Reactive vs. Proactive Pain Control in IBD (PAIN-Sparing)
Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
The investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution's Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive" analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.
Aims:
Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.
Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.
Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.
調査の概要
状態
詳細な説明
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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Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
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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:
- Adults with confirmed IBD diagnosis
- Admitted for primary IBD-related sign or symptom
Exclusion Criteria:
- Admitted for primary non-IBD complaint
- Surgery in the last 30 days
- Alternative (non-IBD) GI diagnosis determined
- Age <18
- Pregnancy
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：ダブル
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：Proactive
Proactive Analgesic Inpatient Narcotic-Sparing: Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol". |
Medications suggested to the physician with enhanced ease of ordering.
他の名前：
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介入なし：Reactive (Control Group)
Pain management in patients in the reactive group (control group) will follow traditional prescribing habits.
As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature.
The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group.
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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 |
|---|---|---|
|
Patient-Reported Pain Scores
時間枠：Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
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Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
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Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
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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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Healthcare Utilization
時間枠：From hospital admission until hospital discharge, typically 7 days.
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Hospital length of stay (in days)
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From hospital admission until hospital discharge, typically 7 days.
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Functional Activity
時間枠：From hospital admission until hospital discharge, typically 7 days.
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FitBit activity (number of steps per day)
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From hospital admission until hospital discharge, typically 7 days.
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Opioid-Consumption
時間枠：From hospital admission until hospital discharge, typically 7 days.
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Milligram morphine-equivalents consumed per day
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From hospital admission until hospital discharge, typically 7 days.
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協力者と研究者
捜査官
- スタディディレクター：Sameer K Berry, MD, MBA、Cedars-Sinai Medical Center
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。