Education of Hemodialysis-Dependent Patients Concerning the Use of Phosphorus Binder in Lieu of Dialysis during Emergencies
Clinical Leadership Theme:
The clinical leadership competency/role and/or magnetism thread that is the framework for this project requires effective transformational leadership practices that can motivate all stakeholders to become educated concerning the use of phosphorus binders in lieu of dialysis (Cook, 2004).
Patient: Hemodialysis-dependent patients
Intervention: EDUCATE and train to use phosphorus binder
Comparison: in lieu of no hemodialysis treatment during power outage or emergency
successful return demonstration of how and when to use phosphorus binders
Time: 80% of 99 patients educated by August 30, 2015.
This project involves training selected clinical staff members to provide educational support services to hemodialysis-dependent patients concerning the use of a phosphorus binding drug, Renagel to prepare them for the event of an emergency situation when dialysis services are unavailable.
AIM statement: The AIM statement that will guide this initiative is as follows: By August 15, 2015, 80% of hemodialysis dependent patients will be educated and prepared/trained to use phosphorus binder in lieu of hemodialysis treatment during power outages or other emergency situations.
The use of phosphorus binders for hemodialysis patients is not new, and the original binders were aluminum-containing phosphorus that were shown to be highly effective in lowering phosphorous levels; however, these original phosphorus binders resulted in multisystem toxicity and their use was therefore discontinued for the most part (Beyzarov, 2009). An alternative was found in calcium-containing binders which were regarded as safer but this intervention was found to cause accumulation of calcifications in multiple tissues that resulted in increased patient mortality, especially among patients with advanced stage chronic kidney disease and their use was largely discontinued as well (Beyzarov, 2009).
Since its approval, the use of non-calcium-, non-aluminum-containing phosphorus binders gained increased acceptance by the healthcare community following the publication of the results of a study in Kidney International that showed patients who were treated with sevelamer experienced significantly lower mortality rates related to the control of coronary artery calcifications vs. patients who were treated with calcium-based phosphate binders (Beyzarov, 2009). These drugs represent potentially life-saving alternative treatments for hemodialysis-dependent patients during emergency situations when power is lost or dialysis equipment is otherwise inoperable (Lemieux & Chamberlinon, 2015).
a. Kotter’s Eight-Step Model (change theory) applies perfectly to the development of my educational project on phosphorus binder for dependent hemodialysis patient. Kotter’s model is best viewed as a vision for the change process and for avoiding major errors in the change process (Mento, Jones & Dirndorfer, 2002). The model calls attention to the key phases in change process. The Kotter’s eight-phase model proposed as follows below.
1. Establish a sense of urgency because opportunities or crisis demand a change now. The development of this project was based on urgent need for change. After national earthquakes, hurricane and general power outages, it was found that hemodialysis-dependent patients did not have an alternate solution available during emergency situations.
2. Create a guiding team to form change agents with credibility, authority and skill to assist in the change process — We have established a core team of educators that go from patient to education and answer questions.
3. Develop a change’s vision and strategy — Part of the education process is making sure that each patient understands the need for phosphorus binders when an emergency hits and they cannot get to dialysis treatments.
4. Clearly communicate the change vision — This is done both in group as well as one-on-one with patients. All well trained team of educators that have the same vision so that the same education is provided to each and every patient.
5. Empower the individuals involved in the change process by removing obstacles, changing structure, rewarding new ideas. This is the main goal of my project, to empower patient with the knowledge they need when my nurse team and myself cannot be there. Giving each individual the booklets and medication is not enough to ensure their survival during a power outage or earthquake when they cannot get needed dialysis treatments.
6. Generate short-term success, celebrate and reward early success — This step is not yet developed, but there is talk for creating a plan to celebrate patient successes.
7. Consolidate gains and continue change — This is part of the long-term plan to including phosphorus binder in all education for all future patients.
8. Make change stick to anchor new behavior into the culture.
It is noted that the model provides a key lessons. The lesson is that the change process goes through a series of phases that are long and considerable amount of time. The lesson is that any mistakes that occur in any phases can have an adverse impact on the momentum of the change process (Mento et al., 2002). It is through the adverse momentum that clinicians will be able to identify needs for adjustment. Each adjustment creates a stronger anchor for a long-term plan of action/change.
b. What actions will you take when the project is implemented? The project will be implemented in a series of steps as follows:
1. Conduct project management and training for CNL students
2. Conduct core staff meetings over a period of 10 weeks
3. Purchase phosphorus binder
4. Conduct staff education over of period of 10 weeks
5. Create printed educational materials (i.e., brochures and leaflets)
6. Conduct follow-up patient evaluations concerning their knowledge levels about the proper use of Renagel when dialysis services are unavailable during emergency situations.
Each of these steps is important to the success of the project, but implementing any type of change in an organizational setting will inevitably experience unexpected obstacles and challenges, including (a) cognitive and psychological barriers, (b) resource limitations, and (c) a lack of motivation to change (Gobble, 2013). Moreover, all stakeholders will need to “buy in” to the change initiative in order for it to succeed. For instance, according to Gobble, “The key to overcoming these barriers, and creating sustained change, is to anchor behavioral or systemic changes in culture change. You can’t change the way an organization behaves without changing the way it thinks. And that means changing the thinking of every individual within the organization” (2013, p. 63).
In order to effect this type of meaningful and sustained change in any type of organizational setting requires more than simply hoping for optimal outcomes, and involves determining what factors are most salient in preventing its uptake by all clinical staff members. This process may require some hard work on the part of the principal researcher in order to overcome these constraints to change. In this regard, Gobble points out that, “Accomplishing that requires leveraging the discoveries of psychology, to motivate people and overcome their cognitive and emotional resistance to change” (2013, p. 63). In addition, in order for this change initiative to succeed, it must have the unflagging support of the organization’s nursing leadership (Tobias, 2015).
c. What data results will you collect to check if your project is effective? All patients who receive educational support services concerning the use of phosphorus binders when dialysis services are unavailable for whatever reason will be tested 2 weeks post training to determine their level of knowledge concerning the proper use of these drugs.
What are your predictions and how will you check your predictions with the expected results? The main prediction of this prospectus is that a significantly higher percentage of patients who receive educational support services from clinical staff members will demonstrate higher levels of knowledge concerning the proper use of this or like drugs when dialysis services are unavailable for whatever reason compared to patients who do not receive such educational support services. A viable approach to checking the accuracy of this prediction is to test a random sample of patients who received educational support services with a comparable group of patients at a different tertiary healthcare facility who did not receive such educational support services.
Data Source/Literature Review:
The focus of this study concerns the use of phosphorus binders when dialysis services are unavailable for whatever reason by hemodialysis-dependent patients. There is a growing body of evidence that supports this alternative. For instance, a study by Sheikh, Maguire, Emmett et al. (2009) reports that phosphorus binding can assume various forms, including a chemical reaction between dietary phosphorus and cation of the binder compound, adsorption of phosphorus ions on the surface of binder particles, or in some cases, a combination of both of these processes. Until fairly recently, a variety of aluminum-containing antacids were used as phosphorus binders but studies have demonstrated that the long-term use of aluminum compounds by patients with chronic renal failure is associated with risk of serious aluminum toxicity which has resulted in a search for safer alternative phosphorus binders (Sheikh et al., 2009).
Similarly, a study by Emmett (2004) argues that the optimal approach for phosphorus maintenance in hemodialysis-dependent patients is to balance the net amount of phosphorus that is absorbed from the gastrointestinal tract to correspond to the decreased kidney function. While chronic dialysis therapy can achieve this balance, it is very challenging to reduce dietary phosphorus to appropriate levels and a wide range of phosphorus binders have been used for this purpose (Emmett, 2004).
More recently, non-calcium-, non-aluminum-containing phosphorus binders have been shown to be considerable improvement over these two interventions (Beyzarov, 2009). In this regard, Beyzarov reports that, “The new binders were not systemically absorbed and provided phosphorus control without concerns of calcium or metal accumulation” (2009, p. 9). Therefore, this study is especially appropriate based on this burgeoning body of evidence that this drug is effective in treating these patients and improves survival rates. For instance, Kalantar-Zadeh (2013) reports that chronic kidney disease has been linked to an increased risk of cardiovascular disease and mortality which is associated with traditional cardiovascular risk factors such as diabetes and hypertension. The research to date also indicates a significant link between elevated serum phosphorus and mortality in dialysis patients (Kalantar-Zadeh, 2013). The highest risk of death in hemodialysis patients is hyperphosphatemia (Kalantar-Zadeh, 2013). Therefore, phosphorus binders represent a valuable tool controlling hyperphosphatemia (Kalantar-Zadeh, 2013).
Likewise, a study by Isakova et al. (2009) evaluated a prospective cohort study of 10,044 incident hemodialysis patients using Cox proportional hazards analyses to analyze 1-year all-cause mortality among patients receiving or not receiving phosphorus binders. These researchers compared patients beginning treatment with phosphorus binders during the first 90-day period following initiation of hemodialysis with patients who were left untreated during the same period of time (Isakova et al., 2009). Based on the results of their study, Isakova and his colleagues found that treatment with phosphorus binders is independently associated with improved survival among incident hemodialysis patients. While additional research in this area is needed, Isakova and his associates conclude that phosphorus binders represent a valuable tool in treating patients with chronic kidney disease.
A study by de Francisco (2008) argues that while there have been a number of researchers have evaluated the efficacy of phosphorus binders in decreasing serum phosphate levels that have uniformly found the intervention effective, there remains a paucity of research to date concerning its efficacy compared to other phosphorus-chelating agents. The results of the few studies in this area have indicated that phosphorus binders and calcium compounds are equally efficacious after 1 year of treatment; however, phosphorus binders were shown to have some additional beneficial effects include a lower incidence of hypercalcemia, a minimal decrease in serum calcium levels, lower incidence of low PTH levels, lower LDL-cholesterol, and a significantly lower percentage in the mean absolute score of calcium within the coronary arteries and aorta (de Francisco, 2008). In addition, phosphorus binders were also shown to decrease C. reactive protein values vs. calcium compounds (de Francisco, 2008). It should be noted, though, that phosphorus binders should not be used for patients with chronic kidney disease who are not actively receiving hemodialysis because it induces metabolic acidosis (de Francisco, 2008).
People from every region of the country who require routine hemodialysis treatments may experience emergency situations such as tornadoes, hurricanes, microbursts, or other natural or manmade disasters that can render this equipment inoperable for lengthy periods of time. Consequently, these patients require a viable alternative until the emergency situation is resolved and hemodialysis services are restored. The research was consistent in showing that phosphorus binders represent a viable intervention for hemodialysis-dependent patients, but these patient must receive appropriate and timely educational support services in order to avoid unnecessary complications and side effects and to improve the long-term effectiveness of the internvention.
Patient, Population, or Problem
The patient population of interest spans all walks of life and regions of the country, but there are some commonalities that are associated with the condition that can help describe them as a group. For instance, dialysis is an uncomfortable and expensive process, and it does not cure chronic kidney disease. The intervention, though, can significantly extend life expectancy for dialysis patients (Dialysis, 2015). According to the U.S. National Kidney Foundation, “Average life expectancy on dialysis is 5-10 years, however, many patients have lived well on dialysis for 20 or even 30 years” (Dialysis, 2015, para.5).
Intervention, Prognostic Factor, or Exposure
The main intervention of this project is hemodialysis-dependent patient education concerning the proper use of phosphorus binders during emergency situations when dialysis services are unavailable. It is well documented that hyperphosphatemia is a risk factor for mortality, but there remains a paucity of timely and relevant studies concerning whether therapy with phosphorus binders affects survival rates among hemodialysis-dependent patients (Isakova, Gutierrez, Chang et al., 2009).
Comparison or Intervention
The main alternative to compare with the intervention is the knowledge level of a comparable group of hemodialysis-dependent patients who did not receive educational support services concerning the proper use of Renagel.
The intended outcome of this intervention is to provide hemodialysis-dependent patients with the education they need to use Renagel when dialysis services are unavailable for whatever reasons to improve their survival rates as indicated by successful return demonstration of how and when to use phosphorus binders.
Timeline: This project started in May 2015 — August 30, 2015 with the goal of having 80% of 99 patients educated by August 30, 2015.
Expected Results: There are two main outcomes that are expected from this initiative as follows:
1. Participating nursing staff members will become more cohesive as a team; and,
2. Hemodialysis-dependent patients will be better prepared for self-care during emergency situations when dialysis services are unavailable.
Nursing Relevance: Nurses are on the front lines of providing patients with the information they need to achieve optimal clinical outcomes and have a fundamental responsibility to help educate their patients concerning effective self-care methods (Xu, Shelley & Shen, 2012).
CNL Student costs = 220 hours for project management and planning = Free
Core staff for meeting attendance = $60 per hour x 5 employees per meeting for 10 wks = $3,000
Cost of Phosphorus binder = Medicare/Medicaid covers cost to all ESRD/CKD patients.
Cost of staff education = $60 x 5 employees with 5 x 30 minute educational meets in 10 weeks = $1,500
Cost of printed education material (brochure, leaflet) =300 brochures and leaflets = $150
Knowledge is power. This educational project aims to empower patients with the ability to protect themselves during a power outage or natural disaster.
Decreasing stress of patients during emergency, because that know that have a short-term alternative (phosphorus binder) in lieu of the needed hemodialysis.
Reduced burden of illness (Chronic Kidney Disease) due to lack of hemodialysis access during emergency
Improvement in life-saving measures by having access to emergency supply of phosphorus binders
No health complication such as cardiac arrest, MI, CVA, neuropathy, and/or problems breathing (respiratory acidosis)
Decreased chance of organ failure due to no access to hemodialysis.
Avoidance of possible hospital admittance.
All of the benefits are invaluable to both the patients and the facility. Patients survive to return to the facility for further treatment. Education is empowering the patient to take an active position in their healthcare. It also helps reassure patients that they will not be a burden on their families during power outages or natural disasters.
The total cost of the project is $4,650. The benefit of this project far exceed the time and cost of the overall project. There is no alternative for dialysis dependent patient during an emergency beside hospital admission or possible death. This project given patients freedom and hope of survival.
Beyzarov, E. (2009, November 19). Improved phosphate binder approved for dialysis patients. Drug Topics, 151(22), 9-11.
Brogdon, R.M. (2013). A self-care educational intervention to improve knowledge of dietary phosphorus control in patients requiring hemodialysis: A pilot study. Nephrology Nursing Journal, 40(4), 313-318, 327.
Cook, M.J. (2004). Learning for clinical leadership. Journal of Nursing Management, 12(6), 436-444.
de Francisco, A.L. (2008). Should we consider the cost-effectiveness of the different therapies when applying the recommendations on phosphorus-chelating agents? Nefrologia, 28(2), 129-134.
Emmett, M. (2004). A comparison of clinically useful phosphorus binders for patients with chronic kidney failure. Kidney International, 66, S25 — S32.
Gobble, M.M. (2013, October). Creating change. Research-Technology Management, 56(5), 62-69.
Kalantar-Zadeh, K. (2013, May 3). Patient education for phosphorus management in chronic kidney disease. Patient Preference & Adherence, 7, 379 — 390. doi: 10.2147/PPA.S43486.
Isakova, T., Gutierrez, O.M., Chang, A.S. et al. (2009, February). Phosphorus binders and survival on hemodialysis. Journal of the American Society of Nephrologists, 20(2), 388 — 396. doi: 10.1681/ASN.2008060609
Lemieux, S.M. & Chamberlin, K.W. (2015, April). FDA approves ferric citrate to treat hyperphosphatemia in dialysis patients. Drug Topics, 159(4), 33.
Mento, A., Jones, R. & Dirndorfer, W. (August 2002). A change management process: Grounded in both theory and practice. Journal of Change Management, 3(1), 45-70. Retrieved from EBSCO Host, AN 7329277.
New products. (2009, May 12). Drug Topics, 152(6), 77-79.
Renagel. (2015). RxList. Retrieved from http://www.rxlist.com/renagel-drug.htm.
Sheikh, M.S., Maguire, J.A., Emmett, M. et al. (2009). Reduction of dietary phosphorus absorption by phosphorus binders. A theoretical, in vitro, and in vivo study. Journal of Clinical Investigation, 83, 66-73.
Tobias, R.M. (2015, Spring). Why do so many organizational change efforts fail? The Public Manager. 44(1), 35-39.
Xu, Y., Staples, S. & Shen, J.J. (2012, December 1). Nonverbal communication behaviors of internationally educated nurses and patient care. Research and Theory for Nursing Practice, 26(4), 290-299.
Young, E.W., Albert, J.M., Satavathum, S. et al. (2005). Predictors and consequences of altered mineral metabolism: The Dialysis Outcomes and Practice Patterns Study. Kidney International, 67, 1179 — 1187.
Root Cause Analysis
Emergency situations demand emergency responses in life-threatening situations, and some alternative must be made available to hemodialysis-dependent patients when these services are unavailable. A growing body of evidence supports the use of phosphorus binders for these patients as a short-term alternative to hemodialysis.
Additional research is needed to determine the long-term effects of phosphorus binders on hemodialysis-dependent patients who experience repeated power outages or other emergency situations on a routine basis.
The results of this study can be used by other hemodialysis facilities as a contingency plan for their own patients during emergency situations that disabled hemodialysis equipment.
n important point made by Young, Albert, Satayathum et al. (2004) is that while phosphorus binders improve survival rates for hemodialysis-dependent patients, patient compliance with phosphorus binding regimens is generally poor and requires careful clinical oversight to ensure patients comply with medication protocols and avoid under- or over-dosages in order to maintain proper blood serum levels, a finding that lends further support to the need for this intervention.
Manufacturer’s clinical guidance concerning the proper use of Renagel (sevelamer hydrochloride)
According to the manufacturer, Renagel is a polymeric amine-binding phosphate that is also available in generic form. Indications for the use of Renagel include the control of serum phosphorus in hemodialysis-dependent patients with chronic kidney disease. It is important to note, though, that the efficacy and safety of the use of Renagel by chronic kidney disease patients who are not receiving dialysis have not been studied. Some side effects that have been reported as a result of using Renagel include (but are not limited to) the following: severe stomach pain, constipation, fever, chills, body aches, or flu symptoms (Renagel, 2015). In addition, allergic reactions to Renagel include hives; difficult breathing; swelling of the face, lips, tongue, or throat (Renagel, 2015). The following side effects require patients to cease taking Renagel and to contact their physician immediately:
Black, bloody, or tarry stools;
Constipation that gets worse or does not clear up;
Severe constipation with stomach pain; or Fever, chills, body aches, flu symptoms (Renagel, 2015).
As shown in Figure 1 below, Renagel is available in 400 mg tablets as well as 800 mg tablets (not pictured).
Figure 1. Representative Renagel tablet (400 mg) (The tablet imprint contains iron oxide black ink.)
The recommended starting dose of Renagel is 800 to 1600mg in patients with chronic kidney disease on dialysis. Renegel decreases ciprofloxacin by about 50% but had no effect on Lanoxin (digoxin), Coumadin (warfarin), Vasotec (enalapril), Lopressor, Toprol XL (metoprolol), and iron. The effect of Renagel on the absorption of vitamins and other nutrients has not been studied in pregnant women. The effect of Renagel on labor and delivery in humans are not known. The safety and effectiveness of Renagel in the pediatric population has not been established (Renagel, 2015).
The active ingredient contained in Renagel tablets is sevelamer hydrochloride, which is a polymeric amine that is a phosphate binder intended for oral administration. According to the manufacturer’s clinical guidance, “Sevelamer hydrochloride is poly (allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly (allylamine-co-N, N’-diallyl 1,3-diamino-2-hydroxypropane) hydrochloride” (Renagel, 2015, para. 3). Although insoluble in water, sevelamer hydrochloride is hydrophilic and its structure is depicted in Figure 2 below.
Figure 2. Chemical Structure of Sevelamer Hydrochloride
As shown in Figure 2 above, the main amine groups in the sevelamer hydrocholoride structure are obtained directly from poly (allylamine hydrochloride) and the crosslinking groups are comprised of two secondary amine groups that are obtained from poly (allylamine hydrochloride) as well a single molecule of epichlorohydrin (Renagel, 2015).
Renagel tablets are packaged in a film-coat and contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis; the drug’s inactive ingredients include hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid (Renagel, 2015).
The precautions for taking sevelamer hcl (Renagel) include the following:
Before taking sevelamer, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood phosphorus levels, stomach/intestinal problems (such as blockage, constipation), stomach/intestinal surgeries, swallowing problems (dysphagia).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits
SIDE EFFECTS: Headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: problems with your dialysis access site, severe constipation/inability to have a bowel movement, stomach/abdominal pain or swelling.
Get medical help right away if you have any very serious side effects, including: trouble breathing, chest pain, pain/redness/swelling in the lower legs.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist (Renagel, 2015, para. 5).
Some important guidelines for the use of Renvela include the following:
The starting dose of Renvela is one to two 800-mg tablets three times per day with meals. The dosage should be adjusted by one tablet per meal in two-week intervals as needed to obtain serum phosphorus target (3.5 to 5.5 mg/dl).
When administering an oral medication for which a reduction in bioavailability would have a clinically significant effect on its safety or efficacy, the drug should be administered at least one hour before or three hours after Renvela.
Most frequently occurring adverse reactions for Renvela in a short-term study included nausea and vomiting. Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported (Beyrazov, 2009).
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