Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter

August 19, 2019 updated by: Danielle McCarthy, Northwestern University
The investigators overall study objective is to improve patients knowledge and safe use of opioid pain relievers upon discharge from the Emergency Department.

Study Overview

Status

Completed

Detailed Description

Recent studies indicate that emergency department (ED) discharge processes - including written and spoken communications - are inadequate, and patients often leave without the knowledge necessary to properly care for themselves. In the context of opioid pain relievers, this lack of knowledge is potentially dangerous, as patients may not possess the requisite knowledge for safe use of their medication or an awareness of the dangers of medication misuse.

The aim of this study was to evaluate the impact of an opioid information sheet and spoken counseling on patient knowledge about opioids and safe use behaviors. The investigators conducted a randomized controlled pilot test of a dual-modality educational intervention (written information sheet and spoken counseling about opioids) to assess if the intervention can increase patient knowledge about opioid pain relievers. These activities were intended to guide future modification of educational interventions and the future development of best practices for emergency physician spoken counseling about opioid pain relievers.

Study Type

Interventional

Enrollment (Actual)

278

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

    • 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:

  • prescribed an opioid pain reliever
  • English Speaking

Exclusion Criteria:

  • Non-English Speaking
  • Clinically unstable, psychologically impaired or intoxicated as judged by the research staff member.
  • 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 interview in 4 - 7 days.

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: Control
Patients in this arm are discharged from the Northwestern Emergency Department with standard communication about their prescribed opioid pain medication from their care providers. They are called for a follow up survey 4-7 days after their visit.
Experimental: Dual Modality Educational Intervention
Patients in this arm are discharged from the ED with an additional information sheet about their prescribed opioid pain medication, via the intervention titled "Additional Opioid Information". The sheet is read aloud to them by a research assistant. They are called 4-7 days later for a follow up survey.
Patients receiving this intervention are given additional information about the opioid pain medication that they are receiving in the form of a one page handout. The hand out was written in a health-literacy appropriate manner. A research assistant read the handout to them out loud, and they were given a copy to take home with them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of medication name
Time Frame: 4-7 days
The primary outcome was the patients ability to identify the medication name of their prescribed opioid pain reliever upon follow-up.
4-7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge and counseling recall outcomes
Time Frame: 4-7 days
In addition to the outcome of medication name patients were asked additional knowledge and recall questions including: active ingredients in the medication, knowledge about safe daily dose of acetaminophen, side effects, recall of counseling about activities to avoid (drinking alcohol, driving vehicle), knowledge about addictive potential of the medication.
4-7 days
Actual Use outcomes
Time Frame: 4-7 days
Patients were queried about their home use of the medication including: pain score at home, average number of tabs per day, and satisfaction with pain reduction. Additionally they were asked about the timing of any alcohol consumption or driving in relation to the timing of medication dosing.
4-7 days
Response to the intervention
Time Frame: 4-7 days
Patients in the intervention arm were asked how they liked the intervention using a series of question with a Likert scale.
4-7 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Danielle McCarthy, MD MS, Northwestern University

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

October 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

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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