNA in the last 3 years).

Exclusion Criteria:

• Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
• History of total colectomy, dementia or metastatic cancer
• Currently on hospice or receiving palliative care
• Uninsured or self-pay patients
• Currently scheduled for a colonoscopy or sigmoidoscopy
• Active order for multitarget stool DNA testing (MT-sDNA)
• History of paraplegia or quadriplegia
• Elevated chance of mortality within 3 years according to mortality risk algorithm
• Active order for Fecal Immunochemical Test (FIT) in the last 60 days
• Positive stool test (FIT or MT-sDNA) result in the last 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1A: Usual Care; 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.	Behavioral: No Direct Patient Outreach; Patient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening.; Behavioral: No Nudge/Text; 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.
Experimental: Arm 2A: Colonoscopy Only and No Nudge/Text; 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.	Behavioral: No Nudge/Text; 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.; Behavioral: Direct Patient Outreach: Colonoscopy Only; Patient will receive direct outreach including an order to schedule and complete colonoscopy.
Experimental: Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text; 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.	Behavioral: Direct Patient Outreach: Colonoscopy Only; Patient will receive direct outreach including an order to schedule and complete colonoscopy.; Behavioral: Visit-Based Nudge/Text; 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.
Experimental: Arm 3A: Sequential Choice and No Nudge/Text; 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.	Behavioral: No Nudge/Text; 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.; Behavioral: Direct Patient Outreach: Sequential Choice; 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.
Experimental: Arm 3B: Sequential Choice and Visit-Based Nudge/Text; 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.	Behavioral: Visit-Based Nudge/Text; 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.; Behavioral: Direct Patient Outreach: Sequential Choice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	3 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Shivan Mehta, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): December 21, 2026

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Cancer Screening; Behavioral Economics
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: UPCC 14022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No