Naloxone Education in Total Joint Patients

The Effect of Universal Pre-hospital Naloxone Education on Patient and Family Safety, Attitudes and Experience in the Surgical Patient: a Prospective Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Opioid Use; Pain, Musculoskeletal; Overdose of Opiate
• Intervention / Treatment: Other: Pre-hospital naloxone education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassandra Mierisch, MD; Phone Number: 540-510-6200; Email: crmierisch@carilionclinic.org
• Study Contact Backup: Name: Sarah F Smith, RN, BSN, MSN; Phone Number: 540-512-1056; Email: sfsmith@carilionclinic.org

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Institute for Orthopedics and Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naloxone education; These participants will receive a pre-hospital naloxone education module during their pre-operative joint class	Other: Pre-hospital naloxone education; a 5-10 minute pre-hospital education module teaching patients and support persons how and when to administer naloxone
No Intervention: Standard Education; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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.; patient reports naloxone is present in the home (or carried with the patient) (assessed by Y/N question); the support person reports knowledge of and immediate access to the naloxone (assessed by Y/N question); 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between indication for surgery (described by International Classification of Diseases 9/10 code) and "Readiness to Use Naloxone"	"Readiness to Use Naloxone" as described in our primary outcome measure will be used in the majority of our secondary outcomes. It functions as a binary variable. Indications for surgery are described by International Classification of Diseases 9/10, which are categorical variables with a uniform unit of measure. These codes are entered into the patient's electronic medical record by the patient's surgeon and would be retrieved by a study team member. Codes expected to be present in the study include: Musculoskeletal 16-Osteoarthritis of the Hip Musculoskeletal 17-Osteoarthritis of the Knee	2 months (time from study enrollment to first post-op visit)
Correlation between procedure (Current Procedural Terminology code) and "Readiness to Use Naloxone"	"Readiness to Use Naloxone" as described in our primary outcome measure will be used in the majority of our secondary outcomes. It functions as a binary variable. The operations that patients undergo are described by Current Procedural Terminology codes, which are categorical variables with a uniform unit of measure. These codes are entered into the patient's electronic medical record by the patient's surgeon and would be retrieved by a study team member. Codes expected to be present in the study include: 1005073- Arthroplasty, knee, condyle and plateau 27130 - Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft	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"	"Readiness to Use Naloxone" as described in our primary outcome measure will be used in the majority of our secondary outcomes. It functions as a binary variable. Comorbidities are other elements of a patient's health that are identified by their primary care physicians or other specialists. These comorbidities International Classification of Diseases 9/10, which are categorical variables with a uniform unit of measure. These codes are entered into the patient's electronic medical record by the patient's surgeon and would be retrieved by a study team member. Codes expected to be present in the study include: Musculoskeletal 16-Osteoarthritis of the Hip Musculoskeletal 17-Osteoarthritis of the Knee	2 months (time from study enrollment to first post-op visit)
correlation between patient age and "Readiness to Use Naloxone"	age (exploratory analysis)	2 months (time from study enrollment to first post-op visit)
correlation between patient sex and "Readiness to Use Naloxone"	sex (exploratory analysis)	2 months (time from study enrollment to first post-op visit)
correlation between patient race and "Readiness to Use Naloxone"	race (exploratory analysis)	2 months (time from study enrollment to first post-op visit)
correlation between patient ethnicity and "Readiness to Use Naloxone"	ethnicity (exploratory analysis)	2 months (time from study enrollment to first post-op visit)
correlation between patient household income and "Readiness to Use Naloxone"	household income (exploratory analysis)	2 months (time from study enrollment to first post-op visit)
Amount of opioid used at home	milligrams of morphine equivalents	7 months (time from enrollment to 6 month follow-up phone call)
Post-operative pain as measured by the Patient Reported Outcome Measurement Information System Pain Interference 6a assessments	Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult 6-item form, the lowest possible raw score is 6; the highest possible raw score is 30 (see all short form scoring tables in Appendix 1). All questions must be answered in order to produce a valid score using the scoring tables. If a participant has skipped a question, use the HealthMeasures Scoring Service (https://www.assessmentcenter.net/ac_scoringservice) to generate a final score. Locate the applicable score conversion table in Appendix 1 and use this table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.	7 months (time from enrollment to 6 month follow-up phone call)
Post-operative pain as measured by the Patient Reported Outcome Measurement Information System Pain Intensity 3a	Each question has five response options ranging in value from one to five. To find the total raw score for the short form, sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15. For most Patient-Reported Outcomes Measurement Information System instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. The T-score is provided with an error term (Standard Error or SE). The Standard Error is a statistical measure of variance and represents the "margin of error" for the T-score. Important: A higher Patient-Reported Outcomes Measurement Information System T-score represents more of the concept being measured.	7 months (time from enrollment to 6 month follow-up phone call)
High risk behavior as measured by the Patient Reported Outcome Measurement Information System Pain Medication Misuse assessment	Each question has five response options ranging in value from one to five. To find the total raw score for the short form, sum the values of the response to each question. For this instrument, the lowest possible raw score is 7; the highest possible raw score is 35. All questions must be answered in order to produce a valid score. For most Patient-Reported Outcomes Measurement Information System instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. The T-score is provided with an error term (Standard Error or SE). The Standard Error is a statistical measure of variance and represents the "margin of error" for the T-score.	7 months (time from enrollment to 6 month follow-up phone call)
Patient and caregiver knowledge	Opioid Overdose Knowledge Scale: The Opioid Overdose Knowledge Scale items use a 'yes/no or don't know'; or 'true/false or don't know' response format. Each correct answer scores one point. 'Don't know' and incorrectly marked responses (mistakes) are scored zero. Total score range: 0-45 points. OPIOID OVERDOSE KNOWLEDGE SCALE (OOKS): INSTRUCTIONS Total Score (45 items): One point if marked (33 Correct/True items): 1a, 1b, 1c, 1d, 1e, 1f, 1g, 1h, 1i, 2b, 2c, 2d, 2e, 2g, 2h, 3a, 3b, 3d, 3f, 3g, 3i, 3j, 4a, 5a, 5b, 5c, 6a, 7a, 8b, 9T, 11T, 12T, 14T One point if NOT marked (12 Incorrect/False items): 2a, 2f, 2i, 2j, 3c, 3e, 3h, 3k, 5d, 5e, 10F, 13F. You might chose to use the 'record into same variables' function of Statistical Package for the Social Sciences and inverse the values of these items.	7 months (time from enrollment to 6 month follow-up phone call)
Patient and caregiver attitude	Opioid Overdose Attitude Scale: SCORING The Opioid Overdose Attitude Scale is scored continuously using a 5-point Likert scale: completely disagree (1 point), disagree (2 points), unsure (3 points), agree (4 points) and completely agree (5 points). Reverse negative items: The following negative items need to be reversed before computing the total of scale points: 4, 6, 7, 9, 11, 15, 16, 17, 18, 23, 24, 25. You can use the 'record into same variables' OPIOID OVERDOSE ATTITUDES SCALE (OOAS): INSTRUCTIONS function of Statistical Package for the Social Sciences. Recode these items as: completely disagree (5 point), disagree (4 points), unsure (3 points), agree (2 points) and completely agree (1 points). Totals Scores: Once negative items have been reversed, add all items' points. The total scale points can range from 28 to 140 points.	7 months (time from enrollment to 6 month follow-up phone call)
Prescription fill rate	patient reports naloxone is present in the home (or carried with the patient)	approximately 2 weeks (from surgery to first follow-up visit)
Naloxone accessibility	"yes/no" answer to the question: "Do you know where naloxone is stored in the home and have immediate access to it in an emergency?"	approximately 2 weeks (from surgery to first follow-up visit)
Rescuer competence measured by modified Opioid Overdose Knowledge Scale Score (see outcome 14 for scoring)	the support person demonstrates competency for naloxone administration by scoring a passing mark (34/45) on the modified Opioid Overdose Knowledge Scale	approximately 2 weeks (from surgery to first follow-up visit)

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Collaborators: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Cassandra Mierisch, MD, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: patient education; naloxone; joint arthroplasty
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose; Musculoskeletal Pain; Opiate Overdose; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: IRB-19-474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No