| CTRI Number |
CTRI/2024/02/062519 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Burden of intensive care survivors on Critical Care Unit and family. |
|
Scientific Title of Study
|
ICU Survivors Follow up: Post Intensive Care Syndrome (PICS) Burden on Critical Care Unit and Family. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Banani Poddar |
| Designation |
Professor and head of department of critical care medicine |
| Affiliation |
Sanjay Gandhi Post Graduate Institute Of Medical Sciences |
| Address |
Room no-1, second floor, Department of critical care medicine, SGPGIMS, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904729 |
| Fax |
05222668017 |
| Email |
bananip@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Banani Poddar |
| Designation |
Professor and head of department of critical care medicine |
| Affiliation |
Sanjay Gandhi Post Graduate Institute Of Medical Sciences |
| Address |
Room no-1, second floor, Department of critical care medicine, SGPGIMS, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904729 |
| Fax |
05222668017 |
| Email |
bananip@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Arnavjyoti Das |
| Designation |
Student of department of critical care medicine |
| Affiliation |
Sanjay Gandhi Post Graduate Institute Of Medical Sciences |
| Address |
CCM ICU 2, Department of Critical Care Medicine, Main hospital, SGPGI campus Lucknow Not applicable. Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004907745 |
| Fax |
05222668017 |
| Email |
alreadyajd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow - 226014 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Not applicable. |
| 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 |
| Banani Poddar |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Critical Care Medicine, SGPGI, Lucknow - 226014
Lucknow UTTAR PRADESH |
8004904729
bananip@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee, SGPGI, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Family members of patients discharged from ICU |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Family members of:
a. Patients who are discharged from ICU with Cerebral Performance Category Scale Score (CPCSS) less than or equals to 4.
b. Patients who are 18-65 years old.
|
|
| ExclusionCriteria |
| Details |
(any of the following)
Family members:
a. Of terminally ill patients discharged for home comfort care.
b. Of patients who are not capable of following up due to socioeconomic or manpower related issues.
c. Of patients with ICU stay less than 7 days.
d. Of patients with pre-illness CPCSS more than or equals to 3.
e. Who are unable to comprehend the ‘Expenditure chart’.
f. Of patients who are Discharged Against Medical Advice or transferred to another institution.
g. Of patients with more than 1 time readmission in CCM during the same course of illness.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the psychological and physical burden of PICS on family. |
2-3 months after discharge from hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the financial burden of PICS on the family.
2. To assess the burden of ICU survivors on department of Critical Care Medicine, SGPGIMS, Lucknow.
3. To attempt an assessment of the expected expenditure at 2 to 3 months for a particular severity of PICS disability. |
Up to 2-3 months after discharge from hospital. |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
17/02/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Intensive care unit (ICU)
survivors often face a myriad of physical, psychological, and cognitive
challenges, collectively known as post-intensive care syndrome (PICS). This
complex condition not only impacts the individual patient but also extends to
their families, known as PICS-F and exerts a significant burden on the critical
care unit during post-discharge care, which plays a crucial role in managing
the long-term consequences of critical illness and improving patient outcomes.
Understanding the burden of PICS on both the ICU and the family is essential
for developing effective interventions and optimizing post-ICU follow-up
strategies.
Family members of the consecutive
patients who are discharged from the ICU, are to be studied on, after
considering the following inclusion and exclusion criteria:
Inclusion criteria: Family members of:
a.
a. Patients
who are discharged from ICU with Cerebral Performance Category Scale Score
(CPCSS) less than or equals to 4.
b.
b. Patients
who are 18-65 years old.
Exclusion criteria: (any of the following) Family members: a. Of
terminally ill patients discharged for home comfort care.
b.
b. Of
patients who are not capable of following up due to socioeconomic or manpower
related issues.
c.
c. Of
patients with ICU stay less than 7 days.
d.
d. Of
patients with pre-illness CPCSS more than or equals to 3.
e.
e. Who
are unable to comprehend the ‘Expenditure chart’.
f.
f. Of patients who are Discharged Against Medical Advice or transferred
to another institution.
g.
g. Of patients with more than 1 time
readmission in CCM during the same course of illness.
Duration of study:
1 year 6 months.
Work plan:
After discharge
from hospital, the ICU survivors will be asked to follow up in the CCM
department at least once after 1 month and once after 2-3 months. The family
members will be counselled regarding the possible post hospital course as well
as they will be explained about the purpose of the study. They will be provided
with an ‘expenditure chart’, a specially made chart exclusive for this study,
to keep track of their expenses during the follow up period. The most important
family member will also be interviewed during the final follow up visit for
assessment of physical and psychological impact of PICS-F by Health Related
Quality of Life (HRQoL-14) Questionnaire originally formulated by Centre of Disease
Control (CDC). Thus, the physical, psychological and economical burden of PICS
on family (PICS-F) will be holistically viewed. The PICS-F, thus understood,
will be stacked against the disability of the ICU survivors in terms of CPCSS
and Clinical Frailty Score (CFS) and compared. During the follow up, the
patients will be attended to their proper needs and the time and manpower utilisation
from CCM department, SGPGIMS during individual follow up visit will be documented
as a novel index specially formulated for this study, named the ‘man-time index’,
which should reflect the burden of ICU survivors on the critical care unit.
Ethical
issues:
This is an
observational study which involves the follow up visits of the ICU survivors
after discharge. This will not affect the routine post discharge care of the patient.
The logistic problems faced by the families of following up to a particular
critical care unit are unavoidable, mostly because of the distances between their
residence and the critical care unit are significant. This is nullified by
encouraging the family to synchronise the multi-disciplinary follow up visits to
a single day as ICU survivors often has multi-disciplinary issues for which
follow up visits to respective disciplines are required. There are no obvious
ethical issues and interventions are planned based on this data. Informed consent
is taken for each inclusion.
Statistical
Analysis:
As there is no adequate literature available to guide this study, this
study can be considered to be a pilot study. Statistical analysis to be performed using software “Statistical package
for social sciences version 23 (SPSS-23) and MedCalc.
|