Improving Fecal Occult Blood Test Completion Rates Among Veterans - Full Text View

Purpose

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	Intervention	Phase
Colorectal Cancer	Behavioral: Stage 1 Behavioral: Stage 2	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Official Title:	Improving Fecal Occult Blood Test Completion Rates Among Veterans

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Philadelphia Veterans Affairs Medical Center:

Primary Outcome Measures:

FOBT completion and return [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	1000
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516489

Locations

United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Philadelphia Veterans Affairs Medical Center

VA Pittsburgh Healthcare System

Investigators

Principal Investigator:	Jeffrey T Kullgren, MD, MS, MPH	Philadelphia Veterans Affairs Medical Center
Study Director:	Steven C Marcus, PhD	Philadelphia Veterans Affairs Medical Center

More Information

No publications provided

Responsible Party:	Steven C. Marcus, PhD, Principal Investigator, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT01516489 History of Changes
Other Study ID Numbers:	01334
Study First Received:	January 19, 2012
Last Updated:	December 6, 2012
Health Authority:	United States: Federal Government

Keywords provided by Philadelphia Veterans Affairs 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

ClinicalTrials.gov processed this record on May 23, 2013