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Use of Virtual Reality for Overdose Management Educational Trainings

Primary Purpose

Drug Overdose, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Education
Standard Education
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Overdose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Education

Virtual Reality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2019
Last Updated
December 1, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04091659
Brief Title
Use of Virtual Reality for Overdose Management Educational Trainings
Official Title
Use of Virtual Reality for Overdose Management Educational Trainings
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose, Virtual Reality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training
Description
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.
Time Frame
Immediately Pre-Training and Within 1 Hour Post-training
Secondary Outcome Measure Information:
Title
Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training
Description
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
Time Frame
Immediately Pre-Training and Within 1 Hour Post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas A Giordano
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Use of Virtual Reality for Overdose Management Educational Trainings

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