search
Back to results

Upper Extremity Life Care Specialist (LCS)

Primary Purpose

Upper Extremity Trauma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life Care Specialist (LCS)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Extremity Trauma focused on measuring Opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients 18 years of age or older
  • Orthopaedic trauma patients with an isolated upper extremity injury requiring surgery
  • Informed consent obtained
  • Working cellphone

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 at elementary school level
  • Unlikely to complete surveys at home, access to phone
  • Incarcerated
  • Pregnant
  • COVID positive

Sites / Locations

  • Grady Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LCS Intervention

No LCS Intervention

Arm Description

With Opioid Risk Education, patients will receive opioid education after completing the validated Opioid Risk Tool (ORT), a detailed substance abuse survey and mental health screening, and Naloxone education. Therapeutic Intervention will include the Community Resiliency Model CRM), progressive muscle relaxation, sound therapy. Clinical Pain Coordination will include directed referrals for complex needs, including mental health and substance use disorders, as needed. In addition to above mentioned 3 intervention components, all patients in the LCS intervention arm will also receive the current standard-of-care.

Patients will receive the current standard-of-care for pain management in the aftermath of trauma, which includes: a standardized prescription protocol, hospital-system approved discharge instructions which provide written instruction on how to taper opioid use, links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.

Outcomes

Primary Outcome Measures

Changes in Pain Numerical rating Scale (NRS)
The NRS is a commonly used pain assessment tool in both clinical practice and research. Improvements in NRS scores, which are collected from participants at each study visit, will be analyzed. The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable".
Changes in Promis Sleep Disturbance Score
The PROMIS Sleep Disturbance examines respondent's global severity of insomnia, sleep disruption, and sleep quality over the past seven days. Each of the 4 Likert scale items' raw score are converted to t-scores, ranging from 0 to 100. Like all PROMIS measures, t-scores are normed to the US population, with a mean of 50 and standard deviation of 10.43 Lower scores indicate better sleep.
Changes in Promis Physical Function Score
PROMIS Physical Function measures participants' self-reported capability to conduct physical activity. This includes capturing function in upper extremities and lower extremities (walking or mobility) as well as a respondent's ability to conduct activities of daily living. There are 4-items on the short form questionnaire and respondents report their capabilities to perform each task on a Likert scale from 5, "without any difficulty", to 1, "unable to do". All 4-items' saw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function.
Changes in Promis Pain Interference Score
The PROMIS Pain Interference scale assesses the extent to which pain impedes engagement with social, cognitive, emotional, physical, and recreational activities over the past 7 days. Pain interference is an essential aspect of pain management to capture in order to better understand how pain impacts the activities of individuals rather than subjective severity alone.15 On each of the scale's 4-items respondents choose how much pain impeded a specific function or activity, ranging from 1, "not at all", to 5, "very much". Scores are summed across all items and transformed to a t-score ranging from 0 to 100, with lower t-scores indicate less interference due to pain
Changes in Promis Prescription Pain Score
38-41 The PROMIS measure of Prescription Pain Medication Misuse assesses current abuse of prescription pain medication, chiefly opioids. The scale has been validated in patient populations with chronic non-cancer pain and has been found to be highly correlated with the Pain Medication Questionnaire (PMQ).

Secondary Outcome Measures

Inpatient Opioid Utilization
Inpatient utilization will be extracted from the electronic health record (EHR) by study staff. Opioid medication dosage will be transformed to a total universal measure known as morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day.

Full Information

First Posted
May 24, 2022
Last Updated
December 7, 2022
Sponsor
Emory University
search

1. Study Identification

Unique Protocol Identification Number
NCT05422014
Brief Title
Upper Extremity Life Care Specialist (LCS)
Official Title
Life Care Specialist (LCS) - Pain Management and Prevention of Substance Misuse in Upper Extremity Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized control trial aimed at learning more about LCS position and the value it provides to the patient's who have sustained upper extremity traumas.
Detailed Description
Opioids are psychoactive substances (narcotics) primarily used for pain relief by producing euphoric effects. Although regularly prescribed by physicians, opioids are highly addictive. Examples include, but are not limited to, morphine, codeine, and oxycodone. 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 can quickly experience severe withdrawal symptoms similar to the flu. In the United States, more than 115 people die from opioid overdose every day. Despite a year-over-year increase in opioid overdose deaths since the year 2000, opioids remain among the most effective medications providers can offer to control pain. Addiction treatment costs near $78.5 billion and rising, less than 10% of people in need receive treatment. Trauma patients are more likely than other types of patients to be under the influence of psychoactive drugs and alcohol use. The strongest risk factor for developing opioid use disorder is pre-existing substance use disorder. Risk factors for opioid overdose mortality include: middle age, history of substance abuse, including prescription and illicit drugs and alcohol, comorbid mental and medical condition, methadone use, unemployment, polysubstance abuse, opioid naivety, sleep apnea, and pain intensity; these are all conditions representative of typical U.S. trauma patient populations. This significant overlap places high importance on implementing alternative solutions to pain management within this population, and aligns with the Center for Disease Control and Prevention, National Conference for Immunization Coalitions and Partnerships (NCICP) research priority alignment to develop and evaluate an innovative prevention strategy to prevent overdose, including those at greatest risk. According to studies of patients discharged from the hospital after being prescribed a new medication: 86% were aware that they had been prescribed new medications. Fewer could identify the name (64%) or number (74%) of their new medications of their dosages (56%), the schedule to take them (68%), or the purpose of the prescription (64%.) Only 22% could name at least one adverse effect. Only 11% could recall being told of any adverse effects. Orthopaedic surgeons are the third-most frequent providers of opioid prescription medications among physicians, and orthopaedic surgical patients are at the highest risk of chronic postoperative opioid use. Orthopaedic trauma surgeons face a very difficult task in managing acute pain and the consequences associated with over-prescription of opioid analgesics. Most patients with orthopaedic trauma injuries have very painful injuries and need appropriate pain control. The Christopher Wolf Crusade (CWC) is a non-profit providing preventative solutions, education, and advocacy for the American opioid epidemic. CWC proposes to introduce a Life Care Specialist (LCS) as an integral member of the clinical team, with a focus on "pain coaching" for trauma patients. In an analogous role served by Certified Child Life Specialists (CCLS) in pediatrics, the LCS will introduce orthopaedic trauma patients to non-pharmacologic coping strategies for pain. Further, LCS will provide much needed patient-centric education on individualized risk for opioid misuse, as well as overdose prevention and safe disposal of unused opioids. This randomized control trial is aimed at learning more about LCS position and the value it provides to the patient's who have sustained upper extremity traumas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Trauma
Keywords
Opioids

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LCS Intervention
Arm Type
Experimental
Arm Description
With Opioid Risk Education, patients will receive opioid education after completing the validated Opioid Risk Tool (ORT), a detailed substance abuse survey and mental health screening, and Naloxone education. Therapeutic Intervention will include the Community Resiliency Model CRM), progressive muscle relaxation, sound therapy. Clinical Pain Coordination will include directed referrals for complex needs, including mental health and substance use disorders, as needed. In addition to above mentioned 3 intervention components, all patients in the LCS intervention arm will also receive the current standard-of-care.
Arm Title
No LCS Intervention
Arm Type
No Intervention
Arm Description
Patients will receive the current standard-of-care for pain management in the aftermath of trauma, which includes: a standardized prescription protocol, hospital-system approved discharge instructions which provide written instruction on how to taper opioid use, links to written/online resources for opioid misuse, overdose prevention, and State-approved disposal options.
Intervention Type
Behavioral
Intervention Name(s)
Life Care Specialist (LCS)
Intervention Description
Life Care Specialist (LCS) will : Provide patients with individualized risk assessment for opioid misuse. Act as patient's "Pain Coach." Providing targeted education and behavior-based pain treatment options. Train and provide CWC evidence based non-pharmaceutical pain management techniques, using the Community Resiliency Model. Use the Opioid Risk Tool (ORT) as the method to identity the risk of substance misuse. Provide education, support and resources, as well as local, state, and national resources to enhance the whole health aspect of the position. These resources include but are not limited to: written documents that outline the key concepts of the pain management techniques taught by the LCS and a list of hotlines and websites. LCS, when applicable, will provide education for caretakers on the risk of opioid use and the non -pharmaceutical pain management protocol. Provide follow up for all patients in intervention group.
Primary Outcome Measure Information:
Title
Changes in Pain Numerical rating Scale (NRS)
Description
The NRS is a commonly used pain assessment tool in both clinical practice and research. Improvements in NRS scores, which are collected from participants at each study visit, will be analyzed. The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable".
Time Frame
Study day 1, week 2 visit, week 6 visit and month 3 visit
Title
Changes in Promis Sleep Disturbance Score
Description
The PROMIS Sleep Disturbance examines respondent's global severity of insomnia, sleep disruption, and sleep quality over the past seven days. Each of the 4 Likert scale items' raw score are converted to t-scores, ranging from 0 to 100. Like all PROMIS measures, t-scores are normed to the US population, with a mean of 50 and standard deviation of 10.43 Lower scores indicate better sleep.
Time Frame
Study day 1, week 2 visit, week 6 visit and month 3 visit
Title
Changes in Promis Physical Function Score
Description
PROMIS Physical Function measures participants' self-reported capability to conduct physical activity. This includes capturing function in upper extremities and lower extremities (walking or mobility) as well as a respondent's ability to conduct activities of daily living. There are 4-items on the short form questionnaire and respondents report their capabilities to perform each task on a Likert scale from 5, "without any difficulty", to 1, "unable to do". All 4-items' saw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function.
Time Frame
Study day 1, week 2 visit, week 6 visit and month 3 visit
Title
Changes in Promis Pain Interference Score
Description
The PROMIS Pain Interference scale assesses the extent to which pain impedes engagement with social, cognitive, emotional, physical, and recreational activities over the past 7 days. Pain interference is an essential aspect of pain management to capture in order to better understand how pain impacts the activities of individuals rather than subjective severity alone.15 On each of the scale's 4-items respondents choose how much pain impeded a specific function or activity, ranging from 1, "not at all", to 5, "very much". Scores are summed across all items and transformed to a t-score ranging from 0 to 100, with lower t-scores indicate less interference due to pain
Time Frame
Study day 1, week 2 visit, week 6 visit and month 3 visit
Title
Changes in Promis Prescription Pain Score
Description
38-41 The PROMIS measure of Prescription Pain Medication Misuse assesses current abuse of prescription pain medication, chiefly opioids. The scale has been validated in patient populations with chronic non-cancer pain and has been found to be highly correlated with the Pain Medication Questionnaire (PMQ).
Time Frame
Study day 1, week 2 visit, week 6 visit and month 3 visit
Secondary Outcome Measure Information:
Title
Inpatient Opioid Utilization
Description
Inpatient utilization will be extracted from the electronic health record (EHR) by study staff. Opioid medication dosage will be transformed to a total universal measure known as morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day.
Time Frame
Study day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients 18 years of age or older Orthopaedic trauma patients with an isolated upper extremity injury requiring surgery Informed consent obtained Working cellphone 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 at elementary school level Unlikely to complete surveys at home, access to phone Incarcerated Pregnant COVID positive
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Zelenski, MD
Phone
(404) 255-0226
Email
nicole.ann.zelenski@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Zelenski, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Zelenski, MD
Phone
404-255-0226
Email
nicole.ann.zelenski@emory.edu
First Name & Middle Initial & Last Name & Degree
Nicole Zelenski, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified outcome data and demographic data will be shared in a csv file.
IPD Sharing Time Frame
Data will be available from July 2025 until end date July 31 2025.
IPD Sharing Access Criteria
Individuals with appropriate Institutional Review Board approved access to conduct confirmatory analyses may access data upon reasonable request. Data will be shared via Emory approved secure share file transfer service or via Emory's Open Access Dataverse.

Learn more about this trial

Upper Extremity Life Care Specialist (LCS)

We'll reach out to this number within 24 hrs