The Effect of Universal Pre-hospital Naloxone Education on Patient and Family Safety, Attitudes and Experience in the Surgical Patient: a Prospective Randomized Trial
Sponsor study identifier
interventional
500
1 country
1
Study Start
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2019
Actual (reported)May 3, 2021
Actual (reported)September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
"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)
Correlation between indication for surgery (described by International Classification of Diseases 9/10 code) and "Readiness to Use Naloxone"
These participants will receive a pre-hospital naloxone education module during their pre-operative joint class
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
a 5-10 minute pre-hospital education module teaching patients and support persons how and when to administer naloxone
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institute for Orthopedics and Neurosciences
Roanoke, Virginia, 24014, United States
Cassandra Mierisch, MD
Carilion Clinic
First Submitted
October 7, 2019
First Posted
May 3, 2021
Study Start
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Strategies for Musculoskeletal Symptoms Relieving and Ergonomy in Operating Room
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)
Contact the study team to confirm eligibility.
Primary Completion
June 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 3, 2021
Record last verified: 2021-04
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