The U.S. health care system is buckling under the burden of a large and growing population of patients with chronic diseases. Yet, the current medical model may not be optimal for serving the needs of these complex patients. Care of chronically ill individuals often suffers from 1) fragmentation, 2) communication gaps, 3) educational deficiencies, and 4) the episodic nature of physician visits. The model works well for younger, healthier individuals and those with acute illnesses, but the flawed current care delivery system with its consequent poor outcomes in CKD demands that newer approaches to care are needed.
Much attention has been paid to chronic diseases such as congestive heart failure (CHF) and COPD, and innovative care models have been developed and tested for these diseases. 1, 2 Chronic kidney disease, in its later stages (stage 4-5), often has substantial overlap (including extensive comorbidity) with these other diseases, sharing many characteristics of CHF and COPD. There are high rates of hospitalizations, medication errors, depression and failure to develop advance directives. Inadequate education and preparation for ESRD result in a low rate of preemptive transplantation (<2%), underuse of home dialysis modalities (<10%) 3 and “rocky starts” on hemodialysis. The best example is that by the time patients reach hemodialysis, 82% have a dialysis catheter in place rather than a permanent access. 3 While it can be argued correctly that many patients never have the opportunity to see a nephrologist prior to ESRD, outcomes are often suboptimal even when a patient receives pre-dialysis care.
Clearly one key need for improved late stage CKD outcomes is earlier patient identification and engagement. That requires broad systematic change to processes related to health screening, education, referrals and access to health care. These are largely beyond the scope of this article. Other barriers to optimal CKD care, however, are recognizable and addressable.
As discussed above, one problem in the care of patients with chronic disease is the episodic nature of medical treatment and the multiple physicians that treat CKD patients. As an example, most nephrologists will recall multiple instances of telling a patient of the need for arteriovenous fistula (AVF) placement and provide a referral to a surgeon, only to have the patient return a month or two later to the nephrologist with no access placed.
Nephrology and other specialty care
With late-stage chronic disease there is a lot that occurs between physician visits that advances the disease: excessive sodium intake leading to volume overload and medication changes, medication errors, and nonadherence to diet and prescribed medications to name a few. Fragmented care can be defined as treatment of the same patient by several different physicians, but with a failure of connection and communication. In late stage CKD, there are often multiple specialists involved with the patient’s care; treatment decisions can often be in conflict with those of other treating physicians, and without meaningful attempts at resolution.
In nephrology a good example is the relationship between nephrologists and cardiologists. In late CKD, impaired salt and water excretion superimposed on a high prevalence of congestive heart failure and left ventricular hypertrophy creates a circumstance in which volume shifts are common and poorly tolerated. The cardiologist sees a patient with dyspnea or edema and raises the diuretic dose. Weeks later the nephrologist finds that the creatinine has risen and lowers the diuretic dose. If not well coordinated, the repetitive bouncing back and forth frequently leads to hospitalization for either volume overload or dehydration and acute kidney injury. Educational gaps lead to delayed renal replacement therapy (RRT) modality selection, underuse of home therapies and preemptive transplantation.
The problems of late-stage CKD (stages 4-5) are analogous to other chronic diseases where innovative models of care have demonstrated success. The Healthy Transitions in Late Stage Kidney Disease Program (HT), developed by the Department of Medicine at Hofstra North Shore-Long Island Jewish School of Medicine in New York, was developed with these considerations in mind. In this article we will describe the program’s design and early results.
The Healthy Transitions program utilizes a collaborative model to improve processes and outcomes. To effectively accomplish reductions in cost, Healthy Transitions recognized that patients who consume the most in medical services must be proactively and comprehensively managed. HT was designed to deliver evidenced-based treatment interventions that focus on decreased hospital utilization and improved preparation for ESRD.
Coordinated efforts to improve health outcomes in the HT program are done through a combination of home visits, monthly telephone calls, telephonic weight management, and patient-specific educational sessions. Computer-based technological interventions, innovative treatment protocols, and principles of patient-centered medical home (PCHM-n) are key elements utilized to deliver comprehensive kidney care. This highly targeted program of medical intervention and disease management training aims to meet the needs of patients as individuals with personal and specific health care goals.
Early on, it was recognized that program design would significantly contribute to the success or failure of this new care model. The team noted that the program must utilize a collaborative model that works to actively incorporate the patient. The ability to deliver effective, patient-centered care is dependent upon the direct involvement of the health care professionals.
HT places an emphasis on specific key drivers in order to control cost and improve outcomes. Key components of the HT care delivery model include RN care managers, CKD informatics system, home visits, disease specific education, and evidence-based program protocol (see Table 1).
HT care managers are registered nurses who received two weeks of focused training on kidney disease. The nurses work in close collaboration with the treating nephrologist. Initially, each case is reviewed by the treating nephrologist and an initial home visit is scheduled once patient goals are determined. Ideally, the patient is visited by any key caregivers present as well. The visit includes kidney disease education, dietary counseling (including a view of the pantry to educate on problematic foods and reading food labels), RRT modality choice education, inspection of the home for potential safety issues, and medication reconciliation (a comparison is made against the physicians existing medication list). Patients are provided with a calibrated scale and instructed on how to do daily weight with phone reporting.
The care manager conducts multiple routine home visits based on risk stratification, service intensity, and educational needs. After the first visit all patients receive at least a monthly phone call. High-risk patients may be seen more frequently in the home as service intensity guidelines dictate. Nurse judgment and insight into patient condition may also warrant more frequent visits in the home. The care manager plays a key role between physician visits to ensure that the care plan is progressing, to address alerts generated by the informatics system, to identify new medical issues that emerge, and to connect information flow between nephrologists, other physicians and care providers. The aim of the care managers is to adequately prepare patients to effectively self manage their CKD and navigate a complex medical system. The nurses work to provide coordinated supportive care to patients as their disease progresses.
The nurses are supported by a CKD-specific informatics system. The system is a relational database with logic built on protocols to generate alerts. Each morning a report is emailed to nurses of their entire patient roster. For each patient, basic logistic and demographic information is included with reminders for upcoming program, or telephone or home visits. Alerts appear on the report for patients who have a significant weight change, medication discrepancies, or who haven’t yet made an ESRD modality selection. For patients choosing preemptive kidney transplantation or peritoneal dialysis, alerts direct the nurse to key preparation steps. For those choosing hemodialysis, alerts are generated using a protocol for making and keeping surgeon appointments, pre-surgical testing, date of surgery, and post-surgery follow-up in two-week steps until AVF maturation is achieved. The nurse uses this report to prioritize their day and to “triage” patients according to need.
A vitally important part of managing late-stage kidney disease patents is preparation for renal replacement therapy. The HT protocol initiates a discussion between the care manager and nephrologist to determine if a renal replacement therapy (RRT) discussion is appropriate. If, for example, metastatic cancer or advanced dementia is present, and RRT is not the best option, then the program goals shift towards supportive care, medical management, and development of advance directives. For all other patients, modality selection is considered to be a critical path step.
Until completed, this retains the highest level of program focus. The program prioritizes, as appropriate, preemptive living donor transplantation first, home dialysis next, and then in-center hemodialysis. Comprehensive education is provided to the patient. If the patient selects preemptive transplantation then the care manager works with the patient and transplant center to facilitate the transplant evaluation. If the patient and potential donors haven’t completed the evaluation in six months, the transplant evaluation continues but the program requires the patient to choose either HD or PD as a potential primary modality to ensure that some definitive modality choice is in place.
If the patient selects peritoneal dialysis, then the program requires a demonstration of commitment by the patient; a full session at the PD center and an appointment with a surgeon for evaluation of the abdomen for suitability for PD. If the patient completes these two steps then PD modality selection is considered to be adequately fulfilled and the patient is monitored until the appropriate time for PD catheter placement. For the patient who chooses in center hemodialysis they are placed immediately on the Countdown to Fistula protocol (see sidebar). For patients resistant to making a modality choice additional education is provided by the care manager and the patient’s nephrologist, preferably with involvement of key caregivers. Techniques of motivational interviewing are employed and staged over time.
'Low Salt Every Day'
Although individualized dietary counseling is provided to all patients, the vast majority also receive focused education on the need to follow a low salt diet every day. In contrast to hypertension, where general adherence to a low salt diet is helpful, in late stage kidney disease salt limitation is even more important. Because of reduced ability to adjust to salt and water excess, the frequent coexistence of congestive heart failure and a high prevalence of left ventricular hypertrophy, salt and volume excess are poorly tolerated by these patients. Moderate compliance with a low sodium diet isn't enough; even a single day of excess may cause pulmonary edema. Therefore, the program’s dietary focus for most patients is not just low sodium, but Low Salt Every Day.
In late-stage kidney disease, changes in volume status can lead to frequent hospitalizations. As a result, patients are expected to perform a daily weight and the weights are tracked for significant changes. The nurses receive an automated alert for any patient with weight changes and contact the patient to assess for symptoms and signs. If necessary the nephrologist is called to determine a treatment plan.
The research arm of the program has found a significant correlation between weight gain and hospitalizations for volume overload / congestive heart failure. Therefore, weight changes have become an instrumental part of disease and symptom management.
Medication sensitivity and errors are common in late stage CKD. Inaccurate medication lists may have a significant impact on patient outcomes in CKD. They may contribute to missed doses, under dosing, over dosing, therapeutic duplication, and polypharmacy. Managing daily medications for patients with complex chronic disease may be overwhelming. The nurse care managers reconcile medications on a monthly basis. The purest form of medication reconciliation occurs during home visits, where the care manager compares actual medications taken to the physician’s medication list. Discrepancies are resolved by discussion with the physician.
In late stage CKD, like most chronic diseases, there is a high prevalence of depression and anxiety. Contributing factors include the burden of illness, fear of uncertainty, lack of support and education and other factors. It is likely that there is under-diagnosis and inadequate treatment. Most of these patients have multiple medical problems; the greater the medical complexity the more likely that depression and anxiety are not recognized or wrongly passed off as symptoms of the patient’s medical illnesses. When present, depression and anxiety both complicate medical treatment as well as degrading the patient’s quality of life. The HT program evaluates for depression and anxiety at all patient contacts and uses PHQ-9 screening every six months to detect risk for depression more objectively. Care managers consult with the patient’s physician to develop treatment plans including referral to psychiatry as needed.
Safe at home
In the midst of multiple medical problems, there may be under attention to home safety, specifically as a risk for falls. During the home visit, the care manager assesses the home environment with special attention to loose carpeting or rugs, inadequate lighting, nightlights, clutter and other risk items. The care managers intervene as necessary to help create a safer home environment.
Dialysis Safe Start
Most new hemodialysis patients in the United States initiate dialysis in the hospital setting. In contrast, the HT program attempts to start dialysis in the outpatient dialysis center. An important prerequisite is in the planning stages, ensuring that the patient has been properly educated and that a working AV fistula is in place. Working closely with the patient’s nephrologist, patient stability is assessed, access function rechecked, and dialysis is appropriately started in the outpatient dialysis center.
The HT program philosophy is that advance directives are advisable for most patients with late stage CKD. The care managers work with the nephrologist, patient, and key caregivers on development of advance directives. Conservative medical management and palliative care options are also considered when patients choose to forego renal replacement therapies. If this is the anticipated plan then the importance of advance directives is greatly heightened.
Results to date
In the first year of operation, 167 patients were enrolled, with 84 patient-years and 1,024 patient-months of exposure. There were two patient deaths, or 0.04per patient-year. The hospitalization rate was 1.14 per patient-year. Modality selection occurred in 88% of eligible patients. The modality selections were in center hemodialysis at 54%, peritoneal dialysis at 32%, and preemptive transplantation in 14% of cases. Among patients actually reaching ESRD, the modality was in center hemodialysis in 64%, peritoneal dialysis in 24% and preemptive transplantation in 12%. (see Figure 1)
If in-center hemodialysis was the initial renal replacement therapy, the dialysis access was a working AV fistula in 68%, AV graft in 5%, catheter in 22% and a developing fistula with a catheter in 5%. Initiation of hemodialysis occurred in the outpatient dialysis center in 59% of cases. Patient satisfaction with the program was rated as satisfied or very satisfied by 96% of patients (see Table 2).
A key critical path step is the patient’s selection of a renal replacement therapy modality. Sufficiently early placement of a fistula or successful preemptive transplantation cannot occur without early modality selection. But there are multiple barriers that delay or block selection. The patient often has a degree of denial that ESRD is probably going to occur. A variety of factors contribute including depression, a lack of understanding about the disease process, fear of dialysis, the burden of multiple medical problems, and at times a lack of support. 4 The program counters these issues with education employing motivational interviewing skills. It was also noted that nephrologists occasionally enable the patient’s denial by not discussing ESRD directly enough. Some reasons for this include avoidance of conflict, viewing progression to ESRD as treatment failure, and misinterpreting periods of stable serum creatinine as true disease stability. Since nephrology is usually practiced without much discussion with peers, these barriers usually go unchallenged.
In the HT program modality selection is viewed as a vitally important when the serum creatinine is less than 20 ml/min. If the patient is appropriate for renal replacement therapy and the nephrologist doesn’t want modality selection discussed with the patient, the care manager reviews and discusses the patient’s case with the nephrologist. If unsuccessful, then the program’s medical director speaks with the nephrologist in an attempt to achieve agreement. Early in the program, nephrologist resistance to modality selection discussion was a major barrier to program success. As time passed the problem gradually receded; even the most resistant nephrologists became more agreeable to modality discussions. The improvement was driven by increasing trust over time with the care managers, sharing program success stories and case reviews.
Other challenges continue to exist. The ability to maintain dietary compliance over time requires repeated reinforcement. Depression is common in this patient population;5 it degrades quality of life and makes treatment compliance more difficult to achieve. With these patients’ multiple medical problems, depression may go unrecognized; patients need to be asked directly and educated on depression symptoms. For some patients, there may have been no previous life experience with depression, so the patient may express atypical symptoms, particular somatic symptoms.
For patients who choose in center hemodialysis, the Countdown to Fistula protocol is employed (see sidebar). However, decisions surrounding dialysis access are complex. In elderly patients and others with shorter life expectancy, an AV fistula is not always the optimal access choice. 6 Discussions with the nephrologist and patients are productive in more complex situations. For patients who have had an AV fistula placed, the program is highly vigilant in fistula post-surgical monitoring. Until maturity is established, an every-two-week assessment occurs with interventions as necessary. Patient acceptance of the intensity of follow up has been generally good.
Medication reconciliation can be difficult to complete. While the program is highly effective in identifying medication discrepancies, resolving medication conflicts can be more difficult. The care manager contacts the treating nephrologist first, but the nephrologist may not have been the prescribing physician. Attempts are made to contact the appropriate physician, but this can be a laborious process. The HT program does not currently have a consulting pharmacist, but in the future this may be an opportunity for further program development since medication errors are common in this population.
A paradigm shift in program nephrology culture and care has taken place since the initiation of Healthy Transitions. Medical management has moved to a more collaborative model. Patients and care team members are engaged in active partnerships. Patients have been empowered to partake in shared decision making. The Healthy Transitions in Late Stage Kidney Disease program has been successful in improving outcomes and patient experience in stages 4-5 CKD. In May 2014 the program was awarded a Centers for Medicare & Medicaid Innovation grant of $2.4 million for further program development and testing. In addition, a formal randomized control trial of the program is in progress. As with other chronic diseases, late stage CKD is ideal for care management and other innovative strategies to improve outcomes.
Countdown to Fistula Protocol
This protocol is designed to create an organized milestone-based approach, consistent with elements of the Fistula First Breakthrough Initiative. The nurses utilize the protocol to move patients forward until a functioning fistula is in place. The informatics system is designed to support these protocol specific alerts that are generated along the way to track progress. Among the major process steps is facilitating a first appointment with a surgeon, ensuring that vessel mapping occurs, reminding the patient to attend the appointment, help to schedule a date for surgery, ensuring that the patient has preadmission testing completed, day of surgery support, and then a protocol driven maturity assessment plan post surgery.
A 51-year-old man presented to a nephrologist in August 2013 following a hospitalization for kidney failure and abnormal labs. On 7/25/13, the patient presented to PMD c/o lethargy; labs revealed mild hyperkalemia and advanced CKD. Recognizing that this patient required intensive follow up and close monitoring, the attending nephrologist referred the patient to the HT program.
The HT program initiated late-stage CKD management including education and preparation for RRT. Effective disease and symptom management, with close collaboration, allowed dialysis to be delayed for five months. Close monitoring helped to avoid any subsequent hospitalizations. During these 5 months the program facilitated expedited transplant evaluation, corrected any medication conflicts, vaccine administration (within CDC and DOH guidelines for the HD patient), anemia management, and close symptom management. Countdown to fistula worked ideally; over a period of 12 weeks an AVF was established and maturation managed.
Office evaluation on 12/18/13 revealed the patient to be experiencing fatigue and lethargy. A planned outpatient “dialysis safe start” was executed by the team. The patient presented to the unit with a functioning AVF; ultrasound evaluation revealed a vein size of 6.2mm, depth of 3.1mm, and blood flow of 1227ml/min. He was successfully cannulated via 17 gauge needles without complication. Treatment was tolerated without complication.
The patient undergoes dialysis three times a week and the supportive and educational services offered by the HT program has allowed him to settle comfortably in his routine. An added success of the program is that this patient continues to pursue a living related donor transplant. Both donor and recipient are being actively evaluated.
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3. http://www.usrds.org/2013/pdf/v2_ch1_13.pdf accessed June 23, 2014
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6) Moist LM, Lok CE, Vachharajani TJ, Xi W, AlJaishi A, Polkinghorne KR, Vazquez M, Lee TC. Optimal hemodialysis vascular access in the elderly patient. Semin Dial. 2012 Nov-Dec; 25(6):640-8