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Annals of Indian Academy of Neurology
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ORIGINAL ARTICLE
Year : 2022  |  Volume : 25  |  Issue : 3  |  Page : 422-427

Smartphone-based telestroke Vs“Stroke Physician” led acute stroke management (SMART INDIA): A protocol for a cluster-randomized trial


1 Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
2 Department of Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
3 Department of Neurology, Indira Gandhi Medical College and Hospital, Shimla, Himachal Pradesh, India
4 Department of Neurology, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
5 Department of Neurology, Andhra Medical College, Vishakhapatnam, Andhra Pradesh, India
6 Department of Neurology, Dr RPG Medical College, Tanda, Himachal Pradesh, India
7 Department of Neurology, Goa Medical College, Goa, India
8 Department of Neurology, AIIMS Himachal, Bilaspur, India
9 Department of Neurology, Armed Forces Medical College, Pune, Maharashtra, India
10 Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India

Correspondence Address:
M V Padma Srivastava
Chief Neurosciences Centre, Head of Department, Neurology, All India Institute of Medical Sciences, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/aian.aian_1052_21

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Background: One of the major challenges is to deliver adequate health care in rural India, where more than two-thirds of India's population lives. There is a severe shortage of specialists in rural areas with one of the world's lowest physician/population ratios. There is only one neurologist per 1.25 million population. Stroke rehabilitation is virtually nonexistent in most district hospitals. 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. The study will include district hospitals from the different states of India. 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. Blinding of patients and clinicians will not be possible. The outcome assessment will be conducted by the blinded central adjudication team. The study includes 12 expert centers involved in the Telestroke arm by providing neurologists and telerehabilitation round the clock for attending calls. These centers will also be the training hub for “stroke physicians” where they will be given intensive short-term training for the management of acute stroke. There will be a preintervention data collection (1 month), followed by the intervention model implementation (3 months). Outcomes: 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. The study will have an open-label extension for 3 more months. Conclusion: SMART INDIA assesses whether the low-cost Telestroke model is superior to the stroke physician model in achieving acute stroke care delivery. The results of this study can be utilized in national programs for stroke and can be a role model for stroke care delivery in low- and middle-Income countries. (CTRI/2021/11/038196)


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