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Pain Management Strategies for Opioid Use Disorder

N/A
Waitlist Available
Led By Mara Schenker, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Orthopaedic trauma patients with planned surgical procedure
Informed consent obtained
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (during inpatient hospitalization), week 2, week 6, month 3
Awards & highlights

Study Summary

This trial will test whether adding a LCS to the clinical care team will help reduce opioid use, pain scores, and improve patient understanding of addiction risk after orthopedic trauma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (during inpatient hospitalization), week 2, week 6, month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (during inpatient hospitalization), week 2, week 6, month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Numeric Rating Scale Average Pain Score
Change in PROMIS Pain Interference - Short Form Score
Change in PROMIS Physical Function - Short Form Score
+1 more
Secondary outcome measures
Change The Defense and Veterans Pain Rating Scale
Change in Opioid Literacy Tool (OLT) Score
Change in Opioid Utilization
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Pilot Study of Pain Management StrategiesExperimental Treatment1 Intervention
Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one year post operation. An official pain management protocol will be developed during the pilot portion of this study.
Group II: Life Care Specialist (LCS) InterventionExperimental Treatment1 Intervention
In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks).
Group III: Standard of Care with Clinical CoordinationActive Control1 Intervention
Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pain Management Strategies
2020
N/A
~220
Life Care Specialist (LCS) Intervention
2020
N/A
~220

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,553 Total Patients Enrolled
Christopher Wolf Crusade (CWC)UNKNOWN
Mara Schenker, MDPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies open for this trial at present?

"Clinicaltrials.gov confirms that this clinical trial, which was initially posted on February 21st 2020 and most recently amended on November 17th 2022, is not currently recruiting for participation. However, there are 141 other medical studies looking to enroll patients at the moment."

Answered by AI

What effects is this investigation hoping to achieve?

"The primary aim of this research, which will be monitored over a 1-day (inpatient hospitalization), 2-week, 6-week and 3-month timeframe is to measure the change in Patient Reported Outcomes Measurement Information System Sleep Disturbance - Short Form Score. Auxiliary outcomes include the assessment of constipation severity with the Patient Assessment of Constipation Symptoms scale (which yields scores from 0 to 4 where lower numbers indicate fewer symptoms) as well as an evaluation of pain's influence on functioning using The Defense and Veterans Pain Rating Scale (scores range from 0 to 10). Lastly, opioid literacy is assessed through Opio"

Answered by AI
~42 spots leftby Mar 2025