目的 3、セーフティネットプライマリケア環境における糖尿病患者の CRC スクリーニングの最適化
セーフティネットプライマリケア環境における糖尿病患者の結腸直腸がんスクリーニングの最適化: ターゲットを絞った実装アプローチ
This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening for patients with diabetes in primary care safety-net settings.
調査の概要
詳細な説明
Aim 3 is a hybrid type 2 effectiveness-implementation pilot study in six primary care safety net clinics. This single-arm study uses a pre-post design to evaluate the targeted implementation strategies impact on: (1) preliminary effectiveness and (2) implementation (i.e., feasibility and acceptability) and a mixed-method comparative case study learning evaluation for safety-net primary care adoption and implementation. Implementation strategies that will be tested were developed through a stakeholder engaged, community-based participatory implementation planning approach. This study uses a tailored combination of implementation strategies that include but are not limited to: identification of patient and practice-level barriers, patient education matierals, patient reminders provider/clinical team education, clinical champions, and audit and feedback. The impact of this evaluation will be measure using mixed methods to assess Exploration, Preparation, Implementation factors related to how organizational and contextual variables affect adoption and implementation for targeting CRC screening among patients with diabetes in safety net clinics at 12 months post intervention. Aim 3 surveys 20 clinicians and staff from 6 clinics (n=120) and conducts key-informant interviews with 8 clinic and staff members at pre- and post-implementation (who have participated in the survey; n=96) and evaluates aggregate data for 30 patients across six clinics (n=180).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New Jersey
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New Brunswick、New Jersey、アメリカ、08903
- RWJBarnabas Health - Robert Wood Johnson University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Diagnosis of diabetes mellitus;
- Participants not up-to-date with CRC screening based on electronic health record (e.g. FOBT/FIT in last year; flexible sigmoidoscopy within four years; or colonoscopy within nine years);
- Age-eligible for CRC screening (50-74 years of age);
- Participants in process of undergoing screening are eligible for participation if they have a FIT/FOBT incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year.
Exclusion Criteria:
• Medical conditions not concordant with standard CRC screening intervals (e.g. prior CRC diagnosis, inflammatory bowel disease, renal failure, etc.).
研究計画
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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Targeted CRC Screening Toolkit
Based on national survey data and a community engagement participatory implemention planning group, a tailored combination of widely accepted implementation strategies will be adapted for targeting CRC screening for patients with diabetes. These strategies include but are not limited to: identification of patient and practice-level barriers, patient education, provider reminders, and audit and feedback. |
Strategies in the toolkit include but are not limited to: identification of patient and practice-level barriers, routine tailored patient reminders, provider reminders, & clinic staff feedback. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Colonoscopy uptake
時間枠：12 months
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Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy |
12 months
|
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Up-to-date CRC screening
時間枠：12 months
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Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes
時間枠：12 months
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Preliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled) |
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant Acceptability
時間枠：12 months
|
Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants |
12 months
|
|
Implementation Fidelity
時間枠：12 months
|
Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets |
12 months
|
協力者と研究者
捜査官
- 主任研究者：Denalee O'Malley, PhD、Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。