Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05693649
• Other study ID #: UPCC 14022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: November 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: August 31, 2027
• Est. primary completion date: December 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• No Direct Patient Outreach
Patient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening.
• Direct Patient Outreach: Colonoscopy Only
Patient will receive direct outreach including an order to schedule and complete colonoscopy.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CRC screening rate	CRC screening completion at 3 years by any modality	3 years
Secondary	Choice of test	The proportion of patients who complete CRC screening by screening type	3 years