Building Engagement Using Financial Incentives Trial - Colorectal Cancer Screening

NCT06124131 | Completed Results

• 2 other identifiers: 2020-1600-BENCOT2HL158287
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to determine feasibility and explore whether financial incentives paid to primary care patients for completing colorectal cancer screening increase completion of colorectal cancer screening. The main questions it aims to answer are:

• Do patient financial incentives for completing colorectal cancer screening increase screening completion?
• Does a patient financial incentive for colorectal cancer screening offered alongside patient financial incentives for COVID-19 and flu shots increase completion of those shots? Participants who are due for colorectal cancer screening will receive telephone outreach from primary care staff who will offer a stool-based colorectal cancer screening. Participants will be randomly assigned to either Group 1 or Group 2. Group 1 participants will be offered financial incentives for completing COVID-19 and flu shots within 2 months of enrollment. Group 2 participants will be offered financial incentives for completing a COVID-19 shot, a flu shot, and colorectal cancer screening within 2 months of enrollment. Researchers will compare to see if completion of a COVID-19 shot, a flu shot, and colorectal cancer screening is different between the two groups.

Conditions

Health Behavior; Colorectal Cancer; Influenza; COVID-19; Vaccine Hesitancy; Vaccine-Preventable Diseases; Healthcare Patient Acceptance

Keywords

Cancer screening; Preventive healthcare; Vaccine uptake; Patient financial incentives; Federally qualified health center; Health services

Outcome Measures

Primary Outcomes (1)

• Difference in Percent of Participants Completing Colorectal Cancer Screening Between Study Arms

  Completion of colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test as documented in electronic health record within two months of study enrollment

  Two months

Secondary Outcomes (4)

• Difference in Percent of Participants Completing COVID-19 Shot Between Study Arms

  Two months

• Difference in Percent of Participants Completing Flu Shot Between Study Arms

  Two months

• Difference in Percent of Participants Completing at Least One of the Following Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot

  Two months

• Difference in Percent of Participants Completing All Three Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot

  Two months

Other Outcomes (4)

• Number of Patients Reached for Recruitment

  Three months

• Number of Patients Assessed for Eligibility

  Three months

• Number of Patients Consented and Randomized

  Three months

Study Arms (2)

Full financial incentives

EXPERIMENTAL

$50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening

Behavioral: Financial incentive for colorectal cancer screening; Behavioral: Financial incentive for flu shot; Behavioral: Financial incentive for COVID-19 shot

Partial financial incentives

ACTIVE COMPARATOR

$50/service patient financial incentive for completion of: COVID-19 shot, flu shot

Behavioral: Financial incentive for flu shot; Behavioral: Financial incentive for COVID-19 shot

Interventions

Financial incentive for colorectal cancer screening BEHAVIORAL

$50 incentive paid to participant for completion of colorectal cancer screening within 2 months of enrollment

Full financial incentives

Financial incentive for flu shot BEHAVIORAL

$50 incentive paid to participant for completion of flu shot within 2 months of enrollment

Full financial incentives; Partial financial incentives

Financial incentive for COVID-19 shot BEHAVIORAL

$50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment

Full financial incentives; Partial financial incentives

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45 to 75
• Receive care at participating primary care clinic
• Due for colorectal cancer screening
• Ability to understand and speak English

You may not qualify if:

• Currently participating in another clinical trial or research study on colorectal cancer screening
• Unable or unwilling to give informed consent

Sponsors & Collaborators

• Tulane University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Health Behavior; Colorectal Neoplasms; Influenza, Human; COVID-19; Vaccination Hesitancy; Vaccine-Preventable Diseases; Patient Acceptance of Health Care

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Laura Perry
• Organization: Tulane University

lperry5@tulane.edu

504-988-8906

Study Officials

• Marie A Krousel-Wood, MD, MSPH

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Primary care outreach staff will recruit and randomize participants and deliver the intervention. Group assignment will be documented in a separate study database not accessible by the primary care provider. Outcomes will be assessed in electronic health records data, which will be queried by primary care staff who do not have access to group assignment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to a study arm for the duration of their two months in the study

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: November 11, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)