Building Engagement Using Financial Incentives Trial - Colorectal Cancer Screening (BENEFIT-C)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Colorectal Cancer; Influenza; Health Behavior; Vaccine-Preventable Diseases; Vaccine Hesitancy; Healthcare Patient Acceptance
• Intervention / Treatment: Behavioral: Financial incentive for colorectal cancer screening; Behavioral: Financial incentive for flu shot; Behavioral: Financial incentive for COVID-19 shot

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin M Peacock, PhD, MPH; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu
• Study Contact Backup: Name: Laura M Perry, PhD; Phone Number: 504-988-8906; Email: lperry5@tulane.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
      • Contact: Erin M Peacock, PhD, MPH; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu
      • Contact: Laura M Perry, PhD; Phone Number: 504-988-8906; Email: lperry5@tulane.edu
      • Principal Investigator: Marie A Krousel-Wood, MD, MSPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full financial incentives; $50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening	Behavioral: Financial incentive for colorectal cancer screening; $50 incentive paid to participant for completion of colorectal cancer screening within 2 months of enrollment; Behavioral: Financial incentive for flu shot; $50 incentive paid to participant for completion of flu shot within 2 months of enrollment; Behavioral: Financial incentive for COVID-19 shot; $50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment
Active Comparator: Partial financial incentives; $50/service patient financial incentive for completion of: COVID-19 shot, flu shot	Behavioral: Financial incentive for flu shot; $50 incentive paid to participant for completion of flu shot within 2 months of enrollment; Behavioral: Financial incentive for COVID-19 shot; $50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion of participants completing COVID-19 shot between study arms	Completion of COVID-19 shot as documented in electronic health record within two months of study enrollment	Two months
Difference in proportion of participants completing flu shot between study arms	Completion of flu shot as documented in electronic health record within two months of study enrollment	Two months
Difference in proportion of participants completing at least one of the following services between study arms: colorectal cancer screening, COVID-19 shot, flu shot	Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, *OR* flu shot as documented in electronic health record within two months of study enrollment	Two months
Difference in proportion of participants completing all three services between study arms: colorectal cancer screening, COVID-19 shot, flu shot	Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, *AND* flu shot as documented in electronic health record within two months of study enrollment	Two months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients approached for recruitment	Number of patients with reachable phone numbers	Three months
Number of patients assessed for eligibility	Number of patients who begin eligibility screener	Three months
Number of patients randomized	Number of patients who consent and are randomized	Three months
Number of patients who receive intended treatment	Number of patients who complete outreach call	Three months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marie A Krousel-Wood, MD, MSPH, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cancer screening; Health services; Federally qualified health center; Vaccine uptake; Preventive healthcare; Patient financial incentives
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Vaccine-Preventable Diseases
• Other Study ID Numbers: 2020-1600-BENC; OT2HL158287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No