Montefiore Opioid and Pain Study (MOPS)

This study will determine pain and opioid outcomes 3 & 6 months after an emergency department visit for acute pain. This is an observational study. Patients are enrolled during an ED visit and followed by telephone 3 & 6 months later. Opioid databases will also be reviewed.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Any oral opioid

• Study Type: Observational
• Enrollment (Actual): 462

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Emergency department patients who are evaluated for acute pain and are prescribed an oral opioid

Description

Inclusion Criteria:

• Adults seen in the emergency department for acute, new-onset pain, defined as: 1)localized pain duration < 10 days and 2) prior to the acute episode, the patient has not had this type of pain in the preceding six months
• Upon emergency department discharge, the patients is prescribed an opioid for pain

Exclusion Criteria:

• Any prescribed opioid use within the previous six months including methadone and buprenorphine

  • Frequent use of any analgesic medication (Use of any analgesic >10 days per month prior to the onset of acute pain)
  • Not available for follow-up

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subsequent opioid prescription	All participants in this study received an opioid prescription at the time of discharge from the emergency department. Using a review of a prescription monitoring database, this study will determine whether participants received a subsequent prescription for an opioid medication.	6 months
Chronic pain in the affected body part	An affirmative response to the following question: its been about 180 days since you left the ER. Have you had pain on more than 50% of these days?	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 item PEG score	This is a validated pain questionnaire with 3 questions	3 months and 6 months after ED discharge
Pain description	Severe, moderate, mild or no pain	3 months and 6 months after ED discharge

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 8, 2017
• Primary Completion (ACTUAL): February 15, 2022
• Study Completion (ACTUAL): February 15, 2022

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2017-8419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No