| CTRI Number |
CTRI/2024/07/070463 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [educational intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Development of patient safety program among newly joined nurses in a cancer care center. |
|
Scientific Title of Study
|
Development of Safer together program among novice oncology nurses in a tertiary cancer care center Roadmap for patient safety champion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Debjani Mukherjee |
| Designation |
Nurse Educator |
| Affiliation |
Tata Medical Center |
| Address |
14 Major Arterial Road (East West) , Rajarhat, Newtown, Kolkata
Department-Nursing
Block-Education, Phase II building,
Room no. 101
114 Major Arterial Road (East West) , Rajarhat, Newtown, Kolkata
Department-Nursing
Block-Education, Phase II building,
Room no. 101
Kolkata
WEST BENGAL
700160
India |
| Phone |
9883422837 |
| Fax |
|
| Email |
debjanim73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chandu Bhardwaj |
| Designation |
Principal cum professor |
| Affiliation |
Indian Nursing Council |
| Address |
Rami devi Nursing and Paramedical Institute
Address-Medi City , NH-12,
Jaipur Road, Deoli, Tonk , Rajasthan, INDIA
Block-Administrative
Department-Nursing
Room No-005
Rami devi Nursing and Paramedical Institute
Address-Medi City , NH-12, Jaipur Road, Deoli, Tonk , Rajasthan, INDIA
Block-Administrative
Department-Nursing
Room No-005
Tonk
RAJASTHAN
304804
India |
| Phone |
9461606380 |
| Fax |
|
| Email |
ckbhardwaj1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Debjani Mukherjee |
| Designation |
Nurse Educator |
| Affiliation |
Tata Medical Center |
| Address |
14 Major Arterial Road East West
Rajarhar, Newtown, Kolkata.
Department-Nursing
Block-education
Room no-101
14 Major Arterial Road East West
Rajarhar, Newtown, Kolkata.
Department-Nursing
Block-education
Room no-101
Kolkata
WEST BENGAL
700160
India |
| Phone |
9883422837 |
| Fax |
|
| Email |
debjanim73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center
14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160,
West Bengal, India. |
|
|
Primary Sponsor
|
| Name |
Debjani Mukherjee |
| Address |
14 Major Arterial Road East West, Rajarhar, Newtown, Kolkata-700160 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrDebjani Mukherjee |
Tata Medical Center |
14 Major Arterial Road (EW) Newtown Rajarhat Kolkata, Phase 2, Education block, Nursing department
Kolkata
WEST BENGAL |
9883422837
debjanim73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center- Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Here study participants are novice nurses who are physically and mentally healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional class of IPSG only |
conventional teaching during induction will continue |
| Intervention |
Safer together program |
Safer together program in the form of educational intervention to be provided to the newly joined oncology nurses to improve patient safety practices. The program will be delivered over two days in 10 hours involving lecture, discussion, demonstration and simulation method. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Newly recruited nurses joined in Tata Medical Center as fresher after Bachelor degree
Nurses who will be consented to participate in the study
|
|
| ExclusionCriteria |
| Details |
Nurses who have worked before as Registered Nurse in any other hospital |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of knowledge, attitude and practice |
at the end of one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Find correlation among knowledge, practice, perception
evaluation of program |
at the end of one month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/08/2024 |
| 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="1" |
|
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
|
TPatient safety culture is defined as the common attitude,
beliefs, values, and behaviours of health caregivers shared in the process of
ensuring patient safety. Recently, Patient safety culture has been increasingly
recognized as a fundamental component of the healthcare system. It has been
proven that positive Patient safety culture helps improve patient outcomes such
as reducing adverse patient outcomes. Enhancing competency in patient safety at
entry to practice requires introduction and integration of patient safety into
health professional education. As efforts to include patient safety in health
professional education increase, it is important to capture new health
professionals’ perspectives of their own patient safety competence at entry to
practice with the primary objective of Development and implementation of ‘safer
together’ program for newly recruited oncology nurses. Experimental method and random
sampling method to be adopted in the study. The study can be implicated for
robust implementation of safer together program and projects on basis of
findings. the program evaluation will be done using Kirkpatrick evaluation
model The findings will be disseminated after the study. |