Auditing Methods for Hospital CleanlinessNCT04956029
Comparing Visual Inspection, Performance Observation, and Aerobic Colony Counts for Evaluating Hospital Cleanliness
An observational study of Auditing Methods for Hospital Cleanliness, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study aims to compare correlation between outcome and performance observations and effectiveness by using aerobic colony counts as a comparator in order to find out which method would be better to be used to assess hospital cleanliness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Auditing Methods for Hospital Cleanliness
- What is being tested?
- There are no any interventions. This is to observe and test hospital cleanliness.
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: rooms after patients are discharged
Who may be able to join
- rooms after patients are discharged
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Ying-Chun Chen, MS contact
Taiwan1 site, 1 recruiting
- Recruiting
Taichung
Taichung, 40705
Ying-Chun Chen, MS
About this study
This study aims to compare correlation between outcome and performance observations and effectiveness by using aerobic colony counts as a comparator in order to find out which method would be better to be used to assess hospital cleanliness.
Read the detailed description
Design and Setting We perform a prospective study which is conducted in a 17-bed adult medical intensive care unit with approximately 352 annually admissions at a tertiary hospital in Taiwan from July 2021 to December 2022. Cleaning performance observation will be performed according to the environmental checklist for monitoring terminal cleaning released by Centers for Disease Control and Prevention in 2014, to select sampling areas of high-touch surfaces in patient rooms, including bed controls, bed rails, cart pulls, light switches, machine controls, tray tables and call buttons.
Data collection The housekeepers start to do terminal cleaning after patients are transferred or discharged, the researcher also starts to observe directly the practices of cleaning at the same time and recorded "compliant" or "not compliant" whenever surfaces are cleaned and disinfected properly or on the contrary. The high-touch surfaces are disinfected with solution which contained Sodium dichloroisocyanurate (NaDCC). Right after the surfaces are cleaned, the researcher inspect the surfaces and record "clean" or "not clean" whenever surfaces are free of dust, debris, and stains immediately after terminal cleaning or on the contrary.
Ten minutes after surfaces are cleaned and disinfected, Hygiena Ultrasnap Surface ATP test will be applied to swab a standard 10*10 cm area on selected surfaces by samping templet. After completing sampling, swabs are replaced back in swab tube and all liquid in bulbs was expelled to activate the reaction. Once activated, samples were read right after shaking swab tube for 5-10 seconds. The ATP readings less than 10 RLU (relative light unit, RLU) are interpreted as "pass".
The designated cleaner and the researcher will be assigned to clean high-touch room surfaces and to be in charge of evaluating and sampling, respectively.
Statistical analysis Descriptive statistics are calculated including numbers, percentage, mean and standard deviation. Inferential statistics are analyzed with SPSS (version 22) to determine correlation between results of performance observation, Visual inspection and ATP interpretation by using Chi-square test or Fisher's exact test. The phi coefficient are calculated to measure strength between two sets of data. The phi coefficient refers to the meaning of Pearson's Correlation coefficients, values 0.01-0.19 as no or negligible, 0.2-0.39 as weak positive, 0.4-0.69 as medium positive, 0.7-1.0 as strong positive.12 The ATP readings were compared between "not compliant" and "compliant", and between "not clean" and "clean" respectively by using Mann-Whitney U test.
- Being tested
- There are no any interventions. This is to observe and test hospital cleanliness.
- Keywords
- visual inspection, performance observation, aerobic colony counts, hospital cleanliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no any interventions. This is to observe and test hospital cleanliness.Other
There are no any interventions. This is to observe and test hospital cleanliness.
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of clean
Free of dust, debris, and stains
Measured: immediately after terminal cleaning
rate of compliant
Surfaces were cleaned and disinfected properly
Measured: up to 10 hours (during cleaning practice)
rate of pass
ATP readings less than 10 RLU
Measured: ten minutes after disinfection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditing Methods for Hospital CleanlinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Ying-Chun, Taichung Veterans General Hospital
- Investigators
- Ying-Chun Chen, MS, Principal investigator, Taichung Veterans General Hospital Infection Control Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956029
- Sponsor's protocol ID
- CW21156B
- Status last verified
- Oct 2021
- First submitted
- 30 Jun 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Visual Inspection, Performance Observation, and Aerobic Colony Counts for Evaluating Hospital Cleanliness
- ClinicalTrials.gov ID
- NCT04956029
- Acronym / sponsor ID
- CW21156B
- Keywords
- visual inspection, performance observation, aerobic colony counts, hospital cleanliness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare correlation between outcome and performance observations and effectiveness by using aerobic colony counts as a comparator in order to find out which method would be better to be used to assess hospital cleanliness.
Detailed description
Design and Setting We perform a prospective study which is conducted in a 17-bed adult medical intensive care unit with approximately 352 annually admissions at a tertiary hospital in Taiwan from July 2021 to December 2022. Cleaning performance observation will be performed according to the environmental checklist for monitoring terminal cleaning released by Centers for Disease Control and Prevention in 2014, to select sampling areas of high-touch surfaces in patient rooms, including bed controls, bed rails, cart pulls, light switches, machine controls, tray tables and call buttons.
Data collection The housekeepers start to do terminal cleaning after patients are transferred or discharged, the researcher also starts to observe directly the practices of cleaning at the same time and recorded "compliant" or "not compliant" whenever surfaces are cleaned and disinfected properly or on the contrary. The high-touch surfaces are disinfected with solution which contained Sodium dichloroisocyanurate (NaDCC). Right after the surfaces are cleaned, the researcher inspect the surfaces and record "clean" or "not clean" whenever surfaces are free of dust, debris, and stains immediately after terminal cleaning or on the contrary.
Ten minutes after surfaces are cleaned and disinfected, Hygiena Ultrasnap Surface ATP test will be applied to swab a standard 10*10 cm area on selected surfaces by samping templet. After completing sampling, swabs are replaced back in swab tube and all liquid in bulbs was expelled to activate the reaction. Once activated, samples were read right after shaking swab tube for 5-10 seconds. The ATP readings less than 10 RLU (relative light unit, RLU) are interpreted as "pass".
The designated cleaner and the researcher will be assigned to clean high-touch room surfaces and to be in charge of evaluating and sampling, respectively.
Statistical analysis Descriptive statistics are calculated including numbers, percentage, mean and standard deviation. Inferential statistics are analyzed with SPSS (version 22) to determine correlation between results of performance observation, Visual inspection and ATP interpretation by using Chi-square test or Fisher's exact test. The phi coefficient are calculated to measure strength between two sets of data. The phi coefficient refers to the meaning of Pearson's Correlation coefficients, values 0.01-0.19 as no or negligible, 0.2-0.39 as weak positive, 0.4-0.69 as medium positive, 0.7-1.0 as strong positive.12 The ATP readings were compared between "not compliant" and "compliant", and between "not clean" and "clean" respectively by using Mann-Whitney U test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- rooms after patients are discharged
Key inclusion criteria (1 listed)
- rooms after patients are discharged
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There are no any interventions. This is to observe and test hospital cleanliness.There are no any interventions. This is to observe and test hospital cleanliness. | Other | – |
Primary outcome
rate of clean
Time frame: immediately after terminal cleaning
Free of dust, debris, and stains
rate of compliant
Time frame: up to 10 hours (during cleaning practice)
Surfaces were cleaned and disinfected properly
rate of pass
Time frame: ten minutes after disinfection
ATP readings less than 10 RLU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Chun Chen, MS contact
Ying-Chun Chen, MS principal investigator
Taichung Veterans General Hospital Infection Control Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auditing Methods for Hospital Cleanliness, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Chun Chen, MS (886-4-23592525 ext. 3085, cychun@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of clean (time frame: immediately after terminal cleaning). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.