先住民族コミュニティにおけるオピオイドと疼痛の治療 (OPTIC) 試験 (OPTIC)
先住民族コミュニティにおけるオピオイドと疼痛の治療 (OPTIC) 試験: スクリーニングと簡単な介入の実施
The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder.
調査の概要
詳細な説明
Given the health disparities in AI/AN populations and lack of access to quality care for comorbid chronic pain and opioid misuse/OUD, the proposed study seeks to build upon the strong relationships between the research team and the AI/AN communities. There is a dearth of prior research examining chronic pain, opioid misuse/OUD, and other comorbid conditions (mood disorders, anxiety disorders, other SUD) in AI/AN populations. Using CBPR methods, the investigators will work with the OPTIC Collaborative Board to develop a culturally centered implementation intervention to improve screening and brief interventions with AI/AN clients with chronic pain and opioid misuse/OUD (Phase I, Aim 1). Specifically, in collaboration with the community partners and the OPTIC Collaborative Board, the investigators will develop a provider training to increase provider skills and self-efficacy to focus conversations on managing chronic pain (rather than trying to eliminate it) and improving client functioning within cultural frameworks of wellbeing. The goal is to develop, implement, and evaluate culturally centered implementation strategies to increase screening and brief intervention for chronic pain, opioid misuse/OUD in clinics serving AI/AN communities. The investigators will conduct a type III effectiveness-implementation trial over the course of 24 months at each clinical site utilizing EMR data and longitudinal staff surveys to test the implementation outcomes (Phase II, Aim 2) as well as patient surveys to test effectiveness outcomes (Phase II, Aim 3) . The investigators hypothesize that the culturally centered approach will increase rates of screening and brief intervention, and ultimately improve outcomes among AI/AN clients with chronic pain and OUD who receive treatment in primary care. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder for the purpose of identifying areas of treatment needs, and examining the efficacy of a provider-level implementation intervention delivered at the sites from which our participants will be sampled.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kamilla L Venner, PhD
- 電話番号：5059252300
- メール：kamilla@unm.edu
研究連絡先のバックアップ
- 名前：Angel R Vasquez, PhD
- メール：vasquez@unm.edu
研究場所
-
-
California
-
Arcata、California、アメリカ、95521
- 募集
- Clinic Site A (blinded pending tribal approval)
-
コンタクト：
- Kamilla L Venner
- 電話番号：505-925-2300
- メール：kamilla@unm.edu
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55404
- まだ募集していません
- Clinic Site C (blinded pending tribal approval)
-
コンタクト：
- Kamilla L Venner
- 電話番号：505-925-2300
- メール：kamilla@unm.edu
-
-
Washington
-
Toppenish、Washington、アメリカ、98948
- まだ募集していません
- Clinic Site B (blinded pending tribal approval)
-
コンタクト：
- Kamilla L Venner
- 電話番号：505-925-2300
- メール：kamilla@unm.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
説明
Inclusion Criteria:
- Willing and able to provide informed consent
- have English comprehension and proficiency
- receiving services at one of our participating study sites
- report current chronic pain and/or opioid misuse/opioid use disorder
- self-identify as American Indian/Alaska Native
Exclusion Criteria:
- if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process
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：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
介入なし：Pre-Intervention
Baseline prior to any involvement with the project |
|
|
介入なし：Intervention
A workgroup for each clinic meets for approximately 6 months to select the specific goals for the clinic to be targeted during the implementation phase. |
|
|
アクティブコンパレータ：Implementation
Evidence-based implementation strategies are put into practice for approximately 6 months. |
Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients |
|
介入なし：Sustainment
Measuring the degree to which the clinic maintains the implementation phase goals. |
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 |
|---|---|---|
|
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
時間枠：6 months (or duration of implementation phase)
|
Derived from electronic medical records |
6 months (or duration of implementation phase)
|
|
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
時間枠：6 months (or duration of sustainment phase)
|
Derived from electronic medical records |
6 months (or duration of sustainment phase)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Matthew R Pearson, PhD、University of New Mexico
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
- 2303044342
- RM1DA055301 (米国 NIH グラント/契約)
- 2206007094 (その他の識別子：University of New Mexico)
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
Each Tribal partner has would need to agree to have their data shared.
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。