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Discrete-Event Simulation to Model the Thrombolysis Process for Acute Ischemic Stroke Patients at Urban and Rural Hospitals

ABSTRACT: Background: Effective treatment with tissue plasminogen activator (tPA) critically relies on rapid treatment. Door-to-needle time (DNT) is a key measure of hospital efficiency linked to patient outcomes. Numerous changes can reduce DNT, but they are difficult to trial and implement. Discrete-event simulation (DES) provides a way to model and determine the impact of process improvements. Methods: A conceptual framework was developed to illustrate the thrombolysis process; allowing for treatment processes to be replicated using a DES model developed in ARENA. Activity time duration distributions from three sites (one urban and two rural) were used. Five scenarios, three process changes, and two reductions in activity durations, were simulated and tested. Scenarios were tested individually and in combinations. The primary outcome measure is median DNT. The study goal is to determine the largest improvement in DNT at each site. Results: Administration of tPA in the imaging area resulted in the largest median DNT reduction for Site 1 and Site 2 for individual test scenarios (12.6%, 95% CI 12.4–12.8%, and 8.2%, 95% CI 7.5–9.0%, respectively). Ensuring that patients arriving via emergency medical services (EMS) remain on the EMS stretcher to imaging resulted in the largest median DNT improvement for Site 3 (9.2%, 95% CI 7.9–10.5%). Reducing both the treatment decision time and tPA preparation time by 35% resulted in a 11.0% (95% CI 10.0–12.0%) maximum reduction in median DNT. The lowest median and 90th percentile DNTs were achieved by combining all test scenarios, with a maximum reduction of 26.7% (95% CI 24.5–28.9%) and 17.1% (95% CI 12.5–21.7%), respectively. Conclusions: The detailed conceptual framework clarifies the intra-hospital logistics of the thrombolysis process. The most significant median DNT improvement at rural hospitals resulted from ensuring patients arriving via EMS remain on the EMS stretcher to imaging, while urban sites benefit more from administering tPA in the imaging area. Reducing the durations of activities on the critical path will provide further DNT improvements. Significant DNT improvements are achievable in urban and rural settings by combining process changes with reducing activity durations.

SUBMITTER: Bulmer T

PROVIDER: S-EPMC8586711 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: Stroke is a devastating disease, but it is treatable with alteplase or tissue plasminogen activator (tPA). The effectiveness of tPA is highly time-dependent, meaning rapid treatment is critical. Fast treatment with tPA has been reported in many urban hospitals, but hospitals in rural locations struggle to reduce treatment times. This qualitative study examines current thrombolysis processes in one urban and two rural hospitals in Nova Scotia, Canada, by mapping and comparing the treatment process in these settings for acute ischemic stroke (AIS) patients, and by analyzing the healthcare professionals views on various treatment topics. Methods: Structured interviews were conducted with healthcare professionals involved in stroke treatment across the three sites. The interviews focused on the various activities in the thrombolysis treatment at each site. Additionally, participants were asked about the following 10 topics: comfort treating acute ischemic stroke patients; perceptions about tPA; appropriate tPA treatment window; stroke patient priority; tPA availability; patient consent; urban-rural treatment differences; efficiency of their treatment process; treatment delays; and suggested process improvements. Results were analyzed using the Framework Method, as well as through the development of process maps. Results: Twenty three healthcare professionals were interviewed at 2 rural hospitals and 1 urban hospital. Acute ischemic stroke patients are triaged as the highest or urgent priority at each included site. Physicians are more hesitant to treat with tPA in rural settings. A total of 11 urban-rural treatment differences were noted by the rural sites. Additionally, 11 patient-related and 29 system treatment delays were described. A process map was developed for each site, representing the arrival by ambulance and by private vehicle pathways. Conclusions: Guidelines and clear protocols are critical in reducing treatment times and ensuring consistent access to treatment. The majority of treatment delays encountered are system delays, which can be appropriately planned for to reduce delays within the care pathway. There is a general consensus that there is an urban-rural treatment gap for acute ischemic stroke patients in Nova Scotia, and that continuing education is key in rural hospitals to improve Emergency Department (ED) physician comfort with treating patients with tPA.

Project description:Tenecteplase is a fibrinolytic drug with higher fibrin specificity and longer half-life than the standard stroke thrombolytic, alteplase, permitting the convenience of single bolus administration. Tenecteplase, at 0.5 mg/kg, has regulatory approval to treat ST-segment-elevation myocardial infarction, for which it has equivalent 30-day mortality and fewer systemic hemorrhages. Investigated as a thrombolytic for ischemic stroke over the past 15 years, tenecteplase is currently being studied in several phase 3 trials. Based on a systematic literature search, we provide a qualitative synthesis of published stroke clinical trials of tenecteplase that (1) performed randomized comparisons with alteplase, (2) compared different doses of tenecteplase, or (3) provided unique quantitative meta-analyses. Four phase 2 and one phase 3 study performed randomized comparisons with alteplase. These and other phase 2 studies compared different tenecteplase doses and effects on early outcomes of recanalization, reperfusion, and substantial neurological improvement, as well as symptomatic intracranial hemorrhage and 3-month disability on the modified Rankin Scale. Although no single trial prospectively demonstrated superiority or noninferiority of tenecteplase on clinical outcome, meta-analyses of these trials (1585 patients randomized) point to tenecteplase superiority in recanalization of large vessel occlusions and noninferiority in disability-free 3-month outcome, without increases in symptomatic intracranial hemorrhage or mortality. Doses of 0.25 and 0.4 mg/kg have been tested, but no advantage of the higher dose has been suggested by the results. Current clinical practice guidelines for stroke include intravenous tenecteplase at either dose as a second-tier option, with the 0.25 mg/kg dose recommended for large vessel occlusions, based on a phase 2 trial that demonstrated superior recanalization and improved 3-month outcome relative to alteplase. Ongoing randomized phase 3 trials may better define the comparative risks and benefits of tenecteplase and alteplase for stroke thrombolysis and answer questions of tenecteplase efficacy in the >4.5-hour time window, in wake-up stroke, and in combination with endovascular thrombectomy.

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Discrete-Event Simulation to Model the Thrombolysis Process for Acute Ischemic Stroke Patients at Urban and Rural Hospitals

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