| CTRI Number |
CTRI/2024/03/063935 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Quantitative observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess the level of satisfaction of patients coming to Pre anaesthesia OPD clinic |
|
Scientific Title of Study
|
A prospective observational project on assessing the satisfaction of patients visiting PAC(Pre-Anaesthetic Clinic) and the factors affecting the satisfaction score in tertiary care institute at South India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MINU N RAJAN |
| Designation |
PG RESIDENT ANAESTHESIA |
| Affiliation |
CMC VELLORE TAMILNADU |
| Address |
DEPARTMENT OF ANAESTHESIA
CMC VELLORE
PIN CODE 632004
TAMILNADU
Vellore TAMIL NADU 632004 India |
| Phone |
9400634782 |
| Fax |
|
| Email |
minunrajan1994@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR EKTA RAI |
| Designation |
HEAD OF DEPARTMENT ANAESTHESIA |
| Affiliation |
CMC VELLORE TAMILNADU |
| Address |
DEPARTMENT OF ANAESTHESIA
CMC VELLORE
PIN CODE 632004
TAMIL NADU
Vellore TAMIL NADU 632004 India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
MINU N RAJAN |
| Designation |
PG RESIDENT ANAESTHESIA |
| Affiliation |
CMC VELLORE TAMILNADU |
| Address |
DEPARTMENT OF ANAESTHESIA
CMC VELLORE
PIN CODE 632004
Vellore TAMIL NADU 632004 India |
| Phone |
9400634782 |
| Fax |
|
| Email |
minunrajan1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal Fluid research grant
HOSPITAL- CMC VELLORE,TAMILNADU |
|
|
Primary Sponsor
|
| Name |
Internal Fluid Research Grant CMC VELLORE |
| Address |
CHRISTIAN MEDICAL COLLEGE VELLORE
VELLORE
TAMIL NADU 632004 |
| Type of Sponsor |
Private 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 Minu N Rajan |
Christian Medical College |
CMC VELLORE
DEPARTMENT OF ANAESTHESIOLOGY Vellore TAMIL NADU |
9400634782
minunrajan1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board and Ethics Committee of CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients visiting PAC more than 18 years and less than 80 years posted for elective surgeries |
|
| ExclusionCriteria |
| Details |
1.Patients with age group less than 18 years
2.Refusal to participate in study
3.Unable to answer questions due to poor medical condition
4.Psychaitric and mentally retarded patients
5.In patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine level of patients satisfaction with pre-operative anaesthetic visit |
Same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to study about factors affecting satisfaction scores
time delay at PAC(Pre anaesthetic clinic) & understanding of PAC Consent |
one week |
|
|
Target Sample Size
|
Total Sample Size="576" Sample Size from India="576"
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)
|
25/03/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background: Patient
satisfaction is an important measure of quality of health care and it is
considered to be an integral part of service quality also. Anaesthetist plays
an important role in perioperative management of a surgical patient at various
stages from first visit at PAC clinic to discharge of the patient. There are
lot of evidence that in-person assessment at PAC clinic is associated with
reduction in morbidity and mortality. Aim of the PAC is not just to clear the
patients for surgery, rather to prepare them for it by explaining about the
need for optimisation of comorbidities, explaining analgesic plans ,ensuring
lesser anxiety,better co-operation and improved satisfaction. But all these are
lesser evaluated in our hospitals.In this background we decided to do an
observational study on to assess
satisfaction of patients attending anaesthesia OPDs(PAC).
Primary
Objective: Aim of the study is to determine the level of patientÂ’s
satisfaction with pre operative anaesthetic visit
Secondary Objective: To study
about the factors affecting satisfaction scores ,time delay at PAC, & understanding
of PAC consent
Study design: observational
study
Study population: Patients
posted for elective surgeries in the age group of 18-80 years visiting PAC Clinic as an out patient.
Location:
Pre anaesthetic clinic (PAC) , Christian
Medical College and Hospital, Vellore.
Methodology:
This
study will be conducted after institutional IRB clearance. Study will be conducted on
570 patients in the age group of 18-80 years whom are posted for elective
surgeries visiting PAC Clinic as an out
patient. Patients will be approached
by primary investigator prior to surgery in the PAC clinic (pre anaesthetic
clinic) in CMC vellore. Informed consent will be taken from the patient. After
obtaining a written informed consent patients were given the questionnaire in English/
Tamil/Malayalam/Hindi/Bangla(Patient survey) . We planned to
conduct face to face interviews with a sample of 25 patients to validate the
questionnaire for our Indian population.
The questionnaire will be given to 20
professionals (Professional survey) including 5 Consultants in Dept. of
Anaesthesia ,5 Senior residents, 1 MRO
and 3 nurses who work at the PAC .
We
are planning to take PEPAC questionnaire
(Patient Experiences with the Preoperative Assessment Clinic) as our
starting point.PEPAC Questionnaire is a reliable, comprehensive and validated
questionnaire to measure patient experiences with PAC clinic .It can be used to
determine the service level of PAC in a single institute as well as to compare
service levels across institutions also.Since this
questionnaire has originated in UK ,hence
we are validating the language and appropriateness of content for Indian
setup before starting the study. |