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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04937257
Other study ID # 2020-11936
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2020
Est. completion date January 27, 2021

Study information

Verified date June 2021
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2). In-person, hands-on training tends to be preferred, however staff shortages limit feasibility and contamination still occurs (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online (5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2). Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training. The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.


Description:

The COVID-19 (Coronavirus Disease 2019) pandemic highlighted concerns regarding personal protective equipment (PPE) utilization in hospitals (10,11). When used correctly, PPE can prevent COVID-19 infection amongst exposed healthcare workers (12,13) . Evidence suggests that up to 90% of doffing procedures are performed incorrectly (14). This failure rate has been linked to healthcare workers being more likely to contract COVID-19 compared to the general community (15). As a result, authorities have turned to increased training as a potential solution (16). All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2) In-person, hands-on training tends to be preferred, however, staff shortages limit feasibility and contamination still occurs 82% of the time (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online(5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2). Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training. The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date January 27, 2021
Est. primary completion date January 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Associates affiliated with the Montefiore Medical Center. - Medical Students at the Albert Einstein College of Medicine. Exclusion Criteria: - None.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual Reality
The training included the following in the specified order: (1) A tutorial with an introduction to the program and a overview of the correct donning and doffing sequence, based on Center for Disease Control (CDC) guidelines, (2) a training mode to practice the correct sequences with step-wise feedback, and (3) a testing mode that repeated until the sequence was completed perfectly without any mistakes. A study member was present to assist with the device and record the duration of training.
E-module
The instructional video included step-by-step instruction and demonstration of adequate donning and doffing procedures. The 14-slide presentation contained the same content as used by the home institution for competency training, based on Center for Disease Control (CDC) guidelines. Participants were instructed to review the material however they liked and their duration of training was recorded.

Locations

Country Name City State
United States Montefiore Einstein Center for Innovation in Simulation Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

Barratt R, Shaban RZ, Gilbert GL. Characteristics of personal protective equipment training programs in Australia and New Zealand hospitals: A survey. Infect Dis Health. 2020 Nov;25(4):253-261. doi: 10.1016/j.idh.2020.05.005. Epub 2020 Jun 26. — View Citation

Christensen L, Rasmussen CS, Benfield T, Franc JM. A Randomized Trial of Instructor-Led Training Versus Video Lesson in Training Health Care Providers in Proper Donning and Doffing of Personal Protective Equipment. Disaster Med Public Health Prep. 2020 Aug;14(4):514-520. doi: 10.1017/dmp.2020.56. Epub 2020 Mar 30. — View Citation

Hung PP, Choi KS, Chiang VC. Using interactive computer simulation for teaching the proper use of personal protective equipment. Comput Inform Nurs. 2015 Feb;33(2):49-57. doi: 10.1097/CIN.0000000000000125. — View Citation

John A, Tomas ME, Hari A, Wilson BM, Donskey CJ. Do medical students receive training in correct use of personal protective equipment? Med Educ Online. 2017;22(1):1264125. doi: 10.1080/10872981.2017.1264125. — View Citation

Kang J, O'Donnell JM, Colaianne B, Bircher N, Ren D, Smith KJ. Use of personal protective equipment among health care personnel: Results of clinical observations and simulations. Am J Infect Control. 2017 Jan 1;45(1):17-23. doi: 10.1016/j.ajic.2016.08.011. — View Citation

Karlsson U, Fraenkel CJ. Covid-19: risks to healthcare workers and their families. BMJ. 2020 Oct 28;371:m3944. doi: 10.1136/bmj.m3944. — View Citation

Kirch DG, Petelle K. Addressing the Physician Shortage: The Peril of Ignoring Demography. JAMA. 2017 May 16;317(19):1947-1948. doi: 10.1001/jama.2017.2714. — View Citation

L Perna AR, R Boruch, N Wang, J Scull, C Evans, S Ahmad. The life cycle of a million MOOC users. MOOC Research Initiative Conference 5; 2013.

McCarthy R, Gino B, d'Entremont P, Barari A, Renouf TS. The Importance of Personal Protective Equipment Design and Donning and Doffing Technique in Mitigating Infectious Disease Spread: A Technical Report. Cureus. 2020 Dec 14;12(12):e12084. doi: 10.7759/cureus.12084. — View Citation

Nguyen LH, Drew DA, Graham MS, Joshi AD, Guo CG, Ma W, Mehta RS, Warner ET, Sikavi DR, Lo CH, Kwon S, Song M, Mucci LA, Stampfer MJ, Willett WC, Eliassen AH, Hart JE, Chavarro JE, Rich-Edwards JW, Davies R, Capdevila J, Lee KA, Lochlainn MN, Varsavsky T, Sudre CH, Cardoso MJ, Wolf J, Spector TD, Ourselin S, Steves CJ, Chan AT; COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet Public Health. 2020 Sep;5(9):e475-e483. doi: 10.1016/S2468-2667(20)30164-X. Epub 2020 Jul 31. — View Citation

Occupational Safety and Health Administration. OSHA Best Practices for HospitalBased First Receivers of Victims from Mass Casualty Incidents Involving the Release of Hazardous Substances. US Department of Labor, OSHA 3249-08N; 2005. https:// www.osha.gov/Publications/osha3249.pdf. Accessed July 30, 2020.

Phan LT, Maita D, Mortiz DC, Weber R, Fritzen-Pedicini C, Bleasdale SC, Jones RM; CDC Prevention Epicenters Program. Personal protective equipment doffing practices of healthcare workers. J Occup Environ Hyg. 2019 Aug;16(8):575-581. doi: 10.1080/15459624.2019.1628350. Epub 2019 Jul 10. — View Citation

Salway RJ, Williams T, Londono C, Roblin P, Koenig K, Arquilla B. Comparing Training Techniques in Personal Protective Equipment Use. Prehosp Disaster Med. 2020 Aug;35(4):364-371. doi: 10.1017/S1049023X20000564. Epub 2020 May 11. Erratum in: Prehosp Disaster Med. 2020 Aug;35(4):472. — View Citation

Samadbeik M, Yaaghobi D, Bastani P, Abhari S, Rezaee R, Garavand A. The Applications of Virtual Reality Technology in Medical Groups Teaching. J Adv Med Educ Prof. 2018 Jul;6(3):123-129. — View Citation

Suzuki T, Hayakawa K, Ainai A, Iwata-Yoshikawa N, Sano K, Nagata N, Suzuki T, Wakimoto Y, Akiyama Y, Miyazato Y, Nakamura K, Ide S, Nomoto H, Nakamoto T, Ota M, Moriyama Y, Sugiki Y, Saito S, Morioka S, Ishikane M, Kinoshita N, Kutsuna S, Ohmagari N. Effectiveness of personal protective equipment in preventing severe acute respiratory syndrome coronavirus 2 infection among healthcare workers. J Infect Chemother. 2021 Jan;27(1):120-122. doi: 10.1016/j.jiac.2020.09.006. Epub 2020 Sep 9. — View Citation

Using Personal Protective Equipment (PPE). In: National Center for Immunization and Respiratory Diseases (NCIRD) DoVD, edAugust 19, 2020

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Donning and Doffing Performance Donning and doffing performance was evaluated using a checklist based on Center for Disease Control (CDC) guidelines. The performance checklist consisted of separate sections for donning and doffing. Scoring for each step was based on (1) completion and (2) correct sequence. All points are totaled for a maximum possible score of 64 points and minimum possible score of 0 points. A higher score indicates a better outcome. Immediately after the intervention
Secondary Subgroup analysis Subgroup analyses were based on the most common occupations listed. The overall study sample was reduced into three groups: medical students, residents, and all other participants. Immediately after the intervention
Secondary Participant experience Analysis of survey data compared participants' perceived preparedness, perceived confidence, and degree of distraction during training. Baseline, pre-intervention and immediately after the intervention
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