Life Care Specialist for Upper Extremity Injury

Overseen By Nicole Zelenski, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Non-English speakers, Incarcerated, Pregnant, COVID-19 positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the benefits of a Life Care Specialist (LCS) for individuals with upper arm or shoulder injuries requiring surgery. The trial compares two groups: one receives standard pain management care, while the other receives additional support from an LCS, including education on safe opioid use, mental health support, and relaxation techniques. It suits those who have undergone surgery for an arm injury, possess a working cellphone, and can read and write in English. As an unphased trial, this study provides a unique opportunity to access extra support and resources during recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Life Care Specialist (LCS) intervention is safe for patients with upper extremity injuries?

Research shows that treatments for arm and shoulder injuries are generally safe and well-tolerated. Studies have found that even severe injuries in these areas have low death rates. For instance, one study reported a death rate of just 1% among patients with serious arm injuries affecting blood vessels, indicating that treatments for these injuries are effective and carry minimal risk.

The Life Care Specialist (LCS) treatment includes components like education about opioids and mental health support, designed to help patients manage pain and reduce the risk of opioid misuse. The trial phase being "not applicable" suggests that the treatment is likely considered safe enough to not require traditional phased testing.

Although specific studies have not directly assessed the safety of LCS, the focus remains on providing safe, supportive care. The treatment includes standard practices like pain management and mental health referrals, which are generally safe and helpful for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Life Care Specialist (LCS) intervention is unique because it combines opioid risk education, therapeutic interventions like the Community Resiliency Model (CRM) and sound therapy, and clinical pain coordination, all alongside the standard pain management protocols. Unlike typical treatments that focus primarily on medication, LCS emphasizes a holistic approach by addressing mental health and potential substance use disorders. Researchers are excited about this treatment because it not only aims to manage pain but also proactively educates patients on opioid risks and incorporates mental health support, potentially leading to better overall recovery outcomes.

What evidence suggests that the Life Care Specialist is effective for upper extremity injury?

Research has shown that injuries to the arms or hands can significantly impact a person's quality of life, leading to longer hospital stays and more complex recovery processes. Studies have found that individuals with these injuries often encounter mental health challenges, complicating their recovery. In this trial, some participants will receive Life Care Specialist (LCS) interventions, which aim to assist by providing education about pain medications, mental health support, and relaxation therapies such as sound therapy. This comprehensive approach is designed to manage pain and enhance overall well-being and strength during recovery. Early evidence suggests that these interventions could help patients better cope with the physical and emotional effects of their injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Nicole Zelenski, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Informed consent obtained

I need surgery for an injury to my arm or hand.

Working cellphone

Exclusion Criteria

Incarcerated

I have tested positive for COVID-19.

Unlikely to complete surveys at home, access to phone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard-of-care or LCS intervention for pain management and opioid misuse prevention

12 weeks

Visits at Day 1, Week 2, Week 6, Month 3

Follow-up

Participants are monitored for changes in physical function, pain medication misuse, pain intensity, sleep disturbance, and pain interference

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Life Care Specialist (LCS)

Trial Overview 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.

How Is the Trial Designed?

Group I: LCS Intervention Experimental Treatment 1 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 Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

American Society for Surgery of the Hand

Collaborator

Trials

11

Recruited

1,100+

Ruth Jackson Orthopaedic Society

Collaborator

Trials

1

Recruited

80+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4153528/

Assessment of the relationship between Quality of Life and ... This study shows that upper extremity impairment due to occupational injuries has an inverse and significant association with various aspects of quality of ...

2. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(21)00754-0/fulltext

The impact of upper-extremity injuries on polytrauma ... Upper-extremity injuries in polytrauma patients are associated with a longer hospitalization, longer intensive care unit stay, and reduced mortality rate.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/1558944717725373

The Use of Psychosocial Services Post Hand and Upper ... Research has shown that patients who have sustained hand and upper limb traumas may suffer from acute and long-term psychological difficulties.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40227360/

Management of upper limb vascular injuries and their ... Results: 69 cases of upper extremity vascular trauma were included. The limb salvage rate was 94%, and the mortality rate was 0%.

5. academic.oup.com academic.oup.com/milmed/article/188/7-8/e1395/6524357

Upper-Extremity Vascular Exposures for Trauma Study outcomes demonstrated significant differences between the baseline performance abilities of the two groups, with general surgeons ...

6. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00925-X/fulltext

Current outcomes following upper and lower extremity ... The overall rate of mortality and amputation was 3% and 11%, respectively. The authors identified that the prognosticators for amputation were ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3949930/

Long-term outcomes after upper limb arterial injuries - PMC Concomitant fractures or nerve injuries in the upper limb were present in 80% and 86% of the patients, respectively. Long-term follow-up data (mean 2 years) ...

8. jvascsurg.org jvascsurg.org/article/S0741-5214(23)02284-X/fulltext

Long-term functional outcomes of upper extremity civilian ... Key Findings: Management of upper extremity vascular trauma in 150 patients resulted in mortality rates of 1% and limb salvage rate of 96%.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8723794/

Predicting and Monitoring Upper-Limb Rehabilitation ... This study aimed to investigate the use of wearable technology in combination with clinical data to predict and monitor the recovery process.

10. sciencedirect.com sciencedirect.com/science/article/pii/S1058274621007540

The impact of upper-extremity injuries on polytrauma ... Upper-extremity injuries in polytrauma patients are associated with a longer hospitalization, longer intensive care unit stay, and reduced mortality rate.