Use of Virtual Reality for Overdose Management Educational Trainings

This cluster-randomized trial will compare changes in attitudes and knowledge on administering naloxone based on exposure to either a virtual reality educational training or the current standard educational trainings (e.g. on-line videos, printed information handouts) offered at local libraries. Individuals attending local library's naloxone training days will voluntarily complete an anonymous validated survey pre and post attending either the virtual reality or standard educational training.

Study Overview

• Status: Completed
• Conditions: Virtual Reality; Drug Overdose
• Intervention / Treatment: Other: Standard Education; Other: Virtual Reality Education

Detailed Description

This study will utilize a cluster-randomized trial design. Entire libraries will be randomized to either offer community members the virtual reality training or the standard educational offerings (e.g. handouts, online videos). Volunteers will be asked to complete the brief, anonymous, and validated Opioid Overdose Knowledge Scale prior to receiving an education intervention (pretest) and then again immediately after (posttest). Neither participants nor investigators will be blinded. Library patrons who do not participate in the study will be offered current standard training materials. Regardless of the library's randomization, to either virtual reality or standard training, all patrons completing pre and post test surveys will have the opportunity to view the virtual reality training or other public health department materials.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to complete paper surveys independently
• Provide verbal consent

Exclusion Criteria:

• Unable to complete immediate post-training assessment
• Individuals under 18 years of age
• Individuals who cannot communicate in English and provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Education; Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education.	Other: Standard Education; Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education.
Experimental: Virtual Reality; Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention.	Other: Virtual Reality Education; Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training	Higher scores on the OOKS indicate greater knowledge on how to identify and appropriately intervene during an opioid related overdose, including proper use of naloxone. The tool has been validated with healthcare professionals and lay persons and used to assess changes in knowledge and attitudes after in-person naloxone trainings. This main outcome of this study is examining changes in the OOKS subscale for signs of an opioid overdose with scores ranging from 0 to 10.	Immediately Pre-Training and Within 1 Hour Post-training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training	The OOAS subscales assessing competencies to manage an opioid overdose (5 items). Study participants were given intranasal naloxone, so all items were adapted to refer to intranasal naloxone rather than injectable naloxone. OOAS items were scored on a Likert-type scale and higher scores suggested more favorable attitudes towards opioid overdose response, where 1=completely disagree, and 5=completely agree	Immediately Pre-Training and Within 1 Hour Post-training

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Nicholas A Giordano, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 16, 2020

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: 833978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD will be made available upon request with approved IRB from requesting institution
• IPD Sharing Time Frame: 1 year after study completion and up to 3 years later
• IPD Sharing Access Criteria: Made available upon request and with approved IRB from requesting institution
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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