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CTRI Number  CTRI/2024/11/077117 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The Role of Management in the Control and Prevention of Infections in Hospitals. 
Scientific Title of Study   A study to explore the managerial methods adopted for initiating and sustaining infection control efforts in healthcare settings. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Vaishakhi 
Designation  Student 
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104

Bangalore
KARNATAKA
576104
India 
Phone  7483519775  
Fax    
Email  krishna.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Usha Rani 
Designation  Associate Professor 
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8310214742  
Fax    
Email  usha.rani@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Krishna Vaishakhi 
Designation  Student 
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  7483519775  
Fax    
Email  krishna.psphmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Healthcare and Hospital Management, Prasanna School of Public Health, Madhav Nagar, Manipal, Udupi, Karnataka, India 576104 
 
Primary Sponsor  
Name  Krishna Vaishakhi 
Address  Department of Healthcare and Hospital Management Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Usha Rani  Prasanna School of Public Health  Room No. 68, Department of Healthcare and Hospital Management, MAHE, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 07483519775

krishna.psphmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infection Control Practices 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Individuals currently working in healthcare settings, including infection control nurses, doctors, and infection control committee members.
Participants should be able to read and comprehend English without difficulty understanding and responding appropriately to the survey questions.
Participants who voluntarily agreed to participate in the survey. 
 
ExclusionCriteria 
Details  Administrative staff, general staff, and physicians who have not specialised in infection control.
Individuals not well-versed in English may have trouble comprehending and accurately responding to survey questions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The rate of compliance with infection control practices among healthcare staff.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
There are no specific intervention or endpoint criteria, as this is an observational study focused on assessing infection control practices in healthcare settings.  Baseline 
 
Target Sample Size   Total Sample Size="422"
Sample Size from India="422" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/11/2024 
Date of Study Completion (India) 28/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Aim:
To explore and evaluate the managerial methods adopted for initiating and sustaining infection control efforts in healthcare settings.

Objectives:
1) To assess the existing infection control practices across healthcare settings through a self-administered survey.
2) To analyse the most effective managerial methods in healthcare settings to prevent and manage hospital-acquired infections.
3) To provide evidence-based recommendations for enhancing infection control practices.

Procedure:
1) A structured questionnaire will be used to collect data. This questionnaire has been adapted from the Centers for Disease Control and Prevention (CDC)’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings. This is an openly accessible resource available on the CDC website, which does not require formal permission for use or adaptation in research settings.
2) The questionnaire shall be validated before use.
3) Convenience sampling method will be followed by which primary contacts and secondary contacts adhering to the inclusion criteria will be selected.
4) The survey will be distributed electronically via email and social media.
5) Administer questionnaire via MS Forms and conduct surveys after obtaining voluntary consent.
6) Enter obtained data into statistical software such as Jamovi and excel.
7) Use proper statistical methods such as frequency distributions, measures of central tendency, measures of dispersion and T-tests to assess the data.
8) Prepare preliminary results and findings that will include graphs and charts.
9) Compare the study findings to the current literature and theoretical frameworks.
10) Create a thorough discussion section that interprets the data about the research questions.
11) Highlight significant findings, their significance, and potential implications for healthcare practices.

Purpose:
1) The study’s findings can help healthcare managers build effective infection control management strategies. This can help with resource allocation, employee training, and infection prevention procedures.
2) The study can discover critical managerial lapses that contribute to HAIs. By addressing these gaps through the recommended suggestions, infection control measures can be developed, resulting in improved patient safety and fewer healthcare-related problems.
 
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