NCT05422014 · Emory University
Upper Extremity Life Care Specialist (LCS)
What this study is about
This is a randomly assigned control trial aimed at learning more about LCS position and the value it provides to the patient's who have sustained upper extremity traumas.
View original scientific description
This is a randomized control trial aimed at learning more about LCS position and the value it provides to the patient's who have sustained upper extremity traumas.
Interventions
BEHAVIORAL
Life Care Specialist (LCS)
Life Care Specialist (LCS) will : * Provide patients with individualized risk assessment for opioid misuse. * Act as patient's "Pain Coach." Providing targeted education and behavior-based pain treatment options. * Train and provide CWC evidence based non-pharmaceutical pain management techniques, using the Community Resiliency Model. * Use the Opioid Risk Tool (ORT) as the method to identity the risk of substance misuse. * Provide education, support and resources, as well as local, state, and national resources to enhance the whole health aspect of the position. These resources include but are not limited to: written documents that outline the key concepts of the pain management techniques taught by the LCS and a list of hotlines and websites. * LCS, when applicable, will provide education for caretakers on the risk of opioid use and the non -pharmaceutical pain management protocol. * Provide follow up for all patients in intervention group.
Primary outcome measures
Changes in Pain Numerical Rating Scale (NRS)
Time frame: Day 1, Week 2, Week 6, Month 3
The NRS is a commonly used pain assessment tool in both clinical practice and research. The NRS asks respondents to rate the intensity of their pain on a scale where "no pain" is scored as 0 and 'the worst pain imaginable" is scored as 10.
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Time frame: Day 1, Week 2, Week 6, Month 3
The PROMIS Sleep Disturbance examines respondent's global severity of insomnia, sleep disruption, and sleep quality over the past seven days. Each of the four Likert scale items' raw score are converted to t-scores, ranging from 0 to 100. Like all PROMIS measures, t-scores are normed to the US population, with a mean of 50 and standard deviation of 10. Lower scores indicate better sleep.
Changes in PROMIS Physical Function Score
Time frame: Day 1, Week 2, Week 6, Month 3
PROMIS Physical Function measures participants' self-reported capability to conduct physical activity. This includes capturing function in upper extremities and lower extremities (walking or mobility) as well as a respondent's ability to conduct activities of daily living. There are 4-items on the short form questionnaire and respondents report their capabilities to perform each task on a Likert scale from 5, "without any difficulty", to 1, "unable to do". All 4-items' saw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function.
Changes in PROMIS Pain Interference Score
Time frame: Day 1, Week 2, Week 6, Month 3
The PROMIS Pain Interference scale assesses the extent to which pain impedes engagement with social, cognitive, emotional, physical, and recreational activities over the past 7 days. Pain interference is an essential aspect of pain management to capture in order to better understand how pain impacts the activities of individuals rather than subjective severity alone.15 On each of the scale's 4-items respondents choose how much pain impeded a specific function or activity, ranging from 1, "not at all", to 5, "very much". Scores are summed across all items and transformed to a t-score ranging from 0 to 100, with lower t-scores indicate less interference due to pain
Changes in PROMIS Prescription Pain Medication Misuse Score
Time frame: Day 1, Week 2, Week 6, Month 3
The PROMIS measure of Prescription Pain Medication Misuse assesses current abuse of prescription pain medication, chiefly opioids. The scale has been validated in patient populations with chronic non-cancer pain and has been found to be highly correlated with the Pain Medication Questionnaire (PMQ).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female patients 18 years of age or older
- Orthopaedic trauma patients with an isolated upper extremity injury requiring surgery
- Informed consent obtained
- Working cellphone
Exclusion criteria
- Enrolled in a study that does not permit co-enrollment
- Unlikely to comply with the follow-up schedule
- Unable to converse, read or write English at elementary school level
- Unlikely to complete surveys at home, access to phone
- Incarcerated
- Coronavirus Disease 2019 (COVID-19) positive
Where
- Atlanta, Georgia
Collaborators
American Society for Surgery of the Hand, Ruth Jackson Orthopaedic Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2025 · Source of record for eligibility and locations