Skip to content

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.

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.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069946
Enrollment
160
Registered
2024-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G969- Disorder of central nervous system, unspecified

Interventions

Intervention1: 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 perio

Sponsors

Swagata Tripathy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Time from the clinician agreeing that the patient can be managed at home to the actual time of patient discharge. Timepoint: 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

MeasureTime frame
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 Timepoint: Till 30 days after ready for step down/ discharge

Countries

India

Contacts

Public ContactDr Swagata Tripathy

AIIMS Bhubaneswar

tripathyswagata@gmail.com8763400534

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026