Virtual RealityREACH_CCTSTNCT06108141
Virtual Reality Intervention to Support Clinicians' Firearm Safety Counseling Behaviors
A study testing Resident Education And Counseling on Household Firearm Safety and Modified American Academy of Pediatrics Safer in people with Virtual Reality and Simulation Based Medical Education, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the efficacy of REACH Firearm Safety in a sample of pediatric residents. The main question it aims to answer are: Do residents who have completed REACH Firearm Safety have increased documentation in the electronic medical records for screening and counseling for safe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Simulation Based Medical Education, Firearm Injury
- What is being tested?
- Resident Education And Counseling on Household Firearm Safety and Modified American Academy of Pediatrics Safer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident with continuity clinic at either Kentucky Clinic South, University of Kentucky (UK) Internal Medicine and Pediatrics group, CCHMC Hopple Street Neighborhood Health Center, or University of Cincinnati (UC) Hoxworth Medicine-Pediatrics Clinic
Who cannot join
- Resident unable to read or speak English
- Resident with continuity clinic outside of inclusion criteria clinics
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Implementation of a Novel Virtual Reality Intervention to Support Clinicians' Firearm Safety Counseling Behaviors
The goal of this clinical trial is to assess the efficacy of REACH Firearm Safety in a sample of pediatric residents. The main question it aims to answer are:
Do residents who have completed REACH Firearm Safety have increased documentation in the electronic medical records for screening and counseling for safe firearm storage?
Participants will be asked to engage in a virtual reality curriculum (REACH Firearm Safety). Researchers will compare the REACH Firearm safety group to a group of participants who complete an abbreviated online training.
Read the detailed description
The American Academy of Pediatrics urges pediatricians to counsel parents on the dangers of childhood access to firearms and restrict access through safe storage practices. However, evidence suggests that most pediatricians do not provide firearm-related counseling in real-world clinical practice. This is notable as firearm-related injury is now the leading cause of death in children aged 1-19 years in the United States. Virtual reality (VR) is a type of simulation-based medical education that allows users to interact with virtual environments and characters in a seemingly realistic way. Investigators developed Resident Education And Counseling on Household (REACH) Firearm Safety, a VR curriculum to allow pediatricians to practice screening and counseling on firearm safety. The objective of this proposal is to assess the efficacy of REACH Firearm Safety, along with key implementation metrics, to justify and inform scale and distribution of the training approach. To achieve the objective, Investigators will: (1) Conduct a multi-site two-arm randomized controlled pilot study assessing the efficacy of REACH Firearm Safety and (2) Measure acceptability, appropriateness, fidelity, feasibility, and cost of implementation of REACH Firearm Safety. The proposed research is significant and innovative because it is the first rigorous effort to evaluate the efficacy of VR as a training platform to teach communication skills related to firearm safety counseling.
- Being tested
- Resident Education And Counseling on Household Firearm Safety, Modified American Academy of Pediatrics Safer
- Keywords
- Virtual Reality, Simulation Based Medical Education, Firearm Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resident Education And Counseling on Household Firearm SafetyBehavioural
Also called REACH Firearm Safety
An intervention that includes a self-directed online curriculum and virtual reality simulations, designed to teach firearm screening and counseling among clinicians.
Modified American Academy of Pediatrics SaferBehavioural
Also called Modified AAP Safer
An intervention that includes a self-directed online curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Resident Education And Counseling on Household (REACH) Firearm Safety | Experimental | Resident participants will complete a modified online self-guided American Academy of Pediatrics (AAP) Safer curriculum. Next, residents will complete REACH individually with a trained facilitator. Receives: Behavioral: Resident Education And Counseling on Household Firearm Safety |
| Modified AAP Safer | Active comparator | Resident participants will complete a modified online self-guided American Academy of Pediatrics (AAP) Safer curriculum. Receives: Behavioral: Modified American Academy of Pediatrics Safer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in the Percentage of Participants with documentation within the medical record of access to firearms.
Documentation of discussion during clinical encounter of access to firearms.
Measured: 6 months
Percent Change From Baseline in the Percentage of Participants with documentation within the medical record of counseling on firearm injury prevention.
Documentation of discussion during clinical encounter of firearm injury prevention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start19 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F. Joseph Real, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108141
- Sponsor's protocol ID
- 2023-0469
- Acronym
- REACH_CCTST
- Status last verified
- Jun 2024
- First submitted
- 23 Oct 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Novel Virtual Reality Intervention to Support Clinicians' Firearm Safety Counseling Behaviors
- ClinicalTrials.gov ID
- NCT06108141
- Acronym / sponsor ID
- REACH_CCTST / 2023-0469
- Keywords
- Virtual Reality, Simulation Based Medical Education, Firearm Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the efficacy of REACH Firearm Safety in a sample of pediatric residents. The main question it aims to answer are:
Do residents who have completed REACH Firearm Safety have increased documentation in the electronic medical records for screening and counseling for safe firearm storage?
Participants will be asked to engage in a virtual reality curriculum (REACH Firearm Safety). Researchers will compare the REACH Firearm safety group to a group of participants who complete an abbreviated online training.
Detailed description
The American Academy of Pediatrics urges pediatricians to counsel parents on the dangers of childhood access to firearms and restrict access through safe storage practices. However, evidence suggests that most pediatricians do not provide firearm-related counseling in real-world clinical practice. This is notable as firearm-related injury is now the leading cause of death in children aged 1-19 years in the United States. Virtual reality (VR) is a type of simulation-based medical education that allows users to interact with virtual environments and characters in a seemingly realistic way. Investigators developed Resident Education And Counseling on Household (REACH) Firearm Safety, a VR curriculum to allow pediatricians to practice screening and counseling on firearm safety. The objective of this proposal is to assess the efficacy of REACH Firearm Safety, along with key implementation metrics, to justify and inform scale and distribution of the training approach. To achieve the objective, Investigators will: (1) Conduct a multi-site two-arm randomized controlled pilot study assessing the efficacy of REACH Firearm Safety and (2) Measure acceptability, appropriateness, fidelity, feasibility, and cost of implementation of REACH Firearm Safety. The proposed research is significant and innovative because it is the first rigorous effort to evaluate the efficacy of VR as a training platform to teach communication skills related to firearm safety counseling.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resident Education And Counseling on Household (REACH) Firearm Safety | Experimental | Behavioral: Resident Education And Counseling on Household Firearm SafetyResident participants will complete a modified online self-guided American Academy of Pediatrics (AAP) Safer curriculum. Next, residents will complete REACH individually with a trained facilitator. |
| Modified AAP Safer | Active comparator | Behavioral: Modified American Academy of Pediatrics SaferResident participants will complete a modified online self-guided American Academy of Pediatrics (AAP) Safer curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resident with continuity clinic at either Kentucky Clinic South, University of Kentucky (UK) Internal Medicine and Pediatrics group, CCHMC Hopple Street Neighborhood Health Center, or University of Cincinnati (UC) Hoxworth Medicine-Pediatrics Clinic
Key exclusion criteria (2 listed)
- Resident unable to read or speak English
- Resident with continuity clinic outside of inclusion criteria clinics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resident Education And Counseling on Household Firearm SafetyAlso: REACH Firearm SafetyAn intervention that includes a self-directed online curriculum and virtual reality simulations, designed to teach firearm screening and counseling among clinicians. | Behavioural | Resident Education And Counseling on Household (REACH) Firearm Safety |
| Modified American Academy of Pediatrics SaferAlso: Modified AAP SaferAn intervention that includes a self-directed online curriculum. | Behavioural | Modified AAP Safer |
Primary outcome
Percent Change From Baseline in the Percentage of Participants with documentation within the medical record of access to firearms.
Time frame: 6 months
Documentation of discussion during clinical encounter of access to firearms.
Percent Change From Baseline in the Percentage of Participants with documentation within the medical record of counseling on firearm injury prevention.
Time frame: 6 months
Documentation of discussion during clinical encounter of firearm injury prevention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resident Education And Counseling on Household Firearm Safety and Modified American Academy of Pediatrics Safer in people with Virtual Reality and Simulation Based Medical Education, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in the Percentage of Participants with documentation within the medical record of access to firearms. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.