Improving Fecal Occult Blood Test Completion Rates Among Veterans
1 other identifier
interventional
1,549
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 colorectal-cancer
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 26, 2015
October 1, 2015
1.7 years
January 19, 2012
October 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FOBT completion and return
30 days
Secondary Outcomes (1)
FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm
30 days
Study Arms (8)
Stage 1 Control Group
NO INTERVENTIONIn the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.
$5 Incentive
EXPERIMENTALIn 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.
$10 Incentive
EXPERIMENTALIn 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.
$20 Incentive
EXPERIMENTALIn 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.
$5 Voucher-Based Incentive
EXPERIMENTALIn 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.
$50 Lottery-Based Incentive
EXPERIMENTALIn 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.
$500 Raffle-Based Incentive
EXPERIMENTALIn 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.
Stage 2 Control Group
NO INTERVENTIONIn the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period.
You may not qualify if:
- None. All PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period will be eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 25402401DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 19, 2012
First Posted
January 25, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2013
Study Completion
June 1, 2015
Last Updated
October 26, 2015
Record last verified: 2015-10