NCT Number: NCT05821699
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.
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Notify Me15 year–45 year
All sexes
Interventional
Not applicable
Emory Orthopaedics and Spine Center, Atlanta, Georgia, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The LCS will work with the patient to create a pain management plan focused on behavioral education. The LCS interventions can encompass all, but not limited to, the information included below:
Patients will receive the current standard-of-care for pain management in the aftermath of surgery: 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.
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable". The NRS is a commonly used pain assessment tool in both clinical practice and research. However, the NRS is a single static measure of pain and does not capture the biopsychosocial presentations of pain including physical functioning. Inpatient NRS, which is recorded by the clinical care team throughout each day, will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital
Time frame: Baseline (Intraoperative and PACU) and 3 months post-surgery
Baseline (intraoperative and Post-Anesthesia Care Unit (PACU)) opioid utilization will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital. Opioid medication dosage will be transformed to morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day. Additionally, the study team will review participants' EHR at each study time point up to 3-months to determine MME throughout postoperative recovery and rehabilitation, and review medication in the MEMS cap.
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
The PROMIS Sleep Disturbance (PROMIS-SD) scale measures self-reported sleep quality, depth, and restoration over the past 7 days. Respondents report their capabilities to perform each task or symptom burden on a Likert scale from 5, "very much", to 1, "never". , with higher scores (T-scores) indicating greater, more severe disturbances. The raw scores of all items are summed before being transformed into t-scores, which range from 0 to 100. A T-score of 50 represents the average with a standard deviation of 10; lower scores indicate better sleep, while scores >=60 indicate mild-to-severe disruption, with higher scores signifying worse sleep.
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
This PROMIS PF scale measures self-reported capabilities. Respondents report their capabilities to perform each task or symptom burden on a Likert scale from 5, "without any difficulty", to 1, "unable to do". The raw scores of all items are summed before being transformed into t-scores. A T-score of 50 represents the average with a standard deviation of 10. Higher T-scores indicate better functioning, while scores below 50 reflect limitations.
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Self-reported pain interference with activities is assessed with the PROMIS Pain Interference - Short Form. Responses to the 4 items are given on a 5-point Likert scale from 1 to 5, no interference to much interference. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and standard deviation of 10. Scores above 50 indicate worse pain interference than the average person.
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
The PROMIS Global Health scale is a 10-item patient-reported survey evaluating overall physical and mental health. It produces two standardized T-scores (Physical/Mental), with a mean of 50 and a standard deviation (SD) of 10, where higher scores indicate better health. Scores <=55 are generally considered within normal limits, while scores below 40-45 indicate significant impairment.
Time frame: 1 month pre-surgery and 3 months post-surgery
The PROMIS Prescription Pain Medication Misuse (PROMIS-Rx Misuse) is a 22-item, patient-reported tool designed to assess the frequency and severity of prescription opioid abuse over the past three months. The 22-item bank uses a 5-point frequency scale (Never, Rarely, Sometimes, Often, Almost Always). Scores are scaled to a mean of 50 and a standard deviation of 10. A T-score of 60 indicates one SD above the average (higher risk), while 40 is one SD below. The scale does not have an officially established, clinically validated "cut-off" score for diagnosing misuse or addiction. Higher scores in this domain are often positively associated with pain intensity, depressive symptoms, and opioid-related side effects such as mental slowness or drowsiness.
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
The MAAS is a validated 15-item scale designed to assess a core characteristic of dispositional mindfulness, specifically open or receptive awareness of and attention to what is happening in the present. Each item is rated on a 6-point Likert scale (1 = Almost Always, 6 = Almost Never). The mean or total score is calculated, with higher scores indicating greater mindfulness (i.e., more awareness and attention to the present moment), and lower scores indicating more automatic or distracted behavior.
Time frame: 1 month pre-surgery, 2 weeks post-surgery
Study participants will be given a wrist actigraphy device during their hospitalization and recovery until their 2-week follow-up appointment with the surgical team or until the watch battery loses its charge, whichever occurs first.
Time frame: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Each participant will complete a questionnaire evaluating knowledge of signs and symptoms of opioid-involved overdose and details of naloxone utilization, if applicable. Higher scores indicate greater knowledge of how to identify and appropriately intervene during an overdose
Emory University
Other
Implementing and Evaluating the Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries to Improve Postoperative Outcomes
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