De-escalating Vital Sign Checks
Using Predictive Analytics to Reduce Vital Sign Checks in Stable Hospitalized Patients
調査の概要
詳細な説明
Patients in the hospital often report poor sleep. A lack of sleep not only affects a patient's recovery from illness and their overall feeling of wellness, but it is a leading factor in the development of delirium in the hospital. One method for improving sleep in the hospital is to reduce the number of patient care related interruptions that a patient experiences. Vital sign checks at night are one example. In hospitalized patients who are clinically stable, vital sign checks that interrupt sleep are often unnecessary. However, identifying which patients can forego these checks is not a simple task. Currently, the hospital's quality improvement team asks physicians to think about this issue every day and order reduced, or "sleep promotion", vital sign checks on patients they believe could safely tolerate it. The investigators goal is to use a predictive analytics tool to reduce the cognitive burden of this task for busy physicians.
The investigators plan to develop a logistic regression model, trained on data from the electronic health record (EHR), to predict, for a given patient on a given night, whether they could safely tolerate the reduction of overnight vital sign checks. The model will use variables, such as the patient's age, the number of days they have been in the hospital, the vital signs from that day, the lab values from that day, and other clinical variables to make its prediction. The outcome is a binary variable, whether the patient will or will not have abnormal vital signs that night. The training data is retrospective therefore it contains the nighttime vitals that were observed, which the investigators will code as a binary variable and use as the outcome variable for the model to train against.
The investigators will incorporate this algorithm into an EHR alert so physicians can observe its output during their work, and use this information, complemented by their own clinical judgment, to decide about ordering reduced vital sign checks for a given patient.
The investigators will study the effect of this EHR alert on several outcomes: in-hospital delirium (measured by nurse assessment), sleep opportunity (a measurement, based on observational EHR data, of patient care related sleep interruptions), and patient satisfaction (measured by nationally-administered post-hospitalization HCAHPS surveys). Balancing measures, to ensure that reduced vital sign checks do not cause patient harm, will be rapid response calls and code blue calls.
Physician teams will be randomized to either see the EHR alert (intervention arm) or not see the EHR alert.
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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California
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San Francisco、California、アメリカ、94143
- UCSF
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参加基準
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
受講資格のある性別
説明
Inclusion Criteria:
- All physician teams that operate under the UCSF Division of Hospital Medicine
Exclusion Criteria:
- N/A
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: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: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:EHR Alert
Physician teams will observe the EHR alert as they perform their clinical duties in the EHR.
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A pop-up window in the EHR will notify a physician that their patient has been judged by a predictive algorithm to be safe for reduced overnight vital sign checks.
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プラセボコンパレーター:No Alert
Physician teams will perform their clinical duties in the EHR as usual, with no visible alert.
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No change to EHR function; no alert visible to providers
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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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delirium
時間枠:average will be measured at study completion (6 months from study start date - Sep 11, 2019)
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Nursing Delirium Screening Scale (Nu-DESC score) - assessed by the nurse, can range from zero to ten, a score > 2 has good accuracy for delirium
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average will be measured at study completion (6 months from study start date - Sep 11, 2019)
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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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sleep opportunity
時間枠:average will be calculated at study completion (6 months from study start date - Sep 11, 2019)
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a *novel* measurement based on observational EHR data - for every night in the hospital, the investigators can extract from the EHR all event timestamps that could have interrupted the patient's sleep (measured between 11 pm and 6 am).
These are blood pressure recordings, fingerstick glucose checks, blood draws for labs, and not-as-needed medication administrations.
The maximum time period between such events is considered the patient's sleep opportunity for that night (measured in hours).
A higher sleep-opportunity on a given night is better.
The investigators can calculate an average sleep-opportunity for a hospital encounter and then an average sleep-opportunity for all encounters in a clinical trial arm.
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average will be calculated at study completion (6 months from study start date - Sep 11, 2019)
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patient satisfaction
時間枠:average score will be measured at study completion (6 months from study start date - Sep 11, 2019)
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results from Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys administered to patients after discharge from the hospital (scale is a categorical response: never, sometimes, usually, or always)
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average score will be measured at study completion (6 months from study start date - Sep 11, 2019)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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number of code blue events
時間枠:average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
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when a patient has a code blue (respiratory or cardiac arrest) called on them in the hospital, the resuscitation team that responds then writes a note documenting the event; the investigators can count these notes as a proxy for counting code blue events themselves (lower number is better)
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average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
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number of rapid response calls
時間枠:average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
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when a patient has a rapid response (significant change in vital signs or alertness) called on them in the hospital, the team that responds writes a note documenting the event and the investigators can count these notes as a proxy for counting rapid response events themselves (lower number is better)
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average number will be calculated at study completion (6 months from study start date - Sep 11, 2019)
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協力者と研究者
捜査官
- スタディディレクター:Mark Pletcher, MD、Director of the UCSF Informatics and Research Innovation Program
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
本研究に関する用語
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
せん妄の臨床試験
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Bozok University募集術後合併症 | 小児患者 | 術前不安(Ameliyat Öncesi Anksiyete) | Emergence Delirium (覚醒時せん妄)トルコ(Türkiye)
Nighttime Vital Sign EHR Alertの臨床試験
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University Hospital, Basel, SwitzerlandClinical Trial Unit, University Hospital Basel, Switzerland完了