| CTRI Number |
CTRI/2024/10/075925 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Early Intervention in ICU: Reducing Time to Palliative Care |
|
Scientific Title of Study
|
Impact of early structured intervention on the time to transition to palliative goals of care in ICU patients with palliative care needs on admission |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajit Raosaheb Desai |
| Designation |
senior resident |
| Affiliation |
Bharati hospital and research centre, Pune |
| Address |
Department of critical care medicine, Bharati Hospital and research centre, katraj, pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
8149861027 |
| Fax |
|
| Email |
rickyforyou2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivakumar Iyer |
| Designation |
HOD and Proffesor |
| Affiliation |
Bharati hospital and research centre, pune |
| Address |
Department of critical care medicine, Bharati Hospital and research centre, Katraj, pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051719 |
| Fax |
|
| Email |
shivkumar.iyer@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shivakumar Iyer |
| Designation |
HOD and Proffesor |
| Affiliation |
Bharati hospital and research centre, pune |
| Address |
Department of critical care medicine, Bharati Hospital and research centre, Katraj, pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051719 |
| Fax |
|
| Email |
shivkumar.iyer@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre, Pune-Satara Road Pune-411043 Maharashtra, India |
|
|
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 Ajit Raosaheb Desai |
Bharati Hospital and Research Centre |
Department of Critical Care Medicine Bharati Hospital and Research Centre,Satara road,Pune-411043
Pune
MAHARASHTRA |
8149861027
rickyforyou2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth medical college Institutional Ethics Committeeo |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z638||Other specified problems related to primary support group, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Palliative care physician |
Standard of Care with referral time to Palliative Care Physician |
| Comparator Agent |
Standard of care |
Family Counselling by ICU physician |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients with age more than 18 years.
All patients admitted in ICU having palliative needs as identified by using a standard palliative care needs assessment tool. |
|
| ExclusionCriteria |
| Details |
post operative patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact of early palliative care intervention on time to transition to palliative care in ICU patients. |
20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of ICU stay |
20 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/11/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Critical care medicine is a speciality that manages all manner of acutely ILL patients in the course of their illnes. acutely ill patient who are not responding to the treatment may need transition to end of life care. We therefore planned a study (phase 1) to asses the palliative care needs in patient with life limiting illness admitted in the ICU and design an appropriate palliative care intervention to promote timely transition to palliative care. in Phase 2 we plan to evaluate the effect of this intervention on the time required for transition to palliative care, reduce the symptom burden for patients with palliative care needs in ICU and promote family satisfaction |