Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries

Implementing and Evaluating the Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries to Improve Postoperative Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Sports Medicine Injuries
• Intervention / Treatment: Behavioral: LCS (Life Care Specialist); Behavioral: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
    • Atlanta, Georgia, United States, 30329
      • Emory Orthopaedics and Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In Person LCS Intervention- With Opioid Risk Education; Patients will receive opioid education and Naloxone education. Therapeutic Intervention will include education on implementing mindfulness practices into postoperative recovery, known as the Community Resiliency Model CRM). Clinical Pain Coordination will include directed referrals for complex needs, including mental health and substance use disorders, as needed. All participants in the LCS intervention arm will also receive the current standard-of-care. The Community Resiliency Model (CRM) is a noncognitive variant of mindfulness, emphasizing attunement to interoceptive and exteroceptive signaling cues for regulation of autonomic responses to stress. CRM skills are introduced over a sixty-to-ninety-minute session, allowing for a brief introduction and application of skills by participants. These will be in person.	Behavioral: LCS (Life Care Specialist); 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: Opioid Risk Education; Therapeutic Intervention; Clinical Pain Coordination
Experimental: Virtual LCS Intervention-With Opioid Risk Education; Participants will receive opioid education, and Naloxone education. Therapeutic Intervention will include education on implementing mindfulness practices into postoperative recovery, known as the Community Resiliency Model CRM). Clinical Pain Coordination will include directed referrals for complex needs, including mental health and substance use disorders, as needed. All participants in the LCS intervention arm will also receive the current standard-of-care. The Community Resiliency Model (CRM) is a noncognitive variant of mindfulness, emphasizing attunement to interoceptive and exteroceptive signaling cues for regulation of autonomic responses to stress. CRM skills are introduced over a sixty-to-ninety-minute session, allowing for a brief introduction and application of skills by participants. These will be in performed virtually via a digital conferencing platform	Behavioral: LCS (Life Care Specialist); 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: Opioid Risk Education; Therapeutic Intervention; Clinical Pain Coordination
Active Comparator: No LCS intervention; Patients will receive the current standard-of-care for pain management in the aftermath of surgery, 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.	Behavioral: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Numerical Rating Scale (NRS)	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	1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Opioid Utilization	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.	Baseline (Intraoperative and PACU) and 3 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance (SD)	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.	1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS- Physical Function (PF)	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.	1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS - Pain Interference	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.	1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS - Global Health Scale	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.	1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
PROMIS Prescription Misuse Scores	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.	1 month pre-surgery and 3 months post-surgery
Mindful Attention Awareness Scale (MAAS)	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.	1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Actigraphy Based Sleep Data	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.	1 month pre-surgery, 2 weeks post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Overdose Knowledge Scale (OOKS)	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	1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Football League
• Investigators: Principal Investigator: Nicholas A Giordano, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): September 19, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative outcome; Personalized Pain Coach; Life Care Specialist
• Additional Relevant MeSH Terms: Wounds and Injuries; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: STUDY00004925; 2025P009229 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in articles, after deidentification
• IPD Sharing Time Frame: Beginning 9 months after study completions and ending 24 months after study completion
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by the Emory IRB and their institution's affiliated IRB and any necessary data use agreements overseen by Emory. Requests should be sent directly to the PI via email summarizing the purpose of utilizing the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No