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CTRI Number  CTRI/2024/12/077956 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Patient Safety Culture Training Interventions Amongst Healthcare Workers 
Scientific Title of Study   To Assess the Perception on Patient Safety Culture and Effectiveness of Patient Safety Culture Training Interventions Amongst Healthcare Workers of Tertiary Care Center- An academic trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinoth Kumar Kalidoss 
Designation  Junior Resident  
Affiliation  AIIMS Mangalagiri 
Address  Department of Hospital Administration
IPD block, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India 
Phone  9944474500  
Fax    
Email  vinob4u@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Desu Rama Mohan 
Designation  Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of Hospital Administration
IPD block, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India 
Phone  9944474500  
Fax    
Email  deptha@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vinoth Kumar Kalidoss 
Designation  Junior Resident  
Affiliation  AIIMS Mangalagiri 
Address  Department of Hospital Administration
IPD block, AIIMS Mangalagiri

ANDHRA PRADESH
522503
India 
Phone  9944474500  
Fax    
Email  vinob4u@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Mangalagiri, Mangalagiri, Guntur District, AP, India 522503 
 
Primary Sponsor  
Name  AIIMS Mangalagiri 
Address  AIIMS Mangalagiri, Mangalagiri, Guntur District, AP, India 522503 
Type of Sponsor  Research institution and hospital 
 
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 Vinoth Kumar Kalidoss  AIIMS Mangalagiri  Room no G 141, Dept of Hospital Administration, IPD Block, AIIMS Mangalagiri, Mangalagiri, Guntur District
Guntur
ANDHRA PRADESH 
9944474500

vinob4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE AIIMS Mangalagiri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient Safety Culture Perception 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Training on patient safety culture  Single Whole Day Training on patient safety culture based on Patient safety curriculum guide: multi-professional edition followed by period review of patient safety event reporting will be done for 6 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. The permanent health care providers like Doctors, Nurses, Pharmacists, Lab Technicians and Supportive Staff working in AIIMS Mangalagiri
2. Temporary health care providers like Doctors, Nurses, Pharmacists, Lab Technicians and Supportive Staff working in AIIMS Mangalagiri for more than 6 months 
 
ExclusionCriteria 
Details  1. The health care providers working in AIIMS Mangalagiri
2. The health workers those not planned to continue work in AIIMS for next 6 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Composite positive response rate on patient safety culture  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
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)   01/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Patient safety in health care includes safety of both patients (clients) and health care providers (HCP). Patient safety culture is defined as the attitudes, perceptions, and values that staffs share within an organization related to patient safety. Patient safety culture can be measured by determining the values, beliefs, norms, and behaviors related to patient safety that are rewarded, supported, expected, and accepted in an organization. Most of the adverse events are preventable and occur due to defect in design of system or organization rather than poor performance of HCP. India is still lacking a regulatory system for the control of medication errors. In India, private sector caters to more than 70% of outpatient care and 30% of inpatient care. The common reasons for underutilization of services in Government sector are due to provision of poor quality of services and attitudes of HCP. Though patient safety is critical issue in health care delivery, there are very few studies on this aspect especially from developing countries like India. Considering dearth of information on this key aspect, this study was planned to assess the perceptions on patient safety culture among health care providers at a tertiary care hospital and assess the effectiveness of customized patient safety culture intervention trainings for health care providers.

In this study, we aim to assess the perceptions on patient safety culture among health care providers at a tertiary care hospital and to compare the perception on patient safety culture among various cadres. This will help develop the need assessment for training on patient safety based on Patient safety curriculum guide: multi-professional edition proposed by WHO and to assess the effectiveness of customized patient safety culture intervention trainings for health care providers.

 
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