EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use (EMC2)
2019年9月23日 更新者：Danielle McCarthy、Northwestern University
The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit.
The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.
調査の概要
詳細な説明
Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge.
The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume >85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.
研究の種類
介入
入学 (実際)
652
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:
- Patient age 18 years and older
- English language speaking
- prescribed pill form of hydrocodone-acetaminophen opioid pain reliever
- own a cell phone with text messaging capabilities
- the patient is the person primarily responsible for administering medication
Exclusion Criteria:
Subjects will be excluded from the study if any of the following conditions are met:
- Aged <18
- non-English speaking
- clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician
- chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days
- admitted to hospital
- unable to complete follow up phone interviews
- pregnant
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Usual Care
Employ the standard of care, no intervention
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実験的：EMC2 strategy
Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.
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Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language.
Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
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実験的：EMC2 strategy + SMS Text Reminders
In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
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Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language.
Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
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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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Safe Medication Dosing (Prescription Understanding)
時間枠：7-14 days after enrollment
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Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions.
Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).
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7-14 days after enrollment
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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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Medication Knowledge
時間枠：7-14 days after enrollment
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The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire.
Patients will be asked about each of the above via structured, open-ended items.
Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included.
The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10.
A higher score on the scale represents better patient knowledge.
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7-14 days after enrollment
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Proper Medication Use (Medication Diary)
時間枠：10 day medication diary
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Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use.
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10 day medication diary
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Current Opioid Misuse Measure (COMM)
時間枠：7-14 days after enrollment
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Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.
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7-14 days after enrollment
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Pain Score
時間枠：7-14 days after enrollment
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Pain scores through structured questions about use in the past 24 hours were collected from participants.
Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores.
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7-14 days after enrollment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Danielle McCarthy, MD、Northwestern University Feinberg School of Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- McCarthy DM, Kim HS, Hur SI, Lank PM, Arroyo C, Opsasnick LA, Piserchia K, Curtis LM, Wolf MS, Courtney DM. Patient-Reported Opioid Pill Consumption After an ED Visit: How Many Pills Are People Using? Pain Med. 2021 Feb 23;22(2):292-302. doi: 10.1093/pm/pnaa048.
- McCarthy DM, Curtis LM, Courtney DM, Cameron KA, Lank PM, Kim HS, Opsasnick LA, Lyden AE, Gravenor SJ, Russell AM, Eifler MR, Hur SI, Rowland ME, Walton SM, Montague E, Kim KA, Wolf MS. A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC2 Randomized Controlled Trial. Acad Emerg Med. 2019 Dec;26(12):1311-1325. doi: 10.1111/acem.13860. Epub 2019 Nov 19.
- Neill LA, Kim HS, Cameron KA, Lank PM, Patel DA, Hur SI, Opsasnick LA, Curtis LM, Eifler MR, Courtney DM, Wolf MS, McCarthy DM. Who Is Keeping Their Unused Opioids and Why? Pain Med. 2020 Jan 1;21(1):84-91. doi: 10.1093/pm/pnz025.
- McCarthy DM, Courtney DM, Lank PM, Cameron KA, Russell AM, Curtis LM, Kim KA, Walton SM, Montague E, Lyden AL, Gravenor SJ, Wolf MS. Electronic medication complete communication strategy for opioid prescriptions in the emergency department: Rationale and design for a three-arm provider randomized trial. Contemp Clin Trials. 2017 Aug;59:22-29. doi: 10.1016/j.cct.2017.05.003. Epub 2017 May 4.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年7月1日
一次修了 (実際)
2017年8月1日
研究の完了 (実際)
2018年9月1日
試験登録日
最初に提出
2015年4月28日
QC基準を満たした最初の提出物
2015年4月30日
最初の投稿 (見積もり)
2015年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2019年9月25日
QC基準を満たした最後の更新が送信されました
2019年9月23日
最終確認日
2019年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 1R18HS023459-01 (米国 AHRQ グラント/契約)
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