EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 652
- Locations
- 2
- Primary Endpoint
- Safe Medication Dosing (Prescription Understanding)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: SMS Text Reminders (Behavioral)
Outcomes
Primary Outcomes
Safe Medication Dosing (Prescription Understanding)
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Danielle McCarthy
Assistant Professor in Emergency Medicine
Northwestern University