Physician Coaching to Reduce Opioid-related Harms
調査の概要
詳細な説明
This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.
The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Wisconsin
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Madison、Wisconsin、アメリカ、53705
- University of Wisconsin - Madison
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.
Exclusion Criteria:
- Residents will be excluded.
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
コホートと介入
グループ/コホート |
介入・治療 |
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Physician coaching
This group includes 4 intervention primary care clinics that are part of the University of Wisconsin's Department of Family Medicine.
These clinics will receive an organizational coaching intervention that includes in-person site visits and phone/email communication.
Each participating clinic will designate one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit (during project month 13, July 2015), a follow-up site visit (month 15, October, 2015), and communicating with the coach throughout the 6-month follow-up period via phone and email.
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The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing. The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice. |
Control Group
This group includes 4 control primary care clinics that will not receive any intervention.
A de-identified dataset will be created to examine differences in outcome variables between intervention and control clinics.
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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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Overall Rate of Opioid Prescribing
時間枠:Up to 3 years
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The proportion of patients with a chronic pain diagnosis receiving daily opioids.
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Up to 3 years
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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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Rate of Opioid / Benzodiazepine Co-prescribing
時間枠:Up to 3 years
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Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
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Up to 3 years
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Urine Drug Screening Rate
時間枠:Up to 3 years
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Proportion of opioid patients completing urine drug screens prior to and during the study intervention
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Up to 3 years
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Mental Health Screening Rate
時間枠:Up to 3 years
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Proportion of opioid patients screened for mental health/substance use problems
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Up to 3 years
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Use of Pain Management Agreements
時間枠:Up to 3 years
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Proportion of opioid patients signing pain management agreements
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Up to 3 years
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High-dose Patients
時間枠:Up to 3 years
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Proportion of opioid prescriptions above 120 mg daily morphine equivalent
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Up to 3 years
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Provider Drop-out Rate
時間枠:3 months
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Number and percentage of providers who drop out of study at 3 months
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3 months
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Participating Patient Demographics
時間枠:Up to 3 years
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Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
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Up to 3 years
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Participating Clinic Characteristics
時間枠:Up to 12 months
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Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
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Up to 12 months
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Participating Staff Characteristics
時間枠:Up to 12 months
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Characteristics of participating staff (profession)
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Up to 12 months
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Intervention Fidelity
時間枠:Up to 12 months
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Total hours of coaching delivered/received among all clinics that received physician coaching.
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Up to 12 months
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Intervention Cost
時間枠:Up to 12 months
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Total cost of coaching intervention among all clinics that received physician coaching.
At clinic level.
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Up to 12 months
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Proportion With MEDD >120 mg
時間枠:Up to 12 months
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The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
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Up to 12 months
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Average Morphine Equivalent Daily Dose (MEDD)
時間枠:Up to 12 months
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The average MEDD in milligrams for patients with consistent opioid Rx.
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Up to 12 months
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協力者と研究者
捜査官
- 主任研究者:Andrew R Quanbeck, PhD、Center for Health Enhancement Systems Studies
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
慢性の痛みの臨床試験
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Dexa Medica Group完了