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CTRI Number  CTRI/2017/08/009330 [Registered on: 09/08/2017] Trial Registered Prospectively
Last Modified On: 08/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   survey 
Study Design  Other 
Public Title of Study   A opinion about patient experience about anaesthesia services after cancer surgery  
Scientific Title of Study   A survey on patient satisfaction with anesthesia services in a tertiary care cancer Centre. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Project no. 1851 V 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Ambulkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, 2nd floor Main Building, Dr. E Borges Road Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reshma Ambulkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, 2nd floor Main Building, Dr. E Borges Road Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alim Patel 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, 2nd floor Main Building, Dr. E Borges Road Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  09595200980  
Fax    
Email  alimpatel93@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Dr Ernest Borges Road, Parel , Mumbai 400012 
Type of Sponsor  Government medical college 
 
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 
Dr Reshma Ambulkar  Tata Memorial Hospital  Dept. of Anaesthesia, Critical Care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA 
9821790448

rambulkar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult patients undergoing elective surgery receiving general/regional anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult patients undergoing elective surgery receiving general/regional anaesthesia
2. Services included will be thoracic,gastrointestinal, urology and gynaecology
3. Patients shifted to ward within 24 hours after surgery
4. Patients included in acute pain service
 
 
ExclusionCriteria 
Details  1. Paediatric patients (Age<18yrs)
2. Patient requiring post-operative ventilation
3. Patient not included in acute pain service
4. Patient staying in ICU/HDU/Recovery area for>24 hours
5. Neurosurgery patients
6. Patient who refuse consent
7 Emergency surgeries
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study aims to assess the patient satisfaction with regards to anaesthesia services provided at Tata Memorial Centre.   Postoperative period- 24 to 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To audit our practices and identify areas for improvement with anaesthesia services at our institute.  24 - 48 hrs post anaesthesia 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   11/09/2017 
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 Applicable 
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)?  

Brief Summary  


                                                                                                                                                      


Introduction


Anaesthetists are involved in providing peri-operative care for the patient undergoing surgery. Patient satisfaction is one of the important quality indicators of health care that can contribute to balanced evaluation of the structure, process and outcome of a service1,2.  The concept of satisfaction is not easy to define and is influenced by cultural, socio-demographic, cognitive and affective factors, amongst others. Thus, there is no single, unifying definition. Patient satisfaction is a subjective and complex concept and is determined by the quality of the care provided and the patient’s expectations of that care1 Dissatisfaction arises if the patient experiences a discrepancy between expected and provided care.1,3  Many factors contribute to patients satisfaction including accessibility and convenience of service ,institutional  structure ,interpersonal relationships, competence of health professionals, patients own expectations and preferances.3 It can be affected by anaesthetist patient interaction, peri-operative anaesthetic management and postoperative follow up. In-addition to the above, it is difficult to measure satisfaction especially during the preoperative and intra operative periods. Measuring the degree of patient satisfaction can be achieved with a variety of tools one such being post-operative visit and questionnaire4.  Existing literature, especially from India, has very little information about any of the aspects discussed above. No previous study has been conducted at our institution assessing patient satisfaction with the anaesthesia services. The aim is to assess patient satisfaction with anaesthesia services at Tata Memorial Centre. This will help us in identification of factors that are associated with incomplete satisfaction and provide an opportunity for us to make changes in our current practice to improve patient satisfaction and make our service patient centered. Hence we decided  to assess patient satisfaction with anaesthesia services and associated factors at Tata Memorial Centre.


 


Aim :


This study aims to assess the patient satisfaction with regards to anaesthesia services provided at Tata Memorial Centre. It will help us to audit our practices and identify areas for improvement with anaesthesia services at our institute.


 


Methodology:

Approval from Departmental and Hospital Research Review Board will be obtained.

  • Study Site: This study will be conducted at Tata Memorial Hospital.

  • Survey Design: Post anaesthesia questionnaire


               Standardized questionnaire will be used for postoperative patient interview.  Two sets of forward and backward translations in Hindi and Marathi of the English questionnaire first completed. The aim of this process was  to achieve different language versions of the English questionnaire to be used in this survey. The questionnaire in each language will be validated. The questionnaire will be validated in three domains namely face validity, construct validity and content validity. The questionnaire will be given to experts (5 consultants from the Department of Anaesthesia not involved in the study) to assess face validity. They will be asked to rate each question as relevant, somewhat relevant and irrelevant. For construct and content validity, questionnaire in each language English, Hindi and Marathi will be pilot tested on 30 patients (10 for each language) after due consent. An appointed research nurse will administer the questionnaire for pilot testing. The 30 questionnaires along with the opinion from experts (Anaesthesia Consultants)  will then be submitted to statistician for tests for validation. The validation report will be submitted to IEC. The duly validated questionnaire will thereafter be used and administered to the patients accrued in the survey after  approval of validation report from the IEC.


All patients depending on the inclusion criteria will be screened in the post-operative period. All patients who can be included in the study will be invited to participate in the study 24 hours after anaesthesia. A patient information sheet regarding the study will be provided to all patients deemed to be eligible to be included in the study. Patients will be explained that participation is voluntary. Formal written informed consent will be taken from patients willing to participate in the study. A research nurse will administer the set of questions to assess the satisfaction of the patient with anaesthesia services.


Timing of Questionnaire Administration: The questionnaire will be administered at 24 - 48 hrs post anaesthesia.


Inclusion Criteria:


  • Adult patients undergoing elective surgery receiving general/regional anaesthesia

  • Services included will be thoracic, gastrointestinal, urology and gynaecology

  • Patients shifted to ward within 24 hours after surgery

  • Patients for whom anaesthetists will be treating pain in the perioperative period, even after shifting from the recovery room/ICU to the ward.


 Exclusion criteria:


  • Paediatric patients (Age<18yrs)

  • Patient requiring post-operative ventilation

  • Patient not included in acute pain service

  • Patient staying in ICU/HDU/Recovery area for>24 hours

  • Neurosurgery patients

  • Patient who refuse consent

  • Emergency surgeries


Sample size: Formal sample size calculation not performed but a convenient sample size of 200.  We expect a 70% response rate hence we will screen around 300 patients. Response rate will also be noted as the number of patients approached to participate in the study and the number of patients who refused to be part of the study.


Data collection and analysis: A research nurse will administer the questionnaire to the consented patients between 24 – 48 hours post-anaesthesia.  After questionnaires are collected from 200 patients, the answers would be entered in SPSS and analysed.


Analysis of the variables:


1) Patients satisfaction and rating of the anaesthesia services: Being a questionnaire survey, no formal statistical tests would be done. Responses will be summarised as percentages


2) Association between factors and satisfaction: Satisfaction scores of pre-anaesthetic clinic, pain team and anaesthesia services will be compared across demographic variables – age, gender and education qualifications using chi square tests and logistic regression tests.


 


 


The results of this survey will help us identify patients’ expectations and satisfaction about anaesthesia services at our institution. This will help to recognize areas and factors where change or improvement is needed to make our services more patient centric 


 


 



 
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