Use of Virtual Reality for Overdose Management Educational Trainings

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04091659
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 24.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Overdose; Virtual Reality	Other: Virtual Reality Education; Other: Standard Education	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 98 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: Sep 18, 2019
• Actual Primary Completion Date: Jan 15, 2020
• Actual Study Completion Date: Jan 16, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training [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 10.

Secondary Outcome Measures

1. Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training [Immediately Pre-Training and Within 1 Hour 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Nicholas A Giordano, Lecturer

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 22, 2019
• Informed Consent Form - Aug 22, 2019

More Information

Publications

None provided.

• Responsible Party: Nicholas Giordano, PhD, RN, Lecturer, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04091659
• Other Study ID Numbers: 833978
• First Posted: Sep 17, 2019
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Drug Overdose

Study Results

Participant Flow

Arm/Group Title	Standard Education	Virtual Reality
Arm/Group 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. 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.	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 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.
Period Title: Overall Study
STARTED	40	58
COMPLETED	37	57
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Standard Education	Virtual Reality	Total
Arm/Group 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. 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.	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 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.	Total of all reporting groups
Overall Participants	37	57	94
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	40	41	40
Sex/Gender, Customized (Count of Participants)
Male	12 32.4%	22 38.6%	34 36.2%
Female	24 64.9%	33 57.9%	57 60.6%
Nonbinary	1 2.7%	2 3.5%	3 3.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 29.7%	13 22.8%	24 25.5%
White	14 37.8%	21 36.8%	35 37.2%
More than one race	12 32.4%	23 40.4%	35 37.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
OOKS (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	5	5	5
OOAS (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	3.3	3.4	3.4

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Higher difference in scores indicates greater improvement from baseline to follow up

Arm/Group Title	Standard Education	Virtual Reality
Arm/Group 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. 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.	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 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.
Measure Participants	37	57
Median (Inter-Quartile Range) [units on a scale]	2	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Education, Virtual Reality
	Comments
	Type of Statistical Test	Equivalence
	Comments	To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.
Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	SEM
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.85 to 0.49
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		The control group, standard education was the reference for this model.

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Higher difference in scores indicates greater improvement from baseline to follow up

Arm/Group Title	Standard Education	Virtual Reality
Arm/Group 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. 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.	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 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.
Measure Participants	37	57
Median (Inter-Quartile Range) [units on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Education, Virtual Reality
	Comments
	Type of Statistical Test	Equivalence
	Comments	To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	SEM
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.26
	Confidence Interval	(2-Sided) 95%; 0.02 to 0.50
	Parameter Dispersion	Type: Value:
	Estimation Comments	The control group, standard education, was the reference

Adverse Events

Time Frame	Not monitored/assessed
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Arm/Group Title	Standard Education		Virtual Reality
Arm/Group 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. 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.		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 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.
All Cause Mortality
	Standard Education		Virtual Reality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Standard Education		Virtual Reality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Standard Education		Virtual Reality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.