Clinical trial NCT05821699: Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries
Official title: Implementing and Evaluating the Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries to Improve Postoperative Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sports Medicine Injuries
Keywords: Personalized Pain Coach
Postoperative outcome
Life Care Specialist
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Football League
First posted: 2023-04-20
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients experiencing sports medicine-related injuries are particularly vulnerable to developing both chronic pain and experiencing prolonged opioid use. This multiarmed randomized controlled trial will quantify the impact of integrating Life Care Specialists, and pain management-focused paraprofessionals, have on increasing access to multimodal pain management approaches and subsequently optimizing both patient-reported pain-related outcomes and objective measures of activity. Life Care Specialists work with patients and clinicians on implementing non-pharmacological pain management approaches, specifically teaching participants how to implement mindfulness-based skills into their recovery, systematically conducting standardized biopsychosocial pain assessments, and coordinating care. By developing a toolbox of pain management approaches with the support of the Life Care Specialist, patients are well positioned to incorporate evidence-based pain management approaches into their recovery that result in improved psychosocial functioning and reduced opioid medication utilization. In total, 150 individuals with sports medicine injuries will be randomized to one of two intervention arms where they will work with a Life Care Specialist in person or over telehealth or receive standard-of-care written postoperative instructions for pain management. Patient-reported outcomes, objective actigraphy movement outcomes captured using wrist-based watches, and opioid utilization captured using medication event monitoring system (MEMS) caps will be evaluated over 3-months postoperatively for a total of 4 study visits.

Detailed description: Longitudinal analyses indicate that both greater pain severity and duration precede poor functioning and prolonged opioid use. This finding suggests that optimizing pain management, soon after painful events, such as orthopaedic injury, is vital to reducing risks related to prolonged opioid use. However, opioid-dominant pain management, which remains the standard of care across many health systems and in orthopaedic surgery, elevates the risks for ineffective pain management and, subsequently, opioid dependency by only targeting a select number of pain receptors.

Multimodal analgesia, which combines analgesic drugs from different classes and employs analgesic techniques that target multiple pain-related receptors, is recommended in the treatment of acute postoperative pain because its synergistic effect maximizes pain relief at lower analgesic doses, thereby reducing the risk of adverse opioid-related effects and chronic pain.

The study team's interdisciplinary team has developed and tested a novel clinical care team role focused on optimizing pain management after surgery, known as a Life Care Specialist. Life Care Specialists provide patient-centered pain management care coordination, teach patients how to implement non-pharmacological pain management approaches, and deliver opioid safety-focused pain education, not only during acute hospitalization but also throughout postoperative recovery.

Life Care Specialists provide pain-focused care coordination for patients with complex needs after orthopedic injury, including communicating patient care needs and goals of care to clinical care team members (e.g. surgeons, acute pain service, physical therapy, nursing staff), connecting patients to yoga instructors, massage therapists, and engaging behavioral health consults to work with patients over time to improve biopsychosocial pain presentations.

For this trial, 150 individuals with sports medicine injuries will be randomized to one of two intervention arms where they will work with a Life Care Specialist in person or over telehealth or receive standard-of-care written postoperative instructions for pain management. Patient-reported outcomes, objective actigraphy movement outcomes captured using wrist-based watches, and opioid utilization captured using MEMS caps will be evaluated over 3-months postoperatively for a total of 4 study visits.

Eligibility criteria: Inclusion Criteria:

* Adults between 15-45 years old
* Scheduled for orthopedic surgery due to sports medicine injuries (e.g., anterior cruciate ligament tears, meniscus injury, rotator cuff injury, etc.), who are actively employed or full-time athletes before injury

Exclusion Criteria:

* Individuals unable to provide consent
* Those undergoing revision procedures
* Individuals without access to an internet-connected device
* Individuals who are unemployed or retired at the time of injury will be ineligible.
* Individuals who are incarcerated or pregnant will not be eligible.
* Individuals unable to communicate in English will be excluded since all surveys are validated in English.

Primary outcomes:
measure: Changes Pain numerical rating scale (NRS)
timeFrame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
measure: Changes to Opioid utilization
timeFrame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Secondary outcomes:
measure: Changes in Opioid Overdose Knowledge Scale (OOKS)
timeFrame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
measure: Changes to PROMIS
timeFrame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
measure: Changes in Mindful Attention Awareness Scale (MAAS)
timeFrame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
measure: Changes to Actigraphy based sleep and activity data
timeFrame: 1 month pre-surgery, 2 weeks post-surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Orthopaedics and Spine Center
state: Georgia
Study officials:
affiliation: Assistant Professor
name: Nicholas A Giordano, PhD
role: PRINCIPAL_INVESTIGATOR
References: