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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Life Care Specialist (LCS) for upper extremity injury?

While there is no direct evidence about the Life Care Specialist treatment, research highlights the importance of follow-up care and outcome measurement in upper extremity injuries, which are key components of effective treatment. Advances like telemedicine and remote monitoring are improving patient outcomes, suggesting that comprehensive care approaches can be beneficial. ^{1 2 3 4 5}

How does the Life Care Specialist treatment for upper extremity injury differ from other treatments?

The Life Care Specialist treatment for upper extremity injury is unique because it likely involves a multidisciplinary approach, similar to the UPPER Program, which includes a team of specialists like physiatrists, occupational therapists, and pain psychologists working together to evaluate and treat patients. This comprehensive team-based approach is different from the usual care where patients are treated by individual physicians and therapists. ^{1 4 6 7 8}

Research Team

Nicole Zelenski, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Injuries to the upper extremities in polytrauma: limited effect on outcome more than ten years after injury - a cohort study in 629 patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Novel Tools to Approach and Measure Outcomes in Patients with Fractures. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Identifying successful outcomes and important factors to consider in upper limb amputation rehabilitation: an international web-based Delphi survey. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mental health and psychosocial support for children with upper limb musculoskeletal conditions. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Factors Influencing the In-hospital Outcome of Injuries of the Upper Extremity]. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

Long-term outcomes after upper limb arterial injuries. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Injuries to the upper extremity: patterns of occurrence. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary team evaluation of upper extremity injuries in a single visit: the UPPER Program. [2019]