Improving Quality of Care - Managing Atrial Fibrillation Through Care Teams and Health Information Technology (IQ-MATCH)
This stepped wedge randomized intervention will apply machine learning algorithms in an electronic health record system to identify primary care patients with non-valvular atrial fibrillation (AF) who are at high risk of stroke and not on anticoagulation therapy. An Anticoagulant Management Service (AMS) will offer support to primary care providers regarding treatment for relevant patients (either warfarin and novel oral anticoagulants).
This study seeks to:
- increase the proportion of appropriately anticoagulated patients with AF,
- understand the reasons for lack of anticoagulation, and
- document the proportion of patients with AF who are appropriately not anticoagulated (e.g. patient refusal, contraindication).
調査の概要
詳細な説明
Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with significant mortality and morbidity from stroke, thromboembolism, and related cardiovascular conditions. While the risk of stroke for AF patients as a whole tends to be greater than the general population; within the AF patient population, the risk of stroke is modified by the presence or absence of additional risk factors such as age, comorbid conditions, and prior stroke history.
There is a wealth of evidence for the effectiveness of anticoagulation therapy to prevent stroke and thromboembolism, but while anticoagulants have been demonstrated to be highly effective at preventing stroke and embolic events among AF patients, they are also known to increase the risk of major bleeding events. Anticoagulation with warfarin and other VKA drugs can be complex to manage. These drugs have narrow therapeutic windows and require close monitoring to stay within the target international normalized ratio (INR). They also have many known food and drug interactions.
In the last few years, several novel oral anticoagulants (NOAC) such as dabigatran, rivaroxaban, and apixaban have entered the market. While each of the NOACs demonstrated non-inferiority to warfarin in a large randomized clinical trial prior to FDA approval, experience with NOACs is limited in practice.
Our intervention will combine the ability of health information technology to filter large volumes of data with human capacity to understand subtleties and barriers for complex clinical decision making. Our intervention will facilitate a connection between patients, treating clinicians, and an established Anticoagulant Management Service (AMS) for coordinated care. We will use information from the EHR to direct additional efforts and resources toward reaching potentially unrecognized or undertreated atrial fibrillation patients with the greatest need for preventive anticoagulation therapy and lowest risk of adverse effects. This electronic safety net will assist with efficient allocation of scarce resources beyond usual care. The proposed clinical decision support/care-coordination process will be designed to address many of these identified barriers to appropriate anticoagulation therapy among AF patients. Here we define "appropriate" anticoagulation as a guideline informed shared decision between individual patients and their care team.
This intervention utilizes a stepped wedge design involving 14 primary care clinics affiliated with the Brigham and Women's Hospital. The timing of clinic entry to the intervention arm will be randomized.
研究の種類
入学 (実際)
段階
- 適用できない
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:
- Non-valvular atrial fibrillation as identified by machine learning algorithms
- Primary care provider within Brigham and Women's Hospital
- No evidence of a prescription for an anticoagulant in medical record for at least 1 year
Exclusion Criteria:
-
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:他の
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- 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 |
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実験的:Intervention
Primary care providers in the intervention arm will receive lists of their patients with AF who are identified as being at high risk of stroke but not currently on anticoagulation therapy.
Along with this list, which includes information on risks and benefits of anticoagulation, primary care providers will receive an offer of assistance from a respected Anticoagulation Management Service within the hospital network to help manage anticoagulation for referred patients.
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The intervention arm offers primary care providers additional information on patient risks and benefits as well as an offer of assistance with managing a patient's anticoagulation from a respected service at BWH.
他の名前:
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介入なし:Usual Care
Primary care providers will provide usual care.
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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 |
|---|---|---|
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Anticoagulation therapy
時間枠:randomization to 1 month post randomization
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the proportion of eligible patients who initiate anticoagulation therapy following randomization to intervention or usual care
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randomization to 1 month post randomization
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協力者と研究者
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
本研究に関する用語
その他の研究ID番号
- 2015P000893/BWH
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。
Interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない