Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections

Hospital-acquired Infections Clinical Trial

— IPC-HAI  

Official title:

Developing and Piloting an Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections in Cambodia and Lao PDR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547373
• Other study ID #: RCP100737ITDC
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: National University of Singapore
• Contact: Sreymom Oy, MSc
• Phone: +85511867468
• Email: smomoy[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hospital-acquired infections (HAIs) are significant public health issues, especially in low- and middle-income countries (LMICs). Hand hygiene and low-level disinfection of equipment (LLDE) practices among healthcare workers (HCWs) are essential to reduce HAIs. Various effective infection prevention and control (IPC) interventions to reduce HAI incidence have been developed. However, which interventions work effectively in LMICs has not been identified. The investigators aim to develop, pilot, and assess the feasibility and acceptability of an IPC intervention in Cambodia and the Lao People's Democratic Republic (PDR).

Description:

This study consists of four phases guided by the Medical Research Council (MRC) framework. Three hospitals from each country will be selected. In Phase 1, the investigators will conduct a gap analysis of IPC implementation and practices among HCWs at each hospital through desk review, direct observation of hand hygiene and LLDE practices, in-depth interviews with HCWs, and key informant interviews with stakeholders. In Phase 2, the investigators will develop an IPC intervention based on results from Phase 1 and interventions selected from the literature review of IPC interventions in LMICs. In Phase 3, the investigators will pilot the developed intervention in the same hospitals selected in Phase 1. Finally, in Phase 4, the investigators will assess the feasibility and acceptability of the developed intervention among HCWs and stakeholders at the selected hospitals. The investigators will employ the MRC framework to develop and evaluate an intervention to reduce HAIs in both countries. The investigators will also use a theoretical framework to explore factors that are barriers and enablers for HCWs to improve hand hygiene compliance. With these approaches, the investigators will be able to develop a comprehensive intervention. Findings from this study would shed light on promising IPC interventions to reduce HAI incidence in Cambodia and Lao PDR. More importantly, the findings may be applied to other LMIC settings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthcare workers working in the selected wards and of chosen hospitals
• Aged 18 years or above
• Working in the selected wards of the chosen hospitals for at least six months
• Being able and agreeing to provide informed consent to participate in the study

Exclusion Criteria:

• Interns and visiting healthcare workers

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Hospital-acquired Infections
• Infections

Intervention

Behavioral:
• Infection prevention and control (IPC)
The intervention will be developed by matching behavioral change components identified in the gap analysis stage with the intervention components extracted from a systematic review. The investigators will use the Behavior Change Wheel (BCW) model as a guide to design this infection control prevention and control intervention. In brief, the intervention development processes will follow eight steps based on the BCW. The steps will include defining the problem in behavioral terms, selecting the target behaviors, specifying the target behaviors, identifying what needs to change, identifying intervention functions, identifying policy categories, identifying behavior change techniques, and identifying the mode of delivery.

Locations

Country	Name	City	State
Cambodia	Khmer-Soviet Friendship Hospital	Phnom Penh

Sponsors (2)

Lead Sponsor	Collaborator
National University of Singapore	Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in hand hygiene compliance among health workers from baseline to endline	The investigators will calculate hand hygiene compliance by having the hand hygiene action of alcohol hand rub or hand washing using soap and water divided by the hand hygiene opportunity and multiple with 100.	At endline (6 months after the intervention started)
Secondary	Perceived feasibility and acceptability of the infection prevention and control intervention among HCWs and stakeholders	The investigators will conduct a post-intervention qualitative evaluation to assess the feasibility and acceptability and identify challenges in implementing the infection prevention and control intervention following the Medical Research Council's framework.	At endline (6 months after the intervention started)