CLEAN Frontline: A Stepped Wedge Cluster Trial

Not Applicable

Completed

• Conditions: Hospital Infections; Environment, Controlled; Infection Control
• Interventions: Behavioral: TEACH CLEAN

• Registration Number: NCT05540886
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-03-01
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Not provided

Exclusion Criteria

• Surfaces outside the patient zone
• Surfaces not in the wards of interest

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	TEACH CLEAN	The main intervention - the training of trainers/champions (ToT) will be delivered to selected facility "cleaning champions" from three or four hospitals within a certain month. Four sets of ToT are expected to happen during the study period.

Primary Outcome Measures

Name	Time	Method
Microbiological cleanliness	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	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.

Trial Locations

Locations (1)

National Insitute of Public Health; 🇰🇭 Phnom Penh, Cambodia