CLEAN Frontline: A Stepped Wedge Cluster Trial

Infection Control Clinical Trial

Official title:

CLEAN FRONTLINE CAMBODIA A Stepped Wedge Cluster Trial of an Environmental Hygiene Educational Intervention Across Thirteen Cambodian Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540886
• Other study ID #: 26637
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. Staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. This issue has been execrated by the COVID-19 pandemic. The only recommended training on environmental hygiene for low resourced facilities, TEACH CLEAN, uses a training of trainers model. A selected cadre "champions" which in turn train their peers with responsibilities on environmental hygiene at the facility level. Early pilot data to test its effectiveness of this training package are very promising.

The main objective is to evaluate the effectiveness of an environmental cleaning bundle to improve microbiological cleanliness in Cambodian hospitals.

The latest TEACH CLEAN will be implemented across all hospitals (13) of three provinces in Cambodia. A stepped wedge randomised trial will be used to evaluate the effectiveness of TEACH CLEAN to improve microbiological cleanliness in Cambodian hospitals. All facilities will receive the intervention. Hospitals are arranged in groups of three or four based on the randomisation with staggered commencement dates of the intervention at four distinct time points. The design will include ten months of data collection. We expect one month gap between the training of champions and the training of staff at the facility level. The main outcome is microbiological cleanliness (<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) measured using a non-specific agar on one side for measuring total Aerobic Colony Counts (ACC/cm2). With 30 sampling sites in each hospital and with a pre-training cleanliness proportion ranging from 30% to 50% will give us over 85% power to detect a 10% absolute post-intervention increase in cleanliness.

Evidence from this trial will contribute to future policy and practice guidelines about hospital environmental hygiene and ultimately reduce healthcare associated infections. This would be the first randomised trial on environmental hygiene in low resource settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria for surfaces sites selected for primary outcome measurement

• Surfaces within the patient zone which frequently touched surfaces of the targeted wards: maternity, pediatric and general medicine

Exclusion Criteria:

• Surfaces outside the patient zone

• Surfaces not in the wards of interest

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection Control
• Infections

Intervention

Behavioral:
• TEACH CLEAN
The intervention is primary a training facility cleaning champions to educate and supervise other existing facility cleaners with environmental hygiene responsibilities - training of trainers (ToT). The training content includes as much as possible the seven contextualized modules of TEACH CLEAN training package (CLEAN BOX): i) Introduction to Infection Prevention and Control, ii) Personal hygiene and dress code, iii) Hand hygiene, iv) Personal protective equipment, v) Housekeeping/control of environment, vi) Waste handling, and vii) Linen handling. Facility training will occur in three selected wards: i) maternity ward, including labour and post-natal rooms, ii) medicine ward, iii) and medicine ward. There is also supervision stage that refers to ongoing mentorship of cleaning champions by the local partner while they educate and supervise existing facility cleaners with environmental hygiene responsibilities.

Locations

Country	Name	City	State
Cambodia	National Insitute of Public Health	Phnom Penh

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	National Institute of Public Health, Cambodia, WaterAid

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes over time in microbiological cleanliness	The unit of measurement is high touch surfaces within the patient zone in each ward. Proportion of microbiological cleanliness (<2.5 cfu/cm2 = clean ; =2.5 cfu/cm2 = not clean) will be calculated for each cluster as the number of sites with <2.5 cfu/cm2 out of the 30 sites sampled per period/month.	Data is collected monthly during the study period from each of the study sites. Because this is a stepped wedge trial with four steps, the data collection period referring to the pre-training/intervention period varies between 2 and 7 months. Whereas the
Primary	Microbiological cleanliness	The unit of measurement is high touch surfaces within the patient zone in each ward. Proportion of microbiological cleanliness (<2.5 cfu/cm2 = clean ; =2.5 cfu/cm2 = not clean) will be calculated for each cluster as the number of sites with <2.5 cfu/cm2 out of the 30 sites sampled per period/month.	Data is collected monthly during the study period from each of the study sites. Because this is a stepped wedge trial with four steps, the data collection period referring to the pre-training/intervention period varies between 2 and 7 months. Whereas the