This cross-sectional descriptive study was performed at the SCU from July to the end of October in 2019 in Zanjan City (Iran).
Zanjan province with the capital of Zanjan city is placed in the northwest of Iran. It includes a population of 105,7461 people, 978 villages, and8 towns. It possesses 10 hospitals connected to Zanjan University of Medical Sciences. Nevertheless, only one stroke care department (in Vali-Asr hospital in Zanjan University of Medical Sciences) in the city provides services for ischemic stroke patients.
SCU in Zanjan established at Vali-Asr Hospital was known as the stroke treatment center in 2016 in Zanjan Province. In Iran, Code 724 is referred to the stroke patients in whom less than 4 hours and 30 minutes have passed since initiating the stroke symptoms. Based on this code, once calling Emergency Medical Services (EMS) by the patient, he/she is asked about the Face-Arms-Speech-Time (FAST) of the symptoms. Then, after transferring the ambulance to the bedside of the patient, the FAST symptoms are examined by the emergency technician, and the SCU is reported followed by confirmation. The patients around the province are immediately transferred from all medical centers to the SCU in that province. After transferring to the hospital, a neurologist examines the patient at the triage unit and send him/her to the CT scan unit when diagnosing a stroke to administer the rTPA medication there.
This study was performed for AIS patients in the SCU of Zanjan. The samples were collected based on a convenience sampling method. The participants of the study included patients referring to the SCU during the sampling interval who met the inclusion criteria. According to the pilot study on 20 AIS patients, the sample size of 181 was considered with an effect size of 0.05, a sampling error of 20 minutes, and a confidence level of 95%. In this study, 204 patients with AIS referring to the SCU were assessed.
The data were collected through interviews with patients and observation, as well as with their families, if necessary. The statistical research population included the patients referring to the stroke ward at Val-Aasr Hospital in Zanjan. Then, a questionnaire was completed associated with the demographic information and the time interval from the start of primary symptoms to the onset of therapeutic interventions. Two researchers monitored the patients 24 h a day during a hospital stay. The researchers made follow-ups for the patients in the ICU of the neurology unit and SCU, as well as 30 days after discharge. A researcher-made questionnaire was used to collect the data and identify the information on demographic features and factors influencing the time-to-treatment and the average period of symptoms onset for treatment. The questionnaires included three sections. The questions regarding the demographic features of the patients were included in the first part. The second part contained questions regarding the pre-hospital delays’ reasons. The third part is comprised of questions about the reasons for the in-hospital delay (Appendix No. 1). The complications frequency was checked using a list of prevalent complications followed by acute strokes in terms of stroke-related papers. The checklist included 28 stroke complications totally checked for one post-acute stroke month (Appendix No. 2). Mortality and complications during hospitalization were recorded through post-discharge phone calls with patients or their families and observation. In case the patient died after discharge, his/her medical record was checked for determining the stroke-associated reasons for complications and death. The treating physician approved these data. To assess the AIS severity, the National Institutes of Health Stroke Scale (NIHSS) was considered. This tool includes 11 items, for which a score of 0 denotes the individual’s average performance in the studied field, and a score of 4 represents the maximum impairment in this concern. The maximum and minimum scores on this scale are 42 and 0, respectively. In this regard, the score 0 denotes lack of stroke symptoms, 1 to 4 is mild stroke, 5-15 is moderate stroke, 16-20 is moderate to severe stroke, and 21-42 denotes severe stroke. In-hospital mortality rates were examined through observation and mortality rates of 30 days by making phone calls with patients or their families.
The questionnaire validity was determined based on content validity. The designed questionnaire was offered to 10 experts to make the essential modifications and alterations in terms of their ideas. The reliability was assessed using the evaluators’ reliability. The questionnaire was simultaneously completed by two researchers for 10 patients. Then, Cohen’s kappa coefficient was assessed between the information of the researchers-completed questionnaire and the evaluators’ reliability was approved by achieving K = 0.973. The reliability and validity of the NIHSS tool were confirmed by Kasner et al. (23).
This study was approved by the Ethics Committee of Zanjan University of Medical Sciences by the Ethics Code of IR.ZUMS.REC.1398.095. All methods were performed in accordance with the relevant guidelines and regulations. The inclusion criteria of the study were described by the researcher to the patients or their families, and written consent was acquired. The participants were guaranteed the confidentiality of all their information and the right for leaving the study at any time.
The patients referring to the SCU were chosen based on the inclusion criteria. The researcher completed the 60-item questionnaire after treatment and relative stabilization with the assistance of the patient or his/her caregivers. The complications were assessed and evaluated using the prepared checklist. It was completed within 1-4 weeks followed by acute stroke. The mortality and complications were evaluated during the hospitalization and through telephone calls after discharge.
The variables in this research were stroke risk factors, demographic variables, affective factors associated with in-hospital and pre-hospital times for starting treatment, mortality, and complications. Moreover, the stroke complications were regarded in terms of the existence of at least one complication on the checklist. The mortality rate was evaluated regarding stroke complications in the hospital and 30 post-hospitalization days.
For mortality occurring within 30 days of hospitalization caused by AIS, the medical records of the patients need to be revised for determining the AIS mortality causes.
SPSS V.16 was used to perform statistical analysis. The data were distributed in terms of the normalized central limit theorem and sample size. The factors related to the delay in treatment and those related to mortality and complications were investigated using logistic regression. In this study, the significance level was considered to be less than 0.05.