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

Emory University

Status: Completed

Conditions: Opioid Use

Treatments: Behavioral: Life Care Specialist (LCS) Intervention; Other: Clinical Coordination with Referrals; Behavioral: Pilot Study of Pain Management Strategies

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04154384

IRB00115061

CDC-IRB00115061 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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333 participants in 3 patient groups

Life Care Specialist (LCS) Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Life Care Specialist (LCS) Intervention

Standard of Care with Clinical Coordination

Active Comparator group

Description:

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.

Treatment:

Other: Clinical Coordination with Referrals

Pilot Study of Pain Management Strategies

Other group

Description:

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

Treatment:

Behavioral: Pilot Study of Pain Management Strategies