CClinicalTrials.gg
WithdrawnNCT05161117Updated Dec 20, 2024

Virtual Reality Fall Education for Caregivers

An interventional study of Virtual reality simulation app for caregiver education and online fall prevention education module in Accidental Fall and Nurse's Role, sponsored by The Cleveland Clinic. Withdrawn at 2 sites in United States. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Other

Why this study was withdrawn
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.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2021, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Accidental Fall
  • Nurse's Role
03

In context

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    virtual reality education

    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

    Behavioral: Virtual reality simulation app for caregiver education · Behavioral: online fall prevention education module

  • Active comparator
    online education only

    The control group will receive an online fall prevention education module

    Behavioral: online fall prevention education module

Interventions

  • BehavioralVirtual reality simulation app for caregiver education

    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."

  • Behavioralonline fall prevention education module

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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).

    Time frame: baseline, 1 month after intervention, and 3 months after intervention

Other outcomes

  1. Change from baseline rating of perceived unit norms for use of environmental fall prevention interventions at 1 month and 3 months post intervention

    Unit norms for use of environmental fall prevention interventions is measured by rating the frequency that participants observe the use of each intervention by peers on the unit (1=rarely, 2=occasionally, 3=sometimes, 4=often, 5=always, or NA=not applicable/no knowledge).

    Time frame: baseline, 1 month after intervention, and 3 months after intervention

  2. Change from baseline rating of availability of resources to implement environmental fall prevention interventions at 1 month and 3 months post intervention

    Availability of resources to implement environmental fall prevention interventions is measured by rating how often resources limit the implementation each intervention. (1=Never, 2=Occasionally, 3=Sometimes, 4=Often, 5=Always or NA=not applicable/no knowledge). Scores will be reversed coded for analysis.

    Time frame: baseline, 1 month after intervention, and 3 months after intervention

07

Study locations

2 sites
  • Cleveland Clinic Avon Hospital
    Avon, Ohio 44011, United States
  • Cleveland Clinic Hillcrest Hospital
    Mayfield Heights, Ohio 44124, United States
08

References and documents

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 23143749 ↗
  • Fehlberg 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 29911187 ↗
  • Florence 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 29512120 ↗
  • Clyburn 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 21724919 ↗
  • Haerling KA. Cost-Utility Analysis of Virtual and Mannequin-Based Simulation. Simul Healthc. 2018 Feb;13(1):33-40. doi: 10.1097/SIH.0000000000000280. PubMed 29373382 ↗
  • Hemming 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 21718530 ↗
  • Pottle 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 31660522 ↗
  • Slade 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 29133324 ↗
  • Soong 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 31843878 ↗
  • Tzeng 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 24107755 ↗
  • Tzeng 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 23815367 ↗
  • Wan 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05161117
Lead sponsor
The Cleveland Clinic
Responsible party
Rose Hosler (Healing Solutions Coordinator, The Cleveland Clinic) — Principal investigator
First posted
Dec 16, 2021
Start date
Mar 12, 2021
Primary completion
Dec 10, 2024
Completion
Dec 10, 2024
Last update
Dec 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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