Clinical trial NCT04154384: Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse
Official title: Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: Orthopedic surgery
Opioid addiction
Rehabilitation
Behavioral research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Christopher Wolf Crusade (CWC)
name: Centers for Disease Control and Prevention
First posted: 2019-11-06
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Numeric Rating Scale Average Pain Score
timeFrame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
measure: Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score
timeFrame: Month 3
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score
timeFrame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
measure: PROMIS Pain Interference - Short Form Score
timeFrame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
measure: PROMIS Physical Function - Short Form Score
timeFrame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
Secondary outcomes:
measure: Opioid Utilization
timeFrame: Day 1 (during inpatient hospitalization)
measure: Opioid Literacy Tool (OLT) Score
timeFrame: Day 1 (during inpatient hospitalization), Month 3
measure: Total Sleep Time
timeFrame: Up to 72 hours (during inpatient hospitalization)
measure: Percentage of Sleep Fragmentation
timeFrame: Day 1 (during inpatient hospitalization)
measure: Patient Satisfaction Survey
timeFrame: Week 2
measure: Number of Pilot Study Participants Reporting Satisfaction With Clinical Care
timeFrame: Week 2
measure: Patient Assessment of Constipation-Symptoms (PAC-SYM) Score
timeFrame: Week 2
measure: Defense and Veterans Pain Rating Scale Score
timeFrame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Mara Schenker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.