CLEAN Frontline: A Stepped Wedge Cluster Trial

NCT05540886 | Completed

• 1 other identifier: 26637
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Infections; Environment, Controlled; Infection Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes over time in 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

Study Arms (2)

Control

NO INTERVENTION

Standard practices are expected at hospitals before the education intervention is deployed

Intervention

EXPERIMENTAL

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

Interventions

TEACH CLEAN BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• National Institute of Public Health, Cambodia: collaborator
• WaterAid: collaborator

Study Sites (1)

National Insitute of Public Health

Phnom Penh, Cambodia

Location

Related Publications (1)

• Gon G, Ma S, Aiken AM, Dancer SJ, Graham WJ, Nash S, Nov V, Mao S, Sarpong B, Pepper M, Vong S, Tang V, Thompson J, Por I. Impact of a multicomponent training intervention (Clean FrontLine) on microbiological cleanliness in Cambodian referral hospitals: a multicentre, stepped-wedge, cluster-randomised trial. Lancet Microbe. 2025 Dec 10:101262. doi: 10.1016/j.lanmic.2025.101262. Online ahead of print.

  PMID: 41389803 DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff who clean will not be blinded as this is not possible. An independent team (not involved in the delivery of the training) will collect monthly primary outcome data from pre-agreed hospital sites. The laboratory team processing the primary outcomes are also blinded.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised cluster controlled trial using a stepped-wedge random allocation. At four distinct time points, 13 hospitals will receive the educational intervention. The unit of analysis is high frequency touches sites in the three wards of interest in each of the study hospitals.

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 15, 2022
• Study Start: March 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 29, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)