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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06124131
Other study ID # 2020-1600-BENC
Secondary ID OT2HL158287
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2023
Est. completion date March 25, 2024

Study information

Verified date April 2024
Source Tulane University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 25, 2024
Est. primary completion date March 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 75 Years
Eligibility 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 Design


Intervention

Behavioral:
Financial incentive for colorectal cancer screening
$50 incentive paid to participant for completion of colorectal cancer screening within 2 months of enrollment
Financial incentive for flu shot
$50 incentive paid to participant for completion of flu shot within 2 months of enrollment
Financial incentive for COVID-19 shot
$50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment

Locations

Country Name City State
United States Tulane University School of Medicine New Orleans Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Tulane University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of patients approached for recruitment Number of patients with reachable phone numbers Three months
Other Number of patients assessed for eligibility Number of patients who begin eligibility screener Three months
Other Number of patients randomized Number of patients who consent and are randomized Three months
Other Number of patients who receive intended treatment Number of patients who complete outreach call Three months
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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