EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- Safe Medication Dosing (Prescription Understanding)
研究概览
简要总结
The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.
详细描述
Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge.
The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume >85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.
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
- 否
入选标准
- •To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:
- •Patient age 18 years and older
- •English language speaking
- •prescribed pill form of hydrocodone-acetaminophen opioid pain reliever
- •own a cell phone with text messaging capabilities
- •the patient is the person primarily responsible for administering medication
排除标准
- •Subjects will be excluded from the study if any of the following conditions are met:
- •non-English speaking
- •clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician
- •chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days
- •admitted to hospital
- •unable to complete follow up phone interviews
研究组 & 干预措施
Usual Care
Employ the standard of care, no intervention
EMC2 strategy
Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.
- A single-page medication information sheet with content from a patients perspective and following health literacy best practices.
- Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.
- Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription.
干预措施: EMC2 Strategy (Behavioral)
EMC2 strategy + SMS Text Reminders
In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
干预措施: EMC2 Strategy (Behavioral)
EMC2 strategy + SMS Text Reminders
In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
干预措施: SMS Text Reminders (Behavioral)
结局指标
主要结局
Safe Medication Dosing (Prescription Understanding)
时间窗: 7-14 days after enrollment
Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).
次要结局
- Proper Medication Use (Medication Diary)(10 day medication diary)
- Medication Knowledge(7-14 days after enrollment)
- Pain Score(7-14 days after enrollment)
- Current Opioid Misuse Measure (COMM)(7-14 days after enrollment)
研究者
Danielle McCarthy
Assistant Professor in Emergency Medicine
Northwestern University