Improving Fecal Occult Blood Test Completion Rates Among Veterans
23 octobre 2015 mis à jour par: Steven C. Marcus, PhD, Corporal Michael J. Crescenz VA Medical Center
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
1549
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Philadelphia Veterans Affairs Medical Center
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune 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.
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|
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Expérimental: $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.
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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.
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Expérimental: $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.
|
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.
|
|
Expérimental: $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.
|
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.
|
|
Expérimental: $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.
|
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.
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|
Expérimental: $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.
|
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.
|
|
Expérimental: $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.
|
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.
|
|
Aucune 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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FOBT completion and return
Délai: 30 days
|
30 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm
Délai: 30 days
|
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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30 days
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeffrey T Kullgren, MD, MS, MPH, Corporal Michael J. Crescenz VA Medical Center
- Directeur d'études: Steven C Marcus, PhD, Corporal Michael J. Crescenz VA Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2012
Achèvement primaire (Réel)
1 octobre 2013
Achèvement de l'étude (Réel)
1 juin 2015
Dates d'inscription aux études
Première soumission
19 janvier 2012
Première soumission répondant aux critères de contrôle qualité
19 janvier 2012
Première publication (Estimation)
25 janvier 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 octobre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 octobre 2015
Dernière vérification
1 octobre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 01334
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