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

NCT05821699 | Recruiting

• 1 other identifier: STUDY00004925
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Sports Medicine Injuries

Keywords

Personalized Pain Coach; Postoperative outcome; Life Care Specialist

Outcome Measures

Primary Outcomes (2)

• Changes 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

• Changes to Opioid utilization

  Inpatient and operating room 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 MEMS cap.

  1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

Secondary Outcomes (4)

• Changes in Opioid Overdose Knowledge Scale (OOKS)

  1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

• Changes to PROMIS

  1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

• Changes in Mindful Attention Awareness Scale (MAAS)

  1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

• Changes to Actigraphy based sleep and activity data

  1 month pre-surgery, 2 weeks post-surgery

Study Arms (3)

In Person LCS Intervention- With Opioid Risk Education

EXPERIMENTAL

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)

Virtual LCS Intervention-With Opioid Risk Education

EXPERIMENTAL

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)

No LCS intervention

ACTIVE COMPARATOR

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

Interventions

LCS (Life Care Specialist) BEHAVIORAL

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

In Person LCS Intervention- With Opioid Risk Education; Virtual LCS Intervention-With Opioid Risk Education

Standard of Care BEHAVIORAL

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.

No LCS intervention

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Football League: collaborator

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nicholas A Giordano, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas A Giordano, PhD

CONTACT

404.727.7980; nicholas.a.giordano@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: August 17, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months after study completions and ending 24 months after study completion
• 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.

Locations

US (2)