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Financial Incentives to Increase Colorectal Cancer Screening in Priority Populations

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auto Mailing Plus Money
Auto Mailing Plus Lottery
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Behavioral: Automated Mailing

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group 1 - Automated Mailing

Group 2 - Auto Mailing Plus Money

Group 3 - Auto Mailing Plus Lottery

Arm Description

The mailing process will be identical to those used in the SOS study. Mailing 1 includes an introductory letter on CRC screening and a pamphlet on CRC testing choices (colonoscopy every 10 years, FIT testing yearly, or flexible sigmoidoscopy every 10 years combined with interval FIT testing), and pros and cons of each. The letter will state that they will soon be receiving a FIT kit in the mail, and a number to call if they prefer another option. Mailing 2 includes a brief letter reaffirming the importance of screening, a FIT kit (the one used by Group Health), pictograph instructions, and a postage-paid return envelope. Mailing 3 a reminder letter, is sent to participants not completing the FIT kit after 3 weeks. The intervention for Group 1 includes no incentive.

Receives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will receive a monetary thank you gift for completing testing (FIT colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the monetary thank you gift for CRC screening completion. Mailing 4 will include the money with a thank you letter for those who complete the screening

Receives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will have a 1 in 10 chance of winning money (FIT, colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the 1 in 10 chance of winning the lottery for CRC screening completion. Mailing 4 will include a thank you letter with money for those who complete their screening and win the lottery. Participants who do not win the lottery will receive a thank you letter.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2017
Last Updated
November 4, 2019
Sponsor
Kaiser Permanente
Collaborators
University of Michigan, University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT03080701
Brief Title
Financial Incentives to Increase Colorectal Cancer Screening in Priority Populations
Official Title
Systems of Support (SOS) to Increase Colon Cancer Screening Disparities Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
University of Michigan, University of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Behavioral: Automated Mailing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The randomization sequence will be concealed to everyone except the study biostatistician.
Allocation
Randomized
Enrollment
898 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Automated Mailing
Arm Type
No Intervention
Arm Description
The mailing process will be identical to those used in the SOS study. Mailing 1 includes an introductory letter on CRC screening and a pamphlet on CRC testing choices (colonoscopy every 10 years, FIT testing yearly, or flexible sigmoidoscopy every 10 years combined with interval FIT testing), and pros and cons of each. The letter will state that they will soon be receiving a FIT kit in the mail, and a number to call if they prefer another option. Mailing 2 includes a brief letter reaffirming the importance of screening, a FIT kit (the one used by Group Health), pictograph instructions, and a postage-paid return envelope. Mailing 3 a reminder letter, is sent to participants not completing the FIT kit after 3 weeks. The intervention for Group 1 includes no incentive.
Arm Title
Group 2 - Auto Mailing Plus Money
Arm Type
Experimental
Arm Description
Receives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will receive a monetary thank you gift for completing testing (FIT colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the monetary thank you gift for CRC screening completion. Mailing 4 will include the money with a thank you letter for those who complete the screening
Arm Title
Group 3 - Auto Mailing Plus Lottery
Arm Type
Experimental
Arm Description
Receives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will have a 1 in 10 chance of winning money (FIT, colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the 1 in 10 chance of winning the lottery for CRC screening completion. Mailing 4 will include a thank you letter with money for those who complete their screening and win the lottery. Participants who do not win the lottery will receive a thank you letter.
Intervention Type
Behavioral
Intervention Name(s)
Auto Mailing Plus Money
Intervention Description
Participant receives money as a thank you for completing CRC screening within 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Auto Mailing Plus Lottery
Intervention Description
Participant has a 1 in 10 chance of winning money in a lottery for completing CRC screening within 6 months.
Primary Outcome Measure Information:
Title
CRC Screening Within 6 Months Following Randomization
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly B Green, MD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Financial Incentives to Increase Colorectal Cancer Screening in Priority Populations

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