Business Plan-Monitoring Clinic

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Business Plan

ANAK Monitoring Clinic with Medtronic Linq

Alana Hernandez, Nicole O’Neil, Abby Romme, and Karin Weinstock University of San Francisco

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Business Plan

Monitoring Clinic with Medtronic Linq

Executive Summary for the ANAK Monitoring Clinic

The proposed implementation of an advanced cardiac monitoring center at the future ANAK Monitoring Clinic will provide cardiac surveillance for all patients who receive newly implanted Medtronic Linq loop recording cardiac devices. The Linq is an arrhythmia detecting recordable loop instrument, which lasts about three years, can be implanted at an outpatient clinic, and allows for more direct patient care. The primary patient cohorts the clinic will be serving include individuals with previously undetectable rhythms that require extensive monitoring for proper identification purposes, patients with previously identified arrhythmias and patients at risk for transient ischemic attacks (TIAs), thrombus, or embolic events that are typically associated with heart arrhythmias. The clinic will also serve patients with newly implanted devices from the ANAK Monitoring Clinic that will register with the clinic for continuous long-term monitoring over the device’s life span. Patients with newly implanted cardiac monitoring will benefit from this advanced monitoring technology through improved health and longevity, decreased hospitalization and emergency room visits, and lessened anxiety associated with unexpected arrhythmia complications (Sposato et al., 2012).

These services will also be made available to outside facilities. Offering these services to other local facilities will allow for a reduction in their needed staffing and resources, but can ultimately lead to more financial gains for the ANAK Monitoring Clinic through efficient use of appropriate roles and decreased needs for unnecessary nursing and physician care. The

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detection based on identification of a single P-wave during cardiac cycle, and 3) a reduction in emergency room visits within the community.

The clinic will work with a diverse group of health care professionals and the device manufacturer to provide a more thorough and effective multidisciplinary team approach to patient care with the ultimate goal leading to improved patient outcomes. This specialty clinic will employ using monitoring technicians specifically trained in reading heart rhythms,

registered nurses providing advanced cardiac assessments and strip identification, physicians to provide additional diagnoses and advanced care when necessary, and secretarial staff to aid in the scheduling process. With the use of highly trained monitoring technicians versus registered nurses, the facility will increase revenue and provide care for a highly proven healthcare need within many communities. The clinic will also save costs through utilizing fewer registered nurses and physician staff.

The clinic will be nurse-led with the objective of lowering hospital admissions,

improving cardiovascular mortality, and integrating program improvements. Nurses will focus on the whole person and not just the diseases, similar to current medical physician practice through preapproved protocols and order sets. Electrophysiologist and cardiologist’s time is extremely valuable and expensive. By having nurses in charge of patient care, critical issues will less likely be missed. Nurses will coordinate direct care plans, will provide informed

communication to the supervising cardiologist in relation to difficult cases, and will encourage patients to practice autonomy in their care (Mandrola, 2014).

Identifying a Need for ANAK Monitoring Clinic

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multitude of other non-heart related conditions and metabolic problems. The extensive nature of these occurrences makes identification of causative factors difficult and time intensive. The causative identification rate for syncopal episodes produces approximately two-thirds of the 800,000 cases of people who suffer from strokes in the United States (Cortez, 2014). Strokes are often linked to erratic heart rates known as atrial fibrillation (A-fib). This arrhythmia is a

prominent factor in syncopal episodes.

Atrial fibrillation occurs when the muscles in the upper chamber of the heart, called the atria, move quickly in a disorganized and erratic fashion (see Appendix A). The result is an irregular heartbeat or arrhythmia with possible atrial beat rates greater than 300 beats per minute and associated ventricular responses exceeding 200 beats per minute. Such cardiac rates are ineffective in sustaining life for extensive periods of time due to decreased profusion to vital organs. Additionally, A-fib causes blood pooling within the atria from ineffective contractions. When not regulated medically or pharmacologically, this pooling blood frequently clots and dislodges, leading to the prominent stroke side effect described previously (Markides & Schilling, 2003). More than 5 million people in the United States have A-fib, and this number promises to increase as the population ages due to the heart’s electrical conduction and muscular system weakening (Atrial fibrillation facts and statistics,” n.d.; Aronow, 2009). With this

increase in number of cardiac arrhythmia, there will be a further increase in the number of syncope, since it is the most common cause of syncope (Fogoros, 2014). A-fib will affect about 4% of people over the age of 60 and 10% of people over the age of 80 (“Atrial fibrillation facts and statistics,” n.d.).

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hospitalizations of patients with A-fib are over 460,000 annually and A-fib has been found to contribute to 80,000 deaths per year (Heart rhythm society, n.d.).

The Medtronic Linq is a device that is designed to continuously monitor and record a patient’s heart rhythm for up to three years. This technology is aimed at assisting doctors in identifying episodes of heart related syncope by providing electronic recordings of data. The device is placed subcutaneously next to the patient’s left sternum about two inches below the nipple and can be injected in an outpatient setting with a local anesthetic (Medtronic, 2014a). It is not visible in many patients, requires minimal healing time, and frequently does not require even a single stitch following placement. The device contains all pertinent data related to the patient, including identifying information, measurable settings, and standards for recording rhythm strips. To help in identifying causative rhythms, patients are able to activate an external handheld device to record rhythms when symptoms are felt. Additionally, rhythms are

transmitted nightly via a wireless transmitting device while the patient sleeps (Medtronic, 2014a). Using the recorded data, physicians are informed to prescribe appropriate therapies such as medication treatment or permanent pacemaker and implantable cardioverter defibrillator implantation when a heart rhythm-related cause is found. Conversely, the doctor will focus on other potential reasons for a patient’s symptoms if heart rhythm causation is ruled out. Studies have shown that an inserted cardiac monitor may diagnose the causes of infrequent, unexplained fainting more often than regular testing (Clinical policy bulletin: Cardiac event monitors, 2008). Implanted monitoring technology will provide early detection and significantly improve patient outcomes and satisfaction (Clinical policy bulletin: Cardiac event monitors, 2008).

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deliver care. Technological advances allow healthcare providers to provide targeted treatment and precise diagnosis. The ANAK Monitoring Clinic is meeting a specific need of the

community in patients who require a monitoring device to detect their probable heart condition. Product Definition for ANAK Monitoring Clinic

The establishment of the ANAK Monitoring Clinic advocates for specialized,

management of cardiac heart rhythm surveillance and analysis. The problem with the existing method of monitoring is staffing. Current nursing staff is maximized in relation to available care services including monitoring additional cardiac device types, and thus, the current staff is unable to sufficiently manage the added patient population of those who are monitored by the Medtronic Linq. Increased appropriate staffing through role delineation would improve monitoring efficiency, response speed, and management of patients.

The ANAK Monitoring Clinic is a nurse-led clinic because the nurse is the first responder in relation to outpatient computer based monitoring patient care. This clinic will deliver holistic health care, in other words, the patient will be examined and cared for as a whole (Mandrola, 2014). A nurse-led clinic puts the person at the center of attention rather than the disease. The nurses will get to know the patient more thoroughly, build a relationship especially in relation to each individual patient’s healthcare needs, and will want to continue working with the patient (“Nurse-led Clinics,” 2012). This care model increases patient satisfaction with their care at the clinic and ultimately provides positive results with patient care.

Several studies on nurse-led clinics have shown results where there is no greater risk of care at nurse-led clinics versus a hospital or another type of medical facility or clinic

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in addition to a combination of counseling, careful assessment, and the relationship that is built between the patient and staff (Schadewaldt & Schultz, 2010).

A multidisciplinary approach is essential in the management of Medtronic Linq patients. Working within the context of an electronic clinic setting, the main players include monitor technicians, nurses, and physicians. The clinical management process begins with monitor technicians receiving a rhythm strip from a secure website powered through the device

manufacturer, Medtronic (Medtronic, 2014a). Educated with fundamental essentials of cardiac rhythms, technicians sift through appropriate and inappropriate transmissions. Appropriate transmissions, identified as true arrhythmias, are forwarded to registered nurses. Nurses provide crucial assessment and evaluate the need for patient-doctor correspondence based on a

predefined decision tree representing multiple plausible possibilities associated with recorded arrhythmias. The process includes nursing interventions such as nursing care, patient education, and support and clinical intervention. Finally, the process ends with the intervention of

cardiologists receiving appropriate notification of true life-threatening arrhythmias and

associated symptoms requiring immediate medical care (Mandrola, 2014). Patients receive the most appropriate care at every step of the clinical management process. Minimizing healthcare costs and freeing physician time for more critical cases is built-in to the model of care and unifies the multidisciplinary team. In short, the clinical process is an efficient filtration process facilitating direct and rapid care by utilizing the right person in the right position at the right time.

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of results to physicians will persist. Patient satisfaction decreases and outcomes would remain mediocre.

By contrast, nurse-led clinics have experienced improved outcomes following nurse-led clinic consultation because the patient is directly involved with their own care plan. A

combination of having this monitoring device, the Medtronic Linq, and nursing assessment and care will help prevent or decrease admissions or readmissions of patients.

In order to implement this desired outcome, training for clinical management of implanted cardiac monitoring will include physicians, nursing staff, and monitor technicians. Periodic in-service training for key players will ensure proper skill sets are maintained and current. A review of nurse competencies will also be completed yearly. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will complete these standards per current recommendations. See Appendix B for an illustration of the Medtronic Linq system.

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Market Analysis for the ANAK Monitoring Clinic

The ANAK Monitoring Clinic will be housed in central Minnesota with a surrounding community of approximately 110,000 individuals (Onboard Informatics, 2013). Due to the extensive size of the institution this monitoring clinic is associated with, patient recruitment for clinical monitoring will focus on extensive populations from the larger Midwestern region, greater United States, and across the world. As a result, creating expansive avenues through remote telemonitoring systems is desired in order to precipitate growth, expansion,

diversification, and revenue expansion. Typically, patients travel to the healthcare center, have the device implanted, return home, and require monitoring despite distances. Another avenue of recruitment is monitoring of devices implanted by outside institutions. These patients have devices implemented in a facility outside of the monitoring organization. However, the initial facility lacks the capability to provide monitoring services, and as such, seeks out the bigger institution to provide monitoring services. In both cases, Linq remote monitoring systems are the common component for these situations.

Currently, roughly thirty new devices are being implanted monthly within the healthcare institution. Additionally, large numbers of implants are performed at smaller institutions. With such a significant need to provide services for these patients, monitoring centers are foundational for appropriate care, device usage, and product management.

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institutions. As a result of the increased device usage and need for appropriate monitoring centers, a competitive market for nurse-led care centers focused on remote device monitoring developed (Medtronic, 2014).

The development of a multidisciplinary, multi-institution process requires evaluation through strengths, weaknesses, opportunities, and threats (SWOT) analysis with a focus on providing appropriate, safe patient care (Penner, 2013). This type of structure presents unique challenges to the assurance of protecting private health information. Patients must be assured that their data is only shared with those requiring the information. Development of means essential to this step will be required prior to implementation of such a program. An additional challenge to this structure is creating the correct form of monitoring based on nursing protocol and procedure to ensure appropriate scope of practice per each pertinent role. The

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Budget Estimates for the ANAK Monitoring Clinic

For the initial year of clinic development, budget estimates will focus on start-up costs: equipment essential to monitoring, office furniture, and nonmedical supply. An estimate for these start-up costs during the first year is $16,300. Table 1 presents the data below.

Table 1: Estimated Start-Up Costs for First Two Years

Materials and Labor 2015

Monitoring Equipment: Computer and Printer $ 4,000

Office Furniture $ 5,000

Office Supply $ 7,300

Total cost for year one: $ 16,300 An operating budget for the proposed clinic includes specifics regarding gross revenue and expenses. Table 2 for outlines this information. ANAK clinic will be associated with the larger institution and located within the hospital grounds. Therefore, facilities fees are not

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Table 2: Estimated Operating Budget for First Two Years

Items 2015 2016

Operating Expenses

Personnel $ 240,000 $ 480,000

Monitoring Equipment $ 4,000

Office Furniture $ 5,000

-Nonmedical Supply $ 7,300 $ 4,800 Monitoring Access $ 50,000 $ 50,000 Total Operating Expenses $ 306,300 $ 534,800

Volume 360 860

Charge Per Patient $ 3,600 $ 3,600 Total Charges (Gross Revenue) $1,300,000 $3,100,000

Additional Financial Analysis for the ANAK Monitoring Clinic

The primary objective of this remote monitoring clinic is to identify potential cardiac arrhythmias for outpatient individuals, initiating the process of early interventions of

complications. As Table 2 outlined, the total operating cost of ANAK clinic in the first two years is estimated to equal $841,100. The clinic is projected to generate $1.3 million dollars in charges in the first year, and then double this figure in the second year. Therefore, the first two years will yield an estimated total of $4.4 million in gross revenue. Although this revenue will be

generated, we will focus on institution savings and prepare a corresponding cost-benefit analysis with a benefit-cost ratio.

Table 3: Projected Savings of ANAK Clinic versus Usual Care Savings

Type of Care ED Visits Average CostPer Patient Annual Cost

Usual Care 461.21 $ 1,526 $ 703,852

ANAK Clinic 253.7 $ 1,526 $ 387,116

Type of Care Length of Stay Per Patient DayAverage Cost Annual Cost

Usual Care 2.3 $ 5,718 $ 13,151

ANAK Clinic 1.9 $ 5,718 $ 10,864

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Projected institution savings generated from ANAK clinic include decreases to emergency department (ED) visits, and length of stay (LOS). Table 3 summarizes savings compared to usual care. The current rate of hospital ED visits related to AF is at a ratio of 5.8 to every 1,000 visits. A simple calculation to convert the number of annual ED visits into those related to AF was performed. ED visits related to AF at approximately 461 per year. This number is used to calculate the annual cost of usual care for AF, at approximately $703,852 per year. ANAK clinic is projected to reduce visits by 45% based on the findings of a similar

monitoring clinic study (Varma, Epstein, Irimpen, Schweikert, & Love, 2010) and is projected to be about 254 per year. This brings cost to $387,116 annually. A savings of $316,736 is projected, noting that the incidence of AF increases each year (AHA, 2014). Length of stay will be

impacted as the clinic will alleviate unnecessary traffic in emergency department related to non-threatening AF episodes. The usual care length of stay is 2.3 days versus the ANAK clinic reduction of LOS to 1.9 days. This reduction translates into a $2,287 savings per patient stay. Table 4 defines the total savings for year 1 and 2.

Table 4: Total Savings for Year 1 & 2

Item Est. Savings Year 1 Est. Savings Year 2

ED Visits Savings $ 316,736 $ 316,736

Length of Stay Savings $ 388,7112 $ 388,711

Total Savings $ 705,447 $ 705,447

2 Annual savings: LOS savings per patient x annual admissions for AF: $2,287 x 170 = $388,711

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Table 5: Cost Benefit Analysis and Benefit/Cost Ratio for the First 2 Years

Item Estimated First 2 Years

Operating Cost $ 841,100

Benefits $ 1,410,954

Cost-Benefit Analysis

Total Net Benefits $ 569,854

B/C Ratio 1.7

It may be simple to see the cost-benefits in dollars. Moreover, the institution will also see gains in qualitative benefits. Patient and nurse satisfaction will be one of the highest scoring of these benefits. Improved quality of life is mediated by piece of mind provided by continuous arrhythmia monitoring, reduction of symptoms, and the potential for elongated life spans through health issue identification and customized therapy. Qualitative benefits as a result of the

implementation of the ANAK Monitoring Clinic will include improved life quality, reduction of symptoms, and the potential for elongated life spans through health issue identification. An additional qualitative benefit includes enhanced patient empowerment and health knowledge base leading to improved direct care and higher patient satisfaction as a result of continuous personalized interaction between patients and their healthcare providers. This benefit was witnessed in a similar study on patients struggling with long-term heart problems and utilizing direct interaction such as this as an improvement strategy (Meyer et al., 2008).

ANAK Monitoring Clinic’s Timeline

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Table D.1: Implanted Cardiac Monitoring Clinic Establishment Timeline

Conclusion and Feasibility Statement for the ANAK Monitoring Clinic

Sudden cardiac arrest is a leading cause of death in the United States with estimates of between 180,000 and 450,000 individual effected annually which equates to roughly 7-18% of all deaths in the United States (AHA, 2014). A main goal of the implementation of this advanced cardiac monitoring clinic is to decrease these numbers by closely evaluating those at risk. The ANAK Monitoring Clinic is designed to treat a diverse group of people and can lead to a significant improvement in patient populations health outcomes (see Appendix E). Some of the many improved health outcomes include early identification of atrial fibrillation, multifocal atrial tachycardia, palpitations, paroxysmal supraventricular tachycardia, bradycardia, as well as, ventricular tachycardia (American Heart Association, 2014).

The healthcare available in the ANAK Monitoring Clinic is an excellent choice for those who recently experienced a heart attack and have been required long-term telemetry or those simply experiencing new onset A-fibrillation. This specific care will aid in the proper

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identification of atypical heart rhythms and help evaluate changes when patients have been recently started on a new cardiac medication. The implementation of the new community clinic will decrease hospital admissions and emergency room visits as cardiac disease and suspected cardiac disease has historically been one of the most common reasons for which adults are admitted to the hospital. Another important consideration is the savings of adding this service to the community. Without this outpatient-monitoring clinic, many will continue to fill up the emergency rooms, and hospital admissions will continue to increase. Often times, many patients are admitted solely for telemetry purposes. Therefore, this proposed clinic could drastically decrease the need for hospital telemonitoring. Also, telemetry in the hospital setting can be expensive and labor intensive. This clinic can lead to positive patient outcomes as often times many patient admissions may be delayed because of limited telemetry bed availability in the local hospitals. Therefore, the ANAK Monitoring Clinic can aid in the reduction of delayed patient care by providing more options for those in need as well as early detection. High revenue, increased efficiency in providing patients with state of the art technology, and immediate

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References

American Heart Association. (2014). Public health burden of sudden cardiac death in the United States. Retrieved from: http://circep.ahajournals.org/content/7/2/212.full

Aronow, W.S. (2009). Management of atrial fibrillation in the elderly. Minera Medica, 100(1), 3-24. Retrieved from

http://www.minervamedica.it/en/journals/minerva-medica/article.php? cod=R10Y2009N01A0003&acquista=1

Caring.com (n.d.) Atrial fibrillation facts and statistics 10 things you should know about atrial fibrillation. Retrieved from http://www.caring.com/articles/atrial-fibrillation-facts Clinical policy bulletin: Cardiac event monitors. (2008). Aetna.com. Retrieved from

http://www.aetna.com/cpb/medical/data/1_99/0073.html

Cortez, M. (2014). Paper clip-sized heart devices open new industry markets. Retrieved from http://www.bloomberg.com/news/2014-09-15/paper-clip-sized-heart-devices-open-new-medtronic-market.html

Crossley, G.H., Boyle, A., Vitense, H., Chang, Y., & Mead, R.H. (2011) The CONNECT (Clinical evaluation of remote notification to reduce time to clinical decision) trial: The value of wireless remote monitoring with automatic clinician alerts. Journal of the

American College of Cardiology, 57(10):1181-1189. doi:10.1016/j.jacc.2010.12.012

Fogoros, R. (2014). Syncope and its causes. About.com. Retrieved from

Heartdisease.about.com/od/syncopefainting/a/Syncope-And-Its-Causes.htm

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References

Mandrola, J. (2014). Dedicated atrial-fibrillation clinics: There is no ‘I’ in team. Medscape.

Retrieved from http://www.medscape.com/viewarticle/830731?nlid=64763_ 785&src=wnl_edit_medp_nurs&spon=24

Markides, V., & Schilling, R.J. (2003). Atrial fibrillation: classification, pathophysiology, mechanisms and drug treatment. Heart, 89(8), 939-943. Retrieved from

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1767799/

Medtronic. (2014a). Retrieved from http://www.medtronic.com/patients/fainting /device/our-insertable-cardiac-monitors/reveal-linq-icm/

Medtronic. (2014b). Hospital and physician reimbursement guide for ICD implants. Retrieved from http://www.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@crdm/documents /documents/2014-reimbursement-guide-icd.pdf

Meyer, C., Muhland, A., Drexhage, C., Floege, J., Goepel, E., Schauerte, P., Kelm, M., & Rassaf, T. (2008). Clinical research for patient empowerment: A qualitative approach on the improvement of heart health promotion in chronic illness. Medical science

monitor,14(7), 358-365.

Onboard Informatics (2013). Rochester, Minnesota [Data file]. Retrieved from http://www.city-data.com/city/Rochester-Minnesota.html.

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References

Probst, M.A., Mower, W. R., Kanzaria, H.K., Hoffman, J. R., Buch, E. F., & Sun, B.C. (2014). Analysis of emergency department visits for palpitations (from the national hospital ambulatory medical care survey). The American journal of cardiology, 113(10), 1685-1690. DOI: 10.1016/j.amjcard.2014.02.020.

Sposato, L.A., Klein, F.R., Jauregui, A., Ferrua, M., Klin, P., Zamora, R., Riccio, P.A., & Rabinstein, A. (2012). Newly diagnosed atrial fibrillation after acute ischemic stroke and transient ischemic attack: Importance of immediate and prolonged continuous cardiac monitoring. Journal of stroke and cerebrovascular disease, 21(3), 210-216. DOI: 10.1016/j.jstrokecerebrovasdix.2010.06.010.

Varma, N., Epstein, A. E., Irimpen, A., Schweikert, R., & Love, C. (2010). Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up the Lumos-T safely reduces routine office device follow-up (TRUST) trial. Circulation,

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Appendix A

Appendix A shows the disorganized and erratic fibrillation of the atria.

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Appendix B Appendix B illustrates the Medtronic Linq system.

Note. The data of the Medtronic Linq system from “Reveal Insertable Cardiac Monitoring

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Figure

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