| CTRI Number |
CTRI/2025/12/098721 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Quality Improvement Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to learn the utility of different approaches in improving the hand hygiene and personal protective equipment use among doctors and nurses in the emergency departement |
|
Scientific Title of Study
|
To determine the improvement of hand hygiene and personal protective equipment adherence rate in the emergency department
through quality improvement study. |
| Trial Acronym |
SHAPE ED |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
naveed ul hassan H |
| Designation |
junior resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of emergency medicine,
EMS building,
JIPMER,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500528906 |
| Fax |
|
| Email |
naveedulhassan1408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
naveed ul hassan H |
| Designation |
junior resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Emergency Medicine,
EMS building,
JIPMER, Puducherry
PONDICHERRY
605006
India |
| Phone |
9500528906 |
| Fax |
|
| Email |
naveedulhassan1408@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
naveed ul hassan H |
| Designation |
junior resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Emergency Medicine,
EMS building,
JIPMER, Puducherry
PONDICHERRY
605006
India |
| Phone |
9500528906 |
| Fax |
|
| Email |
naveedulhassan1408@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dean academic |
| Address |
academic section, JIPMER academic centre, JIPMER,
Puducherry |
| 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 |
| Naveed Ul Hassan H |
JIPMER |
Department of Emergency Medicine, EMS building,
JIPMER, Dhanvantri Nagar, Boomiyanpet,
Puducherry
Pondicherry
PONDICHERRY |
9500528906
naveedulhassan1408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Doctors and Nurses |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Doctors and nurses working in the emergency department during the study period |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve the hand hygiene and personal protective equipment adherence rate among health care workers in Emergency Medicine department during a 15 month period |
Baseline Phase- 1 month
Intervention Phase- 12 months
Sustainability phase- 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to perform the cause effect analysis of adherence to hand hygiene and personal protective equipment. |
15 months |
| To assess the adherence to hand hygiene and Personal Protective Equipments while performing procedures during the one month duration in baseline phase |
1 month |
|
|
Target Sample Size
|
Total Sample Size="466"
Sample Size from India="466"
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)
|
23/12/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The purpose of this study is to assess the improvement in Hand Hygiene and Personal Protective Equipment (PPE) adherence rates through a Quality Improvement (QI) initiative. The QI study will span a total of 15 months, consisting of 1 month for baseline data collection, 12 months for the intervention phase, and 2 months for the sustainability phase. During the baseline phase, data on the Hand Hygiene and PPE adherence rates among doctors and nursing officers will be collected before any interventions are implemented. This data will be gathered from different zones of the Emergency Department over a period of 40 minutes daily for 20 days within the month. Data collection will be conducted using the IBHAR app and Google Forms, and the data will be analyzed accordingly. A core QI team will be formed, which will include the Principal Investigator, Guides, Co-Guides, Senior and Junior Residents, and Senior Nursing Officers. The QI team will evaluate the baseline data and use a fishbone diagram to investigate the causes and effects of adherence issues. The pre-planned interventions will include on-site feedback, monthly audits of hand hygiene and PPE adherence, circulation of audit results, reinforcement strategies, educational sessions, and online pre- and post-test assessments. These interventions will be adjusted based on ongoing assessments during the intervention phase and feedback from the QI team. The monthly audits have been designed to analyze data regularly and to reinforce Hand Hygiene and PPE adherence. After the 12-month intervention phase, a sustainability phase will be implemented to evaluate the effectiveness of these interventions. The collected data will be analyzed, and the final outcomes of the study will be reported. |