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Clinical Trials/NCT02431793
NCT02431793
Completed
Not Applicable

EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use

Northwestern University1 site in 1 country652 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use, Unspecified
Sponsor
Northwestern University
Enrollment
652
Locations
1
Primary Endpoint
Safe Medication Dosing (Prescription Understanding)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.

Detailed Description

Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge. The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume \>85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
September 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Danielle McCarthy

Assistant Professor in Emergency Medicine

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:
  • Patient age 18 years and older
  • English language speaking
  • prescribed pill form of hydrocodone-acetaminophen opioid pain reliever
  • own a cell phone with text messaging capabilities
  • the patient is the person primarily responsible for administering medication

Exclusion Criteria

  • Subjects will be excluded from the study if any of the following conditions are met:
  • non-English speaking
  • clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician
  • 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 interviews

Outcomes

Primary Outcomes

Safe Medication Dosing (Prescription Understanding)

Time Frame: 7-14 days after enrollment

Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).

Secondary Outcomes

  • Proper Medication Use (Medication Diary)(10 day medication diary)
  • Medication Knowledge(7-14 days after enrollment)
  • Pain Score(7-14 days after enrollment)
  • Current Opioid Misuse Measure (COMM)(7-14 days after enrollment)

Study Sites (1)

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