Improving Fecal Occult Blood Test Completion Rates Among Veterans

NCT ID: NCT01516489

Last Updated: 2015-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1549 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

$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.

Group Type EXPERIMENTAL

Stage 1

Intervention Type BEHAVIORAL

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.

$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.

Group Type EXPERIMENTAL

Stage 1

Intervention Type BEHAVIORAL

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.

$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.

Group Type EXPERIMENTAL

Stage 1

Intervention Type BEHAVIORAL

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.

$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.

Group Type EXPERIMENTAL

Stage 2

Intervention Type BEHAVIORAL

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.

$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.

Group Type EXPERIMENTAL

Stage 2

Intervention Type BEHAVIORAL

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.

$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.

Group Type EXPERIMENTAL

Stage 2

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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VA Pittsburgh Healthcare System

FED

Sponsor Role collaborator

Corporal Michael J. Crescenz VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Steven C. Marcus, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey T Kullgren, MD, MS, MPH

Role: PRINCIPAL_INVESTIGATOR

Corporal Michael J. Crescenz VA Medical Center

Steven C Marcus, PhD

Role: STUDY_DIRECTOR

Corporal Michael J. Crescenz VA Medical Center

Locations

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Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25402401 (View on PubMed)

Other Identifiers

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01334

Identifier Type: -

Identifier Source: org_study_id

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