Improving Anticoagulation Control in VISN 1
調査の概要
詳細な説明
Background: Over 100,000 VA patients receive oral anticoagulation (AC) each year to prevent blood clots, including strokes. AC is safer and more effective when it is managed skillfully and therefore well-controlled. AC control can be measured using percent time in therapeutic range (TTR), the proportion of time when patients are sufficiently anticoagulated to prevent clots but not excessively anticoagulated (which increases the risk of bleeding). The investigators have shown that the anticoagulation clinics (ACCs) of the VA vary widely on TTR, from 40% (very poor control) to 70% (excellent control). Improving TTR in the VA would prevent thousands of adverse events, including strokes, major hemorrhages, and deaths. The investigators have further investigated the structures and processes of care that contribute to these wide disparities in TTR performance.
Objectives: We applied proven methods to change provider behavior. The goal was to facilitate the adoption of these evidence-based practices in order to improve TTR in VISN 1. We utilized educational outreach, audit and feedback, internal facilitation, and external facilitation to promote improvements in three evidence-based processes of care; namely, follow-up within 7 days after deranged INR values, minimizing loss to follow-up, and use of guideline concordant INR targets.
Methods: Our clinician-focused intervention used a Dashboard to measure site-level TTR and processes of care and an Algorithm for routine AC management. Both the Dashboard and the Algorithm are concrete representations of our main evidence-based recommendations to improve AC management. We promoted their use through quarterly visits to the sites, at which we delivered audit and feedback and educational outreach, and also provided external facilitation to address ways to improve these performance measures. Our main outcome was change in site TTR over time, which was compared between VISN 1 and non-VISN 1 sites using an interrupted time series. Secondary outcomes included site-level changes in processes of anticoagulation care (measured using automated data). We used a difference-in-differences (DID) model to examine changes in anticoagulation control, measured as percent time in target range (TTR), as well as process measures, and compared VISN 1 sites to 116 VA sites located outside VISN 1. The pre-intervention period was from 5/1/10-5/1/13, while the post-intervention period was from 5/2/13-5/10/16.
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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Massachusetts
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Bedford、Massachusetts、アメリカ、01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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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:
- All patients receiving long-term oral anticoagulation with warfarin within the VA New England Region ("VISN 1")
Exclusion Criteria:
- Patients with valvular heart disease, who may have an INR target range other than 2-3. This usually represents between 10-15% of patients receiving anticoagulation.
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:非ランダム化
- 介入モデル:並列代入
- 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:Intervention Group
VA patients treated at anticoagulation clinics at 8 sites in VISN 1.
The intervention included a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.
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The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.
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介入なし:Control Group
VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1.
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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 |
---|---|---|
Percent Change in Time in Therapeutic Range (TTR)
時間枠:Baseline and 4 years
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We compared TTR after the intervention to before the intervention.
We used a difference in differences analysis to compare the absolute percentage change over time in the intervention group vs. the control group.
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Baseline and 4 years
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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 |
---|---|---|
Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin
時間枠:Baseline and 4 years
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We compared the rate of 56-day gaps per patient year in the pre-intervention and post-intervention period.
We used a difference in differences analysis to compare the intervention and control group.
We are reporting absolute change.
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Baseline and 4 years
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Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)
時間枠:Baseline and 4 years
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We compared the percentage of patients with follow-up within 7 days before and after the intervention.
We used a difference in differences analysis to compare the intervention and control groups.
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Baseline and 4 years
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Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)
時間枠:Baseline and 4 years
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We compared the percentage of patients before and after the intervention.
We used a difference in differences analysis to compare the intervention and control groups.
Absolute percentage is reported.
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Baseline and 4 years
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Percentage of Patients With Mean INR Value Between 2.3 - 2.7
時間枠:Baseline and 4 years
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We compared the absolute percentage of patients with a mean INR of 2.3 - 2.7 before and after the intervention.
We used a difference in differences analysis to compare the intervention and control groups.
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Baseline and 4 years
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協力者と研究者
捜査官
- 主任研究者:Ann M. Borzecki, MD MPH、Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
出版物と役立つリンク
一般刊行物
- Rose AJ, McCullough MB. A Practical Guide to Using the Positive Deviance Method in Health Services Research. Health Serv Res. 2017 Jun;52(3):1207-1222. doi: 10.1111/1475-6773.12524. Epub 2016 Jun 28.
- Rose AJ, Park A, Gillespie C, Van Deusen Lukas C, Ozonoff A, Petrakis BA, Reisman JI, Borzecki AM, Benedict AJ, Lukesh WN, Schmoke TJ, Jones EA, Morreale AP, Ourth HL, Schlosser JE, Mayo-Smith MF, Allen AL, Witt DM, Helfrich CD, McCullough MB. Results of a Regional Effort to Improve Warfarin Management. Ann Pharmacother. 2017 May;51(5):373-379. doi: 10.1177/1060028016681030. Epub 2016 Dec 17.
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 (見積もり)
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。
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