Colorectal Cancer Screening Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters

NCT07636174 | Not Yet Recruiting

• 1 other identifier: 26-6819
• Study Type: interventional
• Target: 3,888
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behavior, Health

Keywords

EHR Nudge; Behavioral Economics; Preventive Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Colonoscopy Completion (12 months)

  Within 12 months after the first eligible primary care visit.

• FIT Completion (6 months)

  Within 6 months after the first eligible primary care visit.

• FIT Completion (12 months)

  Within 12 months after the first eligible primary care visit.

Study Arms (2)

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.

Behavioral: Post-visit patient messaging

Interventions

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.

Active Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must meet the following criteria to be eligible:
• Age 18 years or older
• A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
• Overdue for colorectal cancer screening by health maintenance
• Ordered for FIT or Colonoscopy at the eligible visit

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Shivan Mehta

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivan Mehta

CONTACT

215-898-9807; shivan.mehta@pennmedicine.upenn.edu

Caitlin Brophy

CONTACT

Caitlin.Brophy@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Innovation Officer, Associate Professor of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)