Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse

Study Overview
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Brief Summary
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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
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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).

Official Title
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Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse

Conditions
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Opioid Use

Intervention / Treatment
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* Behavioral: Pain Management Strategies
* Behavioral: Life Care Specialist (LCS) Intervention
* Other: Clinical Coordination with Referrals


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria for Clinical Trial 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 Unlikely to complete surveys at home, access to phone Unlikely to respond to opioid utilization text messaging (SMS) Incarcerated Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Study of Pain Management Strategies<br>Orthopedic trauma patients will work with a Life Care 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. | Behavioral: Pain Management Strategies<br>* The Life Care Specialist (LCS) teaches evidence-informed behavioral interventions and will work with the patient to develop personalized pain management strategies focused on behavioral education, including progressive muscle relaxation (PMR), the Community Resiliency Model (CRM®), motivational interviewing, and reflective listening.<br>|
| Experimental: Life Care Specialist (LCS) Intervention<br>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). | Behavioral: Life Care Specialist (LCS) Intervention<br>* 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.<br>* Other names: Opioid Education;|
| Active Comparator: Standard of Care with Clinical Coordination<br>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. | Other: Clinical Coordination with Referrals<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 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 will be assessed using a 10-point Likert scale where 1 = no pain and 10 = severe pain. After Week 2, pain will be assessed only during the follow up visits. | Day 1 (during inpatient hospitalization) up to discharge (until week 2), Week 6, Month 3 | 
| Change in 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. | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | 
| Change in 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 standard deviation of 10. Scores above 50 indicate better physical function than the average person. | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | 
| Change in PROMIS Pain Interference - Short Form Score | For participants in the dual-arm, clinical trial portion of the study, the extent to which pain has impeded engagement with social, cognitive, emotional, physical, and recreational activities over the past 7 days is assessed with the PROMIS Pain Interference - Short Form. Responses to the 4 items are given on a 5-point Likert scale where 1 = not at all and 5 = very much. 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 less pain interference than the average person. | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid Utilization | For participants in the single-arm pilot study, and in the dual-arm, clinical-trial portion of the study, opioid utilization will be recorded in daily morphine milligram equivalents. After Week 2, opioid utilization will be assessed only during the follow up visits. | Day 1 (during inpatient hospitalization) up to discharge (until week 2), Week 6, Month 3 | 
| Change in 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 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. For these 5 questions, total scores range from 5 to 35 and higher scores indicate improved literacy (accurate understanding of prescription opioid addiction-risk, opioid dependance and risk of opioid overdose). | Day 1 (during inpatient hospitalization), Month 3 | 
| Change in Total Sleep Time | For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices will capture continuous postoperative functional outcomes among patients during their hospitalization and up to 2-weeks postoperatively. Total sleep time is assessed in minutes of sleep per night. | Day 1 (during inpatient hospitalization) up to discharge (until week 2) | 
| Change in Sleep Fragmentation | For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices will capture continuous postoperative functional outcomes among patients during their hospitalization and up to 2-weeks postoperatively. Sleep fragmentation is assessed as the number of awakenings and sleep stage shifts divided by sleep time. | Day 1 (during inpatient hospitalization) up to discharge (until week 2) | 
| Patient Satisfaction Survey | For participants in the single-arm pilot study and in the dual-arm, clinical-trial portion of the study, patient satisfaction with clinical care will be assessed with a modified Press Ganey Integrated Survey. Integrated study-specific questions will align with the conventional rating scale of strongly agree - strongly disagree. This survey will capture a comprehensive picture of each participant's care experience. Higher scores indicate higher satisfaction and will be compared among study arms and to the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) comparative feedback database. | Week 2 | 
| Patient Assessment of Constipation-Symptoms (PAC-SYM) | Used to assess the severity of patient-reported symptoms of constipation A mean total score of the 12 items results in a range of 0-4. The lower the total score, the lower the symptom burden. | Week 2 | 
| Change The Defense and Veterans Pain Rating Scale | 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. | Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthopedic surgery, Opioid addiction, Rehabilitation, Behavioral research