跳至主要内容
临床试验/NCT04295135
NCT04295135已完成不适用

Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design

Indiana University4 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2020年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
4
主要终点
Pain and Function Goal-setting

研究概览

简要总结

The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet clinical decision support tool in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating primary care providers (PCPs) in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.

详细描述

The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) based clinical support tool developed and built in Epic. The OneSheet is a dashboard designed to assist PCPs in treating patients with chronic pain conditions by providing an overview of patient information needed by PCPs when treating these patients. The dashboard does not provide new information to PCPs. Instead, it works by aggregating and structuring information already being collected, available in other places in the medical record. By aggregating and structuring this information more conveniently, the goal of the OneSheet is to make important information in clinical decision-making more readily available and reduce the time PCPs need to spend locating this information.

The study aimed to determine whether and how having access to the Chronic Pain OneSheet activity in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome-measuring behavior of participating PCPs in visits with patients with chronic pain conditions. The investigators also assessed whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain.

To test this, researchers conducted a two-arm pragmatic randomized controlled trial (RCT), enrolling PCPs across two health systems. The randomization occurred at the PCP level; the analysis occurred at the patient-visit level. The PCPs signed an informed consent form, while the data from patient visits was obtained through a waiver of informed consent. The investigators assessed outcomes by analyzing EHR usage log files and PCP ordering records extracted from the healthcare systems' clinical data warehouses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)
  • Can prescribe medication (i.e., Doctor of Medicine (MD), Nurse Practitioner (NP), Physicians Assistant (PA))
  • Sees patients at a primary care clinic at one of the two participating hospital systems

排除标准

  • Does not practice primary care
  • Does not regularly see patients at a primary care clinic at one of the two participating hospital systems
  • Cannot prescribe medication

结局指标

主要结局

Pain and Function Goal-setting

时间窗: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Proportion of visits for patients with chronic pain for whom the PCP documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.

Pain, Enjoyment of Life, and General Activity (PEG) Documentation

时间窗: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Proportion of visits for patients with chronic pain for whom the PCP documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. The PEG has a scale of 1-10, and is used to track an individual's changes over time. With effective therapy, an individual's score should decrease over time.

Urine Drug Screening (UDS) Results Ordered

时间窗: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Proportion of visits for patients with chronic pain on long term opioid therapy (LTOT) for whom the PCP ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse.

Prescription Drug Monitoring Program (PDMP) Reports Reviewed

时间窗: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Proportion of visits for patients with chronic pain on LTOT for whom the PCP accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse.

次要结局

  • Naloxone Prescriptions Ordered(Assessed at baseline (looked back at previous 12 months) and 18-month treatment period)
  • Medications for Opioid Use Disorder Prescription Ordered(Assessed at baseline (looked back at previous 12 months) and 18-month treatment period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olena Mazurenko

Principal Investigator

Indiana University

研究点 (4)

Loading locations...

相似试验