| CTRI Number |
CTRI/2022/07/044147 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of ISBARR tool to improve patient care |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of improving the patient care by using Evidence based patient Hand over tool (ISBARR: Identification, Situation, Background, Assessment, Recommendation and Read Back) in Critical care units (Intensive care units) of Shri Vinoba Bhave Civil Hospital, Silvassa |
| Trial Acronym |
ISBARR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vadivukkarasi P |
| Designation |
Professor |
| Affiliation |
SHRI VINOB ABHAVE COLLEGE OF NURSING, SILVASSA |
| Address |
Shri Vinoba Bhave College of Nursing
Shri Vinoba Bhave Civil Hospital Campus, Silvassa
Dadra & Nagar Haveli
DADRA & NAGAR HAVELI
396230
India |
| Phone |
02602630102-434 |
| Fax |
|
| Email |
krishraghav2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vadivukkarasi P |
| Designation |
Professor |
| Affiliation |
SHRI VINOB ABHAVE COLLEGE OF NURSING, SILVASSA |
| Address |
Shri Vinoba Bhave College of Nursing
Shri Vinoba B have Civil Hospital, Silvassa
Dadra & Nagar Haveli
DADRA & NAGAR HAVELI
396230
India |
| Phone |
02602630102-434 |
| Fax |
|
| Email |
krishraghav2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vadivukkarasi P |
| Designation |
Professor |
| Affiliation |
SHRI VINOB ABHAVE COLLEGE OF NURSING, SILVASSA |
| Address |
Shri Vinoba Bhave College of Nursing
Shri Vinoba B have Civil Hospital, Silvassa
Dadra & Nagar Haveli
DADRA & NAGAR HAVELI
396230
India |
| Phone |
02602630102-434 |
| Fax |
|
| Email |
krishraghav2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Vinoba Bhave Civil Hospital, Silvassa |
|
|
Primary Sponsor
|
| Name |
Shri Vinoba Bhave Civil Hospital |
| Address |
Shri Vinoba Bhave Civil Hospital, Silvassa |
| Type of Sponsor |
Government medical college |
|
|
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 Gargi Majumdar |
Shri Vinoba Bhave Civil Hospital, Silvassa |
ICU with 16 beds and MICU with 50 beds at Shri Vinoba Bhave Civil Hospital, Silvassa
Dadra & Nagar Haveli
DADRA & NAGAR HAVELI |
8690693020
gargisvbch.sil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of NAMO Medical Education & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nursing Officers working in ICU, SVBCH will be selected for the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Nursing Officers working in ICU who are all available, understand English and willing to participate in the study and come for regular follow up will be included |
|
| ExclusionCriteria |
| Details |
Nursing officers whomsoever is transferred to the other wards, Nursing officers on maternity leave will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Nurses Documentation |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Satisfaction Score on patient safety will be improved |
3 months |
| Improvement in Shift handover evaluation checklist score |
3 months |
| Quality of handover information will be improved |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2022 |
| Date of Study Completion (India) |
08/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Communication is essential between health care professionals for quality care. Clinical hand-off is one of the most important communication transactions. Communication failure in a health care setting can lead to serious medical errors. Well performed hand off ensures effective communication, continuity of care, prevention of errors and enhances patient safety. Evidence-based studies demonstrate that the use of a structured standardized hand over tool such as ISBARR improves patient outcomes. According to WHO 22% of errors are related to communication problems at the time of nurses handing over and taking over. The aim of the project is to improve the patient safety by implementation of standardized ISBARR tool. The project will be conducted among the health care professionals working in critical care units of selected hospitals from different states of India. Pre-existing clinical hand-off will be assessed. In consultation with health care professionals a structured hand-off tool (ISBARR) will be developed. Training of the health care professionals will be provided before the implementation of the tool. Effectiveness of implementation of ISBARR tool will be assessed subsequently. Based on the findings of the project, necessary recommendations and follow up with stakeholders for the sustainability will be done.
TITLE Improving patient care introduction use of the evidence based patient hand over tool (ISBAR: Identification, Situation, Background, Assessment, Recommendation and Read back) in Critical care units (Intensive Care Units) in selected Hospitals. AIM Improve patient safety by implementation of the standardized ISBAR hand off system in a selected group of hospitals in India. OBJECTIVES · Assess the pre-existing clinical hand over practices among the nurses and doctors in selected hospitals in India · Implement system of communication clinical hand off through ISBAR process · Evaluate the effectiveness of use of this system HYPOTHESIS There is a significant association between the findings and selected Socio- demographic variables at 0.05 level of significance
|