Peter H Winocour,1 Karen Moore-Haines,2 Andrew Solomon,3 Anne Currie,4 Dawn Hardy4
East and North Herts Institute of Diabetes and Endocrinology (ENHIDE), Howlands Clinic, QEII Hospital, Welwyn Garden City, Herts AL7 4HQ, UK
1 Consultant Diabetologist and Clinical Director
2 Project Manager
3 Consultant Diabetologist
4 Diabetes Specialist Nurse
Address for correspondence: Dr Peter H Winocour
Consultant Diabetologist and Clinical Director, East and North Herts Institute of Diabetes and Endocrinology (ENHIDE), Howlands Clinic, QEII Hospital, Welwyn Garden City, Herts AL7 4HQ, UK
E-mail: peter.winocour@nhs.net
Br J Diabetes 2019;19:53-62
https://doi.org/10.15277/bjd.2019.215
Introduction: Diabetes is considered the main identified cause of end stage renal disease and this combination is becoming more prevalent as populations age and become more obese. Individuals with diabetes and chronic kidney disease (CKD) have additional multi-morbidity and may represent 25–40% of those on diabetes registers in primary care, where the majority receive medical care. The East and North Herts Clinical Commissioning Group (CCG) commissioned the East and North Herts Institute of Diabetes and Endocrinology (ENHIDE) to pilot an innovative approach to the identification and care of this complex cohort in primary care. This paper reports the project design and objectives.
Aims: There were five core objectives of the pilot: (1) to examine the feasibility of extraction of comprehensive datasets from primary care diabetes registers; (2) to examine the feasibility of the individualised data utilisation for patient care; (3) to evaluate the practicality and acceptability of primary care of telehealth virtual case-based reviews; (4) to evaluate the extent of unmet clinical need; and (5) to create new sources of information to improve self-management. In addition, three key performance indicators were set for those with CKD: (1) change in any aspect of management in 20%; (2) reduction of admissions and ambulance call outs for hypoglycaemia in 20%; and (3) reductions in admissions with active foot disease by 20%.
Study outline: All patients with estimated glomerular filtration rates (eGFR) <60 mL/min and/or urine albumin creatinine ratio (ACR) >10 mg/mmol were to be identified from practice diabetes registers enabling a holistic review of ‘15 pillars of care’. In addition to blood glucose management and review of renal function, this included recording of cardiovascular disease (CVD) and CVD risk factor status, risk of hypoglycaemia, assessment of anaemia, metabolic bone disease, foot and retinal health and hospitalisation.
Progress: The project was initiated in December 2016 and data are currently being updated for full analysis. 20 of the 55 general practices in the catchment area of the acute trust agreed to participate in the project, enabling case review of 2,874 cases. This initial phase of the pilot has established that the core principles of the project can be delivered in larger numbers, subject to developing new models of data capture and creation of clinically underpinned care algorithms.
Key words: diabetes, chronic kidney disease, Telehealth, care planning, clinical information systems, albuminuria, cardiovascular disease, hypertension, lipids, glycaemia, retinopathy, foot heath, metabolic bone health
Diabetes mellitus (DM) remains the main identified cause of end stage renal disease in the UK.1 Chronic kidney disease (CKD) can be directly attributed to or associated with diabetes mellitus and is currently graded according to both estimated glomerular filtration (eGFR) and albumin excretion rates, with increased albuminuria still considered the hallmark of classical diabetic nephropathy.2 The incidence of both diabetes and CKD is projected to potentially double through the impact of ageing, obesity and improved case detection. The majority of cases with DM and CKD are likely to be older patients with type 2 diabetes.3–6
The current strategy on managing patients with DM with or at risk of CKD is to focus on glycaemic, lipid and blood pressure control, and national guidelines have been developed to support better management,7–11 recognising nuances of therapy selection in DM CKD, reflecting the impact of obesity and degree of renal disease.
Monitoring of renal function in DM has focused on measuring trends in both estimated GFR (eGFR) and estimates of proteinuria (usually urine albumin:creatinine ratios (ACR)). The current prevalence of CKD based on both reduced eGFR and/or raised ACR is at least 40% of people with type 2 DM and up to 15% with type 1 DM.5 Current models promote delivery of most DM and CKD care in primary care settings. Criteria for specialist referral vary, but mainly reflect advancing proteinuria and/or progressive declining eGFR to the stage of end stage renal disease (stage 4 CKD, eGFR <30 mL/min) or a fall of 5–10 mL/min/1.73 m2 over a year.11,12
However, it is increasingly recognised that the co-existence of DM and CKD needs to be considered more holistically as a complex multi-morbidity disorder.5 Prevalent cardiovascular disease (CVD) and retinopathy are common, as are earlier manifestations of renal anaemia and metabolic bone disease. There is greater vulnerability to acute illness and hospitalisation with a range of issues including cardiovascular and foot emergencies, infections, hypoglycaemia and acute kidney injury.13–17
Failure to provide effective basic care of DM CKD has been reported in the UK and more widely.18–20 One primary care service has published successful review and improved care processes and quality core measures in DM with renal disease, but did not evaluate anaemia, CVD, bone, eye and foot health.21 Virtual clinical review of CKD and use of clinical support system decision-making tools have been reported in the management of CKD but have not focused on the wider care implications of the coexistent diabetes and related vascular disease.22–24
The National Health Service in England currently oversees the planning and delivery of healthcare through Clinical Commissioning Groups (CCGs) usually serving populations of 250,000–500,000. The East and North Herts CCG established a revised care pathway for diabetes care in 2010 whereby all referrals from primary care would be managed by a nurse-led single point of access. Those with specialist needs would either be managed in a community specialist nurse and consultant physician service or, if more complex, would be referred onto the hospital-based specialist services. Patients with advanced renal disease (eGFR <30 mL/min and/or nephrotic range proteinuria) would require referral directly to the nephrology services, but those with ACR >30 mg/mmol and/or lesser degrees of CKD (eGFR 30–54 mL/min) were encouraged to be referred to the hospital diabetologist renal clinics. In addition, annual consultant diabetologist visits to all GP surgeries focused on virtual review of high-risk cases, especially those with levels of HbA1c >75 mmol/mol and/or early onset complications or obesity and suboptimal control.
It was recognised that some patients with type 2 DM and CKD presented late from primary care with poor control of glycaemia and CVD risk factors, advanced renal disease, established foot complications, previously unidentified and correctable metabolic bone health issues and complex anaemia, and had an increased risk for emergency ambulance call out with hypoglycaemia. This corroborated findings from the National Diabetes Audit, where there was poor attainment of glycaemic and blood pressure targets.18
Based on published literature,21,25 we anticipated the majority of those with DM and CKD would only be receiving primary care, but there was no information as to the extent of unmet clinical need.
In 2015 the East and North Herts CCG commissioned a 2-year pilot of a novel method of specialist review and support of patients with type 2 DM and CKD diabetic nephropathy (DM CKD-DN) under primary care. The diabetes renal telehealth service set out to provide virtual holistic care of those with DM CKD-DN identified on a practice-by-practice basis through the GP-held practice DM registers. The purpose of the pilot was five-fold:
This methodology paper describes the process for and challenges with establishing the project.
Initially all cases with ACR >10 mg/mmol and/or eGFR <60 mL/min were identified, but subsequently there was a more detailed focus on those aged <75 years and those aged >75 years with an eGFR <45 mL/min and/or ACR >10 mg/mmol. Patients under hospital specialist diabetes and/or renal care were identified and reviewed as well as those solely under primary care. Reports were initially created for both SystmOne and EMIS (Egton Medical Information Systems) primary care systems to enable identification of the numbers of patients from each practice with CKD. A database was created to enable extraction of the core measures and processes required for comprehensive DM CKD pillars of care (Figure 1). Standards of care were established based on the health status measures (Figure 2).
Renal measures
All available estimated GFR measures over a 2-year period from the most recent available result were reviewed in each case using the Integrated Clinical Environment (ICE) system. The biochemistry laboratory reported eGFR using the Modification of Diet in Renal Disease (MDRD) formula until July 2016 with a transitional period until March 2017 when reports were also provided from a different provider laboratory, from which time the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used. For the purposes of the DM Renal Telehealth Project, we did not differentiate the two methodologies, given recognition that both estimates underestimate true GFR in diabetes but both perform equally in that regard.26 True deterioration in eGFR was recorded if there had been a persistent 10% reduction in eGFR from the value 2 years prior to the most updated result and/or a sustained reduction of >10 mL/min/1.73 m2 over the 2 years. eGFR results were classified as variable when they deteriorated by 10–20% but then improved to the same extent within the 2-year period without a progressive decline. Episodes of transient deterioration in eGFR of >10% were considered to represent potential acute kidney injury with a degree of recovery.
Urine ACRs were measured using a standard polyethylene glycol enhanced immunoturbidimetric assay for albumin and a standard enzymatic assay for urine creatinine, based on a requested early morning urine sample. All available ACR measures over a 2-year period from the most recent available result were reviewed in each case using the ICE laboratory system. Deterioration was documented if the values increased above 3.5 mg/mmol from below that value, and if they increased by more than 20% from the value 2 years prior to the most updated result.
Referral to the nephrology department was generally recommended when eGFR levels were <30 mL/min/1.73 m2 and/or nephrotic range proteinuria was noted whilst not under specialist renal department care. In addition, atypical proteinuria without retinopathy and without concerns regarding glycaemic control would be considered for referral for renal review of non-diabetes causes of proteinuria.
HbA1c, blood pressure, lipids, use of related therapy and antiplatelet medication and body mass index
The most recent blood pressure was recorded from GP and/or hospital records and lipids and HDL and HbA1c measures using the ICE laboratory system and evaluated if within 1 year prior to case review. The list of blood pressure, glucose and lipid-lowering medication was recorded from the downloaded GP records and Summary Care Records on the NHS spine where available.
A clinically significant change in HbA1c was documented if the values had changed by more than 10 mmol/mol from values 2 years prior to the most updated result. Those with HbA1c recorded as <50 mmol/mol on insulin and/or insulin secretagogue therapy with hypoglycaemic potential were considered to be at hypoglycaemic risk and coded accordingly.
Blood pressure targets were set at 140/90 mmHg without albuminuria and 130/80 mmHg with albuminuria, with recognition that patients aged >75 might be conservatively managed with a blood pressure target of 150/90 mmHg.8
Attainment of the non-HDL cholesterol target of 2.5 mmol/L, in keeping with national guidelines, was determined.7
Use of aspirin was recorded from the medication record for each patient. Use of other antiplatelet agents and also warfarin and novel anticoagulants were recorded. Aspirin use or an alternative antiplatelet agent or anticoagulant was considered an appropriate standard for those with established CVD and/or raised albuminuria, in line with JBS3 guidelines.27
Body mass index was recorded from GP records and, where >30 kg/m2, this was taken into account when recommending alternative diabetes therapies where glycaemic control was considered in need of improvement (HbA1c >58, 68, 75 mmol/mol, according to age and presence of co-morbidities).
Referral to specialist diabetes care was recommended where glycaemic control remained poor (HbA1c >75 mmol/mol or there were documented issues with ambulance call outs for hypoglycaemia). Blood pressure >160/100 mmHg was also considered an indication for specialist referral.
Hypoglycaemia enquiry
This was recorded when coded from GP registers using the Read Codes for ‘No significant hypoglycaemic attacks ‘(Y1028) or ‘Hypoglycaemia identified’ (Xa9Ao/Y1027), or recorded ambulance call out for hypoglycaemia (Y1029)
CHD, CVA, smoking, feet status and podiatry access
Documentation of these measures and activity were recorded from the downloaded GP records using appropriate ‘Read Codes’.
Active foot disease or high-risk feet using standardised criteria28 were considered a basis for recommendation for foot care advice or podiatry referral if not already under such care. Smoking cessation priority was flagged up to the practices among smokers with DM CKD-DN.
Retinopathy status
The retinal status of patients was initially provided from the practice records if screening had been recorded in the last year. A more in-depth investigation was carried out from the East and North Herts Retinal Screening reporting system, an accredited service of the National Diabetes Retinal Screening programme.
Retinal status was recorded as available if within 1 year from the date of patient data review and recorded as to presence in one or both eyes and the level of retinopathy (background, pre-proliferative, proliferative or maculopathy).
Metabolic bone health checks
Documented results for serum calcium, vitamin D and parathyroid hormone measures within 1 year prior to case review were taken from the biochemistry report system with the standard that they should be measured in those with eGFR <45, in keeping with national Renal Association guidance.29 Vitamin D deficiency was set at total levels (vitamin D2 and D3) <30 mmol/L using the National Osteoporosis Society criteria.30
Advice regarding initiation of activated vitamin D from raised parathormone was set in line with guidance from the Renal Association based on progressive increases to values at least twice the upper limit of the reference range.29
Anaemia
Haemoglobin (Hb) measurement within the past year from data review was set as a quality standard and values of ≤110 g/L considered as anaemia, in line with the Renal Association NICE guidance.31 If Hb values were greater than this but with prior documentation of anaemia and on treatment, they were considered anaemic for the purpose of classification within the study.
Haematinics measured with or leading up to diagnosis of anaemia including reduced transferrin and iron, B12, folate and ferritin were recorded as evidence of haematinic checks and, where outwith reference ranges, considered as a record of abnormal haematinic levels.
Hospital admissions
Hospital admissions were recorded on the East and North Herts BIMS reporting system, based on hospital records for the 2 years prior to data review. Hospital admissions were recorded and separated into three categories: diabetes foot admission; other causes of diabetes admission; and non-diabetes admission.
Governance
This pilot was approved by CCG Caldicott Guardian. Ethical approval was not required given this was an extension of clinical care to implement national guidelines.
Practices were offered a one-off fee of £200 to enable purchase of a camera for computers and the subsequent Skype 2-hour telehealth meeting. Each participating practice had the option to engage in this, discussing a proportion of the cases with a training session built into the meeting. This session was open to all clinical staff at the practice.
Patients who were under the specialist hospital or community services with DM CKD who were reviewed and considered stable with all pillars of care adequately managed were planned to be discharged back to the practice for ongoing annual virtual review.
In contrast, all patients identified under primary care with poor glycaemic control, progressive renal dysfunction and/or important co-morbidities were to have care escalated for specialist hospital care in either the diabetes or the nephrology services.
All practices were supplied with individualised care plans for all patients in the high-risk criteria and expanded recommendations for 20 cases discussed at the Skype telehealth session.
In addition, all participating practices were supplied with a management summary for the pillars of care (Figure 2).
Outcomes to be measured
The primary outcomes were adherence to recommended targets and process measures in national guidelines and identification of unmet clinical need. There was an expectation of more proactive podiatric support and foot care advice and, in some older cases with CKD, more conservative glycaemic control with potential reduction in the rates of hypoglycaemia. A patient hand-held High-Risk Foot Card was developed for distribution to those with DM CKD with documented at-risk feet (Figure 3), and a patient credit card-sized Sick Day Guidance Card was produced for distribution by practices to all cases included in the renal DM review (Figure 4).
Three key performance indicators of the impact of the project were established by the CCG: (1) changes in any aspect of management in 20% of those with CKD; (2) reduction in admissions and ambulance call outs with hypoglycaemia in those with CKD by 20%; and (3) reduction in admissions with active foot disease in those with CKD by 20%.
Primary care feedback on Skype session
Overall feedback on these sessions was very positive. Responding GPs stated the importance of good communication for optimal management and the educational value and opportunity for discussions when there was uncertainty regarding referral to diabetes and/or renal departments. On a small number of occasions the audio and visual quality of the Skype call was poor, although this was intermittent.
Progress and modification to protocol: challenges in project
Of the 55 practices in East and North Herts, 20 agreed to enable data extraction and to take part in the 2-hour telehealth virtual review sessions.
The main challenges in establishment of the project were data extraction, data mergers and review of clinical information in other systems. Manual searches were often required if core information was not apparent after initial data downloads or was out of date. In addition, two different systems were used by primary care for recording patient information (EMIS Web and Systm One), with inconsistent capturing and recording of clinical information. Two of the practices were located at the boundary of the CCG catchment area and frequently used other acute trust clinical services and biochemistry which were closer to them and not readily accessible.
Corroboration of information required separate additional individual case review on digital retinal screening registers and the separate clinical information systems for those under specialist care. In addition, medication records on the main primary care systems only recorded the strength of medication rather than the prescribed dose. Subsequently, access to individual Summary Care Records enabled contemporary prescriptions including withdrawal due to adverse reactions to be recorded. Consequently, each individual case review required up to 30 minutes of individual consultant time.
After piloting this process in three practices, it became evident that the large caseload (approximately 25% of those on DM registers) meant there was inadequate time in the project to individually review every case. Subsequently, all patients under the age of 75 had individualised review and, in addition, those aged over 75 with eGFR <45 mL/min and/or ACR >10 mg/mmol had individual case review.
The pilot service identified substantial unmet clinical need, challenges in data extraction and a requirement for a cohesive approach to address the 15 pillars of care. In addition, high-risk vulnerable and/or disengaged patients were identified who could justify specialist clinic review but for a range of reasons were not able to access this. As of January 2019, the complete dataset is in the process of being refined and analysed.
This pilot has successfully addressed the five core objectives established at the outset of the project, albeit with practical challenges in data extraction. Given the substantial numbers identified with complex and unmet clinical need, there is little doubt that a new care model such as this is required. Refinements in data capture and processing along with flexible telehealth contact between primary care and specialist teams can enable more effective integrated care of a large population with diabetes and complex multi-morbidity. Assessment of the key performance indicators will be best judged with ongoing evaluation and continuation of the project. Ongoing review of the medium-term outcomes is currently in process, but longer-term review will be necessary to better establish cost effectiveness and clinical benefits in respect of adverse foot and hypoglycaemia ambulance call outs. The project aims to evaluate both qualitative and quantitative beneficial changes in clinical management and outcomes and enable a new surveillance and service model that uses digital technology and an alternative to traditional outpatient reviews, given the large numbers with complex co-morbidity and the stated need of the NHS in England to redesign services. Once fully evaluated, we anticipate the future model will be streamlined to extract comprehensive data more readily and use a new clinical algorithm underpinned with specialist oversight to more readily identify those at greatest need of changes in clinical management.
Conflict of interest: None
Funding: This project was funded by the East and North Herts Clinical Commissioning Group with additional support from an unrestricted medical education grant from Sanofi Aventis towards diabetes specialist nurse salary costs.
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