IRB proposal Sample

EBP and QI Project Proposal Template

Brief Summary of your topic: 

Atrial fibrillation (AF) patients are at risk of stroke if the administration of stroke prevention strategies such as anticoagulation is absent. AF is a common cardiac condition? caused by chaotic electrical signals in the upper chambers of the heart. The American College of Cardiology recommends the use of the CHA2DS2-VASc score for the determination of the risk for thromboembolism for patients with non-valvular AF (Steen, 2014). For patients at high risk of CHA2DS2-VASc score of 2 or higher, oral anticoagulation is recommended. The problem is that clinicians in cardiac units have reported inconsistent use and documentation of the CHA2DS2-VASc score in stroke risk stratification for patients with AF. This is a problem because it prevents the proper prescription of anticoagulants. 

The project focuses on implementing the CHA2DS2-VASc risk score in a hospital setting for patients with AF to understand the outcomes resulting from the stratification. The project will utilize retrospective methods by examining data patients on anticoagulants. Data from electronic patient records will be used to examine the effect of CHA2DS2-VASc score in anticoagulant administration and risk of stroke. 

The rising cost of hospitalization and reducing resources prompt proper use of any available materials and tools to improve the quality of life for patients and meet the goals of the hospital and the healthcare system. By investigating the correct use of the CHA2DS2-VASc risk score, recommendations will contribute to literature and reduce resource wastage. Misappropriation of the CHA2DS2-VASc risk score tool directly impacts the financial burden of treating patients with atrial fibrillation. Anticoagulation costs range from a baseline cost of $35 to more than $200 per month for warfarin and direct anticoagulants, respectively (Shah et al., 2016). Therefore, the proper use of the CHA2DS2-VASc risk stratification is critical as it can directly affect drug administration and the subsequent effectiveness of the drug in the prevention of stroke. Furthermore, patients who develop stroke require costly rehabilitation and assistive devices to reduce their functional impairment. The healthcare system in the US is burdened with approximately $4850 for every patient who suffers from a stroke through the cost of rehabilitation services and other services to assist patients to improve functionality (Rajsic et al., 2019).  

Background 

The American College of Cardiology recommends the use of the CHA2DS2-VASc score for the determination of the risk for thromboembolism for patients with non-valvular AF and recommends oral anticoagulation for patients with a CHA2DS2-VASc score of 2 or higher (Steen, 2014). The problem is that clinicians in the cardiac unit of the acute care facility report inconsistent use and documentation of the CHA2DS2-VASc score in stroke risk stratification for patients with AF. This is a problem because it prevents clinicians from prescribing anticoagulants appropriately to patients with AF based on the current recommendations. Anticoagulants have been associated with bleeding in patients with AF (Stacy & Richter, 2018). This risk of bleeding makes it imperative to perform stroke risk stratification to identify patients with low risk with the CHA2DS2-VASc score, so they do not receive anticoagulants.

Risk stratification enables clinicians to identify the stroke risk of patients and to tailor anticoagulation based on their level of risk. The CHA2DS2-VASc score provides the additional advantage of revealing that the risks of bleeding events and ischemic stroke among patients with atrial fibrillation (Maeda et al., 2020). Furthermore, in patients without anticoagulant use, a higher burden of atrial fibrillation has been associated with higher rates of thromboembolism (Go et al., 2018). The high rates of thromboembolism among patients with atrial fibrillation highlight the need for preventative interventions. The increased risk for thromboembolic events, stroke, and major bleeding in patients with atrial fibrillation underscores the need for my study timeline will hopefully begin in November 2021 and end by January 2022. This will include activities such as reviewing and collecting data from the database, analyzing the data and completing the project. 

1. Objectives of your project The project's main focus is to implement the CHA2DS2-VASc risk score for patients with AF to understand the impacts of the score in the proper administration of anticoagulants and the impact on stroke prevention. Within the hospital setting, the researcher will investigate: 1) To assess the implementation of the CHA2DS2-VASc score stratification for patients with AF in the cardiac unit of an acute care facility; 2) To examine the rate of administration of anticoagulants for patients with AF; 3) To analyze the rate of stroke.

2. Background The American College of Cardiology recommends the use of the CHA2DS2-VASc score for the determination of the risk for thromboembolism for patients with non-valvular AF and recommends oral anticoagulation for patients with a CHA2DS2-VASc score of 2 or higher (Steen, 2014). The problem is that clinicians in the cardiac unit of the acute care facility report inconsistent use and documentation of the CHA2DS2-VASc score in stroke risk stratification for patients with AF. This is a problem because it prevents clinicians from prescribing anticoagulants appropriately to patients with AF based on the current recommendations. Anticoagulants have been associated with bleeding in patients with AF (Stacy & Richter, 2018). This risk of bleeding makes it imperative to perform stroke risk stratification to identify patients with low risk with the CHA2DS2-VASc score, so they do not receive anticoagulants. Anticoagulants have been associated with bleeding in patients with AF (Stacy & Richter, 2018). This risk of bleeding makes it imperative to perform stroke risk stratification to identity patients with low risk with the CHA2DS2-VASc score, so they do not receive anticoagulants. Risk stratification enables clinicians to identify the stroke risk of patients and to tailor anticoagulation based on their level of risk. The CHA2DS2-VASc score provides the additional advantage of revealing that the risks of bleeding events and ischemic stroke among patients with atrial fibrillation (Maeda et al., 2020). Furthermore, in patients without anticoagulant use, a higher burden of atrial fibrillation has been associated with higher rates of thromboembolism (Go et al., 2018). The high rates of thromboembolism among patients with atrial fibrillation highlight the need for preventative interventions. The increased risk for thromboembolic events, stroke, and major bleeding in patients with atrial fibrillation underscores the need for intervention to identify patients with atrial fibrillation at increased risk for stroke and thromboembolic events to prevent the inappropriate administration of anticoagulants that increase the patients' risk for bleeding

3. Setting of the Project 

The setting will be an operational, clinical hospital with a cardiac unit treating patients with AF. In this case, it will be the Mount Sinai Morningside hospital, Telemetry unit 10 east and 9 east that has been selected for the research. All patients in the research will have to have visited and been treated at this facility to be included in the research.

4. Population of interest 

The sample is for patients that have been diagnosed with AF and have received or are receiving medication at a given hospital unit. The patients need to have been seen by a Doctor/NP at Mount Sinai Morningside hospital. The selected sample will be 50 stratified patients and 50 unstratified patients. The sample will be accessed on a Telemetry unit via electronic records access. The patient should be above the age of 64 years to qualify for the study. More importantly, the patient data will be for people treated from 2010 to the current patients receiving treatment. 

5. Intervention plan

1. How will you implement your intervention/project/survey? 

1. Conduct a review of the electronic medical records (EMR) in a retrospective manner in order to get patient sample size of 100.

2. After obtaining the sample size, utilize the CHA2DS2-VASc risk score by applying it to the selected sample size of patients on their admission to the telemetry unit retrospectively. 

3. Based on the CHA2DS2-VASc risk score, the researcher will categorize the patients into two strata of a). stratified and b). unstratified 

4. The two groups will be compared on impact of patients with atrial fibrillation (the use of anticoagulants and the effect on thromboembolic events such as stroke) based on the CHA2DS2-VASc risk score

5. A correlation analysis of the two patient groups categorized according to the CHA2DS2-VASc risk score will be applied retrospectively. The correlation will help reveal what the effects of stratification are and whether opportunities for early stratification of patients with AF can be utilized as a preventive tool for stroke. 

2. Number of Subjects 

The targeted sample size of the project is at least 100 patients to be identified. The reason for this is that it will aid in ensuring statistical significance of the project. If more subjects are available, the number will be revised upwards to increase the statistical significance. 

3. Study Timelines 

The data will be for people treated from 2010 to the current patients receiving treatment. The start date of the project for data collection is expected to be April 2022. By June 2022, I would expect that I have gone through all the EMR to review data. The completion of the project should be around August 2022. 

4. Comparison group 

The data has two groups that are the stratified and unstratified patients with AF. The primary intervention group is that of stratified patients, while the unstratified patients are the comparison group. Patients who are unstratified represents those whose risk of stroke has not been categorized according to the stroke risk scoring system. The data from these two patient groups will be compared to determine the effect of the scoring system. These comparisons to reveal if the use of the scoring system has benefits for patients such as predicting stroke and recommendations on anticoagulant use will help inform doctors in this hospital and others across by ensuring presentation of evidence-based information. Many hospitals across the US and this in particular are not strictly applying the CHA2DS2-VASc risk score system, and thus its effects are not well known on patients with AF. Making comparisons between these two groups brings out opportunities for improved implementation if there are benefits. This will allow resources to be saved and patient quality of care to improve by receiving the right medication and getting proper prediction for stroke events. By knowing if stratification of patients with AF using the stroke risk score is beneficial, decision-making in cardiac units can improve significantly. 

5. Outcomes 

The outcomes of the intervention will be measured by applying correlation regression tests and t-tests to examine the effect of using the risk score on the two patient groups. These tests will be carried out using the SPSS software and presented on tables and graphs. 

The success of the intervention in examining the effects of the CHA2DS2-VASc risk score stratification will be measured using the comparison between the outcomes of the stratified and unstratified patients. Patients in the category with better outcomes such as fewer thrombogenic events and proper use of anticoagulants will indicate which of the procedures between stratified or not stratifying patients is more useful.

6. Data Management and Confidentiality (if relevant

All the data will be stored on the hospital database in order to ensure the patient information is not compromised. The data accessed on the EMR will be encrypted. Only after obtaining the results will the researcher utilize them. The data accessed on the EMR and the output will not have any identifying information such as names, addresses and other information about patients that could be identifiable. 

7. Risk to subjects               

None, the project is a retrospective electronic chart review

8. Citi training

Citi Module Title	Yes	N/A
Rigor, Reproducibility and Ethical Behavior in Bio-medical Research	X
Basic course: Human Research Protection Education	X
Data Security and HIPAA training	X
HIPAA Research Update	X
Good Clinical Practice (GCP) (*required only if clinical trial, FDA-regulated research or obligated by contract)	X

7) References 

Go, A. S., Reynolds, K., Yang, J., Gupta, N., Lenane, J., Sung, S. H., Harrison, T. N., Liu, T. I., & Solomon, M. D. (2018). Association of the burden of atrial fibrillation with risk of ischemic stroke in adults with paroxysmal atrial fibrillation: The KP-RHYTHM Study. JAMA Cardiology, 3(7), 601–608. https://doi.org/10.1001/jamacardio.2018.1176 

Lakens, D. (2013). Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Frontiers in psychology, 4, 863.

Maeda, T., Nishi, T., Funakoshi, S., Tada, K., Tsuji, M., Satoh, A., Kawazoe, M., Yoshimura, C., & Arima, H. (2020). Risks of bleeding and stroke based on CHA2DS2-VASc scores in Japanese patients with atrial fibrillation: A large-scale observational study using real-world data. Journal of the American Heart Association, 9(5), e014574. https://doi.org/10.1161/JAHA.119.014574

Rajsic, S., Gothe, H., Borba, H. H., Sroczynski, G., Vujicic, J., Toell, T., & Siebert, U. (2019). Economic burden of stroke: a systematic review on post-stroke care. The European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care, 20(1), 107–134. https://doi.org/10.1007/s10198-018-0984-0

Stacy, Z. A., & Richter, S. K. (2018). Direct oral anticoagulants for stroke prevention in atrial fibrillation: treatment outcomes and dosing in special populations. Therapeutic Advances in Cardiovascular Disease, 12(9), 247–262. https://doi.org/10.1177/1753944718787384