Background and Aims

India has a severe shortage of specialists in rural areas with one of the world’s lowest physician/population ratios. Two innovative solutions include training physicians in district hospitals to diagnose and manage acute stroke (‘Stroke physician model’) and using a low‑cost Telestroke model. We will be assessing the efficacy of these models through a cluster‑randomized trial with a standard of care database maintained simultaneously in tertiary nodal centers with neurologists.

Methods

SMART INDIA is a multicenter, open‑label cluster‑randomized trial with the hospital as a unit of randomization. We plan to enroll 22 district hospitals where a general physician manages the emergency without the services of a neurologist. These units (hospitals) will be randomized into either of two interventions using computer‑generated random sequences with allocation concealment. The outcome will be assessed by a blinded, central adjudication team. The study includes 12 nodal centers involved in the Telestroke arm by providing neurologists and telerehabilitation round the clock for attending calls. There will be a preintervention data collection (1 month), followed by the intervention model implementation (3 months).

Results

The primary outcome will be the composite score (percentage) of performance of acute stroke care bundle assessed at 1 and 3 months after the intervention. The highest score (100%) will be achieved if all the eligible patients receive the standard stroke care bundle.

Conclusions

SMART INDIA assesses whether the low‑cost Telestroke model is superior to the stroke physician model in achieving acute stroke care delivery in resource limited settings.

Funding: DHR, ICMR, Government of India