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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07636174
Acronym
CRC PROACTIVE
Enrollment
3888
Registered
2026-06-09
Start date
2026-07-28
Completion date
2027-06-01
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Health

Keywords

EHR Nudge, Behavioral Economics, Preventive Health

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.

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.

Interventions

BEHAVIORALPost-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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Colonoscopy Completion (6 months)Within 6 months after first eligible primary care visit.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.

Secondary

MeasureTime frameDescription
Colonoscopy Completion (12 months)Within 12 months after the first eligible primary care visit.The secondary outcome is completion of a colonoscopy within 12 months of the first eligible primary care visit with an order for colonoscopy.
FIT Completion (6 months)Within 6 months after the first eligible primary care visit.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.
FIT Completion (12 months)Within 12 months after the first eligible primary care visit.The secondary outcome is completion of FIT within 12 months of the first eligible primary care visit with an order for a FIT.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORShivan Mehta

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026