An Iranian Comprehensive Code Stroke Management Program (ICSM);A Mixed-Methods Study Protocol

Abstract

Background: Stroke is the second leading cause of death both in Iran and worldwide. However, few studies have monitored performance measures within stroke systems of care, revealing low rates of stroke code activation and intravenous recombinant tissue plasminogen activator administration. To explore experiences, barriers, and effective interventions for improving stroke code management this study was conducted. Methods: This study will use a three-phase, exploratory sequential mixed-methods design and followed SPIRIT guideline for reporting protocol study. In first step, data will be collected through interviews with patients or caregivers and stroke code team members. The development phase will involve consultation with a panel of experts. Finally, based on the data from the qualitative and development phases, an optimized intervention will be implemented and evaluated. Participants will be recruited via purposive sampling with maximum variation. The study is scheduled to commence in March 2024 and conclude in December 2024. Results: In the first step, we will deeply explore the rich data about the problem, and challenges. In the second step, we will find the solution and design the intervention based on the data from the first step. Finally, in the third step, we will implement and evaluate the intervention. Conclusion: This approach aligns with current evidence and best practices by integrating qualitative and quantitative methods to inform the development, execution, and evaluation of a tailored intervention. The findings are anticipated to strengthen Iran’s national stroke code program and offer valuable insights into the facilitators and barriers affecting stroke management.

Keywords

stroke cerebrovascular accident acute cerebrovascular accident ischemic stroke clinical research protocol

Introduction

Stroke is considered the second leading cause of death worldwide, and a leading cause of disability-adjusted life-years (DALYs) (Rexrode et al., 2022). This burden is also significant in Iran, where stroke transitioned from the sixth leading cause of death in 1990 to the second leading cause in 2019 (Fallahzadeh et al., 2022). To improve outcomes, initiatives such as the American Heart Association/American Stroke Association’s Target Stroke advocate for strategies to reduce door-to-needle times. These evidence-based strategies include early hospital notification by emergency medical services, rapid triage, and the timely acquisition of brain imaging data (Leung et al., 2020; National Association of State EMS Officials (NASEMSO), 2022). In alignment with the efforts of the Iranian Stroke Association (IRSA), the Iranian Neurological Society and the Ministry of Health in Iran have undertaken the development of a roadmap and national strategy to establish a stroke treatment network. A key component of this strategy was the introduction of ‘Code 724′ hospitals—facilities operating ‘24/7′ to ensure coverage for a population of at least 300,000. These centers are equipped with essential facilities for acute stroke care, such as thrombolysis. This initiative was rolled out in its initial phase in 2016 across 54 of Iran’s 1000+ hospitals. A parallel program was launched to educate the pre-hospital emergency system, enhancing personnel’s understanding of stroke and facilitating the transfer of cases to these dedicated hospitals. Consequently, eligible stroke patients gained insurance-covered access to intravenous tissue-type plasminogen activator (IV tPA), which ultimately reduced treatment costs (Farhoudi & Sharifipour, 2022).

Limited research has monitored the performance metrics of stroke care systems in Iran and other developing nations (Alijanpour et al., 2020, 2022; Askari-Majdabadi et al., 2022; Nemati et al., 2023). While many existing protocols are adapted from international standards, a lack of comprehensive local data on patient outcomes hinders the ability to tailor effective protocols to Iran’s specific healthcare infrastructure and patient population. Despite the healthcare system’s efforts, the life-threatening and unpredictable nature of stroke continues to pose significant challenges for patients, caregivers, and healthcare professionals (Kendall et al., 2018). For instance, a study by Askari-Majdabadi et al. found that the stroke code was activated for only a small proportion of patients with acute ischemic stroke (Emadikhalaf et al., 2023). Furthermore, only a minority of those patients received IV r-tPA. The authors attributed these low rates to delayed recognition of stroke symptoms and delayed arrival at the emergency department (ED) following symptom onset. Therefore, emphasizing the importance of meeting critical time benchmarks is essential for improving clinical outcomes for eligible patients (Askari-Majdabadi et al., 2022). Therefore, evaluating the efficacy of Iran’s stroke emergency programs is critical for identifying shortcomings and improving the timely delivery of care for acute ischemic stroke patients (Emadikhalaf et al., 2023). There is a pressing need to expand coverage to reach more patients, introduce advanced treatments, and enhance various aspects of stroke patient management (Farhoudi & Sharifipour, 2022).

Hence, given the identified gaps in the literature and the specific context of Iran’s healthcare system, a mixed-methods study was designed to conduct an in-depth investigation of stroke code management. This approach explores associated obstacles, lived experiences, systemic requirements, and potential interventions. Employing a sequential exploratory design integrates qualitative and quantitative approaches, enabling a comprehensive understanding of the factors contributing to delays within the stroke code protocol. The initial qualitative phase will glean insights from experts actively engaged in the process, informing the development of targeted interventions. Subsequently, a quantitative phase will be utilized to formulate and test these evidence-based solutions.

Aims

Therefore, the current study will answer the following questions:

1) What are the lived experiences of stroke code management among healthcare providers, patients and their caregivers in Iran?

2) What are the key perceived barriers and facilitators to effective stroke code management within the Iranian healthcare context?

3) Which contextually adapted interventions are most appropriate for improving stroke code management in Iran?

4) What is the effect of implementing these context-specific interventions on stroke care processes and patient outcomes?

Methodology and Method

Study Design

This study will use a three-phase, exploratory sequential mixed-method design and followed Standard Protocol Items: Recommendations for Interventional Trials (SPIRT) guideline for reporting protocol study (Appendix 1). In the first phase, qualitative data will be collected through interviews with patients, caregivers, and stroke code team members. Subsequently, a panel of experts will be consulted in the development phase to formulate an intervention. Finally, based on the data explored in the qualitative and development phases, an optimized intervention will be implemented. The study is scheduled to commence in March 2024 and continue through December 2024 (Figure 1).

Figure 1.

Conceptual framework of exploratory sequential mixed-method study.

Qualitative Phase

Following the receipt of written permission from the Vice Chancellor of Tehran and Babol University of Medical Sciences, the research team will initiate contact with Ayatollah Rouhani Hospital (a designated ‘Code 724′ hospital in northern Iran) and the Pre-hospital Emergency Organization of Babol University of Medical Sciences. The study’s purpose will be explained to relevant authorities at each site. Participants will be selected through purposive sampling to ensure maximum variation and their ability to provide rich, information-dense data.

Interviews will be conducted in various settings pertinent to the stroke care pathway, including:

⁃ The pre-hospital emergency department (with dispatchers and paramedics).

⁃ The hospital emergency department.

⁃ The stroke care unit.

⁃ Other relevant clinical departments as required.

Data collection will commence with in-depth, unstructured interviews to explore broad experiences, subsequently transitioning to semi-structured interviews for more focused inquiry. To achieve data saturation, a combination of face-to-face, telephone, or focus group interviews will be employed as necessary.

Table 1 presents the semi-structured interview guide for stroke code management. While this guide provides a foundational structure, subsequent questions will be adaptive and based on participants’ responses. Through an iterative process of conducting and analyzing interviews, the guide will be refined to ensure it comprehensively addresses the emergent challenges of stroke code management.

Table 1.

Semi-structured Interview Guide in Stroke Code Management

Category	Questions
Patient or caregiver	Can you explain what happened after the symptoms appeared and what actions were taken?
	What was your experience during this event?
	What factors played a role?
	What was your experience upon arriving at the hospital?
	Which department were you transferred to?
	What procedures were performed in that department?
	In your opinion, what should be done from the moment you call the emergency department until you reach the desired department?
Dispatcher	Can you share your experience with a stroke-related call?
Dispatcher	How can callers assist the emergency department in quickly diagnosing a stroke?
Paramedic	What is your experience in the initial minutes of treating a stroke patient?
Paramedic	What is your experience in transferring a stroke patient to the hospital?
Nurse	Can you discuss your experience in caring for a stroke patient?
Nurse	What challenges have you encountered?
Emergency medical Specialist	Can you explain what happened after the stroke?
Neurologist	Can you explain what happened after the stroke?
Rehabilitation team	Can you explain what happened after the stroke?

In addition to interviews, data will be collected through field notes and the analysis of qualitative documents. These documents will include public records (e.g., newspapers, meeting minutes, official reports) and personal documents (e.g., journals, diaries, correspondence). This methodological triangulation enriches the dataset and allows for a more comprehensive exploration of the research content (Figure 2).

Figure 2.

Trend of the mixed method study.

Development Phase

The transition from the qualitative phase to the development phase will be facilitated through two expert panels. The initial panel will engage in brainstorming and idea generation based on the qualitative findings. A second panel, designated as a prehospital emergency specialist working group, will be convened to formulate evidence-based recommendations for the prehospital setting.

The initial meeting will be held centrally as a hybrid session (in-person and online) in the conference hall of Ayatollah Rohani Hospital in Babol. Relevant codes, subcategories, and categories derived from the qualitative analysis will be distributed to participating experts in advance. This session is designed to facilitate structured brainstorming for the deliberate selection of intervention design elements. Participants will include representatives from the national emergency organization, along with faculty and staff from stroke code teams across Iranian universities of medical sciences.

The prehospital emergency specialist working group will be tasked with identifying and eliminating barriers associated with the existing protocol while facilitating its update. Using purposive sampling, we will recruit experts for this panel, comprising nurses, EMS professionals, neurologists, anesthesiologists, and emergency medicine specialists.

We will utilize the Caspian 10-step method, a systematic approach for developing evidence-based recommendations. This method includes the following steps:

1. Literature Review

2. Critical Appraisal of the evidence

3. Extraction of Recommendations

4. Face and Content Validity assessment

5. Delphi Method

6. RAND Method (/RAND Appropriateness Method)

7. Data Analysis

8. Expert Panel review

9. Stakeholder engagement and feedback

10. Publishing and Dissemination (Alijanpour et al., 2025).

Literature Review

This step involves reviewing articles, guidelines, and protocols to extract recommendations. To mitigate bias and prioritize local innovation, the systematic literature review will be conducted after the initial expert panel. Conducting the review beforehand could predispose panel members towards solutions found in the existing literature, potentially compromising the development of innovative and contextually tailored interventions. Therefore, locally tailored interventions will first be designed using qualitative data and expert insights. Subsequently, the literature review will be conducted to align this preliminary framework with global evidence, modifying it where necessary. This synthesis of local expertise and global evidence will enhance the intervention’s credibility, generalizability, and scientific rigor while ensuring it remains directly responsive to contextual needs.

A systematic search will be conducted for stroke code management guidelines across specialized repositories, including those of the National Institute for Health and Care Excellence (NICE), the National Association of State EMS Officials (National Association of State EMS Officials (NASEMSO), 2022), and other prehospital emergency protocol databases (National Association of State EMS Officials (NASEMSO), 2022). The search will also encompass electronic databases such as PubMed/MEDLINE, Embase, Web of Science, the Cochrane Library, and Google Scholar. The search strategy will aim to identify full-text articles (including systematic reviews, meta-analyses, and clinical trials), clinical guidelines, and protocols published between 2016 and 2024. Following deduplication, retrieved records will undergo a rigorous title/abstract screening process against predefined inclusion and exclusion criteria (Table 2).

Table 2.

PICOS Model in Definition of Question of Research

PICOS	Definition
P	(‘Stroke’ OR ‘CVA’ OR ‘Cerebral Stroke’ OR ‘Cerebrovascular accident’ OR ‘Cerebrovascular Accident, Acute‘ Cerebrovascular Stroke’ OR ‘Stroke, Acute’ OR ‘Stroke, sub-acute’ OR ‘Stroke, chronic’ OR ‘Vascular Accident, brain’)
I	(‘Stroke Code’ OR ’Code Stroke’ OR ’Stroke Notification’ OR ’SAMA Code’ OR ’Code 724′ OR ‘Balance Eye Face Arm Speech Time’ OR ‘Face Arm Speech Time’ OR ‘Stroke Car’ OR ‘Cincinnati Prehospital Stroke Scale’ OR ‘Prehospital Acute Stroke Severity scale’ OR’ Recognition of Stroke’ OR’ Prehospital Care’ OR’ Prehospital Managment’ OR’ Empowerment’ OR’ Training’ OR ‘Education’ OR Protocol’ OR ‘Guideline’ OR’ Assesment’ OR ’Implement’ OR ’Intervention’)
C	(‘Pre-hospital’ OR ‘Emergency’ OR ‘Rehabilitation unit’ OR ‘Stroke care unit’)
O	(‘Diagnose OR ‘Impairment’ OR ‘Handicap’ OR ‘Disability’ OR ‘quality of life’ OR ‘Golden Time’)
S	(‘Intervention Study’ OR ‘Cohort Analysis’ OR ‘Retrospective study’ OR ‘Prospective study’ OR ‘Crossover Trial’ OR ‘Case control study’ OR ‘Randomized Trial’ OR ‘Major Clinical study’ OR ‘Cohort’ OR Systematic review’ OR ‘Protocol’ OR ‘Guideline’ OR ‘Randomized controlled trial’)

Critical Appraise

To critically appraise the identified studies, we will employ the criteria proposed by enhancing the quality and transparency of health research (EQUATOR) network, an international initiative that seeks to improve the credibility and value of published health research literature. The following validated tools will be used to evaluate each specific study type: the STROBE checklist for observational studies, the PRISMA checklist for systematic reviews and meta-analyses, the SPIRIT checklist for protocols, and the AGREE II instrument for clinical guidelines (“https://www.equator-network.org/,” 2025). Similar to the study by Colle et al., we will be determined the level of evidence and the grading of recommendations (Colle et al., 2011) (Table 3).

Table 3.

Level of Evidence and Grade of Recommendations

Level of evidence	Grading criteria	Grade of recommendation
1a	Systematic review of RCT’s including meta-analysis	A
1b	Individual RCT with narrow confidence interval	A
1c	All or none RCT’s	B
2a	Systematic review of cohort studies	B
2b	Individual cohort study and low quality RCT	B
2c	Outcome research study	C
3a	Systematic review of case-control studies	C
3b	Individual case-control studies	C
4	Case series, poor quality cohort and case control studies	C
5	Expert opinion	D

RCT = randomized controlled clinical trial.

The Point of Integration

The qualitative findings will serve as foundational, context-specific data that will identify the most pressing needs and challenges within the studied domain. These findings will be systematically organized into tables comprising codes, subcategories, and categories, which will be provided to the expert panel to inform evidence-based decisions regarding the nature and focus of the intervention. In this study, the integration of the qualitative phase with the intervention development will be conducted in a rigorous, data-driven manner. Additionally, a comprehensive review of relevant literature will be undertaken to enhance and substantiate the final design of the intervention, following the synthesis of expert opinions. The proposed intervention will not be based on generalized assumptions; rather, it will be developed explicitly from data derived during the qualitative phase, combined with expert insights and literature review to maximize its validity and effectiveness. This approach will represent a significant strength of the exploratory mixed-methods design, culminating in a culturally tailored, evidence-based intervention.

Extraction of Recommendations

After evaluating the entered studies, recommendations were extracted to address obstacles and update the pre-hospital emergency protocol using the categories and subcategories explored from the first phase, evidence searched in scientific sources, and the researcher’s clinical experiences. The extracted recommendations were categorized based on the researcher’s experiences into on-scene actions, ambulance actions, and actions upon arrival at the medical center which was referred to as the initial questionnaire.

Face and Content Validity

From five experts (two with Ph.D.s in nursing, one emergency medicine specialist, two pre-hospital care experts), a request was made to perform face and content validity. The selection criteria for these individuals, similar to the study by Nasr and colleagues, included over 5 years of work experience and prior experience in completing face and content validity (61). The original text of the recommendation was placed in the right column of the table, and the translated text, along with the source, was placed in the left column.

The face validity included: suitability of recommendations based on the research topic and objectives, design based on theoretical foundations and related research, review by experts to assess appearance and conformity with research objectives, obtaining feedback and revisions for receiving opinions and suggestions, and final approval by experts and the research team confirming the accuracy of the appearance. The content validity index was used to measure validity. This index was presented by Waltz and Bausell. To calculate it, experts were asked to assess the relevance, simplicity, and clarity of each recommendation with the service delivery stage (on-scene, in the ambulance, upon arrival at the medical center) using a four-point Likert scale. Responses were scored from one to four. For example, in terms of relevance, these responses were specified as (one: irrelevant, two: needs major revision, three: relevant but needs revision, and four: completely relevant). The number of experts who selected options 3 and 4 was divided by the total number of experts. If the resulting value was less than 0.7, the recommendation was rejected. If this score was between 0.7 and 0.79, a revision was performed, and if the score was greater than 0.79, the recommendation was considered acceptable.

Delphi and RAND Method

According to the guidance of participating professors in the face and content validity step, changes and corrections will consider to the set of recommendations in the initial questionnaire or draft of the protocol. We will use RAND method and ask specialists to evaluate each recomendation on a 1–5 scale across five domains: priority, usefulness, feasibility, conceptual clarity, and authorized care providers. EMS personnel were categorized by educational level: associate’s degree (Colle et al.), bachelor’s (BSN), and master’s (MSN). User guidelines appear in Appendix 1. We will ask experts to finalization and filled questionear within 1 month.

Data Analysis

Data will be entered into Excel (Microsoft, 2016), and mean scores will be calculated. A 70% agreement threshold will be established for expert consensus; items scoring below this threshold will be discussed in an expert panel session. During this session, participants’ views on items with <70% agreement will be considered to reach consensus. Following data entry and analysis in Excel 2016), any recommendation failing to achieve ≥70% consensus (e.g., ‘assessment of large vessel involvement in stroke patients’) will be identified for panel review.

Expert Panel

An expert panel typically consists of independent experts who are recognized in at least one of the areas covered by the program being evaluated. These experts reach conclusions and make recommendations through consensus. The panel holds meetings, provides conclusions and recommendations, and includes professionals such as a doctorate in nursing, a neurologist, an emergency medicine specialist, a prehospital emergency dispatcher and paramedics, a physiotherapist, stakeholders, and others.

Stakeholder Participation

After the protocol update is finalized, efforts will be made to enhance engagement with the key stakeholders (namely, emergency medical personnel) to foster collaboration and minimize resistance to its implementation. To this end, the protocol will be distributed in both printed and electronic formats to 135 emergency medical experts from the Babol pre-hospital emergency department. Their feedback regarding the implementation will be solicited.

Emergency medical staff will be invited to share their opinions through a Telegram group titled “Angels of Salvation”. The researcher will be responsible for collecting all feedback. The issues discussed will include training and implementation strategies for the updated protocol, identifying the responsible personnel for receiving reports of problems encountered during the execution of the updated stroke code, and providing further clarifications on related issues.

Implementation challenges and suggestions will be documented by the emergency medical colleagues. The collected information will then be presented and discussed at the Code 724 coordination meeting.

Protocol Dissemination & Implementation

The protocol draft will be circulated to experts for review. Following their approval, the finalized protocol will be submitted to the National Emergency Organization of Iran. Subsequently, it will be distributed to Ayatollah Rohani Hospital (the biggest hospital in north of Iran) and Babol Prehospital Emergency Organization (northern Iran) for pilot testing. The methodology and results from ICSCMPhase II will inform the development of this manuscript.

Quantative Phase

The explored challenges will use to explore the riched data. In the development phase, the protocol of EMS will update according context. Finally, we will implent and evaluation the outcome in this phase. The researcher will quantitatively test and interpret the variables that have been explored. In this phase, the researcher implements and finally evaluates the quantitative part of the study or intervention using a new sample of participants (Figure 1).

Data will be collected using the Excel reports generated by the Babol and Mazandaran pre-hospital emergency data software. These reports will include patient characteristics such as age, gender, and place of residence; time intervals including mission receipt, travel to the patient’s location, arrival at the bedside, transfer to the hospital, and return to the base; and details of the care provided. The software outputs will be obtained in Excel format from the Babol and Mazandaran Emergency Statistics Department. Additionally, a demographic questionnaire will be administered to collect information about emergency medical staff, including age, years of experience, educational qualifications, and the type of base (rural or urban).

The researcher will first visit the National Emergency Organization, followed by the two pre-hospital emergency centers in Babol and Mazandaran, to build trust and cooperation by explaining the purpose of the study. To enhance the effectiveness of the study, the intervention will involve empowering the stroke code team through workshops, content development, and multiple coordination sessions with both pre-hospital and hospital emergency staff. In the third stage, a final evaluation will be conducted based on standard time monitoring, during which the updated pre-hospital emergency protocol will be taught.

The implementation and evaluation stages will be considered as the pre-intervention phase, with the sample size—defined as the number of stroke code missions—determining the timing. The same period will serve as the intervention phase in the following year, allowing for comparison against baseline data over a fixed duration.

Coordination of Code 724

Following stakeholder engagement, potential implementation challenges of the protocol were discussed in a joint meeting with all key executive agents of Babol University of Medical Sciences. Participants included the stroke expert from the deputy for treatment at Rouhani hospital (head, educational supervisor, head of stroke care unit, head of CT scan unit, head nurse of internal medicine, and head nurse of the emergency department), representatives from the Pre-hospital Emergency Department (head, technical deputy, and experts in education, research, and quality improvement), a representative from the neurology department, and residents in this field. During the meeting, the necessary modifications, coordination procedures, and division of responsibilities were outlined and planned. To ensure ongoing collaboration, the outcomes of this meeting were communicated to the affiliated centers within the university. Additionally, a training and empowerment workshop will be organized for the Code 724 team to facilitate smooth implementation.

Training and Empowerment of the Code 724 Group

Following the coordination meeting with the executive agents, an interprofessional workshop focused on both scientific knowledge and practical skills will be organized for the Stroke Code Group. The purpose is to strengthen staff capacity for implementing the updated protocol. During this workshop, common issues related to the implementation of the 724 protocol will be addressed, and the updated Stroke Code Protocol along with time management strategies will be taught through a practical, scenario-based, group-oriented approach. Participants will be divided into groups according to their service locations, including hospitals and pre-hospital emergency departments. Evaluation will be conducted based on the workshop scores, complemented by pre- and post-test theoretical assessments. The practical workshop will comprise 50% of the total score, the pre-test 20%, and the post-test 30%. Content for emergency medical experts will be prepared for an 8-h session by a researcher under the supervision of the Babol Pre-Hospital Emergency Education and Research Unit. The instructional videos will be reviewed and approved for scientific accuracy by an emergency medicine specialist and a member of the Emergency Medical Board.

It is planned that, following the workshop, the quantitative phase of the study will commence. Considering the importance of familiarity with the new protocol, the workshop will adopt a flipped classroom approach, with theoretical and practical components facilitated by professors from Babol University of Medical Sciences. The sessions will be held at the Ayatollah Rouhani Babol Educational and Therapeutic Center over 2 days, from 8:00 to 15:00.

Communication and Engagement With the Stroke Code Group

In the final step of this phase, ongoing interaction and resolution of implementation issues related to the Stroke Code program will be facilitated through the Telegram group Angels of Salvation. Questions and ambiguities will be addressed, and the process of implementing the new Stroke Code will be closely monitored. This phase will run concurrently with the intervention, during which the person responsible for the pre-hospital emergency stroke code will coordinate with hospitals to follow up on pre-hospital emergency missions. Subsequently, in the third phase of the study, the effects of the implementation intervention and its outcomes will be evaluated.

There will be no intervention in the control group. Instead, the stroke code training workshop for the control group will be conducted using the current national emergency protocol, during the same timeframe as the intervention group. This annual training session is held for emergency medical personnel. The main differences between the two groups will lie in the updated protocol, teaching methods, and content development. The control group will receive training in the form of both theoretical and practical workshops.

Data Collection

Data collection will be done done through interviews and notes in the field. Therefore, the researcher should take notes on the behavior and activities of people at the research site. The main research tool will be the interview guide. Demographic and clinical information of the patient will also be obtained during the interview or from the file. Interview with a number of general and open-ended questions with the people involved in the stroke code, including the patient, his caregiver, an expert at dispatcher, an emergency medical expert, a triage nurse, a neurologist, a nurse in the neurology department, and other professions. In the quantitative part, existing tools will be used and if necessary. The data will be analyzed simultaneously with the interview using the conventional content analysis method in the form of continuous comparison. Quantative data will construct after qualitative data.

Recruitment

Purposeful sampling will be conducted to reach saturation in the qualitative phase. We will initially start this study in the north of Iran and then continue to other provinces to increase the holistic approach.

Inclusion Criteria

The inclusion criteria for the study based on the order of the research stages, which first requires a qualitative approach and then a quantitative component, and also based on the people under study, include the following:

• Inclusion criteria for all people

All participant should have informed consent to participate in the research.

• Inclusion criteria of the qualitive phase (according to the national guideline of the stroke code for stroke patients) (Amiri et al., 2020).

Patients should be 18 years old or older (for patients).

The diagnosis of acute stroke has been given by a neurologist (for patients).

Be with the patient during a stroke or take care of a stroke patient (for caregivers of stroke patients).

Be part of the stroke code group or have specific responsibility in the stroke code (for stroke code team).

Be able to communicate and interview.

• Inclusion criteria of the quantitative phase:

It is compiled based on the information obtained from the qualitative phase.

Exclusion Criteria

Exclusion criteria are divided into two parts based on research phases:

1 The participant does not agree to continue the interview and research (for patients, companions, and the stroke code team).

2 It is compiled based on the results obtained from the qualitative section (for patients, companions, and the stroke code team).

Sample Size

Regarding the qualitative study, sampling will continue until reaching saturation. Its mean that category are completed and new data collection does not change the category or sub-category and only the information is repeated. Since the aim of the quantitative phase is to objectively generalize the results to a population, different participants are used in the quantitative follow-up phase compared to the initial qualitative phase. The quantitative procedures require a large sample size with different participants because participants in an in-depth qualitative study may subsequently have different perspectives on the phenomenon. The target population for this study consisted of the Babol and Mazandaran Pre-hospital Emergency Services organizations, which met the inclusion criteria and were accessible for data collection. Before finalizing the sample size, a pilot study will be conducted with 30 stroke patients. The purpose of this preliminary study is to assess the data collection process, evaluate the validity and reliability of the measurement tools, and estimate the statistical parameters needed to determine the appropriate final sample size.

Blinding and Allocation Concealment

Data will be collected by the Babol pre-hospital emergency statistics specialist via the system. The collected data will be transmitted directly to a statistician outside the research team. The researcher will have no involvement in the data collection or analysis processes.

Outcomes

Outcome of current study depends on data were explored in first phase (qualitative) and considering of second phase (panel of expert) to construct a third phase (quantitative).

Data Analysis

The obtained data will be assessed by conventional content analysis using Graneheim and Lundman’s approach (2004). The data were analyzed qualitatively in the five steps, including (1) transcribing the whole interview immediately after completion, (2) reading the whole text to arrive at a general understanding/gist of the content, (3) determining the meaning units and primary codes, (4) categorizing the similar primary codes into more comprehensive categories, and (5) determining the main theme of the categories (Graneheim & Lundman, 2004). In general, data in content analysis are textual and written data. For this purpose, the researcher immediately listens carefully to the recorded interviews several times and after finding a general view of them, the interviews will be written verbatim. Therefore, all interviews and field notes will be prepared in the form of written texts based on the research question. Data management will be done by MAXqda version 20 software which is the professional qualative data analyze software for mixed methods and qualitative data analysis. At this phase, the researcher will try to immerse himself in the data by repeatedly reading all the data and get a general view, the data will be read word by word and line by line rather than the words of the text that include the unit of analysis. The “unit of analysis” refers to the portion of content that will be the basis for decisions made during the development of codes. Then, by identifying important and key phrases in the semantic unit, primary codes are extracted. The main topics and messages of the texts are reviewed again before coding. The codes of each interview are compared with each other and with the codes of other interviews to determine their similarities and differences. Then, the similar codes will be categorized. After merging the similar codes, those with similar meaning are placed in a category (sub-category). At this step, the primary extracted sub-categories are again compared and merged to form the main category.

Quantitative data will be analyzed using both descriptive and inferential statistics. Descriptive statistics will summarize the data through measures such as mean, standard deviation, percentage, and frequency for both quantitative and qualitative variables. The choice of parametric or nonparametric tests will be based on the data distribution, and all analyses will be conducted using SPSS version 23.

Auditing

Since mixed research includes both qualitative and quantitative paths, each requires a specific assessment of trustworthiness. In the qualitative part of this study, from the five criteria of Lincoln and Guba which include: validity or acceptability (equivalent to validity in quantitative research), trust (equivalent to reliability in quantitative research), transferability (equivalent to generalizability in quantitative research), confirmability (equivalent to objectivity in Quantitative research) and reliability will be used to strengthen the data. In the quantitative part, based on the results of the qualitative part and the design of the intervention, the face-content validity, content validity index and the reliability (internal consistency method or retest) will be used according to the concept to be measured. The research team will continue sampling until data saturation is achieved and will aim to establish a connection between the qualitative findings and the quantitative data. The members will review and confirm the transcripts and interpretations provided by the participants. In this study, participants in the qualitative phase will not be included in the quantitative phase. Data interpretation will begin with the qualitative phase, then relate to the quantitative results, and finally be integrated. When publishing the findings, the study protocol and qualitative sections will adhere to the SPIRIT and COREQ checklists to ensure transparency and trustworthiness.

Ethics

Ethics Approval for the study has been obtained from the Research Ethics Committees of the School of Nursing and Midwifery &Rehabilitation - Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1401.036). The researcher fully introduced themselves to all participants and obtained written informed consent for participation, interviews, and audio recordings. Participants were assured that their personal information would remain strictly confidential. They were also informed of their right to withdraw from the study at any point without any consequences. The timing and location of individual interviews were scheduled in accordance with participants’ preferences. The purpose of audio recording and the intended use of the recordings were clearly explained to participants, and they were assured that they could request to turn off the recorder at any time, with their statements being documented as notes if desired. Participants were offered the opportunity to receive a summary of the study results upon request. During the study, workshops were conducted for all participants requiring education on stroke care to address their concerns. The names of participants were omitted from all research documents and interview transcripts to ensure anonymity. Results of the study were shared with willing participants upon request.

Disscussion

The study presented in this paper will be the first mixed-method study in Iran on stroke code management. We opted for a mixed research design since utilizing qualitative and quantitative methods allows for a more comprehensive understanding of the phenomenon under investigation. Rather than focusing on the disparities between the two approaches, it is important to consider how they can complement each other to enhance the study’s overall depiction (Allegue et al., 2020). (Cormican et al., 2023) conducted a systematic review and found that both organizational and professional barriers—such as time constraints, resource limitations, and knowledge gaps—can impede the implementation of stroke guidelines, while facilitators include multidisciplinary teamwork, leadership, and tailored protocols (Cormican et al., 2023). Their review emphasizes that addressing these challenges requires both qualitative insights from healthcare professionals and quantitative evaluation of interventions, mirroring the approach described in this study. By conducting qualitative interviews with participants, we will gain a deeper insight into the challenges related to code stroke. Similarly, (Jones et al., 2023) in the Code Stroke 2.0 study demonstrated the value of combining staff feedback (qualitative) with pre- and post-intervention quantitative measures to improve stroke code activation, protocol uptake, and patient flow in emergency departments (Jones et al., 2023). Their findings highlight that integrating multiple data sources leads to more effective and contextually relevant interventions. Moreover, the valuable data acquired from exploring the experiences of participants will be combined with the quantitative results to support knowledge translation efforts upon completion of the study. Addressing challenges in the realm of stroke necessitates gathering firsthand insights from members of the stroke code team. During the qualitative phase, we uncover this valuable information through interviews with the stroke code team members. Subsequently, leveraging this data, we will progress to develop an intervention aimed at diminishing service delivery times within the stroke code process. To improve the overall representation of the target population in the region, participants will be selected from diverse locations. In the third phase, we will implement and evaluate this intervention.

Conclusion

This study aims to explore the challenges and implementation of an optimal intervention to enhance code stroke management in Iran. This work will be conducted in three steps, with particular consideration given to the context in the first step. By designing the implementation in step 3, it is believed that the effectiveness of stroke code management can be improved. The approach outlined in this study is consistent with current evidence and best practices in stroke code management research, as it leverages the strengths of both qualitative and quantitative methodologies to inform intervention development, implementation, and evaluation. We expect that this study can improve Iranian national program for stroke code management. The evidence obtained from this study will also provide information on the challenges in stroke code management, allowing us to better understand the facilitators and barriers of stroke code management.

Relevance to Practice

This study will deeply consider the context of stroke code by interviewing the stroke survival chain and exploring the experience of the stroke code team in designing, implementing, and evaluating it in practice.

Supplemental Material

Supplemental Material - An Iranian Comprehensive Code Stroke Management Program (ICSM); A Mixed-Methods Study Protocol

Supplemental Material for An Iranian Comprehensive Code Stroke Management Program (ICSM); A Mixed-Methods Study Protocol by Shayan Alijanpour, Fatemeh Bahramnezhad, Ashkan Mowla, Nahid Dehghan Nayeri and Seyedeh Fatemeh Hosseini Aghamolki in International Journal of Qualitative Methods.

Supplemental Material

Supplemental Material - An Iranian Comprehensive Code Stroke Management Program (ICSM); A Mixed-Methods Study Protocol

Footnotes

ORCID iDs

Shayan Alijanpour

Fatemeh Bahramnezhad

Nahid Dehghan Nayeri

Ethical Consideration

This study has been approved by the Ethic Committee of Tehran university of medical sciences (IR.TUMS.FNM.REC.1401.036) (). Written informed consent will be obtained from all participants. The results of the study will be disseminated via peer reviewed publications.

Informed Consent

Informed written consent will be obtained from all participants.

Author Contributions

Dr Dehghan nayeri and Dr. Alijanpour made a significant contribution to the concept, design, acquisition, analysis or interpretation of data. Approved the final version of the article for publication. Dr. Bahram nezhad made a significant contribution to the concept, design, review & editing the article critically for important intellectual content. Approved the final version of the article for publication. Dr. Mowla and Dr. hosseini Aghamolki made a significant contribution to the analysis or interpretation of data and contributed to editing the article critically for important intellectual content. Agreed to be accountable for all aspects of the work and resolved any issues related to its accuracy or integrity and Approved the final version of the article for publication.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was Ph.D. thesis of nursing in education which is found by Tehran university of medical sciences (Proposal Number: 40013199001).

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

Data from this study are available by contacting the Dr. Shayan Alijanpour (sh.alijanpour@mubabol.ac.ir), subject to a reasonable request.

Supplemental Material

Supplemental material for this article is available online.

References

Alijanpour

Alimohamadi

Khafri

Rokni

M. A.

Khorvash

(2022 Nov 1). Caspian nursing process: Impactions on new-onset constipations in admission, discharge, and follow-up of acute stroke patients. Iranian Journal of Nursing and Midwifery Research, 27(6), 509–16.

Alijanpour

Aslani

Alimohammadi

Taleghani

(2020 May 1). Empowerment of nurses: A key to stroke patients’ satisfactions. Iranian journal of nursing and midwifery research, 25(3), 237–41.

Alijanpour

Bahramnezhad

Mowla

Sabet

M. S.

Nayeri

N. D.

(2025). Updated protocol for stroke code management in prehospital settings: The Iranian comprehensive stroke code management program (ICSCM phase II). Archives of Academic Emergency Medicine, 13(1), Article e43. https://doi.org/10.22037/aaemj.v13i1.2633

Allegue

D. R.

Kairy

Higgins

Archambault

Michaud

MillerTousignant

W. M.

(2020). Optimization of upper extremity rehabilitation by combining telerehabilitation with an exergame in people with chronic stroke: Protocol for a mixed methods study. JMIR research protocols, 9(5), Article e14629. https://doi.org/10.2196/14629

Amiri

Zamani

Sasannejad

Saadatnia

Sharifipour

(2020). Standard certificate of acute stroke treatment management services. Tehran: Scientific and executive working group on management of acute stroke treatment. Center for Transplant Management and Disease Treatment, Vice Chancellor of Treatment Affairs, Ministry of Health and Medical Education.

Askari-Majdabadi

Basereh

Soheili

Powers

Soleimani

Mirmohammdkhani

Saleh

T. A.

(2022). Current status of acute ischemic stroke management in Iran: Findings from a single-center study. Turkish journal of emergency medicine, 22(4), 213–220. https://doi.org/10.4103/2452-2473.357344

Colle

Wilmer

Le Moine

Debruyne

Delwaide

Dhondt

Penaloza

Piessevaux

Stéphenne

Van Biervliet

Laterre

P. F.

Stéphenne

(2011). Upper gastrointestinal tract bleeding management: Belgian guidelines for adults and children. Acta gastro-enterologica Belgica, 74(1), 45–66.

Cormican

Hirani

S. P.

McKeown

(2023). Healthcare professionals’ perceived barriers and facilitators of implementing clinical practice guidelines for stroke rehabilitation: A systematic review. Clinical Rehabilitation, 37(5), 701–712. https://doi.org/10.1177/02692155221141036

Emadikhalaf

Ghods

A. A.

Sotodeh-Asl

Mirmohamadkhani

Vaismoradi

(2023). Effects of rose and lavender scents on nurses’ job stress: A randomized controlled trial. Explore, 19(3), 371–375. https://doi.org/10.1016/j.explore.2023.01.002

10.

Enhancing the Quality and Transparency of health Research . (2025). https://www.equator-network.org/

11.

Fallahzadeh

Esfahani

Sheikhy

Keykhaei

Moghaddam

S. S.

Tehrani

Y. S.

Ghasemi

Azadnajafabad

Mohammadi

Koolaji

Shahin

Rezaei

Larijani

Farzadfar

(2022). National and subnational burden of stroke in Iran from 1990 to 2019. Annals of clinical and translational neurology, 9(5), 669–683. https://doi.org/10.1002/acn3.51547

12.

Farhoudi

Sharifipour

(2022). Iranian stroke model-how to involve health policymakers. Pakistan Journal of Neurological Sciences, 17(02), 9–11. https://doi.org/10.56310/pjns.v17i02.178

13.

Graneheim

U. H.

Lundman

(2004). Qualitative content analysis in nursing research: Concepts, procedures and measures to achieve trustworthiness. Nurse Education Today, 24(2), 105–112. https://doi.org/10.1016/j.nedt.2003.10.001

14.

Jones

Fasugba

Dale

Burrows

John

Doncillo

McElduff

Lueck

D’Este

McInnes

Middleton

(2023). Improving stroke emergency department nursing care: The code stroke 2.0 pre-test/post-test feasibility study. Collegian, 30(5), 736–743. https://doi.org/10.1016/j.colegn.2023.04.002

15.

Kendall

Cowey

Mead

Barber

McAlpine

StottMurray

D. J.

(2018). Outcomes, experiences and palliative care in major stroke: A multicentre, mixed-method, longitudinal study. Canadian Medical Association Journal, 190(9), E238–E246. https://doi.org/10.1503/cmaj.170604

16.

Leung

W. C. Y.

Teo

K. C.

Kwok

W. M.

Lam

L. H. C.

Choi

O. M. Y.

Tse

M. M. Y.

Tsang

T. C.

Tsang

A. C. O.

(2020). Pre-hospital stroke screening and notification of patients with reperfusion-eligible acute ischaemic stroke using modified face arm speech time test. Hong Kong Medical Journal, 26(6), 479–485. https://doi.org/10.12809/hkmj208552

17.

National Association of State EMS Officials (NASEMSO) . (2022). National model EMS clinical guidelines. In Version 3.0, March.

18.

Nemati

Saadat

Ahmadi Ahangar

Nematian

Alijanpour

Bijani

(2023 Mar 10). Outcome of Treatment with Intravenous Alteplase in Acute Stroke Patients. Journal of Babol University of Medical Sciences, 25(1), 559–66.

19.

Rexrode

K. M.

Madsen

T. E.

A. Y. X.

Carcel

Lichtman

J. H.

Miller

E. C.

(2022). The impact of sex and gender on stroke. Circulation Research, 130(4), 512–528. https://doi.org/10.1161/CIRCRESAHA.121.319915

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.15 MB

0.72 MB