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 |
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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
|
|
Primary Sponsor
|
Name |
Tata Memorial Centre |
Address |
Dr Ernest Borges Road, Parel , Mumbai 400012 |
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 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
|
|
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.
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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