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Improving Fecal Occult Blood Test Completion Rates Among Veterans

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stage 1
Stage 2
Sponsored by
Corporal Michael J. Crescenz VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring screening, colon cancer, incentives, behavioral economics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period.

Exclusion Criteria:

  • None. All PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period will be eligible.

Sites / Locations

  • Philadelphia Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Stage 1 Control Group

$5 Incentive

$10 Incentive

$20 Incentive

$5 Voucher-Based Incentive

$50 Lottery-Based Incentive

$500 Raffle-Based Incentive

Stage 2 Control Group

Arm Description

In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $10 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $20 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will have a 1 in 10 chance of being mailed a voucher that can be exchanged for $50 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be entered into a raffle in which 1 randomly chosen patient (out of about 100 patients) will be mailed a check in the amount of $500.

In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.

Outcomes

Primary Outcome Measures

FOBT completion and return

Secondary Outcome Measures

FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm
There are 2 secondary outcomes. First, we will compare time to FOBT kit return by arm. Second, we will compare 30 day FOBT completion rates among previously non-adherent patients (i.e., individuals who had failed to complete a prescribed FOBT kit in the year prior to the start of the study) by arm.

Full Information

First Posted
January 19, 2012
Last Updated
October 23, 2015
Sponsor
Corporal Michael J. Crescenz VA Medical Center
Collaborators
VA Pittsburgh Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT01516489
Brief Title
Improving Fecal Occult Blood Test Completion Rates Among Veterans
Official Title
Improving Fecal Occult Blood Test Completion Rates Among Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporal Michael J. Crescenz VA Medical Center
Collaborators
VA Pittsburgh Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial incentives directly integrated into primary care can improve fecal occult blood test (FOBT) completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care, $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of FOBT completion. We also hypothesize that there will be a direct dose-response relationship between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a statistically significant increase in the rate of FOBT completion compared to a fixed payment incentive with an equivalent dollar per patient value.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
screening, colon cancer, incentives, behavioral economics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1549 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 Control Group
Arm Type
No Intervention
Arm Description
In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.
Arm Title
$5 Incentive
Arm Type
Experimental
Arm Description
In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.
Arm Title
$10 Incentive
Arm Type
Experimental
Arm Description
In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $10 at PVAMC.
Arm Title
$20 Incentive
Arm Type
Experimental
Arm Description
In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $20 at PVAMC.
Arm Title
$5 Voucher-Based Incentive
Arm Type
Experimental
Arm Description
In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.
Arm Title
$50 Lottery-Based Incentive
Arm Type
Experimental
Arm Description
In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will have a 1 in 10 chance of being mailed a voucher that can be exchanged for $50 at PVAMC.
Arm Title
$500 Raffle-Based Incentive
Arm Type
Experimental
Arm Description
In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be entered into a raffle in which 1 randomly chosen patient (out of about 100 patients) will be mailed a check in the amount of $500.
Arm Title
Stage 2 Control Group
Arm Type
No Intervention
Arm Description
In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.
Intervention Type
Behavioral
Intervention Name(s)
Stage 1
Intervention Description
Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to.
Intervention Type
Behavioral
Intervention Name(s)
Stage 2
Intervention Description
Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to. The exact dollar amounts for the Voucher-Based Incentive, Lottery-Based Incentive, and Raffle-Based Incentive arms will be based on the results of Stage 1.
Primary Outcome Measure Information:
Title
FOBT completion and return
Time Frame
30 days
Secondary Outcome Measure Information:
Title
FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm
Description
There are 2 secondary outcomes. First, we will compare time to FOBT kit return by arm. Second, we will compare 30 day FOBT completion rates among previously non-adherent patients (i.e., individuals who had failed to complete a prescribed FOBT kit in the year prior to the start of the study) by arm.
Time Frame
30 days

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period. Exclusion Criteria: None. All PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period will be eligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey T Kullgren, MD, MS, MPH
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven C Marcus, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Philadelphia Veterans Affairs Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25402401
Citation
Kullgren JT, Dicks TN, Fu X, Richardson D, Tzanis GL, Tobi M, Marcus SC. Financial incentives for completion of fecal occult blood tests among veterans: a 2-stage, pragmatic, cluster, randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S35-43. doi: 10.7326/M13-3015.
Results Reference
derived

Learn more about this trial

Improving Fecal Occult Blood Test Completion Rates Among Veterans

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