Trial Outcomes & Findings for Use of Virtual Reality for Overdose Management Educational Trainings (NCT NCT04091659)
NCT ID: NCT04091659
Last Updated: 2020-12-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
Immediately Pre-Training and Within 1 Hour Post-training
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
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.
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
58
|
|
Overall Study
COMPLETED
|
37
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
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
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Use of Virtual Reality for Overdose Management Educational Trainings
Baseline characteristics by cohort
| Measure |
Standard Education
n=37 Participants
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
n=57 Participants
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
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
41 years
n=7 Participants
|
40 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
24 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Nonbinary
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
OOKS
|
5 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
5 units on a scale
n=5 Participants
|
|
OOAS
|
3.3 units on a scale
n=5 Participants
|
3.4 units on a scale
n=7 Participants
|
3.4 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately Pre-Training and Within 1 Hour Post-trainingPopulation: Higher difference in scores indicates greater improvement from baseline to follow up
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.
Outcome measures
| Measure |
Standard Education
n=37 Participants
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
n=57 Participants
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.
|
|---|---|---|
|
Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training
|
2 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Immediately Pre-Training and Within 1 Hour Post-trainingPopulation: Higher difference in scores indicates greater improvement from baseline to follow up
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
Outcome measures
| Measure |
Standard Education
n=37 Participants
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
n=57 Participants
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.
|
|---|---|---|
|
Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training
|
1 units on a scale
Interval 0.57 to 4.9
|
1 units on a scale
Interval 0.71 to 1.43
|
Adverse Events
Standard Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Virtual Reality
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nicholas A. Giordano, PhD RN
University of Pennsylvania
Phone: (215) 898-8281
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place