| CTRI Number |
CTRI/2024/07/069946 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of AIIMS ICU Rehabilitation (AIR) a home care intervention facilitating family-led discharge of chronic critically ill patients with a tracheostomy. A multicentric evaluation of a complex healthcare intervention. |
|
Scientific Title of Study
|
Effectiveness of the AIIMS ICU Rehabilitation (AIR) intervention package facilitating supported discharge and family-led home-based care of chronically ill patients with a tracheostomy: a multicentric mixed methods study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Anesthesia and Critical Care
Khordha ORISSA 751019 India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Anesthesia and Critical Care
Khordha ORISSA 751019 India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Anesthesia and Critical Care
Khordha ORISSA 751019 India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Swagata Tripathy |
| Address |
Department of anesthesia And critical care, AIIMS Bhubaneswar, Odisha - 751019, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swagata Tripathy |
AIIMS Bhubaneswar |
Department of Anesthesia & Critical Care,
Room 406, Academic Block,
Sijua, Patrapada Khordha ORISSA |
8763400534
tripathyswagata@gmail.com |
| Dr Ishwar Chandra Behera |
Institue of Medical Sciences (IMS) and SUM Hospital |
Department of Neurosciences, K8, Kalinga Nagar
Bhubaneswar, Odisha, India
Pin Code – 751003 Khordha ORISSA |
9439744318
ishwarchandrabehera@soa.ac.in |
| Dr Narendra Kumar Das |
Kalinga Institute of Medical Sciences |
Department of Neurosurgery, KIMS, Kushabhadra Campus (KIIT Campus-5) Patia, Bhubaneswar Odisha, India – 751024 Khordha ORISSA |
7327096159
narendrakdas@gmail.com |
| Dr Alok Kumar Panigrahy |
SUM Ultimate medicare |
Department of Neurosurgery, K8 , KALINGA NAGAR, GHATIKIA,
BHUBANESWAR, 751003, ODISHA Khordha ORISSA |
7678382555
alokpanigrahy86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IMS & SUM |
Approved |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
| Institutional Ethics Committee, KIMS |
Approved |
| SUM Ultimate Medicare |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tracheostomy group post implementation of AIR intervention |
Adult tracheotomized chronically ill patients who are declared expected fit to discharge by the primary clinician for a period of 4 months |
| Comparator Agent |
Tracheostomy group pre implementation |
Adult tracheotomized patients who are declared expected fit to discharge by the primary clinician before the AIR intervention is implemented for a period of 4 months.
There is another comparator group for the ITS design, which has non tracheostomised patients, to control for historical or cyclic confounders. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult tracheostomised patients in the neurosurgery ICU, expected to survive beyond and need tracheostomy for more than 2 weeks after declared ‘expected fit to discharge’ from the ICU by the treating physician/ surgeon and willingness to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Pediatric patients and patients without an identified family carer willing for home care,
Patients needing greater organ support than manageable at home (home ventilation excluded)
Current participation in an interventional trial with conflicting therapies or primary outcomes
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time from the clinician agreeing that the patient can be managed at home to the actual time of patient discharge.
|
Sixteen time points (at weekly intervals) before and 16 time points after the intervention is implemented. Approximately 5 discharges at every time point. Approximately 160 patients over 10months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Patient & Carer Reported Outcomes measured at 1-months
a. Health related QoL (EQ-5D-3L) of patients at hospital discharge & at 1 month
b. Carer Burden Scores of carers at hospital discharge & at 1 month post discharge
2. Measures of safety
a. Hospital device-associated infections, e.g., CAUTI, VAP, HAP in rate of events within group per unit time.
b. Clinical outcomes– Bed sore, Tracheostomy block, Clinical Deterioration, readmission & mortality (rate/ unit time).
3. Measures of process
a. Adherence to the intervention
i. % consented
ii. % Trained at least 3 sessions
iii. Number of sessions missed.
iv. Subjective & objective scores of carers confidence post training
v. % using mHealth app at least once spontaneously after home discharge
vi. % 1 week home visits completed
vii. Data entry (completion)
b. Clinical
|
Till 30 days after ready for step down/ discharge |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Tracheostomy, a procedure to create an opening in
front of the trachea when performed on critically ill patients in intensive
care units (ICUs) decreases the duration of mechanical ventilation, incidence
of nosocomial infections and length of ICU stay. Its use early during (1)neuro-ICU stayis associated with improved chances
of early rehabilitation and discharge due to decreased secondary insults and
hospital acquired morbidity.(1) However when
there is a lack of out-of-hospital state- sponsored or low cost rehabilitation
facilities for these chronically ill bed ridden patients, timely discharge from
the ICU and hospital becomes a challenge.
These patients need higher intensity care at home, including care of the
tracheostomy and indwelling catheters, home ventilation, nasogastric feeding,
physiotherapy and general nursing care. Fear, stigma and unpreparedness among
family members and healthcare workers of caring for a patient with ‘a hole in
the neck’ prolongs ICU and hospital stay, increasing the very morbidities the
tracheostomy sought to avoid. Cost of care to patient family (carer) and the
health care system increases as resources cannot be offered to more deserving
acutely ill patients.
To
address this gap, in Eastern India, we have developed, and pilot tested the
AIIMS ICU Rehabilitation Intervention. The intervention
with its components of counselling, hands-on training and education,
facilitated discharge and post discharge support aims to implement family led
home rehabilitation of chronically critically ill tracheostomy patients. This trial is to implement the intervention in three centres and evaluate the implementation process and effectiveness of the AIR intervention for family led home discharge of chronically critically ill post ICU patients. |