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Completed

NCT Number: NCT02431793

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

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.

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Key information

Conditions

Opioid Use, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Aged <18
  • 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
  • pregnant

Treatment and study plan

EMC2 Strategy

Behavioral

Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.

SMS Text Reminders

Behavioral

In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days.

Primary outcomes

  1. 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

  1. Medication Knowledge

    Time frame: 7-14 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.

  2. Proper Medication Use (Medication Diary)

    Time frame: 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.

  3. Current Opioid Misuse Measure (COMM)

    Time frame: 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.

  4. Pain Score

    Time frame: 7-14 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: EMC2

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 1, 2015
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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