救急外来を退院した患者に対するオピオイド管理
オピオイドの調剤、モニタリング、廃棄プラットフォームと病院薬局の統合により、救急外来患者の退院によるオピオイド使用を削減
The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid consumption, and determine whether this intervention is acceptable to patients.
調査の概要
詳細な説明
Prescription opioids remain a popular drug class with 143 million (M) opioid prescriptions written in 2020. In that same year, 8.7 million people (2.6% of the US population) misused prescription pain relievers, and overdose deaths from opioids continue to rise to 83,695 in 2022. Across six studies, 67% to 92% of patients prescribed opioids reported unused pills. In 2017, patients were prescribed 3.3 billion excess pills, yet no more than 9% of patients properly disposed of their unused opioids. Despite attempts to reduce overprescribing, increase disposal, and decrease diversion, these issues still contribute to increasing misuse, addiction, and overdose deaths.
Addinex Technologies has developed a novel system to reduce the use of opioids through controlling, monitoring, and disposing of excess opioids. The unique "closed-loop" system starts with clinicians prescribing opioids with the Addinex system. Addinex's partner pharmacy then fills the patented dispenser and delivers it to the patient. The patient uses the Addinex app to access each individual dose code and to obtain education and feedback. Finally, the patient returns the dispenser with any excess pills in a DEA-approved mailer to Addinex's partner disposal company. In a study with Columbia University Medical Center using the Addinex system with 30 post-surgical cancer patients, results showed 70% fewer pills used than prescribed, 60% fewer refills for the same surgeries, and an 84% excess pill disposal rate.
Addinex is now partnering with Brown Emergency Medicine and Rhode Island Hospital ("Brown") to perform a feasibility study using Addinex's system. We will conduct a clinical trial involving 100 patients with extremity fractures treated by the emergency department. Half the patients (25 adults and 25 minors) will utilize the Addinex system, while the other half will have their opioids dispensed in a standard pill bottle as the control group. Addinex's system promotes the return of medication using a pre-paid disposal mailer once patients have completed their course of treatment. The clinical study's main goals involve evaluating the system's effectiveness with patients obtaining same day treatment. This evaluation will encompass an analysis of medication consumption, disposal rates, pain levels, the impact of monitoring policies, and ensuring that the established commercial protocols function seamlessly. Ultimately, the project aims to demonstrate that the Addinex system can successfully operate within the broader hospital environment (same day and scheduled procedures), controlling and monitoring opioid usage, promoting patient well-being, and lowering costs.
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
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02903
- Rhode Island Hospital/Lifespan
-
-
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:
- Ages six years and older
- Ability to swallow pills
- Isolated bone fracture
- Planned to receive opioids in the post-treatment period
- Not taking opioids daily prior to the procedure
- English or Spanish-speaking
- Able to give informed consent or a parent that can give informed consent
- Ownership of and comfort using apps on a smartphone with compatible operating system
- WIFI or cellular access
- Patient not admitted to hospital
Exclusion Criteria:
- Recent opioid use (last 30 days or 2 or more prescriptions in the past 3 months
- Impaired decisional capacity
- In police custody
- Ward of the state
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: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 |
|---|---|
|
アクティブコンパレータ:Control Adult
Patients in this arm will be adults who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25) |
Access and use of opioids in a standard pill bottle. |
|
アクティブコンパレータ:Control Child
Patients in this arm will be children who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25) |
Access and use of opioids in a standard pill bottle. |
|
実験的:Device Adult
Patients in this arm will be adults who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25) |
Medication dispensing system to control and monitor opioid use |
|
実験的:Device Child
Patients in this arm will be children who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25) |
Medication dispensing system to control and monitor opioid use |
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 |
|---|---|---|
|
Median pill consumption
時間枠:One month post treatment
|
Patients are expected to consume at least 16% fewer pills/MMEs using the Addinex system as compared to the control group. |
One month post treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Median disposal of opioids
時間枠:12 months post treatment
|
Patients are expected to dispose of at least 50% of excess opioid pills using the Addinex system vs. 20% in the control group. |
12 months post treatment
|
協力者と研究者
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。