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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
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 13, 2022
    Last Updated
    February 24, 2023
    Sponsor
    National University of Singapore
    Collaborators
    Saglik Bilimleri Universitesi
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    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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