An interventional study of Virtual Reality Education and Standard Education in Drug Overdose and Virtual Reality, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention
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.
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.
139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.
This study's enrollment of 98 is close to the median of 100 across 98 interventional studies indexed under Drug Overdose.
Browse Drug Overdose studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
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.
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.
Time frame: Immediately Pre-Training and Within 1 Hour Post-training
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
Time frame: Immediately Pre-Training and Within 1 Hour Post-training
| Milestone | Standard Education | Virtual Reality |
|---|---|---|
| Started | 40 | 58 |
| Completed | 37 | 57 |
| Not completed | 3 | 1 |
| Withdrew: Protocol violation | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| units on a scale | Standard Education | Virtual Reality |
|---|---|---|
| Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training | 2 (1 to 2) | 1 (0 to 3) |
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
| units on a scale | Standard Education | Virtual Reality |
|---|---|---|
| Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training | 1 (0.57 to 4.9) | 1 (0.71 to 1.43) |
Collected over Not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Education | — | — | — |
| Virtual Reality | — | — | — |
| Age, Continuous(years) | Standard Education | Virtual Reality | Total |
|---|---|---|---|
| Median | 40 (25 to 55) | 41 (30 to 60) | 40 (27 to 57) |
| Sex/Gender, Customized(Participants) | Standard Education | Virtual Reality | Total |
|---|---|---|---|
| Male | 12 | 22 | 34 |
| Female | 24 | 33 | 57 |
| Nonbinary | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Standard Education | Virtual Reality | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 13 | 24 |
| White | 14 | 21 | 35 |
| More than one race | 12 | 23 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| OOKS(units on a scale) | Standard Education | Virtual Reality | Total |
|---|---|---|---|
| Median | 5 (4 to 6) | 5 (3 to 7) | 5 (4 to 6) |
| OOAS(units on a scale) | Standard Education | Virtual Reality | Total |
|---|---|---|---|
| Median | 3.3 (3.1 to 3.6) | 3.4 (3.0 to 3.9) | 3.4 (3.0 to 3.7) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All collected IPD will be made available upon request with approved IRB from requesting institution
Supporting information: Study protocol, Sap
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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