Opioid Use
Conditions
Keywords
Orthopedic surgery, Opioid addiction, Rehabilitation, Behavioral research
Brief summary
The overall hypothesis of this randomized-controlled trial is that the introduction of a Life Care Specialist (LCS) as a novel member of the clinical care team will help reduce opioid utilization, decrease pain scores, and improve patient understanding of their addiction risk in the aftermath of orthopaedic trauma.
Detailed description
Opioids are psychoactive substances (narcotics) primarily used for pain relief by producing morphine-like effects. Although regularly prescribed by physicians, opioids (including morphine, codeine, and oxycodone) are highly addictive. Opioids block feelings of pain and trigger a release of dopamine. Dependence occurs with repeated use, as the parts of the brain naturally responsible for releasing dopamine rely on the drug for proper function. When avoided, patients quickly experience severe withdrawal symptoms similar to the flu. In the United States, millions are prescribed opioids for pain relief. Every day, more than 115 people die from overdose. The highest among them are people aged 25 to 54 years. Addiction treatment costs near $78.5 billion and rising, less than 10% of people in need are receiving it. Within the orthopaedic trauma population at Grady Healthcare in Atlanta, Georgia, 20% of patients report a history of substance abuse, 30% have previously used opioid medications for pain, and nearly 25% report taking opioid pain medications up to 1 year after their trauma. Trauma patients are particularly at high risk. The Christopher Wolf Crusade (CWC) is a 501C3 non-profit providing preventative solutions, education, and advocacy for the American opioid epidemic. CWC's primary focus is to introduce a behavior-specific intervention at the time of inpatient hospitalization for trauma to decrease overall opioid utilization and improve pain control in the post-trauma time period. The goal of this study is to introduce the LCS to the healthcare field to focus on pain management and addiction prevention for patients. The LCS is a behavior-based pain coach who educates patients on risks of opioid dependence and offers non-traditional non-pharmacologic options for pain control. In addition, the LCS will act as a liaison between the patient and the physician to ensure that traditional pharmacologic-based pain control regimens are optimized. The pain management protocol was refined through a pilot, single-center study where the LCS provided personalized pain management strategies to patients combating pain. Participants in the single-arm pilot portion of the study were enrolled beginning in February 2020 and data collection for these 121 participants was completed April 15, 2021. The clinical trial portion of this study will include 200 patients who will be consented, enrolled, and randomized in a 1:1 fashion to A) receive the current standard-of-care for pain management in the aftermath of trauma or B) additional LCS intervention. All participants will have the same quantity and quality of interaction with their usual clinical providers and will be followed in the orthopaedic trauma clinic at routine post-operative intervals (2 weeks, 6 weeks and 3 months post-operatively).
Interventions
BEHAVIORALLife Care Specialist (LCS) Intervention
The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.
OTHERClinical Coordination with Referrals
The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.
BEHAVIORALPilot Study of Pain Management Strategies
Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse.
Sponsors
Christopher Wolf Crusade (CWC)
Centers for Disease Control and Prevention
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
There were 121 participants in the single-arm pilot trial of this study where the intervention was refined. The clinical trial portion of this study randomizes participants to receive the intervention or the standard of care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Single-Arm Pilot Portion of this Study: * Orthopaedic trauma patients with planned surgical procedure * Informed consent obtained
Exclusion criteria
for Single-Arm Pilot Portion of this Study: * Enrolled in a study that does not permit co-enrollment * Unlikely to comply with the follow-up schedule * Unable to converse, read or write English or Spanish at elementary school level Inclusion Criteria for Clinical Trial Portion of this Study: * Orthopaedic trauma patients with an isolated injury requiring surgery * Informed consent obtained * Functioning cellphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale Average Pain Score | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | For participants in the single-arm pilot study and in the dual-arm, clinical-trial portion of the study, daily pain within the last 24 hours was assessed using a 10-point Likert scale where 1 = no pain and 10 = severe pain. After Week 2, pain was assessed only during the follow-up visits. |
| Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score | Month 3 | The number of participants in the dual-arm, clinical-trial portion of the study reporting a decrease in the NRS average pain score at 3 months follow-up compared to the baseline visit. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | For participants in the dual-arm, clinical trial portion of the study, severity of insomnia, sleep disruption, and sleep quality over the past seven days is assessed with the 4-item PROMIS Sleep Disturbance - Short Form. Responses are given on a 5-point Likert scale where 1 is equivalent to best possible and 5 is equivalent to worst possible. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and standard deviation of 10. Scores below 50 indicate better sleep than the average person. |
| PROMIS Pain Interference - Short Form Score | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | For participants in the dual-arm, clinical trial portion of the study, 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 (no interference) to 5 (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. |
| PROMIS Physical Function - Short Form Score | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | For participants in the dual-arm, clinical trial portion of the study, self-reported capability to conduct physical activity is assessed with the PROMIS Physical Function - Short Form. Responses to the 4 items are given on a 5-point Likert scale where 1 = unable to do and 5 = without any difficulty. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better physical function than the average person. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pilot Study Participants Reporting Satisfaction With Clinical Care | Week 2 | For participants in the single-arm pilot study, patient satisfaction with clinical care was assessed by asking: Did you find the interactions with the Life Care Specialist, (LCS) helpful in managing your pain? Response choices ranged from strongly agree to strongly disagree. Responses were dichotomized as finding the LCS helpful or not finding the LCS helpful with managing pain. |
| Opioid Utilization | Day 1 (during inpatient hospitalization) | For participants in the single-arm pilot study, and in the dual-arm, clinical-trial portion of the study, opioid utilization during inpatient hospitalization was recorded in daily morphine milligram equivalents. |
| Defense and Veterans Pain Rating Scale Score | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | The Defense and Veterans Pain Rating Scale is a patient-reported outcome used to measure the degree to which pain influenced a respondent's ability to function over the prior 24 hours. Scores range from 0 to 10 with higher scores indicating impaired functioning due to pain. |
| Patient Assessment of Constipation-Symptoms (PAC-SYM) Score | Week 2 | For participants in the dual-arm, clinical-trial portion of the study, the PAC-SYM instrument was used to assess the severity of patient-reported symptoms of constipation. The instrument includes 12 items with subscales assessing abdominal, rectal, and stool symptoms. Responses are given on a 5-point scale ranging from 0 (symptom absent) to 4 (very severe symptoms). The total score is calculated as the mean of all response and ranges from 0 to 4, where lower scores indicate lower symptom burden. |
| Opioid Literacy Tool (OLT) Score | Day 1 (during inpatient hospitalization), Month 3 | For participants in the dual-arm, clinical trial portion of the study, accuracy of knowledge about opioids (3 questions) and opioid-related risks (5 questions) is assessed with an Opioid Literacy Tool (OLT). Accuracy of opioid knowledge responses are given on a dichotomous scale (yes/no). Responses for accuracy of knowledge about opioid-related risks are given on a 7-point scale where 1 = definitely true and 7 = definitely false. The score is reported as the percent of correct responses. |
| Total Sleep Time | Up to 72 hours (during inpatient hospitalization) | For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization and up to 72 hours postoperatively. Total sleep time is assessed in minutes of sleep per night. |
| Percentage of Sleep Fragmentation | Day 1 (during inpatient hospitalization) | For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization. The percentage of sleep fragmentation is assessed as the number of awakenings and sleep stage shifts divided by the total sleep time \*100. |
| Patient Satisfaction Survey | Week 2 | For participants in the dual-arm, clinical-trial portion of the study, patient satisfaction with clinical care was assessed with a modified Press Ganey Integrated Survey. This survey captured a comprehensive picture of each participant's care experience. Participants were asked Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay? Higher scores indicate higher satisfaction. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Grady Memorial Hospital in Atlanta, Georgia, USA.
Pre-assignment details
The nature of this preliminary research began as a single-arm pilot study but due to the COVID-19 pandemic, the pilot was suspended. Instead, a two-arm Clinical Trial was commenced due to time constraints at a time when non-essential personnel, including research staff, were permitted to safely return to the fast-paced clinical environment once infection control measures were established. The outcomes of the clinical trial portion did not apply to the pilot group.
Participants by arm
| Arm | Count |
|---|---|
| Life Care Specialist (LCS) Intervention In addition to receiving current standard-of-care for pain management in the aftermath of trauma, participants will have the full communication of opioid risk - via the validated Opioid Risk Tool (ORT) and a detailed substance abuse and mental health screening. As part of the daily LCS intervention, the inpatients will engage in behavioral pain management, opioid education and harm-reduction strategies (naloxone education), while also being screened for eligibility for respective referrals for complex needs, such as mental health and substance use disorders. Upon discharge, each participant will be educated by the LCS on future available modes of contact (telephone, email, video-call, follow up- visits at 2-, 6- and 12-weeks).
Life Care Specialist (LCS) Intervention: The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature. | 72 |
| Standard of Care With Clinical Coordination Participants will receive the current standard-of-care for pain management in the aftermath of trauma, including a standardized prescription protocol, and hospital-system approved discharge instructions which provide written instruction on how to taper opioid use and links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.
Clinical Coordination with Referrals: The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program. | 57 |
| Pilot Study of Pain Management Strategies Orthopedic trauma patients will work with a LifeCare Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse. Participants will be followed for one-year post-operation. An official pain management protocol will be developed during the pilot portion of this study. | 121 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 24 | 33 | 0 |
| Overall Study | Missing outcome data | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 18 | 0 |
Baseline characteristics
| Characteristic | Life Care Specialist (LCS) Intervention | Total | Pilot Study of Pain Management Strategies | Standard of Care With Clinical Coordination |
|---|---|---|---|---|
| Age, Continuous | 43.15 years STANDARD_DEVIATION 18.17 | 42.84 years STANDARD_DEVIATION 17.59 | 38.82 years STANDARD_DEVIATION 15 | 42.46 years STANDARD_DEVIATION 16.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 188 Participants | 94 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 13 Participants | 13 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 44 Participants | 12 Participants | 15 Participants |
| Region of Enrollment United States | 72 participants | 129 participants | 121 participants | 57 participants |
| Sex: Female, Male Female | 39 Participants | 124 Participants | 52 Participants | 33 Participants |
| Sex: Female, Male Male | 33 Participants | 126 Participants | 69 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 57 | 0 / 121 |
| other Total, other adverse events | 0 / 72 | 0 / 57 | 0 / 121 |
| serious Total, serious adverse events | 0 / 72 | 0 / 57 | 0 / 121 |
Outcome results
Primary
Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score
The number of participants in the dual-arm, clinical-trial portion of the study reporting a decrease in the NRS average pain score at 3 months follow-up compared to the baseline visit.
Time frame: Month 3
Population: This outcome applies to the clinical trial groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Life Care Specialist (LCS) Intervention | Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score | 64 Participants |
| Standard of Care With Clinical Coordination | Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score | 42 Participants |
p-value: 0.035Chi-squared
Primary
Numeric Rating Scale Average Pain Score
For participants in the single-arm pilot study and in the dual-arm, clinical-trial portion of the study, daily pain within the last 24 hours was assessed using a 10-point Likert scale where 1 = no pain and 10 = severe pain. After Week 2, pain was assessed only during the follow-up visits.
Time frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
Population: Outcomes for the pilot study participants were only collected up to Week 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Numeric Rating Scale Average Pain Score | Day 1 (during inpatient hospitalization) | 7.62 units on a scale | Standard Deviation 2.72 |
| Life Care Specialist (LCS) Intervention | Numeric Rating Scale Average Pain Score | Month 3 | 3.79 units on a scale | Standard Deviation 3.09 |
| Life Care Specialist (LCS) Intervention | Numeric Rating Scale Average Pain Score | Week 6 | 4.36 units on a scale | Standard Deviation 2.91 |
| Life Care Specialist (LCS) Intervention | Numeric Rating Scale Average Pain Score | Week 2 | 5.88 units on a scale | Standard Deviation 2.76 |
| Standard of Care With Clinical Coordination | Numeric Rating Scale Average Pain Score | Month 3 | 3.72 units on a scale | Standard Deviation 3.16 |
| Standard of Care With Clinical Coordination | Numeric Rating Scale Average Pain Score | Day 1 (during inpatient hospitalization) | 7.94 units on a scale | Standard Deviation 2.42 |
| Standard of Care With Clinical Coordination | Numeric Rating Scale Average Pain Score | Week 2 | 5.64 units on a scale | Standard Deviation 2.93 |
| Standard of Care With Clinical Coordination | Numeric Rating Scale Average Pain Score | Week 6 | 4.14 units on a scale | Standard Deviation 3.27 |
| Pilot Study of Pain Management Strategies | Numeric Rating Scale Average Pain Score | Week 2 | 4.74 units on a scale | Standard Deviation 2.68 |
| Pilot Study of Pain Management Strategies | Numeric Rating Scale Average Pain Score | Day 1 (during inpatient hospitalization) | 8.43 units on a scale | Standard Deviation 2.8 |
Primary
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score
For participants in the dual-arm, clinical trial portion of the study, severity of insomnia, sleep disruption, and sleep quality over the past seven days is assessed with the 4-item PROMIS Sleep Disturbance - Short Form. Responses are given on a 5-point Likert scale where 1 is equivalent to best possible and 5 is equivalent to worst possible. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and standard deviation of 10. Scores below 50 indicate better sleep than the average person.
Time frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
Population: This outcome applies to the clinical trial groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Day 1 (during inpatient hospitalization) | 52.89 T-score | Standard Deviation 10.7 |
| Life Care Specialist (LCS) Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Week 2 | 60.16 T-score | Standard Deviation 8.69 |
| Life Care Specialist (LCS) Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Week 6 | 54.74 T-score | Standard Deviation 11.26 |
| Life Care Specialist (LCS) Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Month 3 | 52.68 T-score | Standard Deviation 11.92 |
| Standard of Care With Clinical Coordination | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Month 3 | 51.28 T-score | Standard Deviation 13.13 |
| Standard of Care With Clinical Coordination | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Day 1 (during inpatient hospitalization) | 51.57 T-score | Standard Deviation 10.21 |
| Standard of Care With Clinical Coordination | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Week 6 | 53.81 T-score | Standard Deviation 11.56 |
| Standard of Care With Clinical Coordination | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score | Week 2 | 58.85 T-score | Standard Deviation 9.56 |
Primary
PROMIS Pain Interference - Short Form Score
For participants in the dual-arm, clinical trial portion of the study, 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 (no interference) to 5 (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.
Time frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
Population: This outcome applies to the clinical trial groups only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Life Care Specialist (LCS) Intervention | PROMIS Pain Interference - Short Form Score | Day 1 (during inpatient hospitalization) | 54.14 T-score | Standard Deviation 12.17 |
| Life Care Specialist (LCS) Intervention | PROMIS Pain Interference - Short Form Score | Week 2 | 65.19 T-score | Standard Deviation 6.37 |
| Life Care Specialist (LCS) Intervention | PROMIS Pain Interference - Short Form Score | Week 6 | 62.28 T-score | Standard Deviation 8.59 |
| Life Care Specialist (LCS) Intervention | PROMIS Pain Interference - Short Form Score | Month 3 | 58.89 T-score | Standard Deviation 10.54 |
| Standard of Care With Clinical Coordination | PROMIS Pain Interference - Short Form Score | Month 3 | 58.19 T-score | Standard Deviation 9.27 |
| Standard of Care With Clinical Coordination | PROMIS Pain Interference - Short Form Score | Day 1 (during inpatient hospitalization) | 56.24 T-score | Standard Deviation 11.52 |
| Standard of Care With Clinical Coordination | PROMIS Pain Interference - Short Form Score | Week 6 | 59.36 T-score | Standard Deviation 7.93 |
| Standard of Care With Clinical Coordination | PROMIS Pain Interference - Short Form Score | Week 2 | 65.99 T-score | Standard Deviation 7.16 |
Primary
PROMIS Physical Function - Short Form Score
For participants in the dual-arm, clinical trial portion of the study, self-reported capability to conduct physical activity is assessed with the PROMIS Physical Function - Short Form. Responses to the 4 items are given on a 5-point Likert scale where 1 = unable to do and 5 = without any difficulty. Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better physical function than the average person.
Time frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
Population: This outcome applies to the clinical trial groups only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Life Care Specialist (LCS) Intervention | PROMIS Physical Function - Short Form Score | Day 1 (during inpatient hospitalization) | 42.85 T-score | Standard Deviation 13.75 |
| Life Care Specialist (LCS) Intervention | PROMIS Physical Function - Short Form Score | Week 2 | 26.56 T-score | Standard Deviation 5.27 |
| Life Care Specialist (LCS) Intervention | PROMIS Physical Function - Short Form Score | Week 6 | 30.33 T-score | Standard Deviation 7.31 |
| Life Care Specialist (LCS) Intervention | PROMIS Physical Function - Short Form Score | Month 3 | 37.22 T-score | Standard Deviation 8.43 |
| Standard of Care With Clinical Coordination | PROMIS Physical Function - Short Form Score | Month 3 | 37.53 T-score | Standard Deviation 8 |
| Standard of Care With Clinical Coordination | PROMIS Physical Function - Short Form Score | Day 1 (during inpatient hospitalization) | 42.31 T-score | Standard Deviation 13.14 |
| Standard of Care With Clinical Coordination | PROMIS Physical Function - Short Form Score | Week 6 | 33.59 T-score | Standard Deviation 8.43 |
| Standard of Care With Clinical Coordination | PROMIS Physical Function - Short Form Score | Week 2 | 26.82 T-score | Standard Deviation 6.55 |
Secondary
Defense and Veterans Pain Rating Scale Score
The Defense and Veterans Pain Rating Scale is a patient-reported outcome used to measure the degree to which pain influenced a respondent's ability to function over the prior 24 hours. Scores range from 0 to 10 with higher scores indicating impaired functioning due to pain.
Time frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
Population: This outcome applies to the clinical trial groups only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Defense and Veterans Pain Rating Scale Score | Day 1 (during inpatient hospitalization) | 6.84 score on a scale | Standard Deviation 3.04 |
| Life Care Specialist (LCS) Intervention | Defense and Veterans Pain Rating Scale Score | Week 2 | 5.35 score on a scale | Standard Deviation 2.82 |
| Life Care Specialist (LCS) Intervention | Defense and Veterans Pain Rating Scale Score | Week 6 | 4.13 score on a scale | Standard Deviation 2.76 |
| Life Care Specialist (LCS) Intervention | Defense and Veterans Pain Rating Scale Score | Month 3 | 3.68 score on a scale | Standard Deviation 2.95 |
| Standard of Care With Clinical Coordination | Defense and Veterans Pain Rating Scale Score | Month 3 | 3.56 score on a scale | Standard Deviation 3.25 |
| Standard of Care With Clinical Coordination | Defense and Veterans Pain Rating Scale Score | Day 1 (during inpatient hospitalization) | 7.49 score on a scale | Standard Deviation 2.67 |
| Standard of Care With Clinical Coordination | Defense and Veterans Pain Rating Scale Score | Week 6 | 4.02 score on a scale | Standard Deviation 3.09 |
| Standard of Care With Clinical Coordination | Defense and Veterans Pain Rating Scale Score | Week 2 | 5.54 score on a scale | Standard Deviation 2.69 |
Secondary
Number of Pilot Study Participants Reporting Satisfaction With Clinical Care
For participants in the single-arm pilot study, patient satisfaction with clinical care was assessed by asking: Did you find the interactions with the Life Care Specialist, (LCS) helpful in managing your pain? Response choices ranged from strongly agree to strongly disagree. Responses were dichotomized as finding the LCS helpful or not finding the LCS helpful with managing pain.
Time frame: Week 2
Population: This analysis includes participants in the pilot group who attended their 2 weeks post-operative follow-up appointment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Life Care Specialist (LCS) Intervention | Number of Pilot Study Participants Reporting Satisfaction With Clinical Care | 79 Participants |
Secondary
Opioid Literacy Tool (OLT) Score
For participants in the dual-arm, clinical trial portion of the study, accuracy of knowledge about opioids (3 questions) and opioid-related risks (5 questions) is assessed with an Opioid Literacy Tool (OLT). Accuracy of opioid knowledge responses are given on a dichotomous scale (yes/no). Responses for accuracy of knowledge about opioid-related risks are given on a 7-point scale where 1 = definitely true and 7 = definitely false. The score is reported as the percent of correct responses.
Time frame: Day 1 (during inpatient hospitalization), Month 3
Population: This outcome applies to the clinical trial groups only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Opioid Literacy Tool (OLT) Score | Day 1 (during inpatient hospitalization) | 32.02 percentage out of 100% | Standard Deviation 27.5 |
| Life Care Specialist (LCS) Intervention | Opioid Literacy Tool (OLT) Score | Month 3 | 33.20 percentage out of 100% | Standard Deviation 34.63 |
| Standard of Care With Clinical Coordination | Opioid Literacy Tool (OLT) Score | Day 1 (during inpatient hospitalization) | 32.69 percentage out of 100% | Standard Deviation 31.37 |
| Standard of Care With Clinical Coordination | Opioid Literacy Tool (OLT) Score | Month 3 | 31.25 percentage out of 100% | Standard Deviation 33.32 |
Secondary
Opioid Utilization
For participants in the single-arm pilot study, and in the dual-arm, clinical-trial portion of the study, opioid utilization during inpatient hospitalization was recorded in daily morphine milligram equivalents.
Time frame: Day 1 (during inpatient hospitalization)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Life Care Specialist (LCS) Intervention | Opioid Utilization | 22.52 milligrams |
| Standard of Care With Clinical Coordination | Opioid Utilization | 30.00 milligrams |
| Pilot Study of Pain Management Strategies | Opioid Utilization | 39.77 milligrams |
Secondary
Patient Assessment of Constipation-Symptoms (PAC-SYM) Score
For participants in the dual-arm, clinical-trial portion of the study, the PAC-SYM instrument was used to assess the severity of patient-reported symptoms of constipation. The instrument includes 12 items with subscales assessing abdominal, rectal, and stool symptoms. Responses are given on a 5-point scale ranging from 0 (symptom absent) to 4 (very severe symptoms). The total score is calculated as the mean of all response and ranges from 0 to 4, where lower scores indicate lower symptom burden.
Time frame: Week 2
Population: This outcome applies to the clinical trial groups only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Patient Assessment of Constipation-Symptoms (PAC-SYM) Score | 0.49 score on a scale | Standard Deviation 0.74 |
| Standard of Care With Clinical Coordination | Patient Assessment of Constipation-Symptoms (PAC-SYM) Score | 0.79 score on a scale | Standard Deviation 0.76 |
Secondary
Patient Satisfaction Survey
For participants in the dual-arm, clinical-trial portion of the study, patient satisfaction with clinical care was assessed with a modified Press Ganey Integrated Survey. This survey captured a comprehensive picture of each participant's care experience. Participants were asked Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay? Higher scores indicate higher satisfaction.
Time frame: Week 2
Population: This outcome applies to the clinical trial groups only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Patient Satisfaction Survey | 7.77 units on a scale | Standard Deviation 2.39 |
| Standard of Care With Clinical Coordination | Patient Satisfaction Survey | 7.23 units on a scale | Standard Deviation 2.36 |
Secondary
Percentage of Sleep Fragmentation
For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization. The percentage of sleep fragmentation is assessed as the number of awakenings and sleep stage shifts divided by the total sleep time \*100.
Time frame: Day 1 (during inpatient hospitalization)
Population: This outcome applies to the clinical trial groups only. Only participants who wore the sleeping tracking device were included in this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Percentage of Sleep Fragmentation | 33.77 percentage of sleep fragmentation | Standard Deviation 15.29 |
| Standard of Care With Clinical Coordination | Percentage of Sleep Fragmentation | 32.68 percentage of sleep fragmentation | Standard Deviation 15.17 |
Secondary
Total Sleep Time
For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization and up to 72 hours postoperatively. Total sleep time is assessed in minutes of sleep per night.
Time frame: Up to 72 hours (during inpatient hospitalization)
Population: This outcome applies to the clinical trial groups only. Only participants who wore the sleeping tracking device were included in this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Life Care Specialist (LCS) Intervention | Total Sleep Time | 267.34 minutes/night | Standard Deviation 99.71 |
| Standard of Care With Clinical Coordination | Total Sleep Time | 236.95 minutes/night | Standard Deviation 55.6 |