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

Opioid Use, Unspecified Clinical Trial

— EMC2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431793
• Other study ID #: 1R18HS023459-01
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2018

Study information

• Verified date: September 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: September 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:

1. Patient age 18 years and older

2. English language speaking

3. prescribed pill form of hydrocodone-acetaminophen opioid pain reliever

4. own a cell phone with text messaging capabilities

5. 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:

1. Aged <18

2. non-English speaking

3. clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician

4. chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days

5. admitted to hospital

6. unable to complete follow up phone interviews

7. pregnant

Related Conditions & MeSH terms

• Opioid Use, Unspecified

Intervention

Behavioral:
• EMC2 Strategy
Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
• SMS Text Reminders
In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safe Medication Dosing (Prescription Understanding)	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).	7-14 days after enrollment
Secondary	Medication Knowledge	The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire. Patients will be asked about each of the above via structured, open-ended items. Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included. The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10. A higher score on the scale represents better patient knowledge.	7-14 days after enrollment
Secondary	Proper Medication Use (Medication Diary)	Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use.	10 day medication diary
Secondary	Current Opioid Misuse Measure (COMM)	Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.	7-14 days after enrollment
Secondary	Pain Score	Pain scores through structured questions about use in the past 24 hours were collected from participants. Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores.	7-14 days after enrollment