Improving Fecal Occult Blood Test Completion Rates Among Veterans

Colorectal Cancer Clinical Trial

Official title:

Improving Fecal Occult Blood Test Completion Rates Among Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516489
• Other study ID #: 01334
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 19, 2012
• Last updated: October 23, 2015
• Start date: February 2012
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Philadelphia Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1549
• Est. completion date: June 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Philadelphia Veterans Affairs Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Philadelphia Veterans Affairs Medical Center	VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FOBT completion and return		30 days	No
Secondary	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.	30 days	No