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Nephrology Dialysis Transplantation 2007 22(Supplement 9):ix39-ix44; doi:10.1093/ndt/gfm448
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© The Author [2007]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org


How Do We Re-Design the Treatment?

A Background Paper prepared for the UK Consensus Conference on Early Chronic Kidney Disease

Joy Tomlinson

SpR Public Health Medicine, NHS Greater Glasgow & Clyde

Correspondence to: Dr Joy Tomlinson, SpR Public Health Medicine, NHS Greater Glasgow & Clyde. Email: joy.tomlinson{at}ggc.scot.nhs.uk



   Introduction
Top
 Introduction
Guidelines
 Evidence from the literature
 Models of care
 Quality and outcomes framework
 Cost
 Information strategy
 Conclusion
 References
 
Early chronic kidney disease (CKD) is now known to be a relatively common problem. Prevalence studies worldwide have estimated that between 6% and 11% of the population has CKD [1]. One recent estimate carried out in the UK found that 4.9% of the general practice population studied had an estimated glomerular filtration rate equivalent to stages 3–5 CKD [2].

There is now reliable research evidence to support a variety of clinical interventions that will benefit patients with CKD [3]. However, very little evidence is available in the literature to recommend the most effective way of delivering healthcare for patients with early CKD [3]. These patients comprise a complex group and unfortunately they often have significant comorbid conditions [4,5]. Specialist services would be overwhelmed if they attempted to manage all patients with early CKD [5]. It is important that all countries carefully consider how best to deliver healthcare for this large group of patients in future. This paper will describe the guidance currently available from formal guidelines, research evidence and proposed models of care.



   Guidelines
Top
 Introduction
 Guidelines
Evidence from the literature
 Models of care
 Quality and outcomes framework
 Cost
 Information strategy
 Conclusion
 References
 
Since the introduction of the National Kidney Foundation practice guidelines for chronic kidney disease (K/DOQI) in 2002 [6] a number of guidelines have been developed around the world [7]. In March 2006, the UK guidelines for identification, management and referral [3] were produced and a number of UK regional guidelines have also been developed [8–10]. Currently, the Scottish Intercollegiate Guidelines Network (SIGN) is consulting on draft guidelines for the diagnosis and management of chronic kidney disease [11].

These guidelines have been produced in response to the recognition that early CKD affects large numbers of our population and that by managing the condition optimally at an early stage the number of individuals progressing to established renal failure (ERF) and dying prematurely from cardiovascular disease could be reduced. All of the above guidelines use the K/DOQI classification [12] of CKD stages 1–5. Most guidelines recommend that identifying individual risk factors for CKD is important but stop short of recommending the introduction of population screening for the condition. The UK guidelines discuss the uncertainty of the best methods to use when patients are being monitored or referred for specialist care [3]. The authors note that they do not consider it possible or practicable for all CKD patients to be managed under the care of a nephrologist. They argue that the elements of care that could be delivered in primary care should take place there to avoid overwhelming the specialist service. No specific recommendations are made about how the health service should deliver care to this patient group. The UK guidelines suggest that a variety of models of health care delivery may develop including the traditional shared care model, specialist general practitioner management, involvement of specialist nurses or development of computer-based shared care [3].



   Evidence from the literature
Top
 Introduction
 Guidelines
 Evidence from the literature
Models of care
 Quality and outcomes framework
 Cost
 Information strategy
 Conclusion
 References
 
Very few research studies have been carried out to investigate the effectiveness of health care to patients with early CKD. However, some consensus is emerging about the best way to organize care for these patients. Many commentators emphasize the importance of collaboration between primary and secondary care [4,13,14]. Some emphasize the importance of allowing GPs to take the lead caring for early CKD patients [15]. They suggest that nephrologists would be overwhelmed if they tried to take responsibility for managing this entire group. However, it is also suggested that nephrologists should provide GPs with guidelines and should provide an initial assessment for care [15]. It is clearly important that primary care physicians are able to access nephrology services rapidly and are supported by specialist advice. Later referral to nephrology results in poorer outcomes, less opportunity for adequate renal protection and cardiovascular intervention and inadequate time to prepare for renal replacement therapy [16–18].

Evidence shows that there is a need to identify and manage patients with early CKD to reduce the likelihood of progression to ERF and development of comorbidities [1,19]. However, concerns have been expressed by reviewers that much more research is needed to determine the natural history of patients with GFR between 60 and 90 ml/min [15]. These patients fall into the K/DOQI stages 1 and 2. We do not yet know if they are at risk of developing ERF or if therapeutic intervention at this stage would be beneficial.

Some commentators suggest that population screening should be considered to identify patients with early CKD as a means of attempting to reduce the incidence of patients with ERF [20,21] (this is already happening in Singapore). However, most authors urge caution as many issues are yet to be resolved. The US and UK guidelines do not suggest carrying out mass population screening for CKD. They recommend that specific groups of patients at high risk of CKD should be identified and offered screening. These include patients with hypertension, diabetes or a positive family history of ERF [3,6]. A recent study compared these screening strategies and found that a modified version of the US K/DOQI guidelines was the most effective strategy [22]. However it also found that few patients with CKD stages 3–5 progressed to develop ERF. Population screening targets people who are currently well and the screening process itself may have a negative effect [23] on their health by labelling people as a ‘renal patient’. Further research is necessary to demonstrate if earlier intervention results in better outcomes and the cost-effectiveness of any strategy must be investigated [24].

Secondary care studies
A limited number of research studies have examined care delivery to patients with early CKD in a secondary care setting. One single-centre randomized controlled trial in the US compared an intensive multidisciplinary case management programme with usual care for primary care patients with chronic renal insufficiency [25]. Patients received intensive case management for 2 years and were followed up for 5 years. The study found few demonstrable benefits of the intervention on patient management and there were no effects on patient outcomes.

In contrast, a small UK single-centre cohort study followed up 76 patients with diabetic nephropathy [26]. The aim was to discover whether referral to a nephrology clinic slowed the rate of progression of diabetic nephropathy. The investigators used regression analysis of serum creatinine against time to measure the rate of decline in renal function. In 30 patients, there was significant slowing in the rate of renal decline following attendance at the nephrology clinic. This suggested that referral to a nephrology clinic did slow decline in renal function.

Primary care studies
There are very few studies examining the care of patients with early CKD in primary care. Most studies have been carried out in the US and involve patients belonging to Health Maintenance Organizations. These have found that some areas of care for patients with CKD could be improved [27,28]. In particular, they highlight low levels of ACE inhibitor prescribing and a high prevalence of anaemia. However, it is clearly not possible to extrapolate their findings to health care provided in the UK.

Delivery of care to patients with chronic diseases in primary care is now usually carried out within multidisciplinary teams [29]. These teams may include nurse case managers, clinical pharmacists, social workers, lay health workers and medical specialists. Good communication between team members is essential. One descriptive study in the US was carried out to evaluate whether pharmacists could support primary care physicians in identifying and treating patients with CKD [30]. Investigators carried out a case record review of all diabetic and hypertensive patients treated at a primary care centre. The pharmacists determined whether there was an indication for further monitoring of patients, referral to a nephrologist or changes to medication. The investigators found 30% of recommendations from pharmacists were accepted by physicians without alteration. The authors postulated that the poor uptake of advice occurred because only written advice was left for physicians and that better communication may have higher acceptance levels.



   Models of care
Top
 Introduction
 Guidelines
 Evidence from the literature
 Models of care
Quality and outcomes framework
 Cost
 Information strategy
 Conclusion
 References
 
Increasing numbers of patients are living with chronic diseases worldwide. Providers of health care are struggling to optimally manage these conditions using systems more suited to care of acutely ill individuals. It has been argued that health care systems should be redesigned in order to manage people with chronic conditions. The chronic care model (CCM) described by Edward Wagner [31] is one proposed method of redesigning care for patients with chronic illness. It describes three domains where chronic care takes place, the first within the wider community, the second within the health care system as a whole and the third within the provider organizations (GP surgeries in the UK). He also describes six essential interdependent elements that support this model. Community resources such as home care agencies should be linked to primary care and chronic disease should be a priority within the health care system with adequate reimbursement for care providers. Patients should be enabled to self-manage their condition. The delivery system should separate acute care and planned management of chronic conditions. Decision support is recommended by integrating guidelines into practice. Finally, he recommends that clinical information systems should be available to aid guideline compliance, to give feed back to clinicians and to act as registries to guide population-based care.

In one recent review in the US, the CCM was compared with disease management programmes [32]. Disease management is a system of care allowing private health plan providers to work directly with patients and guide management of their condition without involving primary care practices. In the disease management model nurse case managers co-ordinate patient care, their main focus to change the behaviour of patients rather than to change the practice of primary care physicians. There is no evidence that either model of care provides cost savings, but reviewers suggest that disease management is likely to be favoured by private health plan providers because it gives them greater control over care delivery. The disease management approach has also been described in the care of patients with ERF [33].

A Cochrane review of ‘Interventions to improve management of diabetes in primary care, out-patient and community settings’ included studies with some elements of the CCM [34,35]. The authors concluded that multifaceted interventions could improve the performance of health professionals. However, this review included only a small number of studies and did not look specifically at care for patients with CKD.

A number of reviewers and commentators have emphasized the importance of collaboration between primary and secondary care in the care of patients with CKD. There is an evidence base to support this approach. Stepped care models are described in the literature [36,37] and in this care structure consultants work more closely with general practitioners and may visit health centres to advise on patient care. Four levels of care are provided ranging from delivery entirely in a primary care setting to care delivered predominantly by the specialist service [37]. Primary care doctors are responsible for the initial diagnosis and initiation of treatment. Nurses play a prominent role in actively following up patients and monitoring progress. Specialists provide co-management of patients in the primary care setting when they are not progressing as expected. The care of the most complex cases is taken over entirely by the specialist service. Outcome data are monitored and this allows care to be stepped up or down as needed.



   Quality and outcomes framework
Top
 Introduction
 Guidelines
 Evidence from the literature
 Models of care
 Quality and outcomes framework
Cost
 Information strategy
 Conclusion
 References
 
The new General Medical Services (GMS) contract for General Practice was introduced in April 2004 [38]. This contract was negotiated on a UK-wide basis between representatives of the British Medical Association and the national government. General practitioners are now no longer required to provide out of hours care for their patients and receive additional payments for extra services (described in the contract as enhanced services).

The new GMS contract also includes the development of a Quality and Outcomes Framework (QOF) [39]. The QOF is a voluntary component of the new contract where GP practices can earn up to 1050 points by meeting a detailed list of evidence-based indicators. The framework is split into four sections: a clinical domain with 10 disease areas; an organizational domain; patient experience domain and additional services domain. In national guidance accompanying the new contract it was emphasized that the purpose of the QOF is to resource and reward good practice not to performance manage GPs [40]. The data required to calculate payments for practices are extracted from practices’ own computer systems. No identifiable patient information is extracted from surgeries. The computing system merely counts the number of individuals coded for a particular indicator. Unfortunately this means that we have only limited epidemiological information from the QOF because demographic details, such as the age and sex of patients in the primary care disease registers, remains unknown.

The new GMS contract was reviewed again this year and changes came into effect on 1 April 2006 [41,42]. Several areas within the QOF were revised and there were new additions to the list of indicators. One new addition was for CKD. Practices are now asked to produce a register of patients over 18 with CKD stages 3–5. As well as this, first indicator practices are asked to note those patients with CKD who also have had a blood pressure recorded within the last 15 months. They will also be rewarded if these patients’ blood pressure measurements are below 140/85. The fourth indicator rewards practices for the percentage of patients on the CKD register with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (unless contraindications are noted).

We do not yet know the extent of health gain that will be achieved by the inclusion of indicators for CKD in the QOF. However, one study has attempted to estimate the number of cardiovascular events that might be prevented by introducing quality indicator targets relating to aspects of cardiovascular disease [43]. Using statistical modelling investigators estimated that meeting the targets for hypertension could prevent 15 cardiovascular events over 5 years in a practice of 10 000. They also estimated that meeting cholesterol targets could prevent 29 cardiovascular events.



   Cost
Top
 Introduction
 Guidelines
 Evidence from the literature
 Models of care
 Quality and outcomes framework
 Cost
Information strategy
 Conclusion
 References
 
Assessing the costs of chronic disease is a challenging but important problem. Measurement of costs allows us to compare the effects of different types of health care including screening and also different types of service delivery [44]. Economic evaluations allow comparison of different treatments to ensure that the greatest benefit may be achieved for patients for the least cost. To calculate direct costs of early CKD management we need to know the disease prevalence and the care pathway that patients are likely to follow. Information about patient outcomes is also required in order to assess effectiveness of healthcare [44]. Unfortunately detailed epidemiological information is still limited for CKD and our limited knowledge of the natural history makes it hard to define what the usual care pathway will be. Thus, we cannot at present estimate the direct costs associated with treating patients with early CKD according to the new UK guidelines and QOF. However, there is some evidence that caring for CKD patients is costly [45–47].

One study has estimated the direct costs of treating diabetic nephropathy in the UK and US [46]. The total cost of treating an individual with diabetic nephropathy per annum in the UK was £1758; costs in the US were 40% higher per person. The majority of costs in both countries were attributed to the management of chronic complications. The authors postulated that interventions which prevent the onset of microalbuminuria or delay disease progression would reduce the total cost of diabetic nephropathy in both countries. Another study from America looked at patients of one health maintenance organization. This study also demonstrated a high level of comorbidities among CKD patients suggesting that better management of these conditions could slow progression of renal decline [47].



   Information strategy
Top
 Introduction
 Guidelines
 Evidence from the literature
 Models of care
 Quality and outcomes framework
 Cost
 Information strategy
Conclusion
 References
 
A number of studies highlight the potential benefits of nephrologists and primary care physicians sharing patient information [4,48]. The UK guidelines for identification, management and referral of patients with CKD [3] make specific recommendations for the provision of supporting software packages. They have recommended that a national coding system should be agreed so patients can be identified and tracked and that primary care software packages should allow the recording of eGFR.

In England, the Department of Health has produced an information strategy for renal services [49]. This document recommends that electronic care plans should be developed which can be shared across primary and secondary care settings. It also states that primary care information systems should be enabled to help GPs identify, call up and monitor patients who are at risk of renal disease.

Local examples of shared electronic records already exist. One UK study retrospectively evaluated a shared care programme (Southampton Integrated Monitoring of Nephrology—SIMON) [48]. The review examined 949 new referrals with stages 3–5 CKD enrolled into the programme between 1997 and 2003. In this system, patients enrolled by a nephrologist were sent a form asking them to attend for a blood test every 6–12 months. The GP was also sent a form. Patients who did not attend were followed up by the central database. A recent review showed the local nephrologists were able to follow up a third of their patients in this way with patients remaining stable and few requiring renal replacement therapy.

In Scotland, electronic records for shared care already exist for patients with diabetes and this system is being considered for other conditions.



   Conclusion
Top
 Introduction
 Guidelines
 Evidence from the literature
 Models of care
 Quality and outcomes framework
 Cost
 Information strategy
 Conclusion
References
 
We are fortunate in the UK that all citizens have access to primary care services and that policy developments have prioritized the importance of chronic disease management [50,51]. The new GMS contract incorporates the QOF, designed to support management of common chronic diseases and now incorporating management of stages 3–5 CKD[41]. Many elements of the chronic care model [31] are already in place within our primary care service. However, more needs to be done to ensure there is robust support for management of early CKD. We need to develop IT systems fit for purpose with shared electronic patient records. Local protocols with clear guidance and rapid access to nephrology care must be provided for primary care clinicians. There remains a great deal of uncertainty about the best way to care for patients, especially those with stages 1–3 CKD. There is a need for research into outcomes for these patients. Developing models of health care delivery should be studied and evaluated. Research must be encouraged to evaluate models of health care delivery, the cost-effectiveness of healthcare and the cost-effectiveness of screening programmes.



   References
Top
 Introduction
 Guidelines
 Evidence from the literature
 Models of care
 Quality and outcomes framework
 Cost
 Information strategy
 Conclusion
 References
 

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