Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

Abramson Cancer Center at Penn Medicine

Status: Active, not recruiting

Conditions: Colorectal Cancer

Treatments: Behavioral: No Direct Patient Outreach; Behavioral: Direct Patient Outreach: Sequential Choice; Behavioral: No Nudge/Text; Behavioral: Visit-Based Nudge/Text; Behavioral: Direct Patient Outreach: Colonoscopy Only

Study type: Interventional

Funder types: Other

Identifiers

NCT05693649

UPCC 14022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 50 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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20,000 participants in 5 patient groups

Arm 1A: Usual Care

Experimental group

Description:

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.

Treatment:

Behavioral: No Nudge/Text

Behavioral: No Direct Patient Outreach

Arm 2A: Colonoscopy Only and No Nudge/Text

Experimental group

Description:

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.

Treatment:

Behavioral: Direct Patient Outreach: Colonoscopy Only

Behavioral: No Nudge/Text

Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text

Experimental group

Description:

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.

Treatment:

Behavioral: Direct Patient Outreach: Colonoscopy Only

Behavioral: Visit-Based Nudge/Text

Arm 3A: Sequential Choice and No Nudge/Text

Experimental group

Description:

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.

Treatment:

Behavioral: No Nudge/Text

Behavioral: Direct Patient Outreach: Sequential Choice

Arm 3B: Sequential Choice and Visit-Based Nudge/Text

Experimental group

Description:

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.

Treatment:

Behavioral: Visit-Based Nudge/Text

Behavioral: Direct Patient Outreach: Sequential Choice