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

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ClinicalTrials.gov Identifier: NCT04154384
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2019
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
Christopher Wolf Crusade (CWC)
Information provided by (Responsible Party):
Mara Schenker, Emory University

Tracking Information
First Submitted Date  ICMJE November 2, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE February 21, 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
  • Opioid Pain Medication Usage [ Time Frame: Month 12 ]
    The primary outcome of the single-arm pilot study will be the utilization of opioid pain medication at 1 year after the operation. This value will be compared to the 23% of a historical control cohort reporting continuing to use opioids a year post operation.
  • Change in Pain Management Questionnaire (PMQ) Score [ Time Frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 ]
    For participants in the dual-arm, clinical trial portion of the study, the risk of opioid misuse is assessed with the PMQ. The PMQ is a 26-item questionnaire where responses are given on a 5-point Likert scale where 0 = disagree and 4 = agree. Total scores range from 0 to 104 where higher scores indicate increased risk of opioid misuse.
  • Change in Prescription Drug Use Questionnaire - Patient Version (PDUQp) Score [ Time Frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 ]
    For participants in the dual-arm, clinical trial portion of the study, prescription drug use is assessed with the self-report version of the Prescription Drug Use Questionnaire. The PDUQp includes 31 items which are responded to as "yes" or "no". Responses of "yes" are coded as 1. Only 30 items are summed to provide a total score which can range from 0 to 30. Higher responses indicate opioid misuse behaviors.
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score [ Time Frame: 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.
  • Change in PROMIS Physical Function - Short Form Score [ Time Frame: 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 standard deviation of 10. Scores above 50 indicate better physical function than the average person.
  • Change in PROMIS Pain Interference - Short Form Score [ Time Frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3 ]
    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.
  • Change in Opioid Literacy Tool (OLT) Score [ Time Frame: 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 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).
  • Change in Primary Care Posttraumatic Stress Disorder Screen (PC-PTSD-5) Score [ Time Frame: Day 1, Month 3 ]
    For participants in the dual-arm, clinical trial portion of the study, the Primary Care Posttraumatic Stress Disorder (PTSD) Screen for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; PC-PTSD-5) will be administered. The PC-PTSD-5 is a 5-item instrument used to assess previous exposure to traumatic events and subsequent presence of the DSM-5 diagnostic criteria for PTSD. Responses are given as "yes" or "no" and each response of "yes" is scored as one point. Total scores range from 0 to 5 where higher scores indicate greater symptoms of PTSD. In primary care settings, a minimum of 3 points is considered probable PTSD.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Opioid Pain Medication Usage [ Time Frame: Month 12 ]
The primary outcome of the study will be the utilization of opioid pain medication at 1 year after the operation. This value will be compared to the 23% of a historical control cohort reporting continuing to use opioids a year post operation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
  • Change in Numeric Rating Scale Average Pain Score [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until 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 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.
  • Change in Opioid Utilization [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until 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, opioid utilization will be recorded in daily morphine milligram equivalents. After Week 2, opioid utilization will be assessed only during the follow up visits.
  • Change in Average Steps Per Day [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until week 2) ]
    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. Activity will be measured as the average number of steps per day.
  • Change in Total Sleep Time [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until week 2) ]
    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.
  • Change in Sleep Latency [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until week 2) ]
    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 onset latency is assessed as the length of time, in minutes, that it takes to transition from wakefulness to sleep.
  • Change in Sleep Fragmentation [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until week 2) ]
    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.
  • Change in Wake After Sleep Onset [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until week 2) ]
    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. Wake after sleep onset is assessed as the periods of wakefulness occurring after sleep onset.
  • Change in Sleep Efficiency [ Time Frame: Day 1 (during inpatient hospitalization) up to discharge (until week 2) ]
    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 efficiency is the percentage of time in bed spent sleeping (total sleep time/sleep period time x 100).
  • Patient Satisfaction Survey [ Time Frame: Week 2 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Change in Pain Score [ Time Frame: Week 2, Week 6, Month 3, Month 6, Month 12 ]
    Pain will be assessed using an 11-point Likert scale where 0 = no pain and 10 = severe pain.
  • Change in Opioid Utilization [ Time Frame: Day 1 (at hospital discharge), Week 2, Week 6 ]
    Opioid utilization will be recorded in morphine equivalents.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse
Official Title  ICMJE Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Opioid Use
Intervention  ICMJE
  • Behavioral: Pain Management Strategies
    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.
  • 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 Name: Opioid Education
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Pain Management Strategies
  • 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).
    Intervention: Behavioral: Life Care Specialist (LCS) Intervention
  • 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.
    Intervention: Other: Clinical Coordination with Referrals
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 8, 2021)
321
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
200
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154384
Other Study ID Numbers  ICMJE IRB00115061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified, individual participant data will be made available for sharing upon request from other researchers.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Individual participant data will be available for sharing following publication of the findings from this study until 5 years after publication.
Access Criteria: Researchers interested in accessing data should provide a description of the proposed project to Dr. Schenker at mara.schenker@emory.edu.
Responsible Party Mara Schenker, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Christopher Wolf Crusade (CWC)
Investigators  ICMJE
Principal Investigator: Mara Schenker, MD Emory University
PRS Account Emory University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP