| CTRI Number |
CTRI/2023/12/060601 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive survey design |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify the lost possibilities for end of life care discussion and the impact on health among the patients admitted to intensive care unit |
|
Scientific Title of Study
|
A study to address the missed opportunities for early palliative care discussion and the health outcome among patients admitted to intensive care units of selected tertiary care hospital in Udupi district |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shwetha |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education(MAHE) Manipal |
| Address |
Nurse Practitioner in Critical Care Manipal College of Nursing Manipal Academy of Higher Education(MAHE) Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6363141271 |
| Fax |
|
| Email |
shwethapoojari62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Janet Prameela Dsouza |
| Designation |
Assistant Professor senior scale and Guide |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Medical Surgical 1st floor Nursing Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986417306 |
| Fax |
|
| Email |
janet.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Janet Prameela Dsouza |
| Designation |
Assistant Professor senior scale and Guide |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Medical Surgical Nursing 1st floor Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986417306 |
| Fax |
|
| Email |
janet.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shwetha |
| Address |
Manipal College of Nursing MAHE Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ms Shwetha |
Kasturba Hospital Manipal |
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA |
6363141271
shwethapoojari62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
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 |
Advanced cancer (Stage IV), Multiorgan failure: ≥2 organ systems, Advanced dementia or other cognitive impairment, Chronic life-limiting illness: Decompensated chronic liver disease Child Pugh class C, chronic kidney disease (CKD-5), advanced COPD, severe congestive cardiac failure (class III or IV) ; Non-reversible causes of coma or other major acute neurological insult due to major infarcts, intracranial bleed, or traumatic brain injury; Intracranial haemorrhage requiring mechanical ventilation, In case of specific acute illnesses like hypoxic-ischemic encephalopathy due to cardiac arrest, intracerebral haemorrhage requiring mechanical ventilation. |
|
| ExclusionCriteria |
| Details |
Patients admitted with short term illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study finding would help to reduce the suffering of the patients, can reduce the unwanted ICU admissions and family satisfaction |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
26/12/2023 |
| 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 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
|
A study to address the missed opportunities for early palliative care discussion and the health outcome among patients admitted to intensive care units of selected tertiary care hospital in Udupi district. To find the missed opportunities for early palliative care discussion in ICUs using screening checklist. To identify the trigger points of palliation on admission to emergency and ICU using triggers of palliative care. |