Pilot Study of Safety of Rapid Discharge Low Risk Patients with a Successful PCI after STEMI
Summary
The COVID-19 pandemic has brought pressure of a significant degree on Southlake Regional Health Centre (SRHC) Interventional Department due to limited resources, with staff redeployment, beds availability and personal protective equipment being just a few examples. As limited resources run over capacity, postponing non-urgent procedure such as elective PCI procedures is inevitable. Furthermore, there is also a rise of fear and anxiety from patients that they might contract COVID-19 infection during their hospitalization. The University of Ottawa Heart Institution (UOHI) published a very early discharge protocol (VEDP) to promote shorter length of stay (LOS) in hospital for low risk of STEMI patients (Marbach et al., 2020). Despite such advancements, the safety of prospective data from this novel study is not currently available at the time of writing. The VEDP has not been validated by any study with prospective data at the time of this fellowship. With this in mind, I was planning to adopt this protocol with some mild modification to study the safety data of discharging this patient population home earlier than standard practice. This allows us to minimize the risk of COVID-19 exposure to patients and staff, reduce LOS, and increase beds utility in interventional cardiology department. If rapid discharge of this population is proven safe, the LOS will be significantly reduced by 50% in the low risk STEMI patients.
I am a nurse practitioner who care for all STEMI patients admitted in SRHC before and after PCI procedure. The overall learning goals of this fellowship is to increase my knowledge of the safety of rapid discharge low risk STEMI patients compared with conventional discharge time, and to disseminate this knowledge to other members of the health care team with the intention to improve patient care, and reduce cost of care without increase of patient’s mortality and major adverse cardiovascular events (MACE). My other goal is to develop practical skills in the process from the beginning to the end: the development of a research question, hypothesis, data collection, database management, and data analysis/interpretation and knowledge dissemination. Having dedicated time to develop these skills has given me the opportunity to devote myself in this process. In my graduate degree I learned knowledge and skills from Research class but never had the opportunity to put these skills into use in clinical practice. I was able to do an extensive research using the search skills I learned before, completed a literature review and critically appraised the current literature on Early Discharge on STEMI patients, which gave me a solid background of what is currently known about this topic. I had never been involved in managing my own research database so this was completely new to me. With the guidance of my mentors I developed the basic knowledge and skills required to specifically organize data in a manner that allowed for data analysis. Through studies and mentorship I learned how to perform appropriate statistical analysis on categorical and continuous variables by performing Chi Square, T-tests, means and standard deviations. Some difficulties along the way taught me the importance of ensuring that the database is as accurate as possible in order to trust the results. This drove home the importance of always looking at data through a critical lens.
As the interim analysis was taking place, new ideas developed which provided me the opportunity to explore other research questions and pointed my future clinical research direction into a randomized trial of this patient population. This has been a positive finding and provided insight into potential safe and feasible to discharge STEMI low risk patients home sooner than our current conventional practice.
Outcomes
The mid-term data from this research fellowship discovered that it is safe to discharge low risk STEMI patients in 20-36 hours after a successful PCI procedure. The mid-term data we received so far do not reveal any 30 days major adverse cardiac events (MACE) including composite of total death; MI; stroke, hospitalization because of HF; and revascularization, including percutaneous coronary intervention, and coronary artery bypass graft. Data is being collected continuously until the study is done potentially April 2022. At this point, we find 26% of our STEMI patients are considered low risk and can be beneficial from this VEDP. The midterm findings from study validate the novel VEDP by Marbach et al. (2020). Retrospectively, we enrolled 82 patients from March 2019 –April 2020. When we applied this VEDP to this group, there was no 30 days MACE identified. In our prospective cohort, we have enrolled 77 patients at this point and there is no 30 days MACE so far. We did identify several ER visits and two readmissions related to atypical chest pain but there were no recurrent MI and no unexpected revascularization. There is no increase 30-day re-admission rate.
95% of the patients who were enrolled into this study were satisfied with being able to go home earlier than conventional practice and having an NP calling for follow-ups within 48 hours, 7 days and 30days. At this point, we approached 77 patients for VEDP. Only 5% of the patients wish they could have stayed in hospital longer if they were given the option again, mainly because of insufficient home support or anxiety post MI.
First, the results of the fellowship data analysis were presented to the Clinical Service Team meeting at SRHC which included all interventional cardiologists, Nurse Practitioners, PCI coordinators, department managers and cardiac program director; as well as at a virtual RN grand round which included all cardiac nurses in different areas including: medical cardiology unit, cardiovascular unit, CCU, and PCI recovery unit. As part of the presentation evaluation participants were asked to rate their knowledge of Very Early Discharge Program (VEDP) and provide their thoughts of this study. All of the interventional cardiologists/ staff /colleagues feel interested in learning the final result of this study which is expected to come out in May 2022. They verbalize their interest in following protocol once data come out and support this is a safe practice.
Second, from current data analysis, the LOS was reduced by 42%. Patients spent one night less compared with conventional discharge time. We identified there were about 26% of all our STEMI patients are consider low risk and can be qualified for early discharge. This could potentially save approximately CA$ 125, 000 yearly on the basis of cost per 24 hours of a cardiology ward bed.
Third, Interventional Cardiologists from other cardiac centre verbalized their interest in joining this study until its completion. Due to manpower concern, we are not able to conduct this study together with other centre. This study results will have positive impact on the LOS of other cardiac facilities on their PCI patient population.
Overall experience
I appreciate the opportunity to conduct a clinical research with tremendous help from my team. During these 5 months, I have dedicated time to practice my research knowledge and skills, to learn new knowledge on data production, management and analysis from my mentor team and colleagues. The initial intention of this fellowship was to learn safety data of discharging STEMI PCI patient home much earlier than our conventional practice. My overall experience from this RNAO ACPF is invaluable for my current practice and future professional development.
I am an NP of Interventional Cardiology (IC) for the past 6 years. I look after PCI patients while they are admitted in hospital. Since COVID started we experience tremendous amount of resource shortage and patients/staff anxiety of contracting COVID. Patients prefers to be discharged home earlier, however we do not have evidence support patients’ request. The VED idea came from a proposed VED protocol from University of Ottawa Heart Institute. I appreciate the support I get from SRHC IC team and RNAO ACPF program so that I can quickly come up with a research study protocol to validate the VED protocol. As the fellowship progressed, so did my research skills and my ideas for future research. I was approached by other IC from other centre and proposed they can start the study with us if manpower allows. Unfortunately due to staff shortage we do not the staff to co-ordinate the multicentre study at this time. But further study could possibly conducted in the future with other centres once we have the necessary resources.
One of the most memorable moments occurred during the mid-term data analysis. It was the beginning of analysis and I specifically remember the excitement that I felt when I was finding insignificant differences in two group’s baseline characteristics and significant differences in two groups discharge time. I immediately reviewed these results with my mentors as I wanted to share this excitement with my team. Some challenges during this study are to convince some Interventional Cardiologists to enroll patients into the study while NP is away (weekends, holidays). Although this was not anticipated at the beginning of this study, it was a valuable lesson and experience. I decided to present mid-term results to my team. As the mid-term results comes out, more IC were convinced and patients sample size continue to grow. Another challenge was difficulty obtaining raw data as our data specialist retired in the middle of this study and the new hired specialist was not familiar with data withdraw. I had to spend significant amount of time with cardiac IT support team in order to obtain the data I needed for analysis.
