Clinical trial NCT02431793: EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
Official title: EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use, Unspecified
Keywords: Opioids
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-05-01
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safe Medication Dosing (Prescription Understanding)
timeFrame: 7-14 days after enrollment
Secondary outcomes:
measure: Medication Knowledge
timeFrame: 7-14 days after enrollment
measure: Proper Medication Use (Medication Diary)
timeFrame: 10 day medication diary
measure: Current Opioid Misuse Measure (COMM)
timeFrame: 7-14 days after enrollment
measure: Pain Score
timeFrame: 7-14 days after enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Danielle McCarthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.