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Improving Fecal Occult Blood Test Completion Rates Among Veterans

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ClinicalTrials.gov Identifier: NCT01516489
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 26, 2015
Sponsor:
Collaborator:
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
Steven C. Marcus, PhD, Corporal Michael J. Crescenz VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Stage 1 Behavioral: Stage 2 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Improving Fecal Occult Blood Test Completion Rates Among Veterans
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
No Intervention: Stage 1 Control Group
In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.
Experimental: $5 Incentive
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.
Behavioral: Stage 1
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.

Experimental: $10 Incentive
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.
Behavioral: Stage 1
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.

Experimental: $20 Incentive
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.
Behavioral: Stage 1
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.

Experimental: $5 Voucher-Based Incentive
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.
Behavioral: Stage 2
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.

Experimental: $50 Lottery-Based Incentive
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.
Behavioral: Stage 2
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.

Experimental: $500 Raffle-Based Incentive
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.
Behavioral: Stage 2
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.

No Intervention: Stage 2 Control Group
In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.



Primary Outcome Measures :
  1. FOBT completion and return [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm [ Time Frame: 30 days ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516489


Locations
United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Corporal Michael J. Crescenz VA Medical Center
VA Pittsburgh Healthcare System
Investigators
Principal Investigator: Jeffrey T Kullgren, MD, MS, MPH Corporal Michael J. Crescenz VA Medical Center
Study Director: Steven C Marcus, PhD Corporal Michael J. Crescenz VA Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven C. Marcus, PhD, Principal Investigator, Corporal Michael J. Crescenz VA Medical Center
ClinicalTrials.gov Identifier: NCT01516489     History of Changes
Other Study ID Numbers: 01334
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Steven C. Marcus, PhD, Corporal Michael J. Crescenz VA Medical Center:
screening
colon cancer
incentives
behavioral economics

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases