Effectiveness of a District-Level Comprehensive Acute Stroke Care Model for Management of Patients With Acute Stroke in Karnataka: Protocol for a Quasi-Experimental Study.

Abstract

Stroke is a leading cause of death and disability globally. India, like other low- and middle-income countries, faces rising stroke cases with significant regional variations and burden. Successful management of acute stroke requires timely recognition, quick transportation to a definitive health care facility, and specialized care for reducing mortality and morbidity. Stroke care in India is predominantly urban-oriented, private sector-dominant, with a shortage of trained or specialist personnel and limited access to infrastructure. There is a need to develop stroke care systems across various levels of health care delivery that are comprehensive and standardized for timely intervention, management, and referral. This study aims to develop and assess the effectiveness of a Comprehensive Acute Stroke Care Model (CASCADE) for managing patients who had an acute stroke in Karnataka (a state in South India) with a focus on improving survival, disability, and quality of life. This is a quasi-experimental preinterventional and postinterventional study design with the CASCADE as the intervention. This study will be conducted in 6 secondary and tertiary health care facilities, and the effectiveness of the model will be assessed on 510 patients who had a stroke for the first time (255 each in the preintervention and postintervention arms). Furthermore, the patients will be followed up on 28 days and the 3rd, 6th, and 12th month after the stroke to evaluate survival, disability, and quality of life before and after the intervention. The study is funded by the SKAN Research Trust. Data collection for the preintervention arm has commenced and is currently ongoing. As of manuscript submission, approximately 100 cases have been recruited in the preintervention arm. Data analysis will begin after completion of recruitment. This unique, first-of-its-kind CASCADE encompasses triage algorithm, diagnosis, investigations, treatment, referral, and discharge interventions. An effective model will provide valuable insights into stroke management and is highly translatable into practice. The findings will have significant implications for policymaking and stroke-related public health programming in India. Clinical Trials Registry-India CTRI/2023/04/051370; https://tinyurl.com/44wwehpr. DERR1-10.2196/93984.