Virtual Reality Fall Education for Caregivers

August 22, 2022 updated by: Nancy DeWalt, The Cleveland Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nancy Dewalt, MSN
  • Phone Number: 440-312-8389
  • Email: dewaltn@ccf.org

Study Contact Backup

  • Name: Karen S Distelhorst, PhD
  • Phone Number: 216-445-3355
  • Email: distelk@ccf.org

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44307
        • Not yet recruiting
        • Cleveland Clinic Akron General
        • Contact:
          • Christine Hotes, MSN, RN, NE-BC
          • Phone Number: 330-344-6636
          • Email: hotesc@ccf.org
      • Avon, Ohio, United States, 44011
        • Recruiting
        • Cleveland Clinic Avon Hospital
        • Contact:
          • Beverly Will, MSN, RN, ACCN-AG
          • Phone Number: 216 409-3471
          • Email: bwill1@ccf.org
      • Euclid, Ohio, United States, 44119
        • Recruiting
        • Cleveland Clinic Euclid Hospital
        • Contact:
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Cleveland Clinic Hillcrest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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."
Behavioral: online 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.
Active Comparator: online education only
The control group will receive an online fall prevention education module
Behavioral: online 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline, 1 month after intervention, and 3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
baseline, 1 month after intervention, and 3 months after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline rating of perceived unit norms for 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
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).
baseline, 1 month after intervention, and 3 months after intervention
Change from baseline rating of availability of resources to implement environmental fall prevention interventions at 1 month and 3 months post intervention
Time Frame: baseline, 1 month after intervention, and 3 months after 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.
baseline, 1 month after intervention, and 3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 21-247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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