オピオイド使用障害に対する薬物使用を増やすための臨床意思決定支援
The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. The pathway provides health care providers with information and suggestions for screening and treatment of opioid use disorder, including treatment with medications. The 2022 Centers for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends providers asses for and treat opioid use disorder using approved medications for opioid use disorder (MOUD). This project will implement a passive CDS alert when a provider prescribes an opioid to a patient who may be at risk of opioid use disorder. Providers will also have link access to a clinical care pathway providing support for OUD screening and treatment. Before and after comparisons of buprenorphine (a medication used to treat opioid use disorder) prescribing by providers and outcomes of patients will be examined based on medical records data collected during routine care. The study period will be approximately 18 months.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Heather Tolle, PhD
- 電話番号：303-724-9924
- メール：heather.tolle@cuanschutz.edu
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- 募集
- UCHealth
-
コンタクト：
- Heather Tolle
- 電話番号：720-848-6777
- メール：heather.tolle@cuanschutz.edu
-
-
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
サンプリング方法
調査対象母集団
Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system.
説明
Inclusion Criteria:
- Primary care encounter AND
- Current opioid prescription (not buprenorphine) and Active opioid medications over the last 90 days OR
- Documented as on local Pain Registry "Does the patient fit the criteria to be included on the Pain Registry?" OR
- Has active problem list diagnosis of long-term (current) use of opiate analgesic OR
- Is taking >=90 morphine milligram equivalents (MME) per day OR
- Prior positive toxicology screen for illicit drugs OR
- Diagnosis of opioid use disorder
Exclusion Criteria:
- Active cancer diagnosis in the last 1 year
- Hospice care/palliative care order
- Sickle cell disease diagnosis
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
pre implementation period
Encounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. |
|
|
CDS Notification
Providers will see a clinical decision support tool within the electronic health record when treating a patient at risk for opioid use disorder to encourage the provider to use a clinical care pathway to assess for opioid use disorder and when applicable, treat opioid use disorder with buprenorphine. Smart text will also be available in the electronic health record so that the provider can easily document screening and treatment discussions with the patient. |
Clinical decision support (CDS) in the form of an electronic health record (EHR)-integrated, provider-facing notification suggesting (a) the patient may be at risk for opioid use disorder and could benefit from screening, (b) patients with opioid use disorder would benefit from treatment with buprenorphine and (c) utilization of a clinical care pathway to help treat patients with opioid use disorder with buprenorphine as suggested by the Center for Disease Control and Prevention (CDC) guidelines. |
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 |
|---|---|---|
|
Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder
時間枠：18 months
|
The number of primary care patients identified to be at risk for opioid use disorder treatment with buprenorphine for treatment divided by the total number of patients meeting opioid use disorder criteria |
18 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical decision support (CDS) acceptance rate
時間枠：18 months
|
The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway in treating opioid use disorder. |
18 months
|
|
Subsequent opioid overdose/poisoning rates
時間枠：Six months after an encounter where the opioid use disorder is identified
|
The number of patients who had a diagnosis of opioid overdose or poisoning |
Six months after an encounter where the opioid use disorder is identified
|
|
Buprenorphine initiation
時間枠：Six months after an encounter where the opioid use disorder is identified
|
Number of patients who filled a buprenorphine prescription after being identified at risk. |
Six months after an encounter where the opioid use disorder is identified
|
協力者と研究者
捜査官
- 主任研究者：Jason Hoppe, DO、University of Colorado, Denver
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- 24-1188
- R61DA057610 (米国 NIH グラント/契約)
- 24-1188 (その他の識別子：IRB protocol)
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
De-identified data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) after results of the study are published.
IPD 共有時間枠
Data will be provided to National Addiction and HIV Data Archive Program (NAHDAP) after study results are published in peer-reviewed journals.
IPD 共有アクセス基準
Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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。