Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections (IPC-HAI)
Primary Purpose
Hospital-acquired Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Infection prevention and control (IPC)
Sponsored by
About this trial
This is an interventional prevention trial for Hospital-acquired Infections focused on measuring Infection control, Prevention, Hand hygiene, Healthcare workers, Low- and middle-income countries, Asia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05547373
First Posted
September 13, 2022
Last Updated
February 24, 2023
Sponsor
National University of Singapore
Collaborators
Saglik Bilimleri Universitesi
1. Study Identification
Unique Protocol Identification Number
NCT05547373
Brief Title
Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections
Acronym
IPC-HAI
Official Title
Developing and Piloting an Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections in Cambodia and Lao PDR
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Saglik Bilimleri Universitesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital-acquired Infections
Keywords
Infection control, Prevention, Hand hygiene, Healthcare workers, Low- and middle-income countries, Asia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Infection prevention and control (IPC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in hand hygiene compliance among health workers from baseline to endline
Description
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.
Time Frame
At endline (6 months after the intervention started)
Secondary Outcome Measure Information:
Title
Perceived feasibility and acceptability of the infection prevention and control intervention among HCWs and stakeholders
Description
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.
Time Frame
At endline (6 months after the intervention started)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sreymom Oy, MSc
Phone
+85511867468
Email
smomoy@nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Chan Hang Saing, PhD
Phone
+85512293315
Email
ephchs@nus.edu.sg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Infection Prevention and Control Intervention to Reduce Hospital-acquired Infections
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