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

• ClinicalTrials.gov Identifier: NCT04154384
• Recruitment Status: Enrolling by invitation
• First Posted: November 6, 2019
• Last Update Posted: September 24, 2020
• Sponsor: Emory University
• Collaborator: Christopher Wolf Crusade (CWC)
• Information provided by (Responsible Party): Mara Schenker, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use	Behavioral: Pain Management Strategies	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse
• Actual Study Start Date: February 21, 2020
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm

Intervention/treatment

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.

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Change in Opioid Utilization [ Time Frame: Day 1 (at hospital discharge), Week 2, Week 6 ]
   Opioid utilization will be recorded in morphine equivalents.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Georgia

Grady Health System

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Christopher Wolf Crusade (CWC)

Investigators

• Principal Investigator: Mara Schenker, MD; Emory University

More Information

• Responsible Party: Mara Schenker, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT04154384
• Other Study ID Numbers: IRB00115061
• First Posted: November 6, 2019
• Last Update Posted: September 24, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mara Schenker, Emory University:

Orthopedic surgery; Opioid addiction; Rehabilitation; Behavioral research