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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Taichung

    Taichung, 40705

    Ying-Chun Chen, MS

    Recruiting

Other trials in Taiwan

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.

  1. rate of clean

    Free of dust, debris, and stains

    Measured: immediately after terminal cleaning

  2. rate of compliant

    Surfaces were cleaned and disinfected properly

    Measured: up to 10 hours (during cleaning practice)

  3. 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.

  1. First posted9 Jul 2021
  2. Study start1 Jul 2021
  3. Primary completion30 Nov 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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)
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

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.

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