| CTRI Number |
CTRI/2025/02/081433 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to check Nurses’ end of Shift report after implementation of Identity Situation Background Assessment Recommendation Communication- A Quality Improvement Study |
|
Scientific Title of Study
|
Evaluation of Nurses’ Shift Handover after implementation of ISBAR Communication- A Quality Improvement Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragna Gamit |
| Designation |
Senior Nursing Officer |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
MS Office (Nursing), IPD Building- Ground Floor AIIMS Rajkot,
Village- Khandheri, Tehsil- Paddhari, District- Rajkot, 360110
Rajkot
GUJARAT
360110
India |
| Phone |
7874764625 |
| Fax |
|
| Email |
pragnagamit9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pragna Gamit |
| Designation |
Senior Nursing Officer |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
MS Office (Nursing), IPD Building- Ground floor, AIIMS Rajkot,
Village- Khandheri, Tehsil- Paddhari, District- Rajkot, 360110
Rajkot
GUJARAT
360110
India |
| Phone |
7874764625 |
| Fax |
|
| Email |
pragnagamit9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragna Gamit |
| Designation |
Senior Nursing Officer |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
MS Office (Nursing), IPD Building- Ground Floor, AIIMS Rajkot,
Village- Khandheri, Tehsil- Paddhari, District- Rajkot, 360110
Rajkot
GUJARAT
360110
India |
| Phone |
7874764625 |
| Fax |
|
| Email |
pragnagamit9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PI and Co-PI of the study (Self Sponsored) |
| Address |
AIIMS Rajkot
Khandheri, Rajkot |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Kunal Deokar |
AIIMS Rajkot |
AIIMS Rajkot,
Village- Khandheri, Tehsil- Paddhari, Dist- Rajkot 360110
Rajkot
GUJARAT |
7874764625
pragnagamit9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses Working in Hospital & performing shift handover |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Structured ISBAR handover sheet |
Comprehensive Structured ISBAR handover sheet will be implemented along will teaching sessions & visual reminders in ward. |
| Comparator Agent |
Handover Without ISBAR Tool |
Handover Without ISBAR Tool |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Nursing officers working in inpatient departments of AIIMS Rajkot.
2. Nursing Officers who are present at the time of data collection
3. Nursing Officers performing shift handover process
4. Nursing officers who gave valid consent for participation
|
|
| ExclusionCriteria |
| Details |
1. Nursing officers who are working in outpatient departments
2. Nursing Officers who are not available at the time of data collection
3. Nursing officers who do not perform shift Handover (NO posted in OPD, OT, CSSD,ICN, BSU)
4. Nursing officers who are not willing to participate and give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess adherence to the structure of ISBAR communication before and after intervention regarding Shift Handover among Nursing Officers of selected departments of AIIMS Rajkot. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out association between Shift Handover Practice with selected demographic variables regarding Shift Handover among Nursing Officers of selected departments of AIIMS Rajkot.
To develop standardized ISBAR shift handover format for implementation |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
15/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
In this quality improvement study, Nursing Officers who are performing shift handover in inpatient departments & are ready to participate in the study will be included. Upon obtaining written consent, investigators will provide counseling and discuss the objectives of the study. The participant’s detailed personal history will be obtained through the use of a standard questionnaire. This will include demographic information such as Age, Gender, educational Qualification, Experience, Working unit/ Type of Ward, Status of preparation before handover, Shift handover time, Patient allotted to individual staff, Type of shift , Type of Handover. Handover Practice will be observed using Structured Observational Checklist. Based on findings of the observations a Structured Handover sheet will be formulated based on components of ISBAR handover tool. New Structured handover sheet will be implemented along will teaching sessions & visual reminders in ward. Post implementation of interventions Observations will be performed to check effectiveness of the intervention & changes will be made in next PDSA cycle accordingly until desired compliance is achieved.
1. Even after extensive search, no any similar study of India was found having observed frequency in Mean and Standard Deviation (SD). Thus sample size cannot be calculated using formula for before after study. 3. We will take 50% of Nursing Officers from each dept. for the study after taking informed consent. 3. Thus, sample size for the current study is 206. |