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Physician Coaching to Reduce Opioid-related Harms

2018年7月3日 更新者:University of Wisconsin, Madison
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

53132

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Wisconsin
      • Madison、Wisconsin、美国、53705
        • University Of Wisconsin - Madison

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Clinicians with prescribing authority at community-based primary care clinics

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall Rate of Opioid Prescribing
大体时间:Up to 3 years
The proportion of patients with a chronic pain diagnosis receiving daily opioids.
Up to 3 years

次要结果测量

结果测量
措施说明
大体时间
Rate of Opioid / Benzodiazepine Co-prescribing
大体时间:Up to 3 years
Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
Up to 3 years
Urine Drug Screening Rate
大体时间:Up to 3 years
Proportion of opioid patients completing urine drug screens prior to and during the study intervention
Up to 3 years
Mental Health Screening Rate
大体时间:Up to 3 years
Proportion of opioid patients screened for mental health/substance use problems
Up to 3 years
Use of Pain Management Agreements
大体时间:Up to 3 years
Proportion of opioid patients signing pain management agreements
Up to 3 years
High-dose Patients
大体时间:Up to 3 years
Proportion of opioid prescriptions above 120 mg daily morphine equivalent
Up to 3 years
Provider Drop-out Rate
大体时间:3 months
Number and percentage of providers who drop out of study at 3 months
3 months
Participating Patient Demographics
大体时间:Up to 3 years
Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
Up to 3 years
Participating Clinic Characteristics
大体时间:Up to 12 months
Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
Up to 12 months
Participating Staff Characteristics
大体时间:Up to 12 months
Characteristics of participating staff (profession)
Up to 12 months
Intervention Fidelity
大体时间:Up to 12 months
Total hours of coaching delivered/received among all clinics that received physician coaching.
Up to 12 months
Intervention Cost
大体时间:Up to 12 months
Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.
Up to 12 months
Proportion With MEDD >120 mg
大体时间:Up to 12 months
The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
Up to 12 months
Average Morphine Equivalent Daily Dose (MEDD)
大体时间:Up to 12 months
The average MEDD in milligrams for patients with consistent opioid Rx.
Up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Andrew R Quanbeck, PhD、Center for Health Enhancement Systems Studies

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年7月1日

初级完成 (实际的)

2017年6月30日

研究完成 (实际的)

2017年6月30日

研究注册日期

首次提交

2015年4月20日

首先提交符合 QC 标准的

2015年4月29日

首次发布 (估计)

2015年5月5日

研究记录更新

最后更新发布 (实际的)

2018年7月6日

上次提交的符合 QC 标准的更新

2018年7月3日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2015-0280
  • 1R34DA036720-01A1 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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