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Montefiore Opioid and Pain Study (MOPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03375645
Recruitment Status : Active, not recruiting
First Posted : December 18, 2017
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Tracking Information
First Submitted Date December 12, 2017
First Posted Date December 18, 2017
Last Update Posted Date May 20, 2021
Actual Study Start Date November 8, 2017
Estimated Primary Completion Date March 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2017)
  • Subsequent opioid prescription [ Time Frame: 6 months ]
    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.
  • Chronic pain in the affected body part [ Time Frame: 6 months ]
    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?
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 14, 2017)
  • 3 item PEG score [ Time Frame: 3 months and 6 months after ED discharge ]
    This is a validated pain questionnaire with 3 questions
  • Pain description [ Time Frame: 3 months and 6 months after ED discharge ]
    Severe, moderate, mild or no pain
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Montefiore Opioid and Pain Study
Official Title Montefiore Opioid and Pain Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Emergency department patients who are evaluated for acute pain and are prescribed an oral opioid
Condition Acute Pain
Intervention Drug: Any oral opioid
Emergency department patients who receive a prescription for an oral opioid
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 14, 2017)
462
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 23, 2022
Estimated Primary Completion Date March 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03375645
Other Study ID Numbers 2017-8419
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Benjamin Friedman, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date May 2021