- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05547373
Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections (IPC-HAI)
November 10, 2023 updated by: Siyan Yi, National University of Singapore
Developing and Piloting an Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections in Cambodia and Lao PDR
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sreymom Oy, MSc
- Phone Number: +85511867468
- Email: smomoy@nus.edu.sg
Study Contact Backup
- Name: Chan Hang Saing, PhD
- Phone Number: +85512293315
- Email: ephchs@nus.edu.sg
Study Locations
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-
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Phnom Penh, Cambodia, 12306
- Recruiting
- Khmer-Soviet Friendship Hospital
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Contact:
- Vanthon Hul, MD
- Phone Number: +855 23 217 524
- Email: hpnb.sihanouk@online.com.kh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The investigators will select HCWs from the selected departments at the national hospitals, provincial hospitals, and district referral hospitals to participate in the pilot intervention.
The participants will also include representatives from the Communicable Disease Control Department and the Department of Hospital Services of the Ministry of Health, the provincial hospitals, and the district referral hospitals in Cambodia and Lao PDR.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in hand hygiene compliance among health workers from baseline to endline
Time Frame: At endline (6 months after the intervention started)
|
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.
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At endline (6 months after the intervention started)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived feasibility and acceptability of the infection prevention and control intervention among HCWs and stakeholders
Time Frame: At endline (6 months after the intervention started)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 13, 2022
First Submitted That Met QC Criteria
September 16, 2022
First Posted (Actual)
September 21, 2022
Study Record Updates
Last Update Posted (Actual)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 10, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCP100737ITDC
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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