Trial of Spirometry Fundamentals™ in the Primary Care Setting
Randomized Controlled Trial of Spirometry Fundamentals™ in the Primary Care Setting
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Misclassification of asthma severity has been reported when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment that may result in increased morbidity and increased healthcare utilization/cost. However, even when spirometry is utilized to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society.
The goal of this study is to evaluate the effectiveness of the Spirometry Fundamentals™ tool in training primary care providers and their staff in producing high-quality flow-volume curves as compared to existing training modalities and to gather information in a 'real-world' setting that can be used to improve Spirometry Fundamentals™.
調査の概要
詳細な説明
Currently few self-paced, distance learning programs exist that train staff to perform good quality spirometry tests. This study evaluates the effectiveness of a distance-learning tool for training primary care providers and their medical assistants in the use of spirometry to assist in managing obstructive lung disease (asthma and COPD). This tool is called "Spirometry Fundamentals™: A basic guide to lung function testing". It is a computer-based training program that teaches primary care providers and their staff what spirometry is, how it can be used, the techniques required to perform high-quality spirometry, and clinical interpretation of the spirometric data.
We evaluated the effectiveness of Spirometry Fundamentals in the primary care setting by conducting a randomized controlled trial (RCT). Study participants were primary care physicians (MDs or DOs) and their staff (medical assistants (MAs) or nurses (RNs)) and were recruited as study pairs. The role of the MDs was to utilize spirometry in clinical care by ordering spirometry tests based on their clinical judgment, and the role of the MAs was to perform the spirometry. The patients performed the spirometry as part of their usual care were not considered study subjects.
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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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington
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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:
- Subjects must have internet access in order to transmit spirometry curve and survey data.
- Subjects must have access to a computer with Windows 2000 /Mac OS 10 or higher in order to view Spirometry Fundamentals™.
- Subjects must have access to a ndd Easyone spirometer.
Exclusion Criteria:
- Subjects who lack internet access which will be needed to transmit study data
- Subjects who lack access to a computer with Windows 2000 /Mac OS 10 or higher which will be needed to view Spirometry Fundamentals™.
- Subjects who lack access to a ndd Easyone spirometer.
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：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 |
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介入なし：標準治療
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実験的：Intervention
Spirometry Fundamentals™ CD training program
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MD-MA pairs randomized to the intervention arm of the study received 2 copies of the Spirometry Fundamentals™ CD.
Included with the CDs was a letter explaining that each member of the MD-MA pair should view the CD at their convenience within the following 3 weeks.
This letter included instructions on how to access the study website in order to complete an evaluation survey after viewing the CD.
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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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Spirometry test quality
時間枠：Four months for controls; six months for intervention sites
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Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
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Four months for controls; six months for intervention sites
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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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Effect of frequency of spirometry use on primary outcome
時間枠：Four months for controls; six months for intervention sites
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Examined whether frequency of spirometry use related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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Effect of practice location on primary outcome
時間枠：Four months for controls; six months for intervention sites
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Examined whether practice location (private/community, hospital/university) related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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Effect of practice type on primary outcome
時間枠：Four months for controls; six months for intervention sites
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Examined whether practice type (pediatric/non-pediatric) related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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Effect of practice structure on primary outcome
時間枠：Four months for controls; six months for intervention sites
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Examined whether practice structure related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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Effect of months of spirometry use on primary outcome
時間枠：Four months for controls; six months for intervention sites
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Examined whether months of spirometry use by practice (prior to participating in study) related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Rita Mangione-Smith, MD, MPH、University of Washington/Seattle Children's Hospital
- 主任研究者：James W Stout, MD, MPH、University of Washington
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
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 (見積もり)
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。
Spirometry Fundamentals™ Training CDの臨床試験
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University of CologneMedtronicわからない
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Intec Pharma Ltd.わからないパーキンソン病アメリカ, スペイン, イタリア, イスラエル, ポーランド, イギリス, ブルガリア, ドイツ, スロバキア, ウクライナ
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Intec Pharma Ltd.わからないパーキンソン病アメリカ, イスラエル, イタリア, スペイン, イギリス, ブルガリア, ドイツ, ポーランド, スロバキア, ウクライナ
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Mutual Pharmaceutical Company, Inc.完了