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

NCT04154384 | Completed Results

• 2 other identifiers: IRB00115061CDC-IRB00115061
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use

Keywords

Orthopedic surgery; Opioid addiction; Rehabilitation; Behavioral research

Outcome Measures

Primary Outcomes (5)

• Numeric Rating Scale Average Pain Score

  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 was assessed using a 10-point Likert scale where 1 = no pain and 10 = severe pain. After Week 2, pain was assessed only during the follow-up visits.

  Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

• Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score

  The number of participants in the dual-arm, clinical-trial portion of the study reporting a decrease in the NRS average pain score at 3 months follow-up compared to the baseline visit.

  Month 3

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score

  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.

  Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

• PROMIS Pain Interference - Short Form Score

  For participants in the dual-arm, clinical trial portion of the study, self-reported pain interference with activities is assessed with the PROMIS Pain Interference - Short Form. Responses to the 4 items are given on a 5-point Likert scale from 1 (no interference) to 5 (much interference). 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 worse pain interference than the average person.

  Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

• PROMIS Physical Function - Short Form Score

  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 a standard deviation of 10. Scores above 50 indicate better physical function than the average person.

  Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3

Secondary Outcomes (8)

• Opioid Utilization

  Day 1 (during inpatient hospitalization)

• Opioid Literacy Tool (OLT) Score

  Day 1 (during inpatient hospitalization), Month 3

• Total Sleep Time

  Up to 72 hours (during inpatient hospitalization)

• Percentage of Sleep Fragmentation

  Day 1 (during inpatient hospitalization)

• Patient Satisfaction Survey

  Week 2

Study Arms (3)

Life Care Specialist (LCS) Intervention

EXPERIMENTAL

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).

Behavioral: Life Care Specialist (LCS) Intervention

Standard of Care with Clinical Coordination

ACTIVE COMPARATOR

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.

Other: Clinical Coordination with Referrals

Pilot Study of Pain Management Strategies

OTHER

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

Behavioral: Pilot Study of Pain Management Strategies

Interventions

Life Care Specialist (LCS) Intervention BEHAVIORAL

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.

Also known as: Opioid Education

Life Care Specialist (LCS) Intervention

Clinical Coordination with Referrals OTHER

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.

Standard of Care with Clinical Coordination

Pilot Study of Pain Management Strategies BEHAVIORAL

Orthopedic trauma patients will work with a Life Care Specialist (LCS) and will receive personalized pain management strategies to avoid potential opioid misuse.

Pilot Study of Pain Management Strategies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Orthopaedic trauma patients with an isolated injury requiring surgery
• Informed consent obtained
• Functioning cellphone
• 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

Sponsors & Collaborators

• Emory University: lead
• Christopher Wolf Crusade (CWC): collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

• 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.

  PMID: 34838101 BACKGROUND

• 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.

  PMID: 35477669 RESULT

• 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.

  PMID: 38843502 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methods; Referral and Consultation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques; Professional Practice; Organization and Administration; Health Services Administration

Limitations and Caveats

The nature of this preliminary research began as a single-arm pilot study but due to the coronavirus disease 2019 (COVID-19) pandemic, the pilot was suspended. A two-arm clinical trial was commenced due to time constraints at a time when non-essential personnel, including research staff, were permitted to safely return to the fast-paced clinical environment once infection control measures were established. Many of the outcome measures for the clinical trial did not apply to the pilot study.

Results Point of Contact

• Title: Mara L. Schenker
• Organization: Emory University

mara.schenker@emory.edu

404-778-1550

Study Officials

• Mara Schenker, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 6, 2019
• Study Start: February 21, 2020
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)