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Use of Virtual Reality for Overdose Management Educational Trainings

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ClinicalTrials.gov Identifier: NCT04091659
Recruitment Status : Enrolling by invitation
First Posted : September 17, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nicholas Giordano, PhD, RN, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Drug Overdose Virtual Reality Other: Virtual Reality Education Other: Standard Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Virtual Reality for Overdose Management Educational Trainings
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : December 18, 2019

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.




Primary Outcome Measures :
  1. Change in Opioid Overdose Knowledge Scale (OOKS) from Pre- to Immediately Post-training [ Time Frame: Immediately Pre-Training and Within 1 Hour 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 11.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091659


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Nicholas A Giordano Lecturer

Publications:
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Responsible Party: Nicholas Giordano, PhD, RN, Lecturer, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04091659     History of Changes
Other Study ID Numbers: 833978
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD will be made available upon request with approved IRB from requesting institution
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 1 year after study completion and up to 3 years later
Access Criteria: Made available upon request and with approved IRB from requesting institution

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents