| 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
|
|
|
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
|
|
|
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. |