NCT04091659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
27 days until next milestone

Results Posted

Study results publicly available

February 12, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

September 11, 2019

Results QC Date

January 17, 2020

Last Update Submit

December 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training

    Immediately Pre-Training and Within 1 Hour Post-training

Study Arms (2)

Standard Education

ACTIVE COMPARATOR

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

Virtual Reality

EXPERIMENTAL

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

Interventions

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.

Virtual Reality

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.

Standard Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to complete paper surveys independently
  • Provide verbal consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Nicholas A. Giordano, PhD RN
Organization
University of Pennsylvania

Study Officials

  • Nicholas A Giordano

    Lecturer

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 17, 2019

Study Start

September 18, 2019

Primary Completion

January 15, 2020

Study Completion

January 16, 2020

Last Updated

December 22, 2020

Results First Posted

February 12, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

All collected IPD will be made available upon request with approved IRB from requesting institution

Shared Documents
STUDY PROTOCOL, 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

Locations