Correlation of Quality Metrics of Acute Stroke Care with Clinical Outcomes in an Indian Tertiary-care University Hospital: A Prospective Evidence-based Study

HIGHLIGHTS

• Adherence to intravenous recombinant tissue plasminogen activator (IV-rtPA) therapy, in-hospital (acute) measures, and discharge measures significantly lowered the hazards of the 28th-day mortality in ischemic stroke (IS) and intracerebral hemorrhage (ICH) patients.

• The IS patients compared to the ICH patients showed significant improvement in neurofunctional independence at the 28th-day postdischarge.

• Door-to-imaging time (DIT) and door-to-needle time (DNT) both exhibit scope for improvement, ranging 45–50% and 25–30%, respectively.

• Deep vein thrombosis prophylaxis (DVTp) as an in-hospital (acute) care measure needs attention in both cerebrovascular events.

INTRODUCTION

In India, stroke is now the fifth most common cause of disability and the fourth most common cause of death.¹ Despite the development of evidence-based guidelines for stroke care,² the incidence of stroke in India ranges between 84 and 262 per 100,000 people in rural areas and between 334 and 424 per 100,000 people in urban areas. This incidence rate is on the rise, despite the fact that the country’s overall crude prevalence of stroke, which in the past 10 years has varied from 44.29 to 559/100,000 people.³ Registry-based surveillance studies using the WHO stages stroke instrument have been successfully conducted in western and southern parts of India, which have proposed a proportional mortality rate of 6–8%, where, more than 50% of stroke deaths majorly occurred in tertiary-care hospitals, respectively.^4,5

Considering the intravenous recombinant tissue plasminogen activator (IV-rtPA) therapy which has been used in ischemic stroke (IS) management for >15 years in the United States. The reported administration rate in the United States study was found to be very low (between 1.2 and 9%).⁶ Improving the quality of stroke care has become a worldwide priority now. For measuring the performance of an individual hospital in delivering appropriate acute stroke care, certain quality metrics and performance measures have been devised. The American Heart Association (AHA)/American Stroke Association (ASA) “Get With The Guidelines (GWTG) Stroke Program” is such a stroke quality measurement and improvement program that represents the world’s largest stroke registry.^7,8 After the adoption and implementation of AHA/ASA’s evidence-based guidelines, through continuous quality improvement surveillance and interventions number of patients have benefited from favorable and improved neurofunctional outcomes.^7–10 However, in developing countries this situation is different, where the stroke care services are established but they are not fully developed yet. There is published evidence of the Indian Stroke Association (ISA) recommendations for early management of stroke and transient ischemic attack (TIA) to improve the quality of care.² However, the adoption, implementation, and association of adherence to this evidence-based guideline recommendation with clinical outcomes have not been systematically evaluated in clinical practice. Except for one important study by the Indo-US Collaborative Stroke Project (IUCSP) group, there is a big paucity of Indian data on this instance.

Our tertiary care university hospital follows ISA’s recommendations and AHA/ASA’s evidence-based guidelines.^2,9,11,12 However, the quality assessment of performance in clinical practice has never been measured systematically. Therefore, the current study’s objectives were to describe the hospitalization of stroke patients, investigate the variations in performance metrics stated in evidence-based guidelines, and determine associated clinical outcomes.

MATERIALS AND METHODS

RESULTS

For the 200 (78.1%) IS and 56 (21.9%) ICH patients included in the study, the median (IQR) age was 58 (35–75) and 53 (38–79) years, and more than half (77.3%) were male (overall). Table 1 summarizes the patient demographics and clinical characteristics by cerebrovascular event type. Patients with ICH had a relatively high prevalence of hypertension (71.4%) compared to IS (60%). Prior stroke/TIA was comparable in both the cerebrovascular event types, whereas diabetes (35%), dyslipidemia (21%), atrial fibrillation, or flutter (14%) were majorly present in IS patients. Overall median NIHSS on admission was 10 (5–16), where ICH patients had high stroke severity compared to IS.

According to the ISA consensus statement,² patients who managed to arrive at the stroke unit within 3 hours of symptom onset had better 3-month neurofunctional outcomes. In our study patients, a major time median (P₂₅–P₇₅) was elapsed from symptom onset to emergency medicine department (EMD) arrival [9.2 (2.5–45.2) hours]. The DIT in patients who arrived in less than 3 hours of stroke symptom onset was 40 (22–68) minutes, whereas the DNT in the eligible patients was 55 (45–65) minutes. Furthermore, IV-rtPA was administered at 2.2 (1.5–2.7) hours from the symptom onset (Table 1).

DISCUSSION

This prospective study has provided some crucial understanding of the variances in stroke risk factors, in-hospital (acute) care, discharge care, and clinical outcomes in cohorts of hospitalized patients with IS and ICH. Stroke is on the rise in developing countries. An Indian population registry study reported that IS was present to the tune of range 67.3–80.5%, whereas ICH was responsible for 6.5–19.6% of the cerebrovascular event cases. The present study showed a comparable prevalence and characteristics of IS and ICH patients with those of previously published Indian,^3,16 Chinese,^13,16,17 and the United States studies.^7,10 Both the cerebrovascular event groups developed stroke at relatively younger ages compared to the reports from the Western population. The patients in the present study were younger by an average of 10–12 years than the median age reported by the GWTG-stroke study (United States),¹⁰ the China Stroke Center Alliance (CSCA)-stroke study (China),¹⁷ Close the GAP-stroke study (Japan),¹⁸ and the Arbeitsgemeinschaft Deutschsprachiger Schlaganfall Register (ADSR): stroke study (Germany)¹⁹ patients. Comparable age demographics were observed in the IUCSP-stroke study (India).¹⁶ The gender distribution in the present study showed a male preponderance (>75%), similar to other studies.^13,16–18 However, this was not the case in the GWTG-stroke study patients where 52.4% of females had IS and 49.3% had ICH.¹⁰ There was a relatively high burden of modifiable risk factors in both the cerebrovascular event groups. Hypertension and diabetes prevention require more efforts in India as predicted by other studies as well.¹⁶ The rates of smoking and tobacco use in the present study were much higher compared to other similar studies.^10,16–18 The rates of hypertension and atrial fibrillation were much lower in the present study, the IUCSP-stroke study (India)¹⁶ and China¹⁷ compared to the rates from other studies.^10,18–20

In our study, we compared the critical time targets set by the AHA/ASA and National Institute of the Neurological Disorders and Stroke (NINDS) on stroke management to those accomplished in our study group. Stroke thrombolysis in Indian settings has struggled to match the worldwide criteria set for door-to-imaging time (DIT) and DTN time.²¹ In a recently published Indian study, the majority (73%) of patients had a DIT of 30–60 minutes, whereas only 19% of the patients had less than 30 minutes.²² In our analysis, nearly 45–50% of the patients admitted with ischemic stroke (IS) had DIT below 30 minutes. This means, that a 50% scope of improvement exists at our center. On the contrary, shorter DTN time is associated with minimal complications to thrombolytics and improved patient outcomes (mRS < 2 at 90 days poststroke).^9,23 The DTN time in our study (55 minutes) was comparable with the recently published Indian study (54 minutes),²⁴ whereas it was significantly delayed in another study (100 minutes).²⁵ We still have scope for more improvement, and efforts are on to further reduce DTN time at our center.

There were comparable differences between the present study and other similar studies in regard to stroke severity (measured with the NIHSS). Among IS patients, both the stroke severity and the rates of adherence to IV-rtPA therapy differed significantly (p < 0.05) from the published studies from other parts of the world.^{10,13,16–20} Fifty-two of 56 (92.8%) eligible patients received IV-rtPA therapy within 4.5 hours. Reasons for non-adherence to the guideline in four patients, though eligible, were stroke severity (NIHSS range, 5–10) and unaffordability issues as not covered under insurance schemes. The reason for ineligibility in the rest of the 144 (72%) IS patients was a delay in reporting to EMD (triage). Delay in presentation is the most common reason for exclusion from IV-rtPA therapy. Studies have found that only approximately 20–25% of patients with acute stroke could arrive in the hospital within 3 hours of symptom onset.^6,26,27 Similar findings (28%) were also observed in our study. Although in the present study there was high adherence to IV-rtPA therapy among eligible patients, insurance coverage among overall patients was very low (< 40%). Possible lack of stroke awareness as a neurological life-threatening emergency (“time is brain”), compounded with no or low insurance coverage, and unaffordability of medical expenses for some of the patients in the present study were the primary reasons attributed to the delay in getting admitted to EMD (triage). Also, many of the patients were from the outskirts of the city and rural areas around the city. The unavailability of emergency medical services or nearby health clinic facilities in the rural or outskirts of the city and inaccessibility to governmental health schemes at local hospitals were some additional but unavoidable reasons for not getting IV-rtPA therapy.

Many of the ICH patients (25% with all-or-none measures) did not get the eligible treatments, even those explicitly indicated by the consensus guidelines.^2,9,11,12 These guidelines advocate a quick radio imaging for stroke, DVTp following 48 hours of ICH admission, and smoking cessation. The provision of evidence-based DVTp therapy (UFH or LMWH) was much less frequent in ICH patients compared to IS patients, with the exception that ICH patients were more likely to get rapid radio imaging. The adherence to dysphagia screening as an acute measure was equivalent in both cerebrovascular event types. The relatively better but still suboptimal performance on rapid CT/MRI imaging and dysphagia screening in ICH patients could be related to the known increased ICH severity compared to IS patients. We were able to directly test this hypothesis because the NIHSS is routinely documented in our clinical practice and is a mandatory data element at our tertiary care center. A relatively struggling DVTp adherence rate may be a result of clinicians’ concerns about high NIHSS, the degree of hematoma, and worries about expanding hematoma.

In IS patients, the use of ATs on arrival and at discharge is crucial and is advised to cut down the risk of stroke recurrence, or TIA.^2,9,11 In the present study, the use of ATs was optimal (92.6% in eligible patients) during hospitalization or at discharge, and more than three-quarters of patients with atrial fibrillation received anticoagulants at discharge as international normalized ratio (INR) monitoring was routinely advised in our university hospital. The utilization of lipid-lowering therapies was considerably higher (97.8%) in the present study, which was in line with the findings regarding the utilization of secondary prevention methods for IS in the United States^7,10 and China¹⁷ after a continuous quality improvement program.

Hypertension is the most important risk factor for stroke in India.²⁸ Therefore, it was evident in the present study that the optimal (>80%) use of antihypertensive therapy was present in eligible patients at hospital discharge as a performance measure. Recent data²⁹ proves that diabetes is an important modifiable risk factor for stroke, especially IS. Case–control and cohort studies give insights into the association of diabetes with ICH.³⁰ Hyperglycemia during the acute stroke phase is associated with poor neurofunctional outcomes in both IS and ICH patients. Hence, more than 80% of eligible patients were administered ADs in the present study. There is some evidence that ICH incidence is linked to diabetes and obesity, implying that treating these illnesses might lessen the likelihood of recurrent ICH.³⁰ Whether or not addressing these risk factors minimizes the likelihood of recurrent ICH, primary prevention guidelines for coronary heart disease and IS support their management.

To understand the clinical and statistical relationship between adherence to clinical performance measures and clinical outcomes (especially neurofunctional outcomes), the American Hospital Association/American College of Cardiology task force on performance measures has recommended that stroke outcomes be measured at least 28 days after hospital discharge.^11,12 We observed that adherence to all 5 in-hospital (acute) performance measures was associated with reduced hazards of mortality after admission in both the IS and ICH patients. Also, it was evidently found that optimal adherence to the secondary prevention measures at discharge was associated with a reduced rate of mortality and an increased rate of favorable functional outcome (at the 28th^-day postdischarge). This supports the need for such timely guideline-based interventions and continuous monitoring of the processes to enhance stroke quality of care.

CONCLUSION

The present study showed that both, but especially IS patients, compared to ICH patients who have received an optimal acute and discharge-eligible process of care showed significantly improved functional independence at the end of the 28th-day postdischarge. The provided optimal stroke quality metrics showed a positive relationship between acute reperfusion treatments and neurofunctional recovery in IS patients. DVTp as an in-hospital (acute) care quality metric needs attention in both cerebrovascular event types. Nationwide registry development and such quality assessment and improvement studies are required for the generalization of these results.

AUTHORS’ CONTRIBUTIONS

Authors BKP and VRS conceived the idea; GA, NB, and VRS were involved in data acquisition, interpretation, and statistical analysis; VRS, GA, NB, and BKP performed the review of the literature and drafted the manuscript; BKP, VRS, SI, and JS supervised the study, reviewed the manuscript, improved for intellectual content, and approved the final version.

ACKNOWLEDGMENTS

The authors acknowledge the staff and the experts of the Departments of Medicine, Neurology, Emergency Medicine, and Critical Care Medicine for their immense support in the smooth conduction of the study and providing their valuable insights.

ORCID

Bijoy Kumar Panda https://orcid.org/0000-0001-8807-196X

Vaibhav R Suryawanshi https://orcid.org/0000-0001-8334-4025

Gargi Attarde https://orcid.org/0009-0003-4795-1145

Nilima Borkar https://orcid.org/0009-0008-9402-9504

Shivakumar Iyer https://orcid.org/0000-0001-5814-2691

Jignesh Shah https://orcid.org/0000-0002-8812-8791

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