Clinical trial NCT04783025: A Blended Gaming COVID-19 Training System (BGCTS) With WHO Guidelines for Staff in Residential Care Homes
Official title: A Blended Gaming COVID-19 Training System (BGCTS) With WHO Guidelines for Staff in Residential Care Homes: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection Control
COVID-19
Keywords: COVID-19
Infection control
Training system
Gamification
Residential care homes
Healthcare personnel
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 clusters (Residentials care homes, RCHs) involved in the study will be randomly allocated to two study groups (the intervention group, IG; and the control group, CG). All of the healthcare personnel in one cluster will receive the assigned treatment in the study group accordingly. All units in one RCH will be grouped as IG or CG. Group designations will be decided by a computer-generated randomization list using a free online generator by a statistician in the research team (DYPL) and will have no potential contact with the participants of the study. An opaque, numbered envelope containing a code generated by computerized randomizations will be prepared by a project assistant unconnected to this study. The random coding will also be concealed from the participants and outcome assessors to be involved in the assessments. A standardized checklist will be used for outcome measurements to minimize bias.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 188 healthcare personnel from 20 residential care homes (RCHs) will be recruited to assess the effect of 2-week implementation of Blended Gaming COVID-19 Training System (BGCTS) on RCH staffs' infection control practices. These clusters (RCHs) will be randomly allocated to two study groups (the intervention group, IG; and the control group, CG) to assess 1. whether more staff in the IG perform infection control practices (by on-site observations) than the staff in the CG after receiving BGCTS and 2. whether more staff in the IG have infection control knowledge, positive attitudes towards infection control, and self-reported compliance rates than the staff in the CG. 5 Hypothesis have been set up for this study:

H1. After using BGCTS, a higher proportion of the staff in the IG will exhibit performance in complying with hand hygiene measures than those in the CG.

H2. After using BGCTS, a higher proportion of the staff in the IG will exhibit performance in complying with other infection control practices than those in the CG.

H3. After using BGCTS, a higher proportion of the staff in the IG will have high level of knowledge of infection control than those in the CG.

H4. After using BGCTS, a higher proportion of the staff in the IG will have positive attitudes towards infection control than those in the CG.

H5. After using BGCTS, a higher proportion of the staff in the IG will have a high self-reported compliance rate with infection control measures than those in the CG.

Infection control practices conducted by RCH staffs will be measured through unobtrusive on-site non-participatory observations. RCH staffs' knowledge, attitudes about infection control practice, and self-reported infection control practices will be assessed via an electronic quiz.

Detailed description: Background:

Residents in residential care homes are at a high risk of being infected by COVID-19 due to the advanced age, associated co-morbidities, and state of dependence of the residents . According to the licensing requirements for RCHs in Hong Kong, a registered nurse is designated as an Infection Control Officer (ICO) to coordinate matters related to the prevention and handling of infectious diseases in each RCH. During the pandemic, the ICOs disseminate the COVID-19 guidelines, which were developed by the Centre for Health Protection (CHP) under the Food and Health Bureau of the Hong Kong government, to all staff in RCHs . Whether the staff understand and can correctly interpret the contents and adopt the guidelines into practice is unclear. There is nothing in the literature about the infection control training given by ICOs to the staff in RCHs.

Innovations:

The key innovation in this study is the adoption of the concept of gamification in COVID-19 infection control training. The investigators apply elements of game design (short video clips/interactive video games in the form of quizzes) in non-game environments (RCHs) within non-game contexts (infection control training). Gamification is widely used as an educational tool in different disciplines. For example, in the current study, one of the simulated situations is visitor management to avoid the entry of COVID-19 in RCHs. Sequential allocation in visitor management could be utilized in the gamified training programme, to allow learners the chance to practice in a virtual environment. The inappropriate management of visitors could lead to the spread of COVID-19 infections in an RCH, and learners could have a second chance to do better in a virtual environment.

Gamified training offers many benefits, the major one of which is that it allows learners to learn at a convenience time and place. The use of gamification restructures the experience of a traditional boring activity into something enjoyable, interactive, and competitive, with the result that learners can remain active and engaged throughout the learning process. In addition, training with the use of games can improve compliance with decided behaviour. Learners were found to have developed new skills and/or new habits via gamified training.

Objectives:

This study aims to assess the effect of the Blended Gaming COVID-19 Training System (BGCTS) on infection control practices, compliance rates and knowledge of standard precautions among all staff in residential care homes (RCHs).

The specific objectives and hypothesis of the study include:

1. To assess whether more staff in the intervention group (IG) perform infection control practices (by on-site observations) than the staff in the control group (CG) after receiving the BGCTS;
2. To assess whether more staff in the IG have infection control knowledge, positive attitudes towards infection control, and self-reported compliance rates than the staff in the CG.

Method:

This study collects data through on-site observations of infection control practices which requires resources and special training. Observations will be the primary outcome of this study. Special arrangements on conducting on-site non-participatory unobtrusive observations in RCHs will be made to ensure the validity and reliability of the results.

Unobtrusive non-participatory observations of the infection control practices of healthcare personnel will be conducted in the RCHs. Healthcare personnel will include doctors, nurses, occupational therapists, physiotherapists, health workers, and personal care workers who are working in the RCHs. Observations will be made at baseline (before the intervention) and after the intervention (post-intervention). Observations will be made in five areas: hand hygiene, respiratory hygiene, the use of personal protective equipment (PPE), environmental cleaning and disinfection, and the proper handling of used or contaminated materials. A total of 200 observation opportunities per RCH unit will be made to avoid measurement bias.

At least three cameras (webcams with recording function) will be set up in each RCH to capture the staff's hand hygiene practice. The number of cameras will be determined after site visit to the RCH. The investigators would cover substantial areas of the RCH (including most of the hand washing facilities). Prior to the initiation of camera monitoring, staff of RCHs will be clearly informed about the recording. Camera recording will be made for 2 weeks in each RCH. Each week, the research assistant will go to the RCH and download the recordings to the designated computer for the sake of protecting the security of the recording (data). The obtained video recording will be evaluated by the research nurse, who will randomly select 20 to 30-minute recording per shift for observation (morning shift, afternoon shift and night shift). To protect privacy of the RCH staff, the staff will be de-identified and anonymized before observation, and all actions will be examined in confidentiality. This is designed to minimize the Hawthorn effect due to observations (that is, healthcare personnel perform differently when being observed) because the observer's presence gradually becomes insignificant to the healthcare personnel. In an RCH unit, more than one healthcare personnel provides care to the residents. Observations will be made of the first healthcare personnel to provide direct care to the residents before the other healthcare personnel take action. There will be no interference with the care procedure during the observations.

Data analysis:

To examine the difference in the change in the primary outcome - the observational-based compliance rate for hand hygiene - from baseline to post-intervention between the IG and CG, investigators will perform a linear mixed-effects model with a log link function to control for the clustering effect at the RCH level with Time, Group, and the interaction term (Time x Group) as independent variables. A significant result in the interaction term (Time x Group) will indicate a differential change in the outcome variable between the two groups, and will support hypothesis H1.

To examine differences in the changes in the secondary outcomes, including the observational-based compliance rate with other infection control practices, self-reported compliance, knowledge, and attitude rates (Hypotheses H2 - H5), investigators will perform a separate linear mixed-effects model for each of the secondary outcomes, similar to that for the primary outcome. A significant result in the interaction term (Time x Group) will indicate a differential change in the outcome variable between the two groups.

The investigators will also perform sub-group analyses by demographic and experience data to explore whether the effect of the intervention is homogeneous with respect to the different demographic and experience characteristics of the participants. Specifically, an interaction term, Group x characteristic, will be added to the model to explore the effect of that particular characteristic on the effect of the BGCTs. Further, investigators will also examine a model by adding parameters from the BGCTS (attempts to the video-clips/pictures, the time spent, and the results of each game) as potential factors associated with the outcome.

Eligibility criteria: Inclusion Criteria:

1. Healthcare personnel who are working in the selected Residential care homes (RCHs)
2. Able to read Chinese, and
3. Possess an electronic device (smartphone or tablet) with which to download the BGCTS system.

Exclusion Criteria:

1. Temporary staff who are about to cease employment, be on maternity leave, or go on a long vacation during the data collection period;
2. Students or trainees (including nursing students, physiotherapy students, and health-related trainees), because training institutions are responsible for students' training, and such training may affect students' performance;
3. Volunteer personnel who come to the RCHs at a specific period (for example, to organize activities for the residents during festivals);
4. Clerical and administrative staff, kitchen staff, security staff, and engineering and facilities management staff;
5. Ambulance officers who come to the RCHs to take residents to or from hospitals.

Primary outcomes:
measure: Changes in unobtrusive observational-based compliance rate of infection control practices
timeFrame: T0 (baseline) and T2 (after the intervention at Week 3)
Secondary outcomes:
measure: Knowledge and attitudes towards respiratory infection (KARI)
timeFrame: T0 (baseline) and T2 (after the intervention at Week 3)
measure: Self-reported Infection Control Practice (SICP)
timeFrame: T0 (baseline) and T2 (after the intervention at Week 3)
measure: Demographic data
timeFrame: T0 (baseline)
measure: Data on experience
timeFrame: T0 (baseline)
Other outcomes:
measure: Number of log-ins on Blended Gaming COVID-19 Training System (BGCTS)
timeFrame: T1 (During the intervention: at Week 2)
measure: Number of attempts on Blended Gaming COVID-19 Training System (BGCTS)
timeFrame: T1 (During the intervention at Week 2)
measure: Time spent on Blended Gaming COVID-19 Training System (BGCTS)
timeFrame: T1 (During the intervention at Week 2)
measure: Gaming result on Blended Gaming COVID-19 Training System (BGCTS)
timeFrame: T1 (During the intervention at Week 2)
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Angela Leung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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