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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Behavioral: Life Care Specialist (LCS) Intervention; Other: Clinical Coordination with Referrals; Behavioral: Pilot Study of Pain Management Strategies

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).

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Grady Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.; Other Names: Opioid Education
Active Comparator: 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.	Other: 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.
Other: Pilot 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. 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: Pilot 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
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.	Month 3
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
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.	Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
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.	Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (during inpatient hospitalization)
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.	Day 1 (during inpatient hospitalization), Month 3
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.	Up to 72 hours (during inpatient hospitalization)
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.	Day 1 (during inpatient hospitalization)
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.	Week 2
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.	Week 2
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.	Week 2
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.	Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Centers for Disease Control and Prevention; Christopher Wolf Crusade (CWC)
• Investigators: Principal Investigator: Mara Schenker, MD, Emory University

Publications and helpful links

General Publications

• Giordano NA, Seilern Und Aspang J, Baker J, Rice CW, Barrell B, Kirk L, Ortega E, Wallace M, Steck A, Schenker ML. The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial. Trials. 2021 Nov 27;22(1):858. doi: 10.1186/s13063-021-05841-1.
• Giordano NA, Seilern Und Aspang J, Baker J, Medline A, Rice CW, Barrell B, Kirk L, Ortega E, Wallace M, Steck A, Schenker ML. Integration of Life Care Specialists Into Orthopaedic Trauma Care to Improve Postoperative Outcomes: A Pilot Study. Pain Manag Nurs. 2022 Oct;23(5):608-615. doi: 10.1016/j.pmn.2022.03.010. Epub 2022 Apr 25.
• Giordano NA, Und Aspang JS, Baker J, Holder C, Cantu N, Checo G, Rice CW, Barrell B, Wallace M, Steck AR, Schenker ML. Can Patient-centered Education and Pain Management Delivered by Coaches Improve Pain Outcomes After Orthopaedic Trauma? A Randomized Trial. Clin Orthop Relat Res. 2024 Oct 1;482(10):1858-1869. doi: 10.1097/CORR.0000000000003121. Epub 2024 May 15.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: November 2, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Opioid addiction; Behavioral research; Orthopedic surgery
• Other Study ID Numbers: IRB00115061; CDC-IRB00115061 (Other Identifier: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified, individual participant data will be made available for sharing upon request from other researchers.
• IPD Sharing Time Frame: Individual participant data will be available for sharing following publication of the findings from this study until 5 years after publication.
• IPD Sharing Access Criteria: Researchers interested in accessing data should provide a description of the proposed project to Dr. Schenker at mara.schenker@emory.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No