Improving Fecal Occult Blood Test Completion Rates Among Veterans
2015年10月23日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
1549
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Philadelphia Veterans Affairs Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：$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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実験的：$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.
|
|
実験的：$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.
|
|
実験的：$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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実験的：$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.
|
|
実験的：$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.
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介入なし：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
FOBT completion and return
時間枠：30 days
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30 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm
時間枠：30 days
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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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jeffrey T Kullgren, MD, MS, MPH、Corporal Michael J. Crescenz VA Medical Center
- スタディディレクター：Steven C Marcus, PhD、Corporal Michael J. Crescenz VA Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年2月1日
一次修了 (実際)
2013年10月1日
研究の完了 (実際)
2015年6月1日
試験登録日
最初に提出
2012年1月19日
QC基準を満たした最初の提出物
2012年1月19日
最初の投稿 (見積もり)
2012年1月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月26日
QC基準を満たした最後の更新が送信されました
2015年10月23日
最終確認日
2015年10月1日
詳しくは
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