Study Summary
This trial will explore whether or not 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.
Eligible Conditions
- Accidental Falls
- Nursing
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: baseline, 1 month after intervention, and 3 months after intervention
Month 3
Change from baseline rating of availability of resources to implement environmental fall prevention interventions at 1 month and 3 months post intervention
Change from baseline rating of perceived effectiveness of environmental fall prevention interventions at 1 month and 3 months post intervention
Interventional procedure
Change from baseline rating of self-reported use of environmental fall prevention interventions at 1 month and 3 months post intervention
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
online education only
1 of 2
virtual reality education
1 of 2
Active Control
Experimental Treatment
288 Total Participants · 2 Treatment Groups
Primary Treatment: Virtual reality simulation app for caregiver education · No Placebo Group · N/A
virtual reality educationExperimental Group · 2 Interventions: Virtual reality simulation app for caregiver education, online fall prevention education module · Intervention Types: Behavioral, Behavioral
online education only
Behavioral
ActiveComparator Group · 1 Intervention: online fall prevention education module · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month after intervention, and 3 months after intervention
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
949 Previous Clinical Trials
1,409,485 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People taking part in the study must spend more than half their working hours directly caring for patients.
RNs who work either part-time or full-time, ANMs, and PCNAs who provide patient care.
References
- Hemming, Karla, Alan J Girling, Alice J Sitch, Jennifer Marsh, and Richard J Lilford. 2011. “Sample Size Calculations for Cluster Randomised Controlled Trials with a Fixed Number of Clusters”. BMC Medical Research Methodology. Springer Science and Business Media LLC. doi:10.1186/1471-2288-11-102.
- Tzeng, Huey-Ming, and Chang-Yi Yin. 2013. “Most Frequently Observed Risk Factors for Adult Inpatient Injurious Falls in Hospitals”. Clinical Nurse Specialist. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/nur.0b013e3182a87271.
- Pottle, Jack. 2019. “Virtual Reality and the Transformation of Medical Education”. Future Healthcare Journal. Royal College of Physicians. doi:10.7861/fhj.2019-0036.
- Wan, Xiang, Wenqian Wang, Jiming Liu, and Tiejun Tong. 2014. “Estimating the Sample Mean and Standard Deviation from the Sample Size, Median, Range And/or Interquartile Range”. BMC Medical Research Methodology. Springer Science and Business Media LLC. doi:10.1186/1471-2288-14-135.
- Florence, Curtis S., Gwen Bergen, Adam Atherly, Elizabeth Burns, Judy Stevens, and Cynthia Drake. 2018. “Medical Costs of Fatal and Nonfatal Falls in Older Adults”. Journal of the American Geriatrics Society. Wiley. doi:10.1111/jgs.15304.
- Soong, Christine, and Kaveh G Shojania. 2019. “Education as a Low-value Improvement Intervention: Often Necessary but Rarely Sufficient”. BMJ Quality & Safety. BMJ. doi:10.1136/bmjqs-2019-010411.
- Bouldin, Erin L. D., Elena M. Andresen, Nancy E. Dunton, Michael Simon, Teresa M. Waters, Minzhao Liu, Michael J. Daniels, Lorraine C. Mion, and Ronald I. Shorr. 2013. “Falls Among Adult Patients Hospitalized in the United States”. Journal of Patient Safety. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pts.0b013e3182699b64.
- Haerling, Katie A.. 2018. “Cost-utility Analysis of Virtual and Mannequin-based Simulation”. Simulation in Healthcare: The Journal of the Society for Simulation in Healthcare. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sih.0000000000000280.
- Fehlberg, Elizabeth A, Robert J Lucero, Michael T Weaver, Anna M McDaniel, Michelle Chandler, Phyllis A Richey, Lorraine C Mion, and Ronald I Shorr. 2017. “Impact of the CMS No-pay Policy on Hospital-acquired Fall Prevention Related Practice Patterns”. Innovation in Aging. Oxford University Press (OUP). doi:10.1093/geroni/igx036.
- Clyburn, Terry A., and John A. Heydemann. 2011. “Fall Prevention in the Elderly: Analysis and Comprehensive Review of Methods Used in the Hospital and in the Home”. Journal of the American Academy of Orthopaedic Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.5435/00124635-201107000-00003.
- Tzeng, Huey-Ming, and Chang-Yi Yin. 2013. “Most and Least Helpful Aspects of Fall Prevention Education to Prevent Injurious Falls: A Qualitative Study on Nurses' Perspectives”. Journal of Clinical Nursing. Wiley. doi:10.1111/jocn.12295.
- Slade, Susan C, David L Carey, Anne-Marie Hill, and Meg E Morris. 2017. “Effects of Falls Prevention Interventions on Falls Outcomes for Hospitalised Adults: Protocol for a Systematic Review with Meta-analysis”. BMJ Open. BMJ. doi:10.1136/bmjopen-2017-017864.
- 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. Erratum In: BMC Med Res Methodol. 2017 Jan 19;17 (1):8.
- 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.
- 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.
- 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.
- 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.
- Nancy DeWalt 2021. "Virtual Reality Fall Education for Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05161117.
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Conditions
Cancer Related
Treatments