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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03080701
Other study ID # 4RO1CA121125-09 REVISED
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 23, 2017
Est. completion date November 2, 2018

Study information

Verified date November 2019
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose to build on the success of the Systems of Support to Increase Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less likely to be current for colorectal cancer (CRC) screening. We will test whether financial incentives increases screening uptake and decreases screening disparities. The investigators hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and financial incentives than those offered mailed fecal kits alone.


Description:

Study staff will send invitation letters and a questionnaire to 5,000 patients aged 50-75 not current for CRC screening, two-thirds who are identified in the electronic data as being from a non-White race, ethnicity, or who have Medicaid coverage. Those returning the survey and remaining eligible (estimated N = 1150) will be randomized to either (1) Mailed fecal kit only, or mailed fecal kit plus one of 2 types of financial incentives for completing testing: (2) a guaranteed Monetary incentive or (3) a probabilistic Lottery incentive.


Recruitment information / eligibility

Status Completed
Enrollment 898
Est. completion date November 2, 2018
Est. primary completion date November 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

- No evidence in electronic data of FIT screening in past year or a colonoscopy in the prior 9 years.

- Continuously enrolled in Group Health Cooperative (GHC) for at least one year.

- Patients who have Medicaid coverage or are non-white race or Hispanic any race.

Exclusion Criteria:

- Known high risk for CRC

- History of CRC

- History of inflammatory bowel disease

- Current anticoagulation therapy

- Organ failure

- Serious illness

- Debilitating disease

- Dementia

- Nursing home resident

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Auto Mailing Plus Money
Participant receives money as a thank you for completing CRC screening within 6 months.
Auto Mailing Plus Lottery
Participant has a 1 in 10 chance of winning money in a lottery for completing CRC screening within 6 months.

Locations

Country Name City State
United States Group Health Research Institute Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
Kaiser Permanente University of Michigan, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CRC Screening Within 6 Months Following Randomization We will compare among the 3 arms (1) automated mailing; (2) Auto mailing plus $10; (3) Auto mailing plus $50 lottery for completion and the effect of each on CRC screening completion at 6 months (yes/no) within the following subgroups of each arm: 1. White and not Hispanic versus non-White or Hispanic. 2. Medicaid versus non-Medicaid (Medicare, employer-based, private) insurance. 3. History of prior versus no prior completion of CRC screening tests. 4. High school or less versus college or more education level. 6 months
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