Upper Extremity Life Care Specialist (LCS)

NCT05422014 | Recruiting

• 1 other identifier: STUDY00004303
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Extremity Trauma

Keywords

Opioids

Outcome Measures

Primary Outcomes (5)

• Changes in Pain Numerical Rating Scale (NRS)

  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.

  Day 1, Week 2, Week 6, Month 3

• Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

  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.

  Day 1, Week 2, Week 6, Month 3

• Changes in PROMIS Physical Function Score

  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.

  Day 1, Week 2, Week 6, Month 3

• Changes in PROMIS Pain Interference Score

  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

  Day 1, Week 2, Week 6, Month 3

• Changes in PROMIS Prescription Pain Medication Misuse Score

  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).

  Day 1, Week 2, Week 6, Month 3

Secondary Outcomes (1)

• Inpatient Opioid Utilization

  During hospitalization (the average length of stay is 3.16 days)

Study Arms (2)

LCS Intervention

EXPERIMENTAL

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.

Behavioral: Life Care Specialist (LCS)

No LCS Intervention

NO 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.

Interventions

Life Care Specialist (LCS) BEHAVIORAL

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.

LCS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant
• Coronavirus Disease 2019 (COVID-19) positive

Sponsors & Collaborators

• Emory University: lead
• American Society for Surgery of the Hand: collaborator
• Ruth Jackson Orthopaedic Society: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Study Officials

• Nicole Zelenski, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Zelenski, MD

CONTACT

(404) 255-0226; nicole.ann.zelenski@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 16, 2022
• Study Start: October 17, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for sharing beginning after publication of results from this study and ending July 31 2025.
• Access Criteria: Data will be available for sharing with researchers who submit a proposal to the PI and have appropriate Institutional Review Board approval to conduct confirmatory analyses. Data will be shared via Emory approved secure share file transfer service or via Emory's Open Access Dataverse.

Locations

US (1)