Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05821699
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-04-07
Brief Title:
Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Implementing and Evaluating the Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries to Improve Postoperative Outcomes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 teams 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 eg 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
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 teams 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None