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临床试验/NCT04080037
NCT04080037已完成不适用

Assessing Opioid Care Practices Using CPV Patient Simulation Modules to Improve Alignment With CDC Guidelines

Qure Healthcare, LLC2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
220
试验地点
2
主要终点
Change in provider scores on pre- and post-intervention assessments

研究概览

简要总结

This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and feedback. The cases and feedback have been designed to align with the latest CDC opioid guidelines. The study will also measure the impact of gaming-inspired competition and motivation, including a weekly leaderboard, to improve evidence-based care decisions. The quality of care decisions will be measured in the simulations and in a multiple-choice assessment administered before and after the patient simulations.

详细描述

Primary care providers (PCPs) are often on the front lines of helping patients manage acute and chronic pain. These pain management decisions have become especially important in light of the national opioid crisis that has seen an unsettling rise in opioid dependency, over-doses and fatalities. The Centers for Disease Control has developed specific evidence-based guidelines to help clinicians make more informed decisions about appropriate use of opioids as well as identifying and managing patients at risk for opioid-use disorder and overdose.

The investigators' previous work has shown that patient simulations can rapidly and reliably measure unwarranted practice variation among providers. In addition, published work shows that patient simulations, when administered serially and combined with customized feedback on improvement opportunities can reduce practice variation and improve performance on patient-level quality measures. Given the challenge of the current opioid crisis and the large scope of unwarranted variation in medical practice, there is a need for scalable approaches to measure care decisions, provide feedback on improvement opportunities and benchmark performance to peers.

This study seeks to evaluate the impact of personalized measurement and feedback on evidence-based care decisions made by primary care providers across the country concerning opioid care. The study, a prospective cohort trial, will enroll primary care physicians (PCPs) practicing in the U.S. Upon enrollment, eligible providers will be asked to complete a questionnaire detailing their practice and professional background. They will then be asked to complete the following:

Pretest: Pre-project, participants will take a multiple-choice assessment test. These assessments measure CDC Opioid Guidelines knowledge and adherence. Study administrators will randomize half of providers to take Assessment A pre-intervention, and half to take Assessment B pre-intervention, and have attempted to make these two assessments of equal difficulty.

Intervention: All providers will then care for 1 online CPV QualityIQ patient simulation each week over the course of 6 weeks. The simulated patients will be adults aged 18-75 and present with clinical conditions commonly seen by PCPs, such as chronic or acute pain, for whom opioids are currently in use or may be considered. In the patient simulations, participants will make work-up, diagnostic and treatment decisions relevant to the patient's pain management and will receive real-time feedback on how those decisions align with the CDC recommendations. Each week, participants will receive an email notification with their case score from the previous week, how their care compares to their PCP peers, and a link their new case to be completed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Board-certified in internal medicine or family medicine
  • Minimum patient panel size of 1,000 patients
  • At least 5% of their patients currently or previously using opioid medications
  • English-speaking
  • Access to the internet
  • Informed, signed and voluntarily consented to be in the study

排除标准

  • Not board certified in either internal medicine or family medicine
  • Patient panel size less than 1,000 patients
  • Less than 5% of their patients currently or previously using opioid medications
  • Non-English speaking
  • Unable to access the internet
  • Do not voluntarily consent to be in the study

结局指标

主要结局

Change in provider scores on pre- and post-intervention assessments

时间窗: 2 months

At the beginning and end of the study, participants with complete a 20 multiple-choice question assessment to measure familiarity with the latest CDC opioid guidelines. The assessment scales are known as the "QURE-Ascend Learning Modules: Opioids, Assessment A" and "QURE-Ascend Learning Modules: Opioids, Assessment B," both of which measure familiarity with the latest CDC guidelines via multiple-choice questions. Scores on the scales range from 0 to 100%, with a higher score representing greater familiarity with evidence-based care. There are no subscales within the measures. Between the assessment, they will care for online simulated patients and receive feedback on their care decisions. A primary outcome in the study will be to measure whether performance on the assessments improves after caring for the simulated patients and receiving feedback. Higher scores on the second assessment represent a better outcome.

Change in the overall and the diagnostic and treatment quality scores in the CPV QualityIQ patient simulations.

时间窗: 2 months

In each case, participants will answer multiple-choice questions about their preferred course of action to work-up, diagnose and treat patients in the primary care setting. Each question has specific evidence-based scoring criteria identifying necessary and unnecessary care decisions. Each provider will get a score for each case, ranging from 0 to 100 percentage based on the care decisions they make in the case. Over the course of the project, the investigators will track the percentage of correct, evidence-based care decisions made by participants, with the hypothesis that serial measurement and feedback on evidence-based care decisions will lead to increases in appropriate decisions over time. Higher scores represent a better outcome.

次要结局

  • Participant satisfaction as measured by post-evaluation survey(2 months)
  • Physician engagement throughout the study(2 months)

研究者

发起方
Qure Healthcare, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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