Trial Outcomes & Findings for Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries (NCT NCT05821699)
NCT ID: NCT05821699
Last Updated: 2026-05-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgery
Results posted on
2026-05-19
Participant Flow
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.
Participant milestones
| Measure |
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
50
|
|
Overall Study
COMPLETED
|
41
|
44
|
48
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
2
|
Reasons for withdrawal
| Measure |
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
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.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
No LCS Intervention
n=50 Participants
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.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.36 years
STANDARD_DEVIATION 8.69 • n=49 Participants
|
29.94 years
STANDARD_DEVIATION 8.11 • n=49 Participants
|
27.43 years
STANDARD_DEVIATION 7.17 • n=50 Participants
|
29.7 years
STANDARD_DEVIATION 8.10 • n=148 Participants
|
|
Sex/Gender, Customized
Female
|
21 Participants
n=49 Participants
|
14 Participants
n=49 Participants
|
26 Participants
n=50 Participants
|
61 Participants
n=148 Participants
|
|
Sex/Gender, Customized
Male
|
28 Participants
n=49 Participants
|
34 Participants
n=49 Participants
|
24 Participants
n=50 Participants
|
86 Participants
n=148 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=49 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=148 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
49 participants
n=49 Participants
|
50 participants
n=50 Participants
|
148 participants
n=148 Participants
|
PRIMARY outcome
Timeframe: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
Pain Numerical Rating Scale (NRS)
Baseline (1 month pre-surgery)
|
2.98 score on a scale
Standard Deviation 2.43
|
3.24 score on a scale
Standard Deviation 2.40
|
3.04 score on a scale
Standard Deviation 2.07
|
|
Pain Numerical Rating Scale (NRS)
2 weeks post-surgery
|
2.48 score on a scale
Standard Deviation 2.17
|
3.02 score on a scale
Standard Deviation 1.98
|
3.05 score on a scale
Standard Deviation 1.80
|
|
Pain Numerical Rating Scale (NRS)
6 weeks post-surgery
|
2.04 score on a scale
Standard Deviation 1.90
|
1.76 score on a scale
Standard Deviation 1.79
|
1.90 score on a scale
Standard Deviation 1.45
|
|
Pain Numerical Rating Scale (NRS)
3 months post-surgery
|
1.52 score on a scale
Standard Deviation 1.69
|
1.14 score on a scale
Standard Deviation 1.26
|
1.36 score on a scale
Standard Deviation 1.38
|
PRIMARY outcome
Timeframe: Baseline (Intraoperative and PACU) and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
Opioid Utilization
Baseline (Intraoperative and PACU)
|
10.00 MME/day
Interval 3.12 to 19.38
|
10.00 MME/day
Interval 0.0 to 16.7
|
10.00 MME/day
Interval 0.0 to 15.0
|
|
Opioid Utilization
3 months post- surgery
|
12.60 MME/day
Interval 7.5 to 16.96
|
9.00 MME/day
Interval 7.5 to 15.0
|
10.62 MME/day
Interval 7.5 to 15.0
|
SECONDARY outcome
Timeframe: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance (SD)
Baseline (1 month pre-surgery)
|
50.22 T-Score
Standard Deviation 7.84
|
49.17 T-Score
Standard Deviation 8.26
|
46.92 T-Score
Standard Deviation 9.53
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance (SD)
2 weeks post-surgery
|
54.88 T-Score
Standard Deviation 7.49
|
53.03 T-Score
Standard Deviation 7.60
|
51.49 T-Score
Standard Deviation 8.70
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance (SD)
6 weeks post-surgery
|
50.61 T-Score
Standard Deviation 7.65
|
48.54 T-Score
Standard Deviation 8.08
|
46.76 T-Score
Standard Deviation 6.95
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance (SD)
3 months post-surgery
|
48.39 T-Score
Standard Deviation 7.14
|
45.40 T-Score
Standard Deviation 9.88
|
44.42 T-Score
Standard Deviation 9.06
|
SECONDARY outcome
Timeframe: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
PROMIS- Physical Function (PF)
Baseline (1 month pre-surgery)
|
40.11 T-Score
Standard Deviation 5.86
|
41.14 T-Score
Standard Deviation 7.43
|
40.95 T-Score
Standard Deviation 5.99
|
|
PROMIS- Physical Function (PF)
2 weeks post-surgery
|
34.36 T-Score
Standard Deviation 6.63
|
35.73 T-Score
Standard Deviation 6.59
|
34.90 T-Score
Standard Deviation 6.39
|
|
PROMIS- Physical Function (PF)
6 weeks post-surgery
|
39.56 T-Score
Standard Deviation 6.07
|
43.48 T-Score
Standard Deviation 8.60
|
42.05 T-Score
Standard Deviation 8.04
|
|
PROMIS- Physical Function (PF)
3 months post-surgery
|
45.35 T-Score
Standard Deviation 6.10
|
47.08 T-Score
Standard Deviation 8.22
|
47.59 T-Score
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
PROMIS - Pain Interference
Baseline (1 month pre-surgery)
|
59.71 T-Score
Standard Deviation 7.01
|
58.69 T-Score
Standard Deviation 8.08
|
58.67 T-Score
Standard Deviation 7.49
|
|
PROMIS - Pain Interference
2 weeks post-surgery
|
58.94 T-Score
Standard Deviation 7.48
|
60.05 T-Score
Standard Deviation 7.02
|
58.65 T-Score
Standard Deviation 7.00
|
|
PROMIS - Pain Interference
6 weeks post-surgery
|
54.80 T-Score
Standard Deviation 7.03
|
54.08 T-Score
Standard Deviation 7.31
|
53.52 T-Score
Standard Deviation 6.45
|
|
PROMIS - Pain Interference
3 months post-surgery
|
52.23 T-Score
Standard Deviation 7.56
|
50.72 T-Score
Standard Deviation 8.06
|
51.59 T-Score
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
PROMIS - Global Health Scale
Baseline (1 month pre-surgery)
|
44.57 T-Score
Standard Deviation 5.30
|
46.58 T-Score
Standard Deviation 5.26
|
46.92 T-Score
Standard Deviation 6.33
|
|
PROMIS - Global Health Scale
2 weeks post-surgery
|
41.19 T-Score
Standard Deviation 6.25
|
42.84 T-Score
Standard Deviation 5.70
|
43.49 T-Score
Standard Deviation 6.60
|
|
PROMIS - Global Health Scale
6 weeks post-surgery
|
41.16 T-Score
Standard Deviation 6.02
|
41.92 T-Score
Standard Deviation 4.98
|
43.22 T-Score
Standard Deviation 4.85
|
|
PROMIS - Global Health Scale
3 months post-surgery
|
41.27 T-Score
Standard Deviation 4.26
|
42.75 T-Score
Standard Deviation 4.92
|
43.53 T-Score
Standard Deviation 3.95
|
SECONDARY outcome
Timeframe: 1 month pre-surgery and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
PROMIS Prescription Misuse Scores
Baseline (1 month pre-surgery)
|
42.34 T-Score
Standard Deviation 1.34
|
42.15 T-Score
Standard Deviation 1.28
|
43.89 T-Score
Standard Deviation 4.07
|
|
PROMIS Prescription Misuse Scores
3 months post-surgery
|
42.33 T-Score
Standard Deviation 1.87
|
42.24 T-Score
Standard Deviation 2.17
|
42.65 T-Score
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=50 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=49 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=49 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
Mindful Attention Awareness Scale (MAAS)
Baseline (1 month pre-surgery)
|
4.33 score on a scale
Standard Deviation 0.84
|
4.60 score on a scale
Standard Deviation 0.90
|
4.34 score on a scale
Standard Deviation 0.79
|
|
Mindful Attention Awareness Scale (MAAS)
2 weeks post-surgery
|
4.30 score on a scale
Standard Deviation 0.86
|
4.66 score on a scale
Standard Deviation 0.92
|
4.47 score on a scale
Standard Deviation 0.87
|
|
Mindful Attention Awareness Scale (MAAS)
6 weeks post-surgery
|
4.45 score on a scale
Standard Deviation 0.94
|
4.64 score on a scale
Standard Deviation 0.96
|
4.58 score on a scale
Standard Deviation 0.92
|
|
Mindful Attention Awareness Scale (MAAS)
3 months post-surgery
|
4.57 score on a scale
Standard Deviation 0.85
|
4.83 score on a scale
Standard Deviation 0.99
|
4.80 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 1 month pre-surgery, 2 weeks post-surgeryPopulation: Participants analyzed include those who completed the required protocol tasks at the specified time points and had valid data available for analysis.
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.
Outcome measures
| Measure |
No LCS Intervention
n=45 Participants
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.
|
In Person LCS Intervention- With Opioid Risk Education
n=38 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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
Virtual LCS Intervention-With Opioid Risk Education
n=41 Participants
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:
* Opioid Risk Education
* Therapeutic Intervention
* Clinical Pain Coordination
|
|---|---|---|---|
|
Actigraphy Based Sleep Data
2 weeks post-surgery
|
326.93 minutes of sleep per day
Standard Deviation 185.08
|
316.97 minutes of sleep per day
Standard Deviation 165.86
|
342.39 minutes of sleep per day
Standard Deviation 206.34
|
|
Actigraphy Based Sleep Data
Baseline (pre-surgery)
|
394.85 minutes of sleep per day
Standard Deviation 239.56
|
422.99 minutes of sleep per day
Standard Deviation 270.28
|
423.98 minutes of sleep per day
Standard Deviation 266.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month pre-surgery, 2 weeks, 6 weeks, and 3 months post-surgeryPopulation: 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.
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
Outcome measures
Outcome data not reported
Adverse Events
In Person LCS Intervention- With Opioid Risk Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Virtual LCS Intervention-With Opioid Risk Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No LCS Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place