Colorectal Cancer Screening Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (CRC PROACTIVE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Behavior, Health
• Intervention / Treatment: Behavioral: Post-visit patient messaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 3888
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shivan Mehta; Phone Number: 215-898-9807; Email: shivan.mehta@pennmedicine.upenn.edu
• Study Contact Backup: Name: Caitlin Brophy; Email: Caitlin.Brophy@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
      • Contact: Caitlin Brophy; Phone Number: 267-566-4956; Email: caitlin.brophy@pennmedicine.upenn.edu
      • Principal Investigator: Shivan Mehta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All patients must meet the following criteria to be eligible:

1. Age 18 years or older
2. A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
3. Overdue for colorectal cancer screening by health maintenance
4. Ordered for FIT or Colonoscopy at the eligible visit

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Condition; During the control condition, clinics will receive standard of care.
Experimental: Active Intervention; During the active intervention, clinics will receive patient facing nudges. Patient nudges will be post-visit text message reminders about their overdue CRC screening.	Behavioral: Post-visit patient messaging; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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.

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Shivan Mehta, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): June 8, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): May 23, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Behavioral Economics; Preventive Health; EHR Nudge
• Additional Relevant MeSH Terms: Behavior; Health Behavior
• Other Study ID Numbers: 26-6819

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