Naloxone Education in Total Joint Patients

NCT04868552 | Unknown

• 1 other identifier: IRB-19-474
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Pain, Musculoskeletal; Surgery; Overdose of Opiate

Keywords

naloxone; patient education; joint arthroplasty

Outcome Measures

Primary Outcomes (1)

• "Readiness to Use Naloxone" assessed by survey and Opioid Overdose Knowledge Scale administration

  This measure is expressed as a binary yes/no for each patient-support person pair. It can be assessed with the survey tool used at the patient's follow up appointment. The patient/ support person pair must satisfy each of the three following conditions. 1. patient reports naloxone is present in the home (or carried with the patient) (assessed by Y/N question) 2. the support person reports knowledge of and immediate access to the naloxone (assessed by Y/N question) 3. the support person demonstrates competency for naloxone administration by scoring a passing mark on the modified Opioid Overdose Knowledge Scale (OOKS) (Williams et al. 2013). For our purposes, this will be a score greater than or equal to 34/45. If the three conditions are met, then the pair is assessed a "yes" score on "Readiness to Use Naloxone". If any condition is not met, then the pair is assessed a "no" score on "Readiness to Use Naloxone".

  approximately 2 weeks (from surgery to first follow-up visit)

Secondary Outcomes (17)

• Correlation between indication for surgery (described by International Classification of Diseases 9/10 code) and "Readiness to Use Naloxone"

  2 months (time from study enrollment to first post-op visit)

• Correlation between procedure (Current Procedural Terminology code) and "Readiness to Use Naloxone"

  2 months (time from study enrollment to first post-op visit)

• Correlation between patient comorbidities (described by International Classification of Diseases 9/10 code and "Readiness to Use Naloxone"

  2 months (time from study enrollment to first post-op visit)

• correlation between patient age and "Readiness to Use Naloxone"

  2 months (time from study enrollment to first post-op visit)

• correlation between patient sex and "Readiness to Use Naloxone"

  2 months (time from study enrollment to first post-op visit)

Study Arms (2)

Naloxone education

EXPERIMENTAL

These participants will receive a pre-hospital naloxone education module during their pre-operative joint class

Other: Pre-hospital naloxone education

Standard Education

NO INTERVENTION

These participants will receive the standard pre-hospital education including pain management and opioid safety, but will not specifically be given the new naloxone-education module in the pre-hospital setting

Interventions

Pre-hospital naloxone education OTHER

a 5-10 minute pre-hospital education module teaching patients and support persons how and when to administer naloxone

Naloxone education

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Institute for Orthopedics and Neurosciences

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Opiate Overdose

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Cassandra Mierisch, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Mierisch, MD

CONTACT

540-510-6200; crmierisch@carilionclinic.org

Sarah F Smith, RN, BSN, MSN

CONTACT

540-512-1056; sfsmith@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: investigators analyzing data will not know whether participants are in the intervention or no-intervention group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: May 3, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)