Clinical trial NCT04868552: Naloxone Education in Total Joint Patients
Official title: The Effect of Universal Pre-hospital Naloxone Education on Patient and Family Safety, Attitudes and Experience in the Surgical Patient: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Pain, Musculoskeletal
Surgery
Overdose of Opiate
Keywords: naloxone
patient education
joint arthroplasty
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2021-05-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized
Primary purpose: PREVENTION

Brief summary: This study examines the efficacy of a brief pre-hospital naloxone education module added to the standard "Total Joint Class" curriculum on patient safety and experience. Participants will consist of 250 patient-and-support-person pairs. The primary outcome is "readiness to use" naloxone - a proxy for opioid overdose safety. Patient factors contributing to this primary outcome as well as the effect on patient attitude and experience will also be investigated.

Detailed description: Opioids are powerful pain medications which currently serve a necessary role in recovery after knee or hip replacement surgery. However, opioids also pose a danger to both the patient and to other members of the household in the event of accidental overdose because they can cause respiratory depression and death. To minimize the risk of opioid overdose, patients are educated in appropriate use and storage of their medication. They are also provided with a prescription for naloxone. Naloxone is an emergency-use, potentially life-saving antidote to opioid pain medication. It can be sprayed into the nostrils of the opioid overdose victim by a non-medically trained bystander while waiting for the ambulance to arrive, and can make the difference between life and death for a child or adult. However, only about 30% of patients choose to fill their naloxone prescription when they go home from hospital after joint replacement surgery at Carilion Roanoke Memorial Hospital. The first purpose of this study is to evaluate whether teaching patients about opioid overdose and naloxone treatment influences whether patients fill their naloxone prescription and whether they can appropriately administer naloxone in the event of an overdose in the home. Additionally, this study will look at what factors, other than pre-surgery education, influence whether a patient fills their naloxone prescription or not. The resources available for opioid overdose prevention in the community are limited, and this study will help guide the effective use of those resources.

The participants in this study will be patients who are planning hip or knee replacement surgery. They will enroll together with their primary support person. Two hundred and fifty patient and primary-support-person pairs will be enrolled prospectively over a 9-month period. All participant pairs will be randomized to receive either only the current three-hour pre-operative Joint Class (which is mandatory for all patients with their support person and includes education on opioids and pain management), or to receive, in addition, a new educational module. The new module will consist of a modified version of the REVIVE! Course, a course designed for people without prior medical training on the recognition of an opioid overdose and appropriate response including naloxone administration. Participants will be asked to complete an enrollment questionnaire prior to the educational intervention, a 2-week Recovery Journal (pain and medication diary) following surgery, and a follow-up questionnaire at the first post-operative visit, 2 weeks after surgery. Patients will also receive a short, 3-4 item questionnaire 6 months after surgery to collect data on the risk of long-term opioid use and the outcome of the naloxone in the home.

Demographic and clinical data that is collected will be used to describe the study population and determine factors that act as barriers to effective opioid overdose reversal with naloxone in the home. This study will also examine the influence of education on the experience of the patient within the healthcare system, attitudes of patients towards opioids and naloxone, and patient safety. Standardized assessments that will be used to address these study questions include the Opioid Overdose Knowledge Scale (OOKS), the Opioid Overdose Attitude Scale (OOAS), and the PROMIS Pain Medication Misuse, Pain Intensity, and Pain Interference short forms.

There are few studies that examine the influence of naloxone education for the layperson, so evidence in this field is limited. This study is unique in that it moves the conversation from the arena of chronic pain management and opioid addiction and focuses on the population of patients managing acute pain before and after surgical procedures. Outcomes of this research will help to direct prevention resources by answering very topical questions about the usefulness and effects of naloxone co-prescription with opioids for acute pain.

Eligibility criteria: Inclusion Criteria:

* Patients and "primary support person" pairs in which
* the patient is planning total or partial elective hip replacement at Carilion Roanoke Memorial Hospital OR
* the patient is planning total or partial elective knee replacement at Carilion Roanoke Memorial Hospital OR
* willingness to participate in study activities

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Poor cognitive function
* Poor English language skills
* Inmate

Primary outcomes:
measure: "Readiness to Use Naloxone" assessed by survey and Opioid Overdose Knowledge Scale administration
timeFrame: approximately 2 weeks (from surgery to first follow-up visit)
Secondary outcomes:
measure: Correlation between indication for surgery (described by International Classification of Diseases 9/10 code) and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: Correlation between procedure (Current Procedural Terminology code) and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: Correlation between patient comorbidities (described by International Classification of Diseases 9/10 code and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: correlation between patient age and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: correlation between patient sex and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: correlation between patient race and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: correlation between patient ethnicity and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: correlation between patient household income and "Readiness to Use Naloxone"
timeFrame: 2 months (time from study enrollment to first post-op visit)
measure: Amount of opioid used at home
timeFrame: 7 months (time from enrollment to 6 month follow-up phone call)
measure: Post-operative pain as measured by the Patient Reported Outcome Measurement Information System Pain Interference 6a assessments
timeFrame: 7 months (time from enrollment to 6 month follow-up phone call)
measure: Post-operative pain as measured by the Patient Reported Outcome Measurement Information System Pain Intensity 3a
timeFrame: 7 months (time from enrollment to 6 month follow-up phone call)
measure: High risk behavior as measured by the Patient Reported Outcome Measurement Information System Pain Medication Misuse assessment
timeFrame: 7 months (time from enrollment to 6 month follow-up phone call)
measure: Patient and caregiver knowledge
timeFrame: 7 months (time from enrollment to 6 month follow-up phone call)
measure: Patient and caregiver attitude
timeFrame: 7 months (time from enrollment to 6 month follow-up phone call)
measure: Prescription fill rate
timeFrame: approximately 2 weeks (from surgery to first follow-up visit)
measure: Naloxone accessibility
timeFrame: approximately 2 weeks (from surgery to first follow-up visit)
measure: Rescuer competence measured by modified Opioid Overdose Knowledge Scale Score (see outcome 14 for scoring)
timeFrame: approximately 2 weeks (from surgery to first follow-up visit)
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Institute for Orthopedics and Neurosciences
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Cassandra Mierisch, MD
role: PRINCIPAL_INVESTIGATOR
References: