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Improving Fecal Occult Blood Test Completion Rates Among Veterans

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
Steven C. Marcus, PhD, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01516489
First received: January 19, 2012
Last updated: November 7, 2014
Last verified: November 2014

January 19, 2012
November 7, 2014
February 2012
October 2013   (final data collection date for primary outcome measure)
FOBT completion and return [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516489 on ClinicalTrials.gov Archive Site
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.
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Improving Fecal Occult Blood Test Completion Rates Among Veterans
Improving Fecal Occult Blood Test Completion Rates Among Veterans

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.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Colorectal Cancer
  • 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.
  • 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 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.
    Intervention: Behavioral: Stage 1
  • 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.
    Intervention: Behavioral: Stage 1
  • 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.
    Intervention: Behavioral: Stage 1
  • 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.
    Intervention: Behavioral: Stage 2
  • 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.
    Intervention: Behavioral: Stage 2
  • 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.
    Intervention: Behavioral: Stage 2
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
June 2015
October 2013   (final data collection date for primary outcome measure)

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.
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01516489
01334
No
Steven C. Marcus, PhD, Philadelphia Veterans Affairs Medical Center
Philadelphia Veterans Affairs Medical Center
VA Pittsburgh Healthcare System
Principal Investigator: Jeffrey T Kullgren, MD, MS, MPH Philadelphia Veterans Affairs Medical Center
Study Director: Steven C Marcus, PhD Philadelphia Veterans Affairs Medical Center
Philadelphia Veterans Affairs Medical Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP