Opioid Use, UnspecifiedNCT02299024
Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
A study testing Additional Opioid Information in people with Opioid Use, Unspecified, run by Northwestern University at 1 site in United States.
Trial summary
The investigators overall study objective is to improve patients knowledge and safe use of opioid pain relievers upon discharge from the Emergency Department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Unspecified
- What is being tested?
- Additional Opioid Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prescribed an opioid pain reliever
- English Speaking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators overall study objective is to improve patients knowledge and safe use of opioid pain relievers upon discharge from the Emergency Department.
Read the 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.
- Conditions
- Opioid Use, Unspecified
- Being tested
- Additional Opioid Information
- Keywords
- opioids, health literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional Opioid InformationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Dual Modality Educational Intervention | Experimental | 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. Receives: Behavioral: Additional Opioid Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-7 days
Secondary outcomes (3)
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.
Measured: 4-7 days
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.
Measured: 4-7 days
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.
Measured: 4-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Responsible party
- Principal investigator, Danielle McCarthy, Northwestern University
- Investigators
- Danielle McCarthy, MD MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299024
- Sponsor's protocol ID
- SP0017808
- Status last verified
- Aug 2019
- First submitted
- 20 Nov 2014
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
- ClinicalTrials.gov ID
- NCT02299024
- Acronym / sponsor ID
- SP0017808
- Conditions
- Opioid Use, Unspecified
- Keywords
- opioids, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Dual Modality Educational Intervention | Experimental | Behavioral: Additional Opioid InformationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- prescribed an opioid pain reliever
- English Speaking
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional Opioid InformationPatients 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. | Behavioural | Dual Modality Educational Intervention |
Primary outcome
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.
3 secondary outcomes
Knowledge and counseling recall outcomes
Time frame: 4-7 days
Actual Use outcomes
Time frame: 4-7 days
Response to the intervention
Time frame: 4-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle McCarthy, MD MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional Opioid Information in people with Opioid Use, Unspecified, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of medication name (time frame: 4-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.