Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025P009229 | Other Identifier | Emory Insight Humans IRB |
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| Name | Class |
|---|---|
| National Football League | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| No LCS intervention | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas A Giordano, PhD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory Orthopaedics and Spine Center |
Individual participant data that underlie the results reported in articles, after deidentification
Beginning 9 months after study completions and ending 24 months after study completion
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.
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Participants were recruited from Emory Healthcare Orthopedics and Spine Center and Grady Memorial Hospital in Atlanta, Georgia, USA. Participant enrollment began August 17, 2023, and all follow-up was completed by September 19, 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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:
|
| FG001 | 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 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:
|
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery |
|
Information on adverse events was collected beginning at the time consent to participate in the study up to three (3) months post-surgery.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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:
|
Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas A Giordano, PhD | Emory University | 404.727.7980 | nicholas.a.giordano@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2024 | Oct 21, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
|
|
| 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. |
|
| 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 |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| BG001 | 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 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:
|
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. 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:
|
| OG001 | 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 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:
|
| OG002 | 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. 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. |
|
|
| Primary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Median | Inter-Quartile Range | MME/day | Baseline (Intraoperative and PACU) and 3 months post-surgery |
|
|
|
| Secondary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | T-Score | 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery |
|
|
|
| Secondary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | T-Score | 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery |
|
|
|
| Secondary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | T-Score | 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery |
|
|
|
| Secondary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | T-Score | 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery |
|
|
|
| Secondary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | T-Score | 1 month pre-surgery and 3 months post-surgery |
|
|
|
| Secondary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery |
|
|
|
| Secondary | 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. | Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis. | Posted | Mean | Standard Deviation | minutes of sleep per day | 1 month pre-surgery, 2 weeks post-surgery |
|
|
|
| Other Pre-specified | 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 | This survey measure was not included in the study at the recommendation of the community advisory board to reduce survey burden on participants. This pre-specified study outcome was exploratory in nature (not Primary or Secondary), and data were therefore not collected. Data collection and analysis for this measure will not be conducted in the future. | Posted | 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery |
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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 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:
| 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | 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. 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. | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 3 months post- surgery |
|
|
| 2 weeks post-surgery |
|
|
| 6 weeks post-surgery |
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| 3 months post-surgery |
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| 2 weeks post-surgery |
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| 6 weeks post-surgery |
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| 3 months post-surgery |
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| 2 weeks post-surgery |
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| 6 weeks post-surgery |
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| 3 months post-surgery |
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| 2 weeks post-surgery |
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| 6 weeks post-surgery |
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| 3 months post-surgery |
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| 3 months post-surgery |
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| 2 weeks post-surgery |
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| 6 weeks post-surgery |
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| 3 months post-surgery |
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| 2 weeks post-surgery |
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