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CTRI Number  CTRI/2023/05/052803 [Registered on: 17/05/2023] Trial Registered Prospectively
Last Modified On: 16/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Identification of key factors affecting patient satisfaction levels in the Emergency medicine department of a teaching hospital. 
Scientific Title of Study   Study of factors affecting patient satisfaction in the Emergency Medicine department of a tertiary care teaching hospital  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aahaan Agrawal 
Designation  4th year MBBS Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Emergency Medicine, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7048261973  
Fax    
Email  aahaan.agrawal@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Prithvishree Ravindra  
Designation  Associate Professor  
Affiliation  Kasturba Medical College, Manipal 
Address  Associate Professor, Department of Emergency Medicine, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9035296971  
Fax    
Email  prithvishree.r@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Aahaan Agrawal 
Designation  4th year MBBS Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Emergency Medicine, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7048261973  
Fax    
Email  aahaan.agrawal@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Emergency Medicine, Kasturba Hospital, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Aahaan Agrawal 
Address  Department of Emergency Medicine, Kasturba Hospital, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aahaan Agrawal  Kasturba Hospital, Manipal  Ground floor, Department of Emergency Medicine
Udupi
KARNATAKA 
7048261973

aahaan.agrawal@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics committee.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  All patients admitted to the emergency medicine department over the age of 18 years. 
 
ExclusionCriteria 
Details  1. Patients with altered sensorium
2. Patients not willing to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of overall level of patient satisfaction would be calculated, along with the strength of association of overall level of satisfaction with each factor.  Data collected will be analyzed at the end of each month at till a total period of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="381"
Sample Size from India="381" 
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)   01/06/2023 
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)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
1. Aims & objectives:
- To identify and assess the key factors influencing patient satisfaction in the Emergency department
- To assess the strength of correlation between each factor and the overall level of patient satisfaction

2. Detailed description of procedure / processes: A questionnaire in both Kannada and English will be provided to the patient which will include various questions with a likert scale ranging from 1-5, designed to assess the patient’s satisfaction in the emergency department.
The questionnaire is divided into 2 parts, the first asking for the Patient details, which would include: 
- Age, gender (to be filled by the patients)
- Triage category, Diagnosis, time for initial assessment by EM doctors and nurse, and time taken for admission /discharge /shifting of patient (to be entered by the nurse present during discharge)
The second part would consist of questions related to factors that most likely contribute to patient satisfaction, which would include General questions on management, treatment and discharge, questions on factors related to the physical environment of the ED, and questions on factors assessing bystander comfort. Each item would be rated by the patients and bystanders on a Likert scale of 1-5, with 1 signifying extreme dissatisfaction and 5 signifying extreme satisfaction.
Consent of the patient will be taken before providing the questionnaire and a translator will be provided as well. At the end, all the questionnaires collected will be compiled and the data will be analyzed using Pearson coefficient to determine the relation between each factor and the overall satisfaction level in the patient.

3. Outcome measures: Descriptive statistics would be used to analyze responses to items for patient’s satisfaction. Pearson correlation coefficient would be used to measure the strength of association of overall level of satisfaction with each factor.
 
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