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

Primary Purpose

Opioid Use, Unspecified

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Additional Opioid Information
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use, Unspecified focused on measuring opioids, health literacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Dual Modality Educational Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Knowledge of medication name
The primary outcome was the patients ability to identify the medication name of their prescribed opioid pain reliever upon follow-up.

Secondary Outcome Measures

Knowledge and counseling recall outcomes
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.
Actual Use outcomes
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.
Response to the intervention
Patients in the intervention arm were asked how they liked the intervention using a series of question with a Likert scale.

Full Information

First Posted
November 20, 2014
Last Updated
August 19, 2019
Sponsor
Northwestern University
Collaborators
Emergency Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02299024
Brief Title
Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
Official Title
Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Emergency Medicine Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators overall study objective is to improve patients knowledge and safe use of opioid pain relievers upon discharge from the Emergency Department.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Unspecified
Keywords
opioids, health literacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Dual Modality Educational Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Additional Opioid Information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of medication name
Description
The primary outcome was the patients ability to identify the medication name of their prescribed opioid pain reliever upon follow-up.
Time Frame
4-7 days
Secondary Outcome Measure Information:
Title
Knowledge and counseling recall outcomes
Description
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.
Time Frame
4-7 days
Title
Actual Use outcomes
Description
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.
Time Frame
4-7 days
Title
Response to the intervention
Description
Patients in the intervention arm were asked how they liked the intervention using a series of question with a Likert scale.
Time Frame
4-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle McCarthy, MD MS
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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