- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299024
Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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
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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.
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Danielle McCarthy, MD MS, Northwestern University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP0017808
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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