NCT02299024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

November 20, 2014

Last Update Submit

August 19, 2019

Conditions

Keywords

opioidshealth literacy

Outcome Measures

Primary Outcomes (1)

  • 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.

    4-7 days

Secondary Outcomes (3)

  • Knowledge and counseling recall outcomes

    4-7 days

  • Actual Use outcomes

    4-7 days

  • Response to the intervention

    4-7 days

Study Arms (2)

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.

Behavioral: Additional Opioid Information

Interventions

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.

Dual Modality Educational Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • prescribed an opioid pain reliever
  • English Speaking

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Danielle McCarthy, MD MS

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations