| CTRI Number |
CTRI/2021/08/036000 [Registered on: 27/08/2021] Trial Registered Prospectively |
| Last Modified On: |
09/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Role of Palliative care consultation in Emergency department: A retrospective study |
|
Scientific Title of Study
|
Palliative care consultation in Emergency department: a single centre retrospective analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of palliative medicine, Room number 75, Main building, E borges road, Tata memorial hospital, parel
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person Scientific Query
|
| Name |
Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of palliative medicine, Room number 75, Main building, E borges road, Tata memorial hospital, parel
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person Public Query
|
| Name |
Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of palliative medicine, Room number 75, Main building, E borges road, Tata memorial hospital, parel
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Room 75, Tata Memorial hospital, E borges road, parel mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Jayita Deodhar |
Tata Memorial Hospital |
Room 75, main building, parel, mumbai Mumbai MAHARASHTRA |
02224177000
jukd2000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult patients referred for specialist palliative care (SPC) consultation in ED
2)Patients newly referred for SPC consultation
3)Patients who are already registered with the oncology hospital’s specialist
palliative care services |
|
| ExclusionCriteria |
| Details |
1)Incomplete medical records.
2)Patients not primarily registered with the oncology hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome and outcome measures:
The outcome of the SPC consultation will be as documented under the
categories as frequency and percentages:
1)Admission - Continuing care in ED
Inpatient admissions in ward/ ICU in same hospital
Referral for inpatient admissions in ward/ ICU in same other
hospital/hospice care/respite care
2)Discharge to home
3)Death |
At presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the reasons for referral |
1 |
|
|
Target Sample Size
|
Total Sample Size="800" Sample Size from India="800"
Final Enrollment numbers achieved (Total)= "712"
Final Enrollment numbers achieved (India)="712" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
01/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/03/2022 |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Project Title Palliative Care consultation in Emergency Department : A single centre
retrospective analysis
Background- Patients with advanced cancer present to the Emergency
Department (ED) with complex symptoms. Many patients at the end of life are
admitted to EDs and receive unwanted aggressive investigations and
interventions which may hamper the goals of care. Palliative Medicine
consultation in Emergency Department has shown to reduce symptom burden
in patients.
Aim- To determine the symptom profiles and outcome of patients referred for
specialist palliative care consultation in the Emergency Department.
Study Procedure- This is a retrospective analysis of medical records of
patient presenting to ED from July 2017 to June 2019.
Statistical analysis will be done to understand the frequency of symptom profile
and outcome.
Significance- The study will help us to understand the symptom profile of
terminally ill patients presenting to ED and the referral pattern and reasons for
new consultations in ED. This will help in formulating better care plans for
home- based care and anticipatory symptom management in these patients. |