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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154384
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2019
Last Update Posted : September 24, 2020
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 September 24, 2020
Actual Study Start Date  ICMJE February 21, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
  • Change in Pain Score [ Time Frame: Day 1, Week 2, Week 6, Month 3, Month 6, Month 12 ]
    Pain will be assessed using a 10-point Likert scale where 1 = 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.
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 This is a pilot, single-center study where the Life Care Specialist (LCS) will provide personalized pain management strategies to patients combating pain. LCS assessments will focus on the level of risk the patient has for potential substance misuse and the Pain Plans will be unique to each patient. Participants will be followed for one year post operation.
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 Life Care Specialists (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.

Potential patients will be identified during their initial presentation to Grady Hospital during morning trauma board rounds within the first 24 hours of admission. Once the consent process is complete, the participants will be referred to the LCS team. Participants will be followed in the orthopaedic trauma clinic at routine post-operative intervals (2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Opioid Use
Intervention  ICMJE Behavioral: Pain Management Strategies
The Life Care Specialist (LCS) will work with the patient to develop personalized pain management strategies focused on behavioral education, and will act as a liaison with physicians to optimize the pharmacologic component of pain management. The pain management strategies includes education about substance misuse and provides non-pharmacological pain management options.
Study Arms  ICMJE Experimental: 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.
Intervention: Behavioral: Pain Management Strategies
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: September 22, 2020)
500
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
200
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Orthopaedic trauma patients with planned surgical procedure
  • Informed consent obtained

Exclusion Criteria:

  • 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
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: No
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 September 2020

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