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Opioid UseNCT04154384

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

A study testing Life Care Specialist (LCS) Intervention, Clinical Coordination with Referrals and Pilot Study of Pain Management Strategies in people with Opioid Use, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use
What is being tested?
Life Care Specialist (LCS) Intervention, Clinical Coordination with Referrals and Pilot Study of Pain Management Strategies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
1 siteUnited States
Study dates
21 Feb 2020to 19 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

United States1 site

  • Grady Health System

    Atlanta, Georgia, 30322

Other trials in United States

About this study

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.

Read the 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).

Conditions
Opioid Use
Being tested
Life Care Specialist (LCS) Intervention, Clinical Coordination with Referrals, Pilot Study of Pain Management Strategies
Keywords
Orthopedic surgery, Opioid addiction, Rehabilitation, Behavioral research
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Life Care Specialist (LCS) InterventionBehavioural

    Also called Opioid Education

    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.

  • Clinical Coordination with ReferralsOther

    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.

  • Pilot Study of Pain Management StrategiesBehavioural

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

Study groups in NCT04154384
Study groupRoleWhat they receive
Life Care Specialist (LCS) InterventionExperimentalIn 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).
Receives: Behavioral: Life Care Specialist (LCS) Intervention
Standard of Care with Clinical CoordinationActive comparatorParticipants 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.
Receives: Other: Clinical Coordination with Referrals
Pilot Study of Pain Management StrategiesOtherOrthopedic 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
Receives: Behavioral: Pilot Study of Pain Management Strategies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: Month 3

  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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (8)

  1. Opioid Utilization

    For participants in the single-arm pilot study, and in the dual-arm, clinical-trial portion of the study, opioid utilization during inpatient hospitalization was recorded in daily morphine milligram equivalents.

    Measured: Day 1 (during inpatient hospitalization)

  2. Opioid Literacy Tool (OLT) Score

    For participants in the dual-arm, clinical trial portion of the study, accuracy of knowledge about opioids (3 questions) and opioid-related risks (5 questions) is assessed with an Opioid Literacy Tool (OLT). Accuracy of opioid knowledge responses are given on a dichotomous scale (yes/no). Responses for accuracy of knowledge about opioid-related risks are given on a 7-point scale where 1 = definitely true and 7 = definitely false. The score is reported as the percent of correct responses.

    Measured: Day 1 (during inpatient hospitalization), Month 3

  3. Total Sleep Time

    For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization and up to 72 hours postoperatively. Total sleep time is assessed in minutes of sleep per night.

    Measured: Up to 72 hours (during inpatient hospitalization)

  4. Percentage of Sleep Fragmentation

    For participants in the dual-arm, clinical trial portion of the study, wrist-actigraphy devices captured continuous postoperative functional outcomes among patients during their hospitalization. The percentage of sleep fragmentation is assessed as the number of awakenings and sleep stage shifts divided by the total sleep time *100.

    Measured: Day 1 (during inpatient hospitalization)

  5. Patient Satisfaction Survey

    For participants in the dual-arm, clinical-trial portion of the study, patient satisfaction with clinical care was assessed with a modified Press Ganey Integrated Survey. This survey captured a comprehensive picture of each participant's care experience. Participants were asked "Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay?" Higher scores indicate higher satisfaction.

    Measured: Week 2

  6. Number of Pilot Study Participants Reporting Satisfaction With Clinical Care

    For participants in the single-arm pilot study, patient satisfaction with clinical care was assessed by asking: "Did you find the interactions with the Life Care Specialist, (LCS) helpful in managing your pain?" Response choices ranged from "strongly agree" to "strongly disagree". Responses were dichotomized as finding the LCS helpful or not finding the LCS helpful with managing pain.

    Measured: Week 2

  7. Patient Assessment of Constipation-Symptoms (PAC-SYM) Score

    For participants in the dual-arm, clinical-trial portion of the study, the PAC-SYM instrument was used to assess the severity of patient-reported symptoms of constipation. The instrument includes 12 items with subscales assessing abdominal, rectal, and stool symptoms. Responses are given on a 5-point scale ranging from 0 (symptom absent) to 4 (very severe symptoms). The total score is calculated as the mean of all response and ranges from 0 to 4, where lower scores indicate lower symptom burden.

    Measured: Week 2

  8. Defense and Veterans Pain Rating Scale Score

    The Defense and Veterans Pain Rating Scale is a patient-reported outcome used to measure the degree to which pain influenced a respondent's ability to function over the prior 24 hours. Scores range from 0 to 10 with higher scores indicating impaired functioning due to pain.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start21 Feb 2020
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04154384
Sponsor's protocol ID
IRB00115061
Other IDs
CDC-IRB00115061
Status last verified
Nov 2024
First submitted
2 Nov 2019
Last updated
21 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified, individual participant data will be made available for sharing upon request from other researchers.

Publications

  • 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.

    PubMed 34838101

  • 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.

    PubMed 35477669

  • 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.

    PubMed 38843502

  • Marvin D, Hudson J, Ahn J, Schenker M, Und Aspang JS, Lewis J, Cantu N, Yawman JP, Giordano NA. Fragmented Sleep And Opioid Medication Utilization During Hospitalization Following Orthopaedic Trauma. J Orthop Trauma. 2026 Jun 22. doi: 10.1097/BOT.0000000000003237. Online ahead of print.

    PubMed 42320006

Questions about this trial

What is this clinical trial studying?

A study testing Life Care Specialist (LCS) Intervention, Clinical Coordination with Referrals and Pilot Study of Pain Management Strategies in people with Opioid Use, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale Average Pain Score (time frame: Day 1 (during inpatient hospitalization), Week 2, Week 6, Month 3). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04154384, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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