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Life Care Specialist (LCS) for Upper Extremity Injury
N/A
Recruiting
Led By Nicole Zelenski, 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 an isolated upper extremity injury requiring surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, week 2, week 6, month 3
Awards & highlights
Study Summary
This trial is studying the effects of different shoulder positions on patients who have had upper extremity trauma.
Who is the study for?
This trial is for adults over 18 with an upper extremity injury needing surgery. They must understand English at least at an elementary school level, be able to complete surveys, have a working cellphone, and not be in another study that forbids joining more than one. Pregnant individuals, COVID-19 positive patients or those unlikely to follow the trial's schedule are excluded.Check my eligibility
What is being tested?
The trial is examining the role of a Life Care Specialist (LCS) in aiding recovery from upper extremity injuries requiring surgery. It randomly assigns participants to receive LCS support or standard care to compare outcomes.See study design
What are the potential side effects?
Since this intervention involves specialist support rather than medication, traditional side effects are not applicable. However, there may be emotional or psychological impacts from receiving additional care which will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for an injury to my arm or hand.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, week 2, week 6, month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, week 2, week 6, month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in PROMIS Pain Interference Score
Changes in PROMIS Physical Function Score
Changes in PROMIS Prescription Pain Medication Misuse Score
+2 moreSecondary outcome measures
Inpatient Opioid Utilization
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LCS InterventionExperimental Treatment1 Intervention
With Opioid Risk Education, patients will receive opioid education after completing the validated Opioid Risk Tool (ORT), a detailed substance abuse survey and mental health screening, and Naloxone education. Therapeutic Intervention will include the Community Resiliency Model CRM), progressive muscle relaxation, sound therapy. Clinical Pain Coordination will include directed referrals for complex needs, including mental health and substance use disorders, as needed. In addition to above mentioned 3 intervention components, all patients in the LCS intervention arm will also receive the current standard-of-care.
Group II: No LCS InterventionActive Control1 Intervention
Patients will receive the current standard-of-care for pain management in the aftermath of trauma, which includes: a standardized prescription protocol, hospital-system approved discharge instructions which provide written instruction on how to taper opioid use, links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.
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Who is running the clinical trial?
American Society for Surgery of the HandOTHER
10 Previous Clinical Trials
1,001 Total Patients Enrolled
Ruth Jackson Orthopaedic SocietyUNKNOWN
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,616 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tested positive for COVID-19.I need surgery for an injury to my arm or hand.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: No LCS Intervention
- Group 2: LCS Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to participate in this survey for individuals?
"As indicated on clinicaltrials.gov, the trial that was initially posted in October of 2022 is no longer enrolling patients; however there are over 700 other medical studies actively recruiting volunteers."
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