Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
調査の概要
詳細な説明
This study will be a randomized controlled trial for primary, unilateral total knee arthroplasty (TKA) patients at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center to determine the impact of using a SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7.
The SDA includes factual information about the World Health Organization pain ladder, the 0-10 NRS pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in TKA patients. The SDA has been developed by the principal investigator solely for the purpose of this study.
Patients will be enrolled on postoperative day 0 or 1 and randomized to intervention or control groups. The intervention group will view the SDA slides on the study iPad. SDA viewing will be guided by the research assistant, who will read a pre-written script as each slide is viewed. Following the guided viewing of the SDA, subjects in the intervention group will have the opportunity to ask questions to the research assistant to confirm their comprehension of the presented facts. The control group will receive no intervention and will receive standard of care and standard discharge prescriptions. The intervention group subjects will choose the number of opioid pills they wish to include in their discharge opioid prescription (anywhere from 0 to the maximum allowable as determined by clinical practice and/or state law).
Daily analgesic intake, adverse effects and numeric rating scale (NRS) pain scores will be collected and analyzed.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Naida Cole, MD
- 電話番号：9176576692
- メール：nmcole@bsd.uchicago.edu
研究連絡先のバックアップ
- 名前：Laura Mendez, MD
- 電話番号：8574004065
- メール：lmendez-pino@bwh.harvard.edu
研究場所
-
-
Illinois
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Chicago、Illinois、アメリカ、60637
- 募集
- University of Chicago Medical Center
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コンタクト：
- Naida Cole, MD
- メール：nmcole@bsd.uchicago.edu
-
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- 募集
- Brigham and Women's Hospital
-
コンタクト：
- Jose Zeballos, MD
- メール：jzeballos@bwh.harvard.edu
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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:
- Primary unilateral TKA under spinal anesthesia at Brigham & Women's Faulkner Hospital (BWFH), Brigham and Women's Hospital or University of Chicago Medical Center by a participating surgeon
- >18 years of age
Planned discharge with the typical analgesic medications prescribed at discharge:
- standing around-the clock Tylenol with or without an NSAID
- tramadol PRN
- hydromorphone (dilaudid) or oxycodone PRN
Exclusion Criteria:
- Diagnosis of dementia
- <18 years old
- Contraindication or allergy to opioids
- Contraindication or allergy to Tylenol
- Contraindication or allergy to gabapentin
- History of substance use disorder
- Preoperative pain requiring a >1-month prescription for >/=45 daily MMEs
- 4 or more preoperative analgesic prescriptions
- Hospital admission >1 day
- Discharge to a skilled nursing facility/inpatient rehabilitation center
- Non-English speaking patients
- Requirement for general anesthesia intra-operatively
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：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Decision Aid
The shared decision aid (SDA) includes factual information about the World Health Organization pain ladder, the 0-10 numeric rating score pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in total knee arthroplasty patients.
Subjects in the decision aid group will view the decision aid and have the opportunity to participate in shared decision-making for their discharge opioid prescriptions.
|
The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator.
The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.
|
|
介入なし：Control
Subjects in the control group will undergo standard care and discharge practices.
Baseline pain and psychosocial factors will be documented as well as postoperative pain and analgesic consumption.
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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 |
時間枠 |
|---|---|
|
Leftover opioid pills
時間枠：30 days postoperatively
|
30 days postoperatively
|
|
Average 0-10 NRS pain score
時間枠：postoperative day 7
|
postoperative day 7
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Quantity of opioid consumed
時間枠：30 days postoperatively
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30 days postoperatively
|
|
Satisfaction with pain management
時間枠：30 days postoperatively
|
30 days postoperatively
|
|
Quantity of opioid pills prescribed
時間枠：postoperative day 1 at hospital discharge
|
postoperative day 1 at hospital discharge
|
協力者と研究者
捜査官
- 主任研究者：Naida Cole, MD、University of Chicago
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- 2020P002342
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?
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。
Shared Decision Makingの臨床試験
-
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-
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University of Alabama at BirminghamNational Cancer Institute (NCI)積極的、募集していない
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Madigan Army Medical CenterTelemedicine & Advanced Technology Research Center; Analytics4Medicine, LLC終了しました
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Columbia UniversityNational Institute of Nursing Research (NINR); Brigham and Women's Hospital完了
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University of PittsburghNational Institute on Minority Health and Health Disparities (NIMHD); University of California... と他の協力者完了
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)募集