Clinical trial NCT05422014: Upper Extremity Life Care Specialist (LCS)
Official title: Life Care Specialist (LCS) - Pain Management and Prevention of Substance Misuse in Upper Extremity Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Extremity Trauma
Keywords: Opioids
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Society for Surgery of the Hand
name: Ruth Jackson Orthopaedic Society
First posted: 2022-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Opioids are psychoactive substances (narcotics) primarily used for pain relief by producing euphoric effects. Although regularly prescribed by physicians, opioids are highly addictive. Examples include, but are not limited to, morphine, codeine, and oxycodone. Opioids block feelings of pain and trigger a release of dopamine. Dependence occurs with repeated use, as the parts of the brain naturally responsible for releasing dopamine rely on the drug for proper function. When avoided, patients can quickly experience severe withdrawal symptoms similar to the flu. In the United States, more than 115 people die from opioid overdose every day. Despite a year-over-year increase in opioid overdose deaths since the year 2000, opioids remain among the most effective medications providers can offer to control pain. Addiction treatment costs near $78.5 billion and rising, less than 10% of people in need receive treatment. Trauma patients are more likely than other types of patients to be under the influence of psychoactive drugs and alcohol use. The strongest risk factor for developing opioid use disorder is pre-existing substance use disorder. Risk factors for opioid overdose mortality include: middle age, history of substance abuse, including prescription and illicit drugs and alcohol, comorbid mental and medical condition, methadone use, unemployment, polysubstance abuse, opioid naivety, sleep apnea, and pain intensity; these are all conditions representative of typical U.S. trauma patient populations. This significant overlap places high importance on implementing alternative solutions to pain management within this population, and aligns with the Center for Disease Control and Prevention, National Conference for Immunization Coalitions and Partnerships (NCICP) research priority alignment to develop and evaluate an innovative prevention strategy to prevent overdose, including those at greatest risk.

According to studies of patients discharged from the hospital after being prescribed a new medication:

* 86% were aware that they had been prescribed new medications.
* Fewer could identify the name (64%) or number (74%) of their new medications of their dosages (56%), the schedule to take them (68%), or the purpose of the prescription (64%.)
* Only 22% could name at least one adverse effect.
* Only 11% could recall being told of any adverse effects.

Orthopaedic surgeons are the third-most frequent providers of opioid prescription medications among physicians, and orthopaedic surgical patients are at the highest risk of chronic postoperative opioid use. Orthopaedic trauma surgeons face a very difficult task in managing acute pain and the consequences associated with over-prescription of opioid analgesics. Most patients with orthopaedic trauma injuries have very painful injuries and need appropriate pain control.

The Christopher Wolf Crusade (CWC) is a non-profit providing preventative solutions, education, and advocacy for the American opioid epidemic. CWC proposes to introduce a Life Care Specialist (LCS) as an integral member of the clinical team, with a focus on "pain coaching" for trauma patients. In an analogous role served by Certified Child Life Specialists (CCLS) in pediatrics, the LCS will introduce orthopaedic trauma patients to non-pharmacologic coping strategies for pain. Further, LCS will provide much needed patient-centric education on individualized risk for opioid misuse, as well as overdose prevention and safe disposal of unused opioids.

This randomized control trial is aimed at learning more about LCS position and the value it provides to the patient's who have sustained upper extremity traumas.

Eligibility criteria: 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
* Pregnant
* Coronavirus Disease 2019 (COVID-19) positive

Primary outcomes:
measure: Changes in Pain Numerical Rating Scale (NRS)
timeFrame: Day 1, Week 2, Week 6, Month 3
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
timeFrame: Day 1, Week 2, Week 6, Month 3
measure: Changes in PROMIS Physical Function Score
timeFrame: Day 1, Week 2, Week 6, Month 3
measure: Changes in PROMIS Pain Interference Score
timeFrame: Day 1, Week 2, Week 6, Month 3
measure: Changes in PROMIS Prescription Pain Medication Misuse Score
timeFrame: Day 1, Week 2, Week 6, Month 3
Secondary outcomes:
measure: Inpatient Opioid Utilization
timeFrame: During hospitalization (the average length of stay is 3.16 days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Nicole Zelenski, MD
role: PRINCIPAL_INVESTIGATOR
References: