Date of Award

Spring 6-7-2024

Scholarly Projects

Projects: SPU Access Only

Degree Name

Doctor of Nursing Practice (DNP)

Department

Nursing

Faculty Chair

Melissa Hutchinson

Faculty Reader

Katie Butte

Faculty Reader

Debbie Saknit

Executive Summary

Executive Summary

Background and Significance

Acute ischemic stroke (AIS) patients who qualify and receive thrombolytics are often less disabled than those who delay care (CDC, 2023). In severe stroke, the patient loses almost two million neurons every minute (Saver, 2006). Alteplase was the only FDA-approved thrombolytic to treat AIS within 3 hours since last known well; however, the American Heart Association (AHA) guidelines (Powers et al., 2019) support Tenecteplase (TNKase) as an alternative thrombolytic for the early management of AIS. Significant differences between alteplase and TNKase include administration and cost. TNKase is easier to administer, which could result in improved neurological outcomes by preserving salvageable brain cells, and each dose of TNKase is about $500 less expensive, which could lead to facility cost savings.

Problem Statement / Clinical Question

For every hour the severely ischemic brain is left untreated, it ages approximately 3.6 years (Saver, 2006). Adequate sustained brain perfusion is critical to preserve brain function. A common practice to shorten Door-to-Needle (DTN) time is to premix a thrombolytic ahead of time for a potential candidate before obtaining imaging results. However, clinicians must be cautious in premixing TNKase since the manufacturer will not reimburse any opened and unused product for the drug’s off-label use in ischemic stroke. In addition, complications could develop after thrombolytics, such as intracranial hemorrhage (ICH), and it requires expensive reversal protocol treatment. The effectiveness of thrombolytic treatment can be assessed by the National Institutes of Health Stroke Scale (NIHSS), the validated and most commonly used tool to assess ischemic stroke severity and deficits. A reduction in the NIHSS indicates neurological improvement after treatment, whereas the transformation of ICH following a thrombolytic can lead to further neurologic deterioration, as evidenced by an increase in the NIHSS. In brief, this project aims to compare the safety and efficacy of alteplase and TNKase in 1) stroke severity based on NIHSS, 2) DTN treatment times, and 3) financial savings in patients with AIS at a community hospital in the Pacific Northwest.

Methodology

The methodology was a prospective consecutive patient selection with retrospective data abstractions and summative evaluation. The parameters of demographic characteristics (age, sex, ethnicity), risk factors (tobacco use, hypertension, hyperlipidemia, diabetes mellitus, atrial fibrillation, and obstructive sleep apnea), prior history of stroke, NIHSS on admission and discharge, and DTN time were collected prospectively. Patients eligible for thrombolytic received alteplase before March 15, 2023, and TNKase was introduced after this date. The inclusion criteria were patients 18 years and older, within 4.5 hours of last known well (LKW), and disabling ischemic stroke symptoms in the Emergency Department (ED). Exclusion and inclusion criteria followed the AHA guidelines (Powers et al., 2019) and the providers’ clinical judgment. Data were analyzed using SPSS Statistical Software. Outliers were checked for subsequent analyses. Descriptive statistics and frequency counts were used for demographic and outcome variables. Independent samples of t-tests and Chi-Square tests were used to compare treatment groups in demographic and risk factor variables for continuous and categorical variables, respectively. Independent samples of t-tests were used to compare differences between treatments and outcomes of DTN and NIHSS. Significance was set at p

Results and Outcomes

A total of 175 patients (82 for alteplase and 93 for TNKase) were eligible for thrombolytic therapy during the study period. The results were as follows: 1) no significant differences between the two groups in age, gender, ethnicity, tobacco use, diabetes, atrial fibrillation, hypertension, hyperlipidemia, or previous stroke history. However, the alteplase group had significantly more patients with obstructive sleep apnea than the TNKase group (N: 14:4, p = 0.013). 2) for DTN time, there was no statistically significant difference after excluding delayed cases due to the patient's clinical condition (alteplase vs. TNKase: 32.45 ± 15.58 vs. 29.94 ± 17.96 minutes, p=0.20). After excluding three patients, two (one for each group) were initially not triaged as a stroke, and another TNKase outlier was due to the hospital CT being down to one scanner. This result was statistically significant (31.1 ± 12.1 vs. 27.5 ± 10.1 minutes, p=0.036). 3) no differences were observed in NIHSS on admission (alteplase vs. TNkase: mean 10.27 vs. 10.25, p=0.49) or discharge (2.78 vs 3.44, p= 0.19). The discharge NIHSS had a higher incompletion rate in TNKase than alteplase (38.5% vs 21%) for unknown reasons. 4) TNKase is roughly $500 cheaper than alteplase ($2400 vs $1900). The medication savings for TNKase were over $40,000 in the nine months of study. Additional cost savings were not calculated during the study, including supplies (IV tubing, pump) and labor costs for pharmacy and nursing.

Sustainability

The ongoing evaluation of the outcome and performance measures, knowledge dissemination, and interprofessional collaborations are vital to achieving sustainability. Data collection, analysis, and results will continue to be reported to the stroke committee. Data utilization will also guide the stroke care protocol and facilitate process improvement. The team shall periodically review the stroke protocol, care pathways, and order sets to remain updated based on national guidelines and research. The team members will share knowledge through conferences and education sessions. Furthermore, leaders should encourage engagement and collaboration to promote process improvement and optimal patient outcomes.

Implications

The implications of the project included the impact of two different thrombolytics (alteplase and TNKase) for stroke on clinical practice, patient outcomes, and health quality. Our data supported no differences between TNKase and alteplase on outcome variables. Study results affirm the current organizational AIS treatment protocol by choosing TNKase instead of FDA-approved alteplase. The hope is that reduced door-to-thrombolytic time may potentially enhance patients’ outcomes. Processes can be further streamlined to optimize stroke care, such as imaging results to door-to-puncture (DTP) neurointerventional time. The medication cost savings may help allocate other resources within the organization. Overall, the project provided new perspectives to address clinical gaps, cost-effective implications, and treatment policy.

References

Centers for Disease Control and Prevention. (2023). Stroke facts. https://www.cdc.gov/stroke/facts.htm

Powers, W. J., Rabinstein, A. A., Ackerson, T., Adeoye, O. M., Bambakidis, N. C., Becker, K., biller, J., Brown, M., Demaers

Centers for Disease Control and Prevention. (2023). Stroke facts. https://www.cdc.gov/stroke/facts.htm

Powers, W. J., Rabinstein, A. A., Ackerson, T., Adeoye, O. M., Bambakidis, N. C., Becker, K., biller, J., Brown, M., Demaerschalk, B. M. Hoh, B., Jauch, E. C. Kidwell, C. S. Leslie-Mazwi., T. M., Ovbiagele, B., Scott. P. A., Sheth, C. S., Southerland, A. M., summers. D. V. Tirschwell, D. L., & American Heart Association Stroke Council. (2019). Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke, 50(12), e344-e41 https://www.ahajournals.org/doi/full/10.1161/STR.0000000000000211

Saver, J. L. (2006). Time is brain—quantified. Stroke, 37(1), 263-266. https://doi.org/10.1161/01.STR.0000196957.55928.ab

Additional Files
CcTu digital poster 2024 (1).pptx (127 kB)
Digital poster
Download

Share

COinS