Accidental FallNCT05161117
Virtual Reality Fall Education for Caregivers
A study testing Virtual reality simulation app for caregiver education and online fall prevention education module in people with Accidental Fall and Nurse's Role, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
Falls place a huge financial burden on healthcare delivery systems, as well as physical and emotional harm to patients and families. Nurses are responsible for identifying fall risks and educating patients about fall risks and prevention, but first must have a thorough understanding of fall risk hazards themselves. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Nurse's Role
- What is being tested?
- Virtual reality simulation app for caregiver education and online fall prevention education module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2021to 10 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- part-time and full-time registered nurses (RNs), Assistant Nurse Managers (ANMs), and patient care nursing assistants (PCNAs);
- participants must have greater than 50% of work time in direct patient care
Who cannot join
- holds PRN (as needed) or float position
- newly employed or in orientation at the time of the study
- reported history of dizziness or motion sickness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Avon Hospital
Avon, Ohio, 44011
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, 44124
About this study
Official title: Creating a Safe Inpatient Environment-Can Virtual Reality Fall Education Change Caregiver's Attitudes and Behaviors?
Falls place a huge financial burden on healthcare delivery systems, as well as physical and emotional harm to patients and families. Nurses are responsible for identifying fall risks and educating patients about fall risks and prevention, but first must have a thorough understanding of fall risk hazards themselves. The purpose of the study is to determine if enhanced education for caregivers using Virtual Reality simulation increases self-reported use of environmental fall risk interventions, and perceived effectiveness of those interventions, for caregivers on a medical-surgical unit. A secondary purpose is to explore the relationship between perceived effectiveness, unit norms, availability of resources, and self-reported behavior related to the use environmental interventions.
The study will use a matched-pair, clustered randomized controlled trial design. The setting is eight medical-surgical units across four hospitals. Unit-pairs at each hospital will be randomly assigned to control or intervention group. The sample will consist of clinical registered nurses and patient care nursing assistants. All participants will receive standard online fall risk education. Participants from the intervention units will also complete virtual reality simulation education delivered via an app on an iPhone that is attached to a headset. The Injurious Fall Risk Factors and Fall Prevention Interventions Survey will be used at baseline, 1 month post-, and 3 months post-education to measure perceived effectiveness, self-reported use, unit peer use, and availability of resources for use of environmental fall prevention interventions. A sample size of 30 participants per nursing unit will be needed for 90% power to detect mean differences of at least 0.5 points between groups.
- Conditions
- Accidental Fall, Nurse's Role
- Being tested
- Virtual reality simulation app for caregiver education, online fall prevention education module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality simulation app for caregiver educationBehavioural
Using a virtual reality headset/goggles, caregivers will engage with an interactive app experience to identify and mediate fall risk hazards in the inpatient care environment. The app will present a hospital bedroom and bathroom laden with fall risks. As the caregiver progresses through the experience, the caregiver will ambulate (virtually) through the environment with the goal of identifying fall risks inherent within that inpatient setting. Fall risks will be targeted and identified using the app "sighting" function and after focusing on the fall risk for the allotted "marking" time, will "self-resolve."
online fall prevention education moduleBehavioural
Participants in both intervention and control groups will complete a 20 minute online module: Management of the Patient at Risk for Falls, through the MyLearning education platform. Most caregivers would have taken this module during competencies or orientation, but at various times. It will be taken by all participants in this study to serve as a baseline understanding of identifying and caring for patients at risk for falls. Participants will be enrolled in the module by a member of the research team, and learner transcripts will available through MyLearning education to confirm completion.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality education | Experimental | The experimental group will receive both an online fall prevention education module and additional education using a virtual reality simulation app for mobile devices designed for specifically for hospital caregivers Receives: Behavioral: Virtual reality simulation app for caregiver education; Behavioral: online fall prevention education module |
| online education only | Active comparator | The control group will receive an online fall prevention education module Receives: Behavioral: online fall prevention education module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline rating of self-reported use of environmental fall prevention interventions at 1 month and 3 months post intervention
Using the Injurious Fall Risk Factors and Fall Prevention Interventions Survey, Part II (Tzeng \& Yin, 2013), caregivers are asked to rate 23 interventions for reducing falls or injuries using a 5-point likert scale. Self-reported use of environmental fall prevention interventions is measured by rating the frequency of each intervention used by the participant in his or her practice over the last 30 days (1=rarely, 2=occasionally, 3=sometimes, 4=often, 5=always, or NA=not applicable/no knowledge).
Measured: baseline, 1 month after intervention, and 3 months after intervention
Secondary outcomes (1)
Change from baseline rating of perceived effectiveness of environmental fall prevention interventions at 1 month and 3 months post intervention
Using the Injurious Fall Risk Factors and Fall Prevention Interventions Survey, Part II (Tzeng \& Yin, 2013), caregivers are asked to rate 23 interventions for reducing falls or injuries using a 5-point likert scale. Perceived effectiveness of environmental fall prevention interventions is measured by rating the effectiveness of each of the 23 interventions for reducing falls or injuries (1=Never effective, 2=Occasionally effective, 3=Sometimes effective, 4=Often effective, 5=Always effective or NA=not applicable/no knowledge).
Measured: baseline, 1 month after intervention, and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start12 Mar 2021
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Why it stopped: The original principal investigator had an illness and then retired. After reorganization of research team, the study was changed to a single group pretest posttest design for feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rose Hosler, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161117
- Sponsor's protocol ID
- 21-247
- Status last verified
- Dec 2024
- First submitted
- 8 Oct 2021
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouldin EL, Andresen EM, Dunton NE, Simon M, Waters TM, Liu M, Daniels MJ, Mion LC, Shorr RI. Falls among adult patients hospitalized in the United States: prevalence and trends. J Patient Saf. 2013 Mar;9(1):13-7. doi: 10.1097/PTS.0b013e3182699b64.
PubMed 23143749Fehlberg EA, Lucero RJ, Weaver MT, McDaniel AM, Chandler AM, Richey PA, Mion LC, Shorr RI. Impact of the CMS No-Pay Policy on Hospital-Acquired Fall Prevention Related Practice Patterns. Innov Aging. 2017 Nov;1(3):igx036. doi: 10.1093/geroni/igx036. Epub 2018 Feb 2.
PubMed 29911187Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.
PubMed 29512120Clyburn TA, Heydemann JA. Fall prevention in the elderly: analysis and comprehensive review of methods used in the hospital and in the home. J Am Acad Orthop Surg. 2011 Jul;19(7):402-9. doi: 10.5435/00124635-201107000-00003.
PubMed 21724919Haerling KA. Cost-Utility Analysis of Virtual and Mannequin-Based Simulation. Simul Healthc. 2018 Feb;13(1):33-40. doi: 10.1097/SIH.0000000000000280.
PubMed 29373382Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol. 2011 Jun 30;11:102. doi: 10.1186/1471-2288-11-102.
PubMed 21718530Pottle J. Virtual reality and the transformation of medical education. Future Healthc J. 2019 Oct;6(3):181-185. doi: 10.7861/fhj.2019-0036.
PubMed 31660522Slade SC, Carey DL, Hill AM, Morris ME. Effects of falls prevention interventions on falls outcomes for hospitalised adults: protocol for a systematic review with meta-analysis. BMJ Open. 2017 Nov 12;7(11):e017864. doi: 10.1136/bmjopen-2017-017864.
PubMed 29133324Soong C, Shojania KG. Education as a low-value improvement intervention: often necessary but rarely sufficient. BMJ Qual Saf. 2020 May;29(5):353-357. doi: 10.1136/bmjqs-2019-010411. Epub 2019 Dec 16. No abstract available.
PubMed 31843878Tzeng HM, Yin CY. Most frequently observed risk factors for adult inpatient injurious falls in hospitals. Clin Nurse Spec. 2013 Nov-Dec;27(6):314-22. doi: 10.1097/NUR.0b013e3182a87271.
PubMed 24107755Tzeng HM, Yin CY. Most and least helpful aspects of fall prevention education to prevent injurious falls: a qualitative study on nurses' perspectives. J Clin Nurs. 2014 Sep;23(17-18):2676-9. doi: 10.1111/jocn.12295. Epub 2013 Jul 2. No abstract available.
PubMed 23815367Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.
PubMed 25524443
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Safe Inpatient Environment-Can Virtual Reality Fall Education Change Caregiver's Attitudes and Behaviors?
- ClinicalTrials.gov ID
- NCT05161117
- Acronym / sponsor ID
- 21-247
- Conditions
- Accidental Fall, Nurse's Role
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The original principal investigator had an illness and then retired. After reorganization of research team, the study was changed to a single group pretest posttest design for feasibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 16 Dec 2021 (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.
Falls place a huge financial burden on healthcare delivery systems, as well as physical and emotional harm to patients and families. Nurses are responsible for identifying fall risks and educating patients about fall risks and prevention, but first must have a thorough understanding of fall risk hazards themselves. The purpose of the study is to determine if enhanced education for caregivers using Virtual Reality simulation increases self-reported use of environmental fall risk interventions, and perceived effectiveness of those interventions, for caregivers on a medical-surgical unit. A secondary purpose is to explore the relationship between perceived effectiveness, unit norms, availability of resources, and self-reported behavior related to the use environmental interventions.
The study will use a matched-pair, clustered randomized controlled trial design. The setting is eight medical-surgical units across four hospitals. Unit-pairs at each hospital will be randomly assigned to control or intervention group. The sample will consist of clinical registered nurses and patient care nursing assistants. All participants will receive standard online fall risk education. Participants from the intervention units will also complete virtual reality simulation education delivered via an app on an iPhone that is attached to a headset. The Injurious Fall Risk Factors and Fall Prevention Interventions Survey will be used at baseline, 1 month post-, and 3 months post-education to measure perceived effectiveness, self-reported use, unit peer use, and availability of resources for use of environmental fall prevention interventions. A sample size of 30 participants per nursing unit will be needed for 90% power to detect mean differences of at least 0.5 points between groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality education | Experimental | Behavioral: Virtual reality simulation app for caregiver education, Behavioral: online fall prevention education moduleThe experimental group will receive both an online fall prevention education module and additional education using a virtual reality simulation app for mobile devices designed for specifically for hospital caregivers |
| online education only | Active comparator | Behavioral: online fall prevention education moduleThe control group will receive an online fall prevention education module |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- part-time and full-time registered nurses (RNs), Assistant Nurse Managers (ANMs), and patient care nursing assistants (PCNAs);
- participants must have greater than 50% of work time in direct patient care
Key exclusion criteria (3 listed)
- holds PRN (as needed) or float position
- newly employed or in orientation at the time of the study
- reported history of dizziness or motion sickness
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 |
|---|---|---|
| Virtual reality simulation app for caregiver educationUsing a virtual reality headset/goggles, caregivers will engage with an interactive app experience to identify and mediate fall risk hazards in the inpatient care environment. The app will present a hospital bedroom and bathroom laden with fall risks. As the caregiver progresses through the experience, the caregiver will ambulate (virtually) through the environment with the goal of identifying fall risks inherent within that inpatient setting. Fall risks will be targeted and identified using the app "sighting" function and after focusing on the fall risk for the allotted "marking" time, will "self-resolve." | Behavioural | virtual reality education |
| online fall prevention education moduleParticipants in both intervention and control groups will complete a 20 minute online module: Management of the Patient at Risk for Falls, through the MyLearning education platform. Most caregivers would have taken this module during competencies or orientation, but at various times. It will be taken by all participants in this study to serve as a baseline understanding of identifying and caring for patients at risk for falls. Participants will be enrolled in the module by a member of the research team, and learner transcripts will available through MyLearning education to confirm completion. | Behavioural | online education only, virtual reality education |
Primary outcome
Change from baseline rating of self-reported use of environmental fall prevention interventions at 1 month and 3 months post intervention
Time frame: baseline, 1 month after intervention, and 3 months after intervention
Using the Injurious Fall Risk Factors and Fall Prevention Interventions Survey, Part II (Tzeng \& Yin, 2013), caregivers are asked to rate 23 interventions for reducing falls or injuries using a 5-point likert scale. Self-reported use of environmental fall prevention interventions is measured by rating the frequency of each intervention used by the participant in his or her practice over the last 30 days (1=rarely, 2=occasionally, 3=sometimes, 4=often, 5=always, or NA=not applicable/no knowledge).
1 secondary outcome
Change from baseline rating of perceived effectiveness of environmental fall prevention interventions at 1 month and 3 months post intervention
Time frame: baseline, 1 month after intervention, and 3 months after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 23143749Bouldin EL, Andresen EM, Dunton NE, Simon M, Waters TM, Liu M, Daniels MJ, Mion LC, Shorr RI. Falls among adult patients hospitalized in the United States: prevalence and trends. J Patient Saf. 2013 Mar;9(1):13-7. doi: 10.1097/PTS.0b013e3182699b64.
- Background: PubMed 29911187Fehlberg EA, Lucero RJ, Weaver MT, McDaniel AM, Chandler AM, Richey PA, Mion LC, Shorr RI. Impact of the CMS No-Pay Policy on Hospital-Acquired Fall Prevention Related Practice Patterns. Innov Aging. 2017 Nov;1(3):igx036. doi: 10.1093/geroni/igx036. Epub 2018 Feb 2.
- Background: PubMed 29512120Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.
- Background: PubMed 21724919Clyburn TA, Heydemann JA. Fall prevention in the elderly: analysis and comprehensive review of methods used in the hospital and in the home. J Am Acad Orthop Surg. 2011 Jul;19(7):402-9. doi: 10.5435/00124635-201107000-00003.
- Background: PubMed 29373382Haerling KA. Cost-Utility Analysis of Virtual and Mannequin-Based Simulation. Simul Healthc. 2018 Feb;13(1):33-40. doi: 10.1097/SIH.0000000000000280.
- Background: PubMed 21718530Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol. 2011 Jun 30;11:102. doi: 10.1186/1471-2288-11-102.
- Background: PubMed 31660522Pottle J. Virtual reality and the transformation of medical education. Future Healthc J. 2019 Oct;6(3):181-185. doi: 10.7861/fhj.2019-0036.
- Background: PubMed 29133324Slade SC, Carey DL, Hill AM, Morris ME. Effects of falls prevention interventions on falls outcomes for hospitalised adults: protocol for a systematic review with meta-analysis. BMJ Open. 2017 Nov 12;7(11):e017864. doi: 10.1136/bmjopen-2017-017864.
- Background: PubMed 31843878Soong C, Shojania KG. Education as a low-value improvement intervention: often necessary but rarely sufficient. BMJ Qual Saf. 2020 May;29(5):353-357. doi: 10.1136/bmjqs-2019-010411. Epub 2019 Dec 16. No abstract available.
- Background: PubMed 24107755Tzeng HM, Yin CY. Most frequently observed risk factors for adult inpatient injurious falls in hospitals. Clin Nurse Spec. 2013 Nov-Dec;27(6):314-22. doi: 10.1097/NUR.0b013e3182a87271.
- Background: PubMed 23815367Tzeng HM, Yin CY. Most and least helpful aspects of fall prevention education to prevent injurious falls: a qualitative study on nurses' perspectives. J Clin Nurs. 2014 Sep;23(17-18):2676-9. doi: 10.1111/jocn.12295. Epub 2013 Jul 2. No abstract available.
- Background: PubMed 25524443Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality simulation app for caregiver education and online fall prevention education module in people with Accidental Fall and Nurse's Role, run by The Cleveland Clinic at 2 sites 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline rating of self-reported use of environmental fall prevention interventions at 1 month and 3 months post intervention (time frame: baseline, 1 month after intervention, and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161117, which also lists 12 linked publications.
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 20 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.