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CTRI Number  CTRI/2020/05/025066 [Registered on: 06/05/2020] Trial Registered Prospectively
Last Modified On: 01/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate understanding, acceptance and application of hand hygiene measures in patients at KIMS Bhubaneswar 
Scientific Title of Study   Evaluation of knowledge, attitude and practice regarding hand hygiene practices among inpatients of KIMS Bhubaneswar- a preliminary study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pardipta Das 
Designation  Associate Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Surgery Kalinga Institute of Medical Sciences Campus 5 KIIT Road Patia Bhubaneswar

Khordha
ORISSA
751024
India 
Phone    
Fax    
Email  dr.pradiptadas@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pardipta Das 
Designation  Associate Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Surgery Kalinga Institute of Medical Sciences Campus 5 KIIT Road Patia Bhubaneswar

Khordha
ORISSA
751024
India 
Phone    
Fax    
Email  dr.pradiptadas@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pardipta Das 
Designation  Associate Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Surgery Kalinga Institute of Medical Sciences Campus 5 KIIT Road Patia Bhubaneswar

Khordha
ORISSA
751024
India 
Phone    
Fax    
Email  dr.pradiptadas@yahoo.co.in  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  Dr Pradipta Das 
Address  Associate Professor Department of Surgery Kalinga Institute of Medical Sciences Bhubaneswar Pin 751024 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Pradipta Das  Kalinga Institute of Medical Sciences Bhubaneswar  Department of Surgery Kalinga Institute of Medical Sciences Bhubaneswar Pin 751024
Khordha
ORISSA 
9937213626

dr.pradiptadas@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kalinga Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Visual reminder aids for a correct infection control programme  Visual reminder aids for a correct infection control behavior will be installed in the patient rooms and sanitary facilities as well as in the corridors.  
Intervention  WHO hand hygiene practice training  A multimodal package of informational and motivational material will be implemented, including e.g. posters, brochures and video presentations for patients. The brochure shall contain information on different aspects of infection prevention behaviour for patients and relatives in the hospital and at home. In particular, instructions for hand hygiene, food hygiene, bathroom hygiene, and hygiene behaviour as a patient as well as information on antibiotic intake are given. Other topics include signs for infections, behaviour under contact precautions, attention to correct standard precaution of the personnel as well as tips to be able to communicate personnel will be surveyed with an independent questionnaire on their expectations, observations and perceptions to address abnormalities politely but directly. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Adult patients over 18 years age of either gender admitted in the KIMS Hospital, Bhubaneswar Surgical wards and giving written informed consent to participate in the study.
2.Willing to comply with all study related procedures.
 
 
ExclusionCriteria 
Details  1.Patients unable to realize the hand hygiene concept, e.g. due to lack of understanding, and not able to follow the study procedure.
2.Patients not willing to co-operate or do not give consent.
3.Patients with mental confusion or advanced dementia.
4.Patient with depression or schizophrenia
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in total scores of the knowledge attitude and practice of the inpatients of surgical ward of KIMS, Bhubaneswar before and after the WHO hand hygiene training  Day 0 and Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Implementation and acceptance of hand hygiene practice in health care workers in surgical wards of KIMS Bhubaneswar  Day 0
Day 180 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Nosocomial infections or healthcare associated infections occur in patients under medical care. These infections occur both in developed and developing countries.Thousands of people die of hospital acquired infections while receiving  the health care. Nosocomial infections accounts for 7% in developed and 10% in developing countries.They cause prolonged hospitilisation, disability, and economic burden. According to WHO estimates, approximately 15% of all hospitalized patients suffer from nosocomial infections. During hospitalization, patient is exposed to pathogens through different sources environment, healthcare staff, and other infected patients. Hands are the main pathways of infectious diseases. Therefore, hand hygiene is the most important measure to avoid the transmission and can prevent health care-associated infections.The crucial role of hand hygiene in the prevention of health care–associated infection (HAI) was initially established independently by Oliver Wendell Holmes and Ignaz Semmelweis in the 1840s. Semmelweis, in his “germ theory” recognized that the hands of medical staff  were contaminated while performing autopsies and consequently were responsible for the transmission of “cadaverous particles” during obstetric examinations, leading to puerperal sepsis and death. Mortimer and colleagues established the importance of hand hygiene in preventing Staphylococcus aureus transmission in a neonatal unit. From the time of Semmelweis’, evidence of the benefits of hand hygiene has not been translated into immediate adoption of the practice. Despite the advances and the development of well-accepted guidelines regarding the practice of hand hygiene, rates of hand hygiene performance by health care workers remain disappointingly low. 

Avoidance of hospital-acquired infections (HAI) has become an integral part of patient safety. Since creation of the World Health Organization (WHO) resolution “Quality of care: patient safety” at the 55th World Health Assembly in 2002, infection control and prevention (ICP) has also become a global focus . Consequently the World Alliance for Safer Health Care was established in 2004 followed by the “SAVE LIVES: Clean your Hands” campaign in 2009. Now, it has been recognized that the participation of patients could represent one of the most obvious advantages in ICP and patient safety.  The prevention of nosocomial or hospital acquired infections requires participation from the patients themselves. In the past, however, patients have been apprehensive to point out hygiene-relevant behaviour to the healthcare personnel. AHOI" stands for the "Activation of patients, persons in need of care and care givers for a Hygiene-conscious participatiOn in Infection control. There are few studies done in Germany and other developed countries regarding the adherence, empowerment and acceptance of the hand hygiene practice among patients and health care workers. There are some studies regarding knowledge attitude and practice of medical students and health care givers regarding the same . But there is no AHOI study done in patients in India to provide evidence regarding the above three dimensions i.e. adherence, empowerment and acceptance of the WHO hand hygiene practice. So this study is being undertaken in the inpatients of a tertiary care teaching hospital, Kalinga Institute of Medical Sciences, Bhubaneswar, India.

Primary Objective:To evaluate implementation and acceptance of the AHOI (WHO hand hygiene training) to the in patients in the surgical wards of KIMS, Bhubaneswar.

Secondary objective:To evaluate the implementation of hand hygiene training in health care workers in surgical wards of KIMS, Bhubaneswar

Inclusion Criteria:

1.     1. Adult patients over 18 years age of either gender admitted in the KIMS Hospital, Bhubaneswar Surgical wards and giving written informed consent to participate in the study.

2.     2. Willing to comply with all study related procedures.

Exclusion criteria:

1.    1. Patients unable to realize the hand hygiene concept, e.g. due to lack of understanding, and not able to follow the study procedure.

2.     2. Patients not willing to co-operate or do not give consent.

3.     3. Patients with mental confusion or advanced dementia.

4.     4. Patient with depression or schizophrenia

MMETHODS: The study will be conducted according to ICH-GCP protocol. The present study will be conducted at the Department of Surgery, KIMS, Bhubaneswar after approval from institutional ethics committee and permission from the Medical Superintendent, KIMS, Bhubaneswar . The developed AHOI intervention will be carried out on wards of the General Surgery, Oncosurgery, Gastrointestinal Surgery, Thoracic and Vascular Surgery for a time period of 6 months. Participants will be both surgical and medical patients.  The participation will be voluntary and pseudonymized. Before recruitment of study participants, the treatment team of the wards will receive six-hour training on three different occasions. The curriculum will convey the AHOI approach and its background. The interdisciplinary “train-the-trainer-teaching” team members will be trained by communication tools and will be taught the skills by role-playing. The healthcare personnel would be introduced to AHOI and learn to accept patients who are more involved in infection prevention.

A multimodal package of informational and motivational material will be implemented, including e.g. posters, brochures and video presentations for patients. An essential part is the “AHOI-welcome-box” that will be handed out to patients upon admission. This will contain not only supportive incentives but also the AHOI brochure which is a motivational hygiene guide with entertaining images. The brochure shall contain information on different aspects of infection prevention behaviour for patients and relatives in the hospital and at home. In particular, instructions for hand hygiene, food hygiene, bathroom hygiene, and hygiene behaviour as a patient as well as information on antibiotic intake are given. Other topics include signs for infections, behaviour under contact precautions, attention to correct standard precaution of the personnel as well as tips to be able to communicate  personnel will be surveyed with an independent questionnaire on their expectations, observations and perceptions to address abnormalities politely but directly.

Data collection will be questionnaire based, mainly with closed questions which were nominally or ordinally scaled (e.g. “yes – no”; or as a 10-point scale: “negative – positive”). To avoid priming of the respondents, the questionnaire will be split into two parts. An ID realized matching of both parts. Every respondent will receive the questionnaires and two blank envelopes for the anonymous return within the AHOI box. They will be requested to answer the first part directly at the beginning without looking at the rest of the content. The second part will have to be filled out at the last day of their stay. An information sheet in the box invited the respondents to participate voluntarily and anonymously. The return of the questionnaires in closed envelopes will be viewed as informed consent. Study nurses will be responsible for distribution of the AHOI boxes whereby the respondents will be informed about the goal of the study and motivated to participate properly according to the procedure.

The question catalogue will cover five main categories:

1. Role-understanding, perception of integration into the treatment security and wish for integration

2. Expectations and observations in interaction with the personnel (Empowerment)

3. Acceptance of the changed roles of the healthcare personnel through AHOI from the perspective of patients

4. Knowledge and implementation of hygiene standards (Adherence)

5. Evaluation of information materials 

Outcome Measures:

Primary Outcomes:Change in total scores of the knowledge attitude and practice of the inpatients of surgical ward of KIMS, Bhubaneswar before and after the WHO hand hygiene training

Secondary Outcome:Implementation and acceptance of hand hygiene practice in health care workers in surgical wards of KIMS Bhubaneswar

Data processing and data analysis:The collected data will be entered in case record forms and then all patients’ data will be compiled in an excel sheet by two independent research assistants.

Statistical Analysis:Descriptive statistics will be used for analysis of the data. Inferential methods like correlation tests of Spearman Rho and Pearson’s R etc. will be applied and reported when significant and decisive results are found. Data comparison between the two time points, will be evaluated only from questionnaires, where both questionnaire sections were available. For questions appearing in only one section, full individual sample size will be reported.

Study design: prospective cross sectional study by questionnaire method

Study Duration: six months




 
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