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EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use

Not Applicable
Completed
Conditions
Opioid Use, Unspecified
Interventions
Behavioral: EMC2 Strategy
Behavioral: SMS Text Reminders
Registration Number
NCT02431793
Lead Sponsor
Northwestern University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
652
Inclusion Criteria
  • To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:

    1. Patient age 18 years and older
    2. English language speaking
    3. prescribed pill form of hydrocodone-acetaminophen opioid pain reliever
    4. own a cell phone with text messaging capabilities
    5. the patient is the person primarily responsible for administering medication
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Exclusion Criteria
  • Subjects will be excluded from the study if any of the following conditions are met:

    1. Aged <18
    2. non-English speaking
    3. clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician
    4. chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days
    5. admitted to hospital
    6. unable to complete follow up phone interviews
    7. pregnant
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EMC2 strategy + SMS Text RemindersEMC2 StrategyIn addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
EMC2 strategy + SMS Text RemindersSMS Text RemindersIn addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
EMC2 strategyEMC2 StrategyPatients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids. 1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices. 2. 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. 3. 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.
Primary Outcome Measures
NameTimeMethod
Safe Medication Dosing (Prescription Understanding)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 Outcome Measures
NameTimeMethod
Proper Medication Use (Medication Diary)10 day medication diary

Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use.

Medication Knowledge7-14 days after enrollment

The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire. Patients will be asked about each of the above via structured, open-ended items. Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included. The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10. A higher score on the scale represents better patient knowledge.

Pain Score7-14 days after enrollment

Pain scores through structured questions about use in the past 24 hours were collected from participants. Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores.

Current Opioid Misuse Measure (COMM)7-14 days after enrollment

Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.

Trial Locations

Locations (1)

Northwestern University

🇺🇸

Chicago, Illinois, United States

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