EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use (EMC2)

September 23, 2019 updated by: Danielle McCarthy, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

652

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Employ the standard of care, no intervention
Experimental: 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.

  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.
Behavioral: EMC2 Strategy
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.
Experimental: 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.
Behavioral: EMC2 Strategy
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.
Behavioral: SMS Text Reminders
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7-14 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7-14 days after enrollment
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.
10 day medication diary
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.
7-14 days after enrollment
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.
7-14 days after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Danielle McCarthy, MD, Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R18HS023459-01 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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