EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use (EMC2)

Northwestern University

Status: Completed

Conditions: Opioid Use, Unspecified

Treatments: Behavioral: EMC2 Strategy; Behavioral: SMS Text Reminders

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02431793

1R18HS023459-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 652 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

652 participants in 3 patient groups

Usual Care

No Intervention group

Description:

Employ the standard of care, no intervention

EMC2 strategy

Experimental group

Description:

Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids. 1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices. 2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose. 3. Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription.

Treatment:

Behavioral: EMC2 Strategy

EMC2 strategy + SMS Text Reminders

Experimental group

Description:

In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.

Treatment:

Behavioral: SMS Text Reminders

Behavioral: EMC2 Strategy