CLEAN Frontline: A Stepped Wedge Cluster Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Hospital Infections; Infection Control; Environment, Controlled
• Intervention / Treatment: Behavioral: TEACH CLEAN

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • National Insitute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard practices are expected at hospitals before the education intervention is deployed
Experimental: Intervention; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: National Institute of Public Health, Cambodia; WaterAid

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: 26637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No