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

Primary Purpose

Sports Medicine Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LCS (Life Care Specialist)
Standard of Care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sports Medicine Injuries focused on measuring Personalized Pain Coach, Postoperative outcome, Life Care Specialist

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults between 18-45 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 prior to injury BMI <40 will be eligible. 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 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 the all surveys are validated in English.

Sites / Locations

  • Grady Memorial HospitalRecruiting
  • Emory Orthopaedics and Spine CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

In Person LCS Intervention- With Opioid Risk Education

Virtual LCS Intervention-With Opioid Risk Education

No LCS intervention

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Changes in 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 indicating greater knowledge on how to identify and appropriately intervene during an overdose
Changes to PROMIS
Sleep Disturbance, Physical Function, Pain Interference, Prescription Pain Medication Misuse. These PROMIS measures capture their respective domains of health. 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". All items' raw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function, whereas higher scores on the other domains indicate worse symptom presentation.
Changes in Mindful Attention Awareness Scale (MAAS)
The MAAS is a validated 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present
Changes to Actigraphy based sleep and activity data
Study participants will be provided with a wrist actigraphy device to wear during their hospitalization and throughout their recovery.

Full Information

First Posted
April 7, 2023
Last Updated
September 13, 2023
Sponsor
Emory University
Collaborators
National Football League
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1. Study Identification

Unique Protocol Identification Number
NCT05821699
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Football League

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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 coordinate 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 interventions arms where they will work with a Life Care Specialists 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 interventions arms where they will work with a Life Care Specialists 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Medicine Injuries
Keywords
Personalized Pain Coach, Postoperative outcome, Life Care Specialist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In Person LCS Intervention- With Opioid Risk Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual LCS Intervention-With Opioid Risk Education
Arm Type
Experimental
Arm Description
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
Arm Title
No LCS intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LCS (Life Care Specialist)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes Pain numerical rating scale (NRS)
Description
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
1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Title
Changes to Opioid utilization
Description
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.
Time Frame
1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Secondary Outcome Measure Information:
Title
Changes in Opioid Overdose Knowledge Scale (OOKS)
Description
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 indicating greater knowledge on how to identify and appropriately intervene during an overdose
Time Frame
1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Title
Changes to PROMIS
Description
Sleep Disturbance, Physical Function, Pain Interference, Prescription Pain Medication Misuse. These PROMIS measures capture their respective domains of health. 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". All items' raw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function, whereas higher scores on the other domains indicate worse symptom presentation.
Time Frame
1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Title
Changes in Mindful Attention Awareness Scale (MAAS)
Description
The MAAS is a validated 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present
Time Frame
1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Title
Changes to Actigraphy based sleep and activity data
Description
Study participants will be provided with a wrist actigraphy device to wear during their hospitalization and throughout their recovery.
Time Frame
1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults between 18-45 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 prior to injury BMI <40 will be eligible. 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 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 the all surveys are validated in English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas A Giordano, PhD
Phone
404.727.7980
Email
nicholas.a.giordano@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas A Giordano, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas A Giordano, PhD
Phone
404-727-7980
Email
nicholas.a.giordano@emory.edu
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas A Giordano, PhD
Phone
404-727-7980
Email
nicholas.a.giordano@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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