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

Sponsor
Tulane University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06124131
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
50
1
2
6.6
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Financial incentive for colorectal cancer screening
  • Behavioral: Financial incentive for flu shot
  • Behavioral: Financial incentive for COVID-19 shot
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to a study arm for the duration of their two months in the studyParticipants will be randomly assigned to a study arm for the duration of their two months in the study
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Screening
Official Title:
Building Engagement Using Financial Incentives Trial - Colorectal Cancer Screening
Actual Study Start Date :
Nov 11, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Difference in proportion of participants completing colorectal cancer screening between study arms [Two months]

    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

Secondary Outcome Measures

  1. Difference in proportion of participants completing COVID-19 shot between study arms [Two months]

    Completion of COVID-19 shot as documented in electronic health record within two months of study enrollment

  2. Difference in proportion of participants completing flu shot between study arms [Two months]

    Completion of flu shot as documented in electronic health record within two months of study enrollment

  3. Difference in proportion of participants completing at least one of the following services between study arms: colorectal cancer screening, COVID-19 shot, flu shot [Two months]

    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

  4. Difference in proportion of participants completing all three services between study arms: colorectal cancer screening, COVID-19 shot, flu shot [Two months]

    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

Other Outcome Measures

  1. Number of patients approached for recruitment [Three months]

    Number of patients with reachable phone numbers

  2. Number of patients assessed for eligibility [Three months]

    Number of patients who begin eligibility screener

  3. Number of patients randomized [Three months]

    Number of patients who consent and are randomized

  4. Number of patients who receive intended treatment [Three months]

    Number of patients who complete outreach call

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tulane University School of Medicine New Orleans Louisiana United States 70112

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Marie A Krousel-Wood, MD, MSPH, Tulane University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tulane University
ClinicalTrials.gov Identifier:
NCT06124131
Other Study ID Numbers:
  • 2020-1600-BENC
  • OT2HL158287
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tulane University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023