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

NCT02431793 | Completed Results DMC

• 1 other identifier: 1R18HS023459-01
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use, Unspecified

Keywords

Opioids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Medication Knowledge

  7-14 days after enrollment

• Proper Medication Use (Medication Diary)

  10 day medication diary

• Current Opioid Misuse Measure (COMM)

  7-14 days after enrollment

• Pain Score

  7-14 days after enrollment

Study Arms (3)

Usual Care

NO INTERVENTION

Employ the standard of care, no intervention

EMC2 strategy

EXPERIMENTAL

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.

Behavioral: EMC2 Strategy

EMC2 strategy + SMS Text Reminders

EXPERIMENTAL

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

Behavioral: EMC2 Strategy; Behavioral: SMS Text Reminders

Interventions

EMC2 Strategy BEHAVIORAL

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.

EMC2 strategy; EMC2 strategy + SMS Text Reminders

SMS Text Reminders BEHAVIORAL

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.

EMC2 strategy + SMS Text Reminders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects will be excluded from the study if any of the following conditions are met:
• Aged \<18
• 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
• pregnant

Sponsors & Collaborators

• Northwestern University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• McCarthy DM, Kim HS, Hur SI, Lank PM, Arroyo C, Opsasnick LA, Piserchia K, Curtis LM, Wolf MS, Courtney DM. Patient-Reported Opioid Pill Consumption After an ED Visit: How Many Pills Are People Using? Pain Med. 2021 Feb 23;22(2):292-302. doi: 10.1093/pm/pnaa048.

  PMID: 32219431 DERIVED

• McCarthy DM, Curtis LM, Courtney DM, Cameron KA, Lank PM, Kim HS, Opsasnick LA, Lyden AE, Gravenor SJ, Russell AM, Eifler MR, Hur SI, Rowland ME, Walton SM, Montague E, Kim KA, Wolf MS. A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC2 Randomized Controlled Trial. Acad Emerg Med. 2019 Dec;26(12):1311-1325. doi: 10.1111/acem.13860. Epub 2019 Nov 19.

  PMID: 31742823 DERIVED

• Neill LA, Kim HS, Cameron KA, Lank PM, Patel DA, Hur SI, Opsasnick LA, Curtis LM, Eifler MR, Courtney DM, Wolf MS, McCarthy DM. Who Is Keeping Their Unused Opioids and Why? Pain Med. 2020 Jan 1;21(1):84-91. doi: 10.1093/pm/pnz025.

  PMID: 30903661 DERIVED

• McCarthy DM, Courtney DM, Lank PM, Cameron KA, Russell AM, Curtis LM, Kim KA, Walton SM, Montague E, Lyden AL, Gravenor SJ, Wolf MS. Electronic medication complete communication strategy for opioid prescriptions in the emergency department: Rationale and design for a three-arm provider randomized trial. Contemp Clin Trials. 2017 Aug;59:22-29. doi: 10.1016/j.cct.2017.05.003. Epub 2017 May 4.

  PMID: 28479220 DERIVED

Results Point of Contact

• Title: Dr. Danielle McCarthy
• Organization: Northwestern University

d-mccarthy2@northwestern.edu

312-926-7532

Study Officials

• Danielle McCarthy, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 in Emergency Medicine

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2018
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-09

Locations

US (1)