Comparison of the efficacy and relative satisfaction of Remote Audio-visual Doffing Surveillance (RADS) technique versus the standard buddy technique for monitoring the doffing process of health care workers during COVID 19 pandemic : an observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To study and compare the incidence of error with regard to the standard CDC doffing guidelines during the doffing process of health care workers while they are being monitored by a buddy and also when they are being monitored using Remote Audio-visual Doffing Surveillance (RADS) monitoring system.
研究概览
简要总结
MATERIAL AND METHODS
Design: Single center observational study
Study setting: Nehru hospital and Nehru extension block, PGIMER, Chandigarh
Study Participants: Health care workers (HCW’s) in Post Graduate Institute of Medical Education and Research, Chandigarh who were trained in the process of donning and doffing for one or two days.
Study protocol:
The senior and junior residents, nursing officers, health and sanitation attendants will all be included in the study. The participants will be classified into three categories as under:
Category 1: Doctors
Category 2: Nursing staff
Category 3: Health and Sanitation staff
The doffing process of at least 200 HCW’s belonging to all the categories will be observed. This will include 100 HCW’s who will be doffing with the help of an assistant (group Buddy) and 100 other HCW’s who will be doffing under the Remote Audio-visual Doffing Surveillance (group RADS) system. Both the groups (Buddy and RADS) will be monitored by a third person who will be blinded to the purpose of the study and will note the errors based on the CDC guidelines of doffing process.
These HCW’s of both the groups will later be requested to fill a short questionnaire based on Likert scale in order to analyze separately their level of satisfaction regarding multiple factors during the doffing process. Their satisfaction would be analyzed on the basis of safety, communicability, ease and reassurance provided during the doffing process. Suggestions would be taken and also, they would be asked to rate their doffing experience on a scale of 5, in order to compare the two techniques of monitoring.
Statistical analysis:
This is an observational study and we intend to include volunteers who will be working in the designated COVID / COVID suspect units in the OR/ICU/HDU areas during the study period of three months.
Sample size calculation:
We are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the failure rate among controls (buddy system) is 0.40. If the true failure rate for experimental subjects is 0.20 (a 50% change), we will need to study 91 subjects in each group/ technique to be able to reject the null hypothesis that the failure rates for the two techniques are equal with probability (power) 0.80. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use a chi-squared statistic or Fisher’s exact test to evaluate this null hypothesis.
Assuming a 10% drop out rate we thus would conduct the study in at least 200 subjects, 100 belonging to each group.
References:
-
Tomas ME, Kundrapu S, Thota P, et al. Contamination of Health Care Personnel During Removal of Personal Protective Equipment. JAMA Intern Med. 2015;175(12):1904-1910.
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Edmond MB, Diekema DJ, Perencevich EN. Ebola virus disease and the need for new personal protective equipment. JAMA. 2014;312(23):2495-2496.
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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;45(1):17-23.
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Osei-Bonsu K, Masroor N, Cooper K, et al. Alternative doffing strategies of personal protective equipment to prevent self-contamination in the health care setting. Am J Infect Control. 2019;47(5):534-539.
PROFORMA
Serial number:
Group: RADS / BUDDY TECHNIQUE
Name:
Age:
Sex:
Phone no:
Designation:
Duty shift:
Area of posting:
Reason for doffing: REGULAR / EMERGENCY
Category of the HCW:
| S.num |
Step
Correctly done
Error made
|1.
Engage trained observer
|2.
Inspect
|3.
Disinfect outer gloves
|4.
Remove apron
|5.
Inspect
|6.
Disinfect and remove outer gloves
|7.
Inspect and disinfect inner gloves
|8.
Remove face shield
|9.
Disinfect inner gloves
|10.
Remove surgical hood
|11.
Disinfect inner gloves
|12.
Remove coverall
|13.
Disinfect inner gloves
|14.
Remove boot covers
|15.
Disinfect and change inner gloves
|16.
Remove N95 respirator
|17.
Disinfect inner gloves
|18.
Disinfect washable shoes
|19.
Disinfect and remove inner gloves
|20.
Perform hand hygiene
|21.
Inspect
Total number of errors made:
Questionnaire for the HCW
How was your experience during the doffing process with regard to:
| Very bad |
1/5
Bad
2/5
Average
3/5
Good
4/5
Very Good
5/5
|Your anxiety
|The quality of monitoring during the doffing process
|Your satisfaction regarding the doffing experience
|Overall rating of the safety you felt
Suggestions for improvement:
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Should have undergone training in the donning and doffing process at least once or twice.
- •2.A member of the staff working at the COVID unit in PGIMER.
排除标准
- •1.The HCW who will be doffing for the first time.
- •2.The HCW doffing due to an emergency (health issue of the HCW, or due to an observed damage in the PPE).
- •3.Pregnant, breast feeding, history of joint replacements or other prosthetic devices, inflammatory skin conditions or having open wounds.
- •4.Refuses to participate in the study.
- •5.HCW who is performing this study.
结局指标
主要结局
To study and compare the incidence of error with regard to the standard CDC doffing guidelines during the doffing process of health care workers while they are being monitored by a buddy and also when they are being monitored using Remote Audio-visual Doffing Surveillance (RADS) monitoring system.
时间窗: Comparison will be done after completion of all the case observations i.e at the end of the study
次要结局
- To compare the satisfaction of the HCW’s regarding their own safety while they are being monitored by the two techniques.(The comparison of the satisfaction among the two groups will be done at the end of the study.)