ABSTRACT
Background: In Italian primary care, chronic heart failure (CHF) patients are mainly managed by general practitioners (GPs). However, there are few studies analysing CHF management challenges in primary care and identifying opportunities for improvement. Objectives: To describe CHF care as implemented by GPs in the Veneto Region and to identify opportunities for improvement. Methods: In 2008, using an audit process, 114 Venetian GPs analysed their electronic health records, identified CHF patients and collected clinical and care related information: prevalence, co-morbidity, caring conditions, diagnostic and therapeutic management, and hospitalization. After two training sessions, data on pharmacotherapy were analysed again in 2009. Results: The prevalence of CHF was 1.2% (95% CI: 1.1–1.3%). Diagnostic echocardiography was used in 57% of cases. At baseline, the proportions of patients that used specific medication were: diuretics 88%; angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) 77%, beta-blockers 46% and anti-aldosterone agents 32%. After two training sessions, the use of ACE inhibitors/ARB and beta-blockers increased to 80% and 56%, respectively. Renal failure, chronic obstructive pulmonary disease (COPD), diabetes mellitus and dementia were the most prevalent concomitant diseases, posing specific management problems. Half of the patients were generally visited at home; they were dependent on some kind of care given.
Conclusion: In Veneto a large number of CHF patients are mainly managed by GPs. Further improvements are necessary to meet standards of care with regard to diagnosis, medication, follow-up and home care. The care situation affected hospitalization and the quality of follow-up visits.
INTRODUCTION
Substantial evidence supports the importance of enrolling CHF patients in primary care follow-up and monitoring programmes. A recent Cochrane review on the organization of CHF clinical services documented that there is a link between a good organization of CHF clinical assistance services and a reduction in overall mortality and hospitalization due to both CHF and other causes (Citation1). These studies show that primary care personnel trained for the assistance and care of patients with chronic illnesses, such as nurses or trained caregivers, can support GPs in counselling activities, in the therapeutic management and monitoring of patients (Citation2,Citation3). However, in Italy, due to the lack of primary care nurses, GPs deal with the majority of CHF patients by themselves, either in their practice or in the patient's home (Citation4,Citation5); therefore, a proactive approach is rarely adopted as this would be too demanding for them. In Italy, there are few studies analysing CHF management challenges in primary care and identifying opportunities for improvement.
For these reasons, in October 2007, the regional section of the Italian Society of General Practice (SIMG) of Veneto promoted a cross-sectional study (ReVAN, Regione Veneto Audit Net) to gather data on the diagnostic process, therapy and management of CHF patients, paying particular attention to those looked after at home, and to compare these data with national and international primary care standards.
METHODS
Pilot: preparation of the audit
In November 2007, a project group of 5 GPs held a workshop to carry out a critical appraisal of the major available international guidelines for CHF (SIGN 2007, ESC 2005 and NICE 2003) employing the AGREE method. They chose the Scottish Intercollegiate Guidelines Network (SIGN) guidelines as the most appropriate approach for their situation (Citation6).
Then, two queries were run in the health record databases of their practices: the first to identify patients with a CHF diagnosis already codified (ICD-IX 428.x code); the second to find CHF patients without codified diagnosis (e.g. patients with coronary heart disease, who develop CHF but the GP does not change the ICD-IX code). The latter category was identified by the presence of at least one of the following clinical and therapeutic markers:
ICD-IX codes related to coronary heart disease, valve disease, and hypertension;
Cardiology hospitalization in the previous three years;
Prescription of at least three boxes of diuretics, beta-blockers or ACE inhibitors/ARBs in the previous 12 months.
Finally, an electronic data sheet was prepared in order to collect diagnostic, therapeutic, follow-up and care-related data regarding each patient identified as having CHF.
Audit: data collection
In the spring of 2008 in each of the 21 local health units of the Veneto Region a group of four or five GPs and a GP group leader was enrolled on a voluntary basis, 114 GPs in total. In May to June 2008, all 114 GPs involved in the study ran the same two queries tested before by the project group in their health record databases to select already codified CHF patients and potential CHF patients.
The GPs upgraded the ICD-IX code of each potential CHF patient on the basis of patient history, i.e. previous hospital admissions or cardiologic visits with the diagnosis of CHF. In potential CHF patients without previous diagnosis, when signs or symptoms suggestive of CHF were present, supplementary testing (blood sample, ECG, echocardiography and, whenever appropriate, chest X-ray) was carried out to confirm or to differentiate CHF from other conditions with similar signs and symptoms. At the end, each GP got a final list of CHF patients.
In July 2008, a cross-sectional study was carried out by the 114 GPs to find out the current profile of CHF primary care in the Veneto Region. For each CHF patient they returned the electronic data sheet to the SIMG project group.
Analysis
Clinical data were arranged using the following indicators:
Epidemiology: CHF prevalence, based on GP's diagnosis;
Comorbidity: cardiovascular and other;
Quality indicators: percentage of CHF cases diagnosed by echocardiography; percentage of CHF cases with at least semi-annual check-up of blood pressure (BP) and weight and blood sample for electrolytes; percentage of CHF cases treated with diuretics, ACE inhibitors/ARB, and beta-blockers.
The care process was described by data on care setting (surgery, home, nursing home), and social and family environment (autonomous, non-autonomous with appropriate or partly appropriate caregiver, non-autonomous without caregiver), respectively.
CHF hospitalization rate was investigated retrospectively (at least one CHF hospitalization versus no CHF hospitalization in the previous three years), evaluating gender, age, co-morbidity and care setting as possible associated factors. Chi-Square tests were performed to determine whether there was statistical significance of the results. Factors related with previous hospitalizations were estimated through a multivariate logistic regression analysis.
Interventions following the audit
In the summer of 2008 the SIMG project group organized three workshops for the 21 local GP group leaders, during which all the data were analysed, and the obstacles for diagnostic process, therapy and follow-up for CHF patients were identified. The data of the cross-sectional study were reported to be discussed during local meetings with all GPs involved in the audit.
Finally, two local health unit training meetings for participating GPs were held during the two years project, focused on the following topics: the audit circle, the diagnostic process, therapy and follow-up of patient with CHF.
In addition, educational material for patients and caregivers was produced:
A self evaluation questionnaire;
A paper with health information and advice illustrated by the GP and handed over to CHF patients and their caregivers during the next follow-up visit.
The educational material for patients and caregivers was distributed to all GPs involved.
To highlight improvements that followed the audit implementation, therapy of CHF with ACE-inhibitors/ARBs and beta-blockers was assessed again in the autumn of 2009.
RESULTS
Epidemiology
The 155 605 patients of the GPs involved in ReVAN audit constitute 4% of Veneto's population, similarly distributed according to gender and age. Of them, 1905 (1.2%; 95% CI: 1.1–1.3%) were diagnosed as CHF, rising from 4.8% in the people over 65 years old to 7.5% in the people over 75 years old (). 90% of CHF patients were over 65 years old. The average age was 76 years in males and 81 years in females.
Table I. Age, co-morbidity and caring conditions of 1905 CHF primary care patients.
Comorbidity
Hypertension (52%), coronary heart disease (45%), atrial fibrillation (43%), diabetes mellitus (32%), chronic obstructive pulmonary disease (COPD, 25%) and renal failure (creatinine ≥ 1.5 mg/dl) (24%) were the most frequent diseases recorded in the electronic sheets of CHF patients at the beginning of the audit process (). Moreover, dementia (16%) raised compliance or nursing management issues in CHF patients.
Caring conditions
GPs indicated that 47% of patients were autonomous, 39% were not autonomous, but had an appropriate caregiver, 11% were not autonomous and had a partly appropriate caregiver and 3%, although not autonomous, had no caregiver. This distribution was gender influenced (). Furthermore, care settings were variable: 4% of patients were cared for in a nursing-home, 44% mainly at home and 51% were outpatients.
Clinical quality indicators
Diagnosis. Access to brain natriuretic peptide (BNP) plasma test was not generally available for GPs in the different local health units of the Veneto region, as it is generally considered a test within the competency of a specialist and must, therefore, be prescribed by the cardiologist. 86% of patients had either a specific diagnosis of CHF on discharge from the hospital or in a cardiology report. Of the remaining 14% of patients without a confirmed diagnosis 56% were followed up at home, 35% in out-patient clinics and 9% in nursing home. For 88% of patients an ECG had been done at the time of the initial diagnosis.
Only 57% of all cases had a diagnostic echocardiography record, which was markedly related to gender (65% males versus 49% females, χ2 = 50.12; df1; P < 0.001), age (72% < 65, 66% 65–74, 53% > 75; χ2 = 37.93; 2 df; P < 0.001) and care setting (66% of outpatients, 51% of home patients and 22% of nursing-home patients (χ2 = 84.43; 2 df; P < 0.001). Only 40% of patients afflicted by dementia had a diagnostic confirmation by echocardiography (see ). The ejection fraction (EF) was not recorded in 31% of cases; when it was recorded, it was normal in 42% of cases. The echocardiogram findings of right heart failure (e.g. right atrial enlargement, alterations of the E/A ratio, thickening of the septum) were often reported qualitatively or not in a standardized format.
Table II. Diagnosis, treatment and follow-up of 1905 CHF primary care patients.
If echocardiography or cardiologic visits were considered as alternative criteria of diagnostic validation, the percentage of confirmed diagnoses increased to 67% of CHF patients.
Pharmacotherapy. The baseline assessment showed that a pharmacological therapy with diuretics was applied in 88% of cases; in 32% of the patients an anti-aldosterone agent was employed.
ACE inhibitors/ARB were used in 77% of cases, showing a higher percentage of use in males and in patients over 75 years-old. In the post-training assessment one year later, the percentage of patients treated with ACE inhibitors/ARB went up to 80% (χ2 = 7.15; 1 df; P = 0.008) (see ).
The use of β-blockers was 46% in the baseline assessment and 56% one year later (χ2 = 44.57; 1 df; P < 0.001). Younger age (< 75 years 64% vs. ≥ 75 years 38%; χ2 = 110.65; 1 df; P < 0.001) and the coexistence of a coronary disease (49% yes versus 43% no; χ2 = 8.16; 1 df; P = 0.004) were associated with a higher percentage of β-blocker use, whereas the coexistence of COPD was associated with a reduction in their prescription (33% yes versus 50% no; χ2 = 37.33; 1 df; P < 0.001). Other factors related to a low use of β-blockers were: coexistence of dementia (34% yes versus 48% no; χ2 = 19.86; 1 df; P < 0.001), care setting (38% home, 22% nursing home, 54% outpatient setting; P > 0.001), and caring environment (56% in autonomous patients, 30% in non-autonomous patients with a appropriate caregiver, 31% in non-autonomous patients with partially appropriate or no caregiver; P < 0.001).
Follow-up. As regards the follow-up, 88% of ReVAN patients had a six-month documentation of electrolytes, 89% had a blood pressure (BP) recorded and only 57% had their weight recorded. The six-month clinical check-up was less frequent in patients with caring difficulties (59% in autonomous patients, 56% in non-autonomous patients with appropriate caregiver, 47% in non-autonomous patients with partially appropriate or no caregiver; P = 0.004).
Hospitalization
Approximately 46% of CHF patients had had ≥ 1 CHF related hospitalization in the previous three years. Hospitalization risk was highly associated with male sex, coronary disease aetiology, atrial fibrillation, kidney failure and, above all, COPD (see ). Home or nursing-home setting and caring difficulties (statistically significant only in the univariate analysis) were associated as well.
Table III. Conditions associated to a previous CHF hospitalization in 1905 primary care patients: univariate and multivariate analysis.
DISCUSSION
Main findings
In Veneto, the prevalence of CHF was 1.2% (95% CI: 1.1–1.3%). Diagnostic echocardiography was used in 57% of cases. A BNP-test was hardly available, but an ECG was performed in 88% of cases at the time of initial diagnosis. At baseline, the proportion of patients that used ACE-inhibitors or ARB was 77%; for beta-blockers the proportion was 46%. The audit process allowed for an improvement in the drug therapy of CHF: after two training sessions the use of ACE inhibitors/ARB and beta-blockers increased to 85% and 56%, respectively. Renal failure, chronic obstructive pulmonary disease (COPD), diabetes mellitus and dementia were the most prevalent concomitant diseases and posed specific treatment and follow-up problems. Half of the patients were generally visited at home; they were not autonomous and were dependent on some kind of care giving. 14% lived in a difficult social and family environment. About half of all CHF patients had had at least one CHF related hospitalization in the previous three years. The use of diagnostic tests, pharmacological treatments and hospitalization were strongly associated with age, gender, disability, care setting and care related issues.
Strengths and limitations
A strong point of this study is the involvement of a large number of GPs in a regional network of audit groups, discussing data of their patients and comparing them with selected guideline. The collaboration between a general practice society (SIMG) and the regional epidemiological service allowed to link data of the regional health service with the data of the GPs’ electronic medical records. The most relevant limitation was the lack of registration by the GPs of home care data, which required the use of a sheet for each patient.
Epidemiology
Of the adult population in the ReVAN audit 1.2% suffered from CHF. This is concordant with former Italian epidemiological research, such as the ILSA study and the Studio Veneto of Relevance (Citation10,Citation11). The available studies carried out by the Italian Society of General Practice (SIMG) followed a population approach (Citation12,Citation13) and are, therefore, more interesting than the ones based on randomized clinical trials. In particular, SIMG Italian Net Health Search performs a yearly monitoring of the health records of over 850 selected GPs which show similar figures as the ReVAN audit (prevalence of CHF was 0.9% in the population over 18 years old) (Citation14).
However, prevalence of CHF was largely variable among the GPs taking part in ReVAN (interquartile range: 0.6–2.1%). Apart from the differences tied to the case-mix, it is likely that such variability reflects a certain degree of diagnostic uncertainty; therefore, the application of common and standardized diagnostic criteria would surely represent an important step forward.
When we analyse ReVAN's CHF prevalence rate and the Italian CHF hospitalization rate, we notice that GPs look after a CHF population three times larger than the one hospitalized for this disease in one year (Citation15).
Diagnosis in primary and secondary care
The records of an initial CHF diagnosis with an echocardiography or a cardiologist examination (57.3%) are in line with the Health Search (Citation16) data (66%), whereas the British physicians’ contract sets a gold standard of 90% for the cases diagnosed since 2006 (Citation17). Therefore, a major effort is needed not only to facilitate the access to echocardiography, but also to store and make available to GPs the information regarding the CHF diagnostic process (discharge summary, cardiology visits, instrumental reports).
European and British (Citation7–9) guidelines have recently underlined the importance of BNP test in patients with a history and symptoms suggestive of CHF and of making an accurate differential diagnosis of common conditions and of pathologies, which can mimic the signs and symptoms of the disease. However, the BNP test is not routine practice in Italy. Moreover, CHF cases certified by GPs have not been stratified according to their clinical severity (e.g. using NYHA classification), since this information was frequently lacking even in clinical documentation by the specialist (specialist reports, discharge summaries).
Pharmacotherapy
The level of ACE/ARB prescription noted in the ReVAN study (77% in the pre- and 80% in the post-training assessment) was higher than that recorded by other Italian studies: 61% in the Health Search data (Citation16); and 57% according to data recorded by Veneto's Regional Epidemiologic Service (RES) referring to ongoing therapies at the moment of hospitalization (Citation18). The standards considered acceptable by the Italian Society of General Practice (SIMG) (Citation14) and by the Italian Consensus Conference on Chronic Heart Failure (Citation4,Citation5) are 70% and 85%, respectively, whereas UK's general physicians’ contract (Citation17) requires an 80% standard. At baseline, the β-blocker prescription in Veneto was 46%, as compared to 30% in the national Italian Consensus Conference data (Citation4,Citation5), 31% in Veneto's RES data (Citation18), and 32% in the Health Search data (Citation14). The accepted standard of β-blocker usage suggested by SIMG, by the Italian Consensus Conference on CHF and, more recently, by the UK's general physicians’ contract is 50% (Citation4,Citation5,Citation14,Citation17). In the post-training assessment which followed the audit, this standard was largely met (56%) (). However, the co-existence of COPD was still generally considered a contraindication to the use of beta-blockers and was associated with a general decrease in their prescription. This aspect has been recently clarified by a retrospective observational study. The infrequent use of beta-blockers in this population of sick elderly patients is worrying, as they would obviously benefit from this treatment, as highlighted in the SENIORS trial and MERIT-HF sub-study (Citation20,Citation21).
Hospitalization and follow-up
CHF hospitalization rate has only been monitored retrospectively, from three years before the start of the study on. The patients’ social conditions mostly related to hospitalization largely correspond to those pointed out by a recent systematic review (Citation22). Among them, the care setting is of great interest for primary care: the follow-up must be personalized according to the clinical characteristics of the CHF, comorbidities and, last but not least, caring context and difficulties. The 2010 NICE guidelines set a clinical and laboratory check-up every six months as a minimum standard. However, the current data gathered by GPs involved in the ReVAN study suggests that this standard is far from being met (Citation8). In order to achieve this, patients would need to be summoned for a check-up, but less than a fifth of participant GPs had a nurse available for at least six hours a week.
Implications
Several Italian studies have recently tried to define a diagnostic-therapeutic pathway for patients affected by CHF (Citation23–29). These studies are usually centred on the development of a hospital outpatient service for the follow up of autonomous patients. However, several data of this audit highlight the crucial role of home care for non-autonomous patients and of the education of the caregivers.
Diagnosis and treatment of CHF still require significant improvement in primary care in the Veneto region. A major effort is needed to facilitate the access to echocardiography, but also to store and make available to GPs the information regarding the CHF diagnostic process (discharge summary, cardiology visits, and instrumental reports). International guidelines stimulate a debate on introducing the BNP test in the diagnostic process of CHF in general practice.
Patients and their caregivers should have a better health education and be trained to monitor simple but useful parameters (weight, pulse, blood pressure) and to recognize and report a few key symptoms (nocturnal dyspnoea, peripheral oedema) which may indicate a relapse of the underlying disease, whilst GPs—with or without a nurse—should follow up patients with CHF, who cannot attend the practice, more frequently in the home care setting.
Disabilities and care setting need further investigation since they could considerably affect the quality of the clinical process of CHF patients and can also influence its outcome.
Conclusion
In the Veneto region a large number of CHF patients are mainly managed by GPs. Further improvements are necessary to meet standards of care with regard to diagnosis (use of BNP and echocardiography), medication (prescription of β-blockers), follow-up and home care. The care situation affected hospitalization and the quality of follow-up visits.
ACKNOWLEDGEMENTS
The ReVAN project has been granted by Veneto Region Health Research Fund. The authors thank the Health and Social Services Secretary Dr Domenico Mantoan and the Director of Verona University Hospital Dr. Sandro Caffi for their support to the project. Acknowledgements to Dr Olivia Maria Thomas for revising the English version of this paper.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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