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Contents lists available at ScienceDirect
Primary Care Diabetes journal homepage: http://www.elsevier.com/locate/pcd
Original research
Health care delivery in type 2 diabetes. A survey in an Italian primary care practice Andrea Modesti a , Roberto Bartaloni a , Franca Bellagamba a , Rossano Caglieri a , Katia Cenori a , Giorgio Ciampalini a , Attilio Costagli a , Vanni Galloni a , Cecilia Del Papa a , Leonardo Modesti a , Giulia Dell’Omo b , Roberto Pedrinelli b,∗ a b
“Modulo Pontedera” Progetto Regionale di Medicina d’Iniziativa, Pontedera, Italy Dipartimento di Patologia Chirurgica, Medica, Molecolare e dell’Area Critica, Università di Pisa, Italy
a r t i c l e
i n f o
a b s t r a c t
Article history:
Aims: Evidence-based guidelines provide targets and performance measures for the
Received 28 February 2014
treatment of type 2 diabetic patients but a wide gap separates guidelines-driven recom-
Received in revised form
mendations from their clinical application, a phenomenon hindering the transfer of proven
22 April 2014
benefits to affected populations.
Accepted 23 April 2014
Methods: We analyzed the quality of diabetic care delivered by 8 general practitioners joint
Available online xxx
in a group practice attending 571 diabetic patients (5.6% of the total enlisted subjects) by assessing process (% of HbA1c , SBP and LDL-C determinations) and intermediate outcome (%
Keywords:
of patients with HbA1c 8%, systolic BP 140 mmHg, LDL-cholesterol
Health services
130 mg/dL) indicators.
Outcomes research
Results: HbA1c was at target in 49% of patients and >8% in 22%; SBP and LDL-C determination
Type 2 diabetes
was available in about two-thirds of patients, only a minority at target for SBP and LDL-C.
Primary care
Antihyperglycemic and antihypertensive treatment was prescribed in most patients but only a third was on statins. During the post-evaluation phase, percentages of patients with HbA1c >8%, SBP < 130 mmHg and LDL-C < 100 mg/dL and the drug prescription pattern did not change. Conclusions: Several weaknesses affect primary care delivery to type 2 diabetic patients and efforts are needed to improve the management of this high-risk group. © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
∗ Corresponding author at: Dipartimento di Patologia Chirurgica, Medica, Molecolare e dell’Area Critica, Università di Pisa, 56100 Pisa, Italy. Tel.: +39 050 996712; fax: +39 050 540522. E-mail address: [email protected] (R. Pedrinelli). http://dx.doi.org/10.1016/j.pcd.2014.04.008 1751-9918/© 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
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1.
Introduction
Type 2 diabetic patients are exposed to morbid cardiovascular events and early death (e.g. [1,2]), a poor outcome postponed and, to some extent, prevented by persistent normalization of abnormal metabolic parameters and effective long-term treatment of coexisting high blood pressure (BP) and low density lipoprotein (LDL) cholesterol (C) [3], a solid evidence incorporated in guidelines providing treatment targets and performance measures for field clinicians (e.g. [4]). However, a wide gap separates evidence-based recommendations from their daily application, a worldwide phenomenon (e.g. [5–7]) documented also by Italian studies carried out in Diabetes Outpatient Clinic (DOC)s [8–10] and primary care practices [11–14]. Since this latter setting plays a pivotal role for successful primary and secondary cardiovascular prevention [15,16], additional information about the way general practitioner (GP)s approach the management of patients with type 2 diabetes is an essential step in the process of improving health care delivery and resource allocation by national community and political stakeholders. For this reason, we analyzed the quality of care provided to a large group of type 2 diabetic patients in charge of an Italian primary care group practice.
2.
Material and methods
2.1.
Setting
The analysis involved 8 primary care physicians (A.M. coordinator, R.B., R.C., G.C., A.C, V.G., C.D.P., L.M., 1 female, mean age: 60 ± 2 yrs) and 2 nurses (F.B., K.C) partnered in a practice enlisting 10,156 adult subjects in Pontedera, a town in northwestern Tuscany (population ≥16 yrs: 24,489 according to the 2011 national census). The data were gathered in the context of “Medicina d’Iniziativa”, a project sponsored by Regione Toscana, the regional branch of the publicly funded Italian National Health System aiming at the promotion of proactive, planned and population-based treatment strategies of chronic diseases in primary care [17]. According to the Italian law, a group practice is an organizational unit in which 3–10 partnered GPs share facilities and patient electronic health record systems, meet on a regular basis to adopt common guidelines and assess quality of care and prescription appropriateness under the coordination of a team physician [18]. GPs agreed to transfer their clinical records to two academic clinicians (GDO, RP) expert in cardiovascular prevention who analyzed the data.
2.2.
Performance measures
Performance measures included process (i.e. the procedures actually done to the patient independent of their outcome) and intermediate outcome (i.e. surrogate measures related to incident hard end-points) indicators. The two sets of performance indicators are complementary in that a process measure (e.g. HbA1c determination) can be obtained and still remaining outside the desirable range of values.
Process indicators utilized for the audit were percentages of patients with available HbA1C , SBP and LDL-C determinations; outcome indicators were percentages of patients at target or not for HbA1C (8%), systolic (S) BP (140 mmHg) and low density lipoprotein-cholesterol (LDL-C) (130 mg/dL) as recommended at the time of the audit by the Italian association of family physicians (Società Italiana di Medicina Generale, SIMG) [19] following internationally accepted standards of care. HbA1C determinations obtained from 3 to 9 months after the baseline evaluation were defined as appropriately timed. Antihyperglycemic, antihypertensive and statin treatment was coded as prescribed or not while no information about specific drugs was available in the records. Patients with HbA1C levels >8% were considered in need of therapeutic adjustment to achieve a better metabolic control. According to the Italian law, patients can access the local DOC either as referrals or on a voluntary basis.
2.3.
Protocol
2.3.1.
Baseline evaluation
Following the requirements of the project “Medicina d’Iniziativa” [17] and the agreements stipulated with Regional Health Administration, GPs were required to collect HbA1c levels of all patients (fasting plasma glucose levels 126 mg/dL and/or prescription of antihyperglycemic drugs) attending the practice, either known or newly diagnosed, irrespective of age, diabetes duration or treatment. The baseline evaluation, carried out between March 2009 and November 2011, yielded 571 patients (5.6% of the overall enlisted population). To exclude patients with juvenile forms of type 1 diabetes, only subjects with diabetes diagnosed by age 30 or more were included in the analysis.
2.3.2.
Post-baseline evaluations
After the baseline HbA1c evaluation required by the “Medicina d’Iniziativa” project, management and timing of the postbaseline clinical and analytical controls was left to the clinical judgment of each individual GPs.
2.4.
Analytical methods
HbA1C were carried out by High Performance Liquid Chromatography at the local community Hospital of Pontedera. Quality control across laboratories is provided in Tuscany by the regional branch of the National Health System (Regione Toscana, Controllo di Qualità in Medicina di Laboratorio, see http://www.aou-careggi.toscana.it/crrveq for details). LDL-C were derived from Friedwald’s formula on samples analyzed for total, high density lipoprotein cholesterol and triglycerides by enzymatic methods; BP determinations were obtained by standard methods either by nurses or GPs.
2.5.
Statistics
Differences between means and proportions were analyzed by unpaired t-tests and chi-square, respectively (p < 0.05 as limit of statistical significance). Descriptive statistics were
Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
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means ± SD or proportions for continuous and dichotomic variables, respectively.
3.
Results
3.1.
Baseline evaluation
HbA1c was 8% in 45% in 22% respectively. SBP and LDL-C determinations were available in 69% and 77% of the of the overall sample (n = 571). Target SBP ( 8% (26% vs 19%), SBP > 140 mmHg (23% vs 27%), LDL-C > 130 mmHg (31% vs 25%) and antihyperglycemic (91% vs 89%), antihypertensive (74% vs 63%) and statin (30% vs 39%) prescription rates. Males (n = 295, 52%) and females (n = 276, 48%) did not differ by HbA1c > 8% (23% vs 21%), SBP > 140 mmHg (27% vs 30%), LDLC > 130 mg/dL (35% vs 41%) nor by antihyperglycemic (90% vs 91%), antihypertensive (66% vs 71%) and statin (36% vs 32%) prescription rates.
3.2.
Post-baseline evaluation data
Following the baseline evaluation phase, HbA1c was repeated once in 507 (89%) and twice in 365 (64%) patients. The percentage of patients with HbA1c > 8% did not change (Table 1) irrespective of attendance to the local DOC or not (data not shown) and was heterogeneously distributed among team physicians, an interindividual difference that tended to widen in the longer term (Fig. 1). Only about half of the determinations was carried out at appropriately timed intervals (Table 1). Process and intermediate outcome indicators as well as rates of antihyperglycemic, antihypertensive and statin
Fig. 1 – Percentages of type 2 diabetic patients with HbA1c >8% out of the total in charge of each GPs of the practice. Data recorded at the baseline evaluation (black histograms) and the first (dark gray histograms) and second (light gray histograms) post-evaluation monitoring, respectively.
prescriptions showed no statistically significant changes from those assessed in the initial baseline evaluation (Fig. 2).
4.
Discussion
A first point worth of comment raised by this analysis of the activity of an Italian primary care group practice regards the clinical approach toward that minority of patients with HbA1c > 8% whose poor metabolic control should have prompted actions apt to restore metabolic control within acceptable ranges. However, HbA1c was unchanged following baseline determination, a trend indicative of a reluctance to modify therapeutic strategies in front of clearly abnormal clinical parameters. Quite notably, GPs shared that behavior, frequently referred to as “therapeutic inertia” [20], with local diabetologists since patients of the practice seen at the local DOC behaved as those primarily in charge of family physicians, a result in line with previous studies [21,22]. Although “therapeutic inertia” has a negative connotation, some words
Table 1 – Process and outcome indicators recorded at the baseline and post-baseline evaluation periods. Variables
Baseline evaluation N = 571
Post-baseline evaluation 1 Post-baseline evaluation 1 N = 507 N = 365
Days from baseline evaluation (median and range)
–
304 (31–712)
545 (268–882)
Process indicators HbA1c determination (%) Appropriately timed (3–9 months) SBP determination LDL-C determination
571/571 (100%) – 394/571 (69%) 439/571 (77%)
507/571 (89%) 201/507(40%) 432/507 (85%) 392/507 (77%)
365/571 (64%) 184/365 (50%) 303/365 (83%) 243/365 (67%)
Intermediate outcome indicators HbA1c > 8% HbA1c < 7% SBP > 140 mmHg SBP < 130 mmHg LDL-C > 130 mg/dL LDL-C < 100 mg/dL
127/571 (22%) 280/571 (49%) 101/394 (26%) 89/394 (22%) 157/439 (36%) 123/439 (28%)
111/507 (22%) 246/507 (48%) 96/432 (22%) 91/432 (21%) 150/392 (38%) 110/392 (28%)
94/365 (25%) 170/365 (47%) 65/303 (18%) 73/303 (25%) 98/243 (40%) 80/243 (33%)
Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
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Fig. 2 – Percentages of patients with antihyperglycemic, antihypertensive and statin prescriptions (Rx) at the baseline (black histograms) and first (dark gray histograms) and second (light gray histograms) post-evaluation monitoring, respectively.
of caution are needed about the aggressive pursuit of lower glycemic levels in the elders largely represented in this sample well representative of the aging trend of the Italian population whose increasing longevity is accompanied by an augmented risk of multiple diseases, disability and loss of autonomy [23]. In fact, intensified antihyperglycemic treatment does not confer cardiovascular protection in elderly diabetic patients with severely impaired metabolic control [24] while increasing the risk of dangerous hypoglycemia [25] and worse quality of life [26]. Rather, this group of patients should be addressed cautiously [27] reserving the achievement of HbA1c values 8% among the GPs belonging to the group practice, a large interindividual spread explained by several factors including discrepant medical competence and personal motivation, defective communication of the common goals to be reached as a team and ignorance and/or unwillingness to accept guidelines recommendations [28,29]. This latter possibility applies also to the way physicians monitored the metabolic status of their patients since about half of the post-baseline evaluation HbA1c determinations were obtained at time intervals either too short (less than 3 months) or too long (more than 9 months) to be used as a meaningful clinical guide quite in contrast with guidelines requiring HbA1c determinations 2 times each year in stable patients at target and quarterly in those not meeting glycemic goals [4,19]. On the other hand, it should be considered that, albeit unsatisfactory as regards both timing and reevaluation volumes, HbA1c determinations were still much more frequent than those routinely adopted by Italian family physicians [11,13] and the absence of age- and gender-related differences shows a reassuring lack of prejudices toward women and elders reported in previous surveys in Italian primary care practices [30,31]. Some additional comments deserves the approach of team physicians toward BP management since, despite the missing recording of BP values in about two thirds of the sample at baseline evaluation, measurements were later available in
most of the patients who underwent a repeated HbA1c determination. Moreover, target systolic BP (SBP < 130 mmHg) was achieved in about 20% of patients, a rate low but still about 2fold greater than that attained by diabetic patients subjected to a program of intensive risk factor treatment in Italian DOCs [32]. It should also be considered that BP thresholds recommended at the time of this survey [19] have nowadays been relinquished given the lack of clinical benefit associated with their achievement [33] moving target SBP to 140 mmHg [34] by which most of the patients of this series should have been considered adequately treated. Much more concern raises the approach toward LDL-C since values were frequently not recorded, when so they were persistently above 130 mg/dL and, quite disconcertingly, statins were prescribed in only one third of patients to indicate lack of consensus about the evidence [35,36] that led to recommend prescription of those drugs in most type 2 diabetic patients regardless of lipid levels [37], a disregard, however and again, shared with Italian specialists in diabetology [9,32,38,39] (Fig. 2). This study has obvious limitations to be taken into account including the external validity of our conclusions since the team of GPs under evaluation volunteered to participate to a quality improving program and was financially rewarded for its participation. Thus, these results likely overestimate the average performance of Italian GPs at large, even more since cultural and organizational differences distinguish primary care providers of one region from the other [40], although the behavioral pitfalls emerging from this survey were common to those reported in Italian studies independent of the setting-be it generalist or specialist, under evaluation. Moreover, intermediate outcome and process indicators could be at least partially dependent on unmeasured patient factors and unsatisfactory process and intermediate outcomes may not only result from out-of-standard medical interventions [41]. Not to be underestimated is also the frequently evolving treatment targets and management strategies advocated by guidelines panels that make it difficult for general practitioners and clinical diabetologists as well to change consolidated habits and adapt to new therapeutic options. As a matter of fact, enhancement in the processes and outcomes of care is not a painless process and acceptance of being audited by external sources implies a willing attitude to improve compliance to guidelines. In fact, the true utility of quality measurement lies in its ability to inspire quality improvement in clinical care and delivery of equitable and cost-effective diabetic care and improvement of health outcomes is the ultimate goal of any healthcare system.
Funding No extramural funding was used to support this work. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Conflict of interest statement The authors state that they have no conflict of interest.
Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
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Contents lists available at ScienceDirect
Primary Care Diabetes journal homepage: http://www.elsevier.com/locate/pcd
Original research
Health care delivery in type 2 diabetes. A survey in an Italian primary care practice Andrea Modesti a , Roberto Bartaloni a , Franca Bellagamba a , Rossano Caglieri a , Katia Cenori a , Giorgio Ciampalini a , Attilio Costagli a , Vanni Galloni a , Cecilia Del Papa a , Leonardo Modesti a , Giulia Dell’Omo b , Roberto Pedrinelli b,∗ a b
“Modulo Pontedera” Progetto Regionale di Medicina d’Iniziativa, Pontedera, Italy Dipartimento di Patologia Chirurgica, Medica, Molecolare e dell’Area Critica, Università di Pisa, Italy
a r t i c l e
i n f o
a b s t r a c t
Article history:
Aims: Evidence-based guidelines provide targets and performance measures for the
Received 28 February 2014
treatment of type 2 diabetic patients but a wide gap separates guidelines-driven recom-
Received in revised form
mendations from their clinical application, a phenomenon hindering the transfer of proven
22 April 2014
benefits to affected populations.
Accepted 23 April 2014
Methods: We analyzed the quality of diabetic care delivered by 8 general practitioners joint
Available online xxx
in a group practice attending 571 diabetic patients (5.6% of the total enlisted subjects) by assessing process (% of HbA1c , SBP and LDL-C determinations) and intermediate outcome (%
Keywords:
of patients with HbA1c 8%, systolic BP 140 mmHg, LDL-cholesterol
Health services
130 mg/dL) indicators.
Outcomes research
Results: HbA1c was at target in 49% of patients and >8% in 22%; SBP and LDL-C determination
Type 2 diabetes
was available in about two-thirds of patients, only a minority at target for SBP and LDL-C.
Primary care
Antihyperglycemic and antihypertensive treatment was prescribed in most patients but only a third was on statins. During the post-evaluation phase, percentages of patients with HbA1c >8%, SBP < 130 mmHg and LDL-C < 100 mg/dL and the drug prescription pattern did not change. Conclusions: Several weaknesses affect primary care delivery to type 2 diabetic patients and efforts are needed to improve the management of this high-risk group. © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
∗ Corresponding author at: Dipartimento di Patologia Chirurgica, Medica, Molecolare e dell’Area Critica, Università di Pisa, 56100 Pisa, Italy. Tel.: +39 050 996712; fax: +39 050 540522. E-mail address: [email protected] (R. Pedrinelli). http://dx.doi.org/10.1016/j.pcd.2014.04.008 1751-9918/© 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
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1.
Introduction
Type 2 diabetic patients are exposed to morbid cardiovascular events and early death (e.g. [1,2]), a poor outcome postponed and, to some extent, prevented by persistent normalization of abnormal metabolic parameters and effective long-term treatment of coexisting high blood pressure (BP) and low density lipoprotein (LDL) cholesterol (C) [3], a solid evidence incorporated in guidelines providing treatment targets and performance measures for field clinicians (e.g. [4]). However, a wide gap separates evidence-based recommendations from their daily application, a worldwide phenomenon (e.g. [5–7]) documented also by Italian studies carried out in Diabetes Outpatient Clinic (DOC)s [8–10] and primary care practices [11–14]. Since this latter setting plays a pivotal role for successful primary and secondary cardiovascular prevention [15,16], additional information about the way general practitioner (GP)s approach the management of patients with type 2 diabetes is an essential step in the process of improving health care delivery and resource allocation by national community and political stakeholders. For this reason, we analyzed the quality of care provided to a large group of type 2 diabetic patients in charge of an Italian primary care group practice.
2.
Material and methods
2.1.
Setting
The analysis involved 8 primary care physicians (A.M. coordinator, R.B., R.C., G.C., A.C, V.G., C.D.P., L.M., 1 female, mean age: 60 ± 2 yrs) and 2 nurses (F.B., K.C) partnered in a practice enlisting 10,156 adult subjects in Pontedera, a town in northwestern Tuscany (population ≥16 yrs: 24,489 according to the 2011 national census). The data were gathered in the context of “Medicina d’Iniziativa”, a project sponsored by Regione Toscana, the regional branch of the publicly funded Italian National Health System aiming at the promotion of proactive, planned and population-based treatment strategies of chronic diseases in primary care [17]. According to the Italian law, a group practice is an organizational unit in which 3–10 partnered GPs share facilities and patient electronic health record systems, meet on a regular basis to adopt common guidelines and assess quality of care and prescription appropriateness under the coordination of a team physician [18]. GPs agreed to transfer their clinical records to two academic clinicians (GDO, RP) expert in cardiovascular prevention who analyzed the data.
2.2.
Performance measures
Performance measures included process (i.e. the procedures actually done to the patient independent of their outcome) and intermediate outcome (i.e. surrogate measures related to incident hard end-points) indicators. The two sets of performance indicators are complementary in that a process measure (e.g. HbA1c determination) can be obtained and still remaining outside the desirable range of values.
Process indicators utilized for the audit were percentages of patients with available HbA1C , SBP and LDL-C determinations; outcome indicators were percentages of patients at target or not for HbA1C (8%), systolic (S) BP (140 mmHg) and low density lipoprotein-cholesterol (LDL-C) (130 mg/dL) as recommended at the time of the audit by the Italian association of family physicians (Società Italiana di Medicina Generale, SIMG) [19] following internationally accepted standards of care. HbA1C determinations obtained from 3 to 9 months after the baseline evaluation were defined as appropriately timed. Antihyperglycemic, antihypertensive and statin treatment was coded as prescribed or not while no information about specific drugs was available in the records. Patients with HbA1C levels >8% were considered in need of therapeutic adjustment to achieve a better metabolic control. According to the Italian law, patients can access the local DOC either as referrals or on a voluntary basis.
2.3.
Protocol
2.3.1.
Baseline evaluation
Following the requirements of the project “Medicina d’Iniziativa” [17] and the agreements stipulated with Regional Health Administration, GPs were required to collect HbA1c levels of all patients (fasting plasma glucose levels 126 mg/dL and/or prescription of antihyperglycemic drugs) attending the practice, either known or newly diagnosed, irrespective of age, diabetes duration or treatment. The baseline evaluation, carried out between March 2009 and November 2011, yielded 571 patients (5.6% of the overall enlisted population). To exclude patients with juvenile forms of type 1 diabetes, only subjects with diabetes diagnosed by age 30 or more were included in the analysis.
2.3.2.
Post-baseline evaluations
After the baseline HbA1c evaluation required by the “Medicina d’Iniziativa” project, management and timing of the postbaseline clinical and analytical controls was left to the clinical judgment of each individual GPs.
2.4.
Analytical methods
HbA1C were carried out by High Performance Liquid Chromatography at the local community Hospital of Pontedera. Quality control across laboratories is provided in Tuscany by the regional branch of the National Health System (Regione Toscana, Controllo di Qualità in Medicina di Laboratorio, see http://www.aou-careggi.toscana.it/crrveq for details). LDL-C were derived from Friedwald’s formula on samples analyzed for total, high density lipoprotein cholesterol and triglycerides by enzymatic methods; BP determinations were obtained by standard methods either by nurses or GPs.
2.5.
Statistics
Differences between means and proportions were analyzed by unpaired t-tests and chi-square, respectively (p < 0.05 as limit of statistical significance). Descriptive statistics were
Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
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means ± SD or proportions for continuous and dichotomic variables, respectively.
3.
Results
3.1.
Baseline evaluation
HbA1c was 8% in 45% in 22% respectively. SBP and LDL-C determinations were available in 69% and 77% of the of the overall sample (n = 571). Target SBP ( 8% (26% vs 19%), SBP > 140 mmHg (23% vs 27%), LDL-C > 130 mmHg (31% vs 25%) and antihyperglycemic (91% vs 89%), antihypertensive (74% vs 63%) and statin (30% vs 39%) prescription rates. Males (n = 295, 52%) and females (n = 276, 48%) did not differ by HbA1c > 8% (23% vs 21%), SBP > 140 mmHg (27% vs 30%), LDLC > 130 mg/dL (35% vs 41%) nor by antihyperglycemic (90% vs 91%), antihypertensive (66% vs 71%) and statin (36% vs 32%) prescription rates.
3.2.
Post-baseline evaluation data
Following the baseline evaluation phase, HbA1c was repeated once in 507 (89%) and twice in 365 (64%) patients. The percentage of patients with HbA1c > 8% did not change (Table 1) irrespective of attendance to the local DOC or not (data not shown) and was heterogeneously distributed among team physicians, an interindividual difference that tended to widen in the longer term (Fig. 1). Only about half of the determinations was carried out at appropriately timed intervals (Table 1). Process and intermediate outcome indicators as well as rates of antihyperglycemic, antihypertensive and statin
Fig. 1 – Percentages of type 2 diabetic patients with HbA1c >8% out of the total in charge of each GPs of the practice. Data recorded at the baseline evaluation (black histograms) and the first (dark gray histograms) and second (light gray histograms) post-evaluation monitoring, respectively.
prescriptions showed no statistically significant changes from those assessed in the initial baseline evaluation (Fig. 2).
4.
Discussion
A first point worth of comment raised by this analysis of the activity of an Italian primary care group practice regards the clinical approach toward that minority of patients with HbA1c > 8% whose poor metabolic control should have prompted actions apt to restore metabolic control within acceptable ranges. However, HbA1c was unchanged following baseline determination, a trend indicative of a reluctance to modify therapeutic strategies in front of clearly abnormal clinical parameters. Quite notably, GPs shared that behavior, frequently referred to as “therapeutic inertia” [20], with local diabetologists since patients of the practice seen at the local DOC behaved as those primarily in charge of family physicians, a result in line with previous studies [21,22]. Although “therapeutic inertia” has a negative connotation, some words
Table 1 – Process and outcome indicators recorded at the baseline and post-baseline evaluation periods. Variables
Baseline evaluation N = 571
Post-baseline evaluation 1 Post-baseline evaluation 1 N = 507 N = 365
Days from baseline evaluation (median and range)
–
304 (31–712)
545 (268–882)
Process indicators HbA1c determination (%) Appropriately timed (3–9 months) SBP determination LDL-C determination
571/571 (100%) – 394/571 (69%) 439/571 (77%)
507/571 (89%) 201/507(40%) 432/507 (85%) 392/507 (77%)
365/571 (64%) 184/365 (50%) 303/365 (83%) 243/365 (67%)
Intermediate outcome indicators HbA1c > 8% HbA1c < 7% SBP > 140 mmHg SBP < 130 mmHg LDL-C > 130 mg/dL LDL-C < 100 mg/dL
127/571 (22%) 280/571 (49%) 101/394 (26%) 89/394 (22%) 157/439 (36%) 123/439 (28%)
111/507 (22%) 246/507 (48%) 96/432 (22%) 91/432 (21%) 150/392 (38%) 110/392 (28%)
94/365 (25%) 170/365 (47%) 65/303 (18%) 73/303 (25%) 98/243 (40%) 80/243 (33%)
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Fig. 2 – Percentages of patients with antihyperglycemic, antihypertensive and statin prescriptions (Rx) at the baseline (black histograms) and first (dark gray histograms) and second (light gray histograms) post-evaluation monitoring, respectively.
of caution are needed about the aggressive pursuit of lower glycemic levels in the elders largely represented in this sample well representative of the aging trend of the Italian population whose increasing longevity is accompanied by an augmented risk of multiple diseases, disability and loss of autonomy [23]. In fact, intensified antihyperglycemic treatment does not confer cardiovascular protection in elderly diabetic patients with severely impaired metabolic control [24] while increasing the risk of dangerous hypoglycemia [25] and worse quality of life [26]. Rather, this group of patients should be addressed cautiously [27] reserving the achievement of HbA1c values 8% among the GPs belonging to the group practice, a large interindividual spread explained by several factors including discrepant medical competence and personal motivation, defective communication of the common goals to be reached as a team and ignorance and/or unwillingness to accept guidelines recommendations [28,29]. This latter possibility applies also to the way physicians monitored the metabolic status of their patients since about half of the post-baseline evaluation HbA1c determinations were obtained at time intervals either too short (less than 3 months) or too long (more than 9 months) to be used as a meaningful clinical guide quite in contrast with guidelines requiring HbA1c determinations 2 times each year in stable patients at target and quarterly in those not meeting glycemic goals [4,19]. On the other hand, it should be considered that, albeit unsatisfactory as regards both timing and reevaluation volumes, HbA1c determinations were still much more frequent than those routinely adopted by Italian family physicians [11,13] and the absence of age- and gender-related differences shows a reassuring lack of prejudices toward women and elders reported in previous surveys in Italian primary care practices [30,31]. Some additional comments deserves the approach of team physicians toward BP management since, despite the missing recording of BP values in about two thirds of the sample at baseline evaluation, measurements were later available in
most of the patients who underwent a repeated HbA1c determination. Moreover, target systolic BP (SBP < 130 mmHg) was achieved in about 20% of patients, a rate low but still about 2fold greater than that attained by diabetic patients subjected to a program of intensive risk factor treatment in Italian DOCs [32]. It should also be considered that BP thresholds recommended at the time of this survey [19] have nowadays been relinquished given the lack of clinical benefit associated with their achievement [33] moving target SBP to 140 mmHg [34] by which most of the patients of this series should have been considered adequately treated. Much more concern raises the approach toward LDL-C since values were frequently not recorded, when so they were persistently above 130 mg/dL and, quite disconcertingly, statins were prescribed in only one third of patients to indicate lack of consensus about the evidence [35,36] that led to recommend prescription of those drugs in most type 2 diabetic patients regardless of lipid levels [37], a disregard, however and again, shared with Italian specialists in diabetology [9,32,38,39] (Fig. 2). This study has obvious limitations to be taken into account including the external validity of our conclusions since the team of GPs under evaluation volunteered to participate to a quality improving program and was financially rewarded for its participation. Thus, these results likely overestimate the average performance of Italian GPs at large, even more since cultural and organizational differences distinguish primary care providers of one region from the other [40], although the behavioral pitfalls emerging from this survey were common to those reported in Italian studies independent of the setting-be it generalist or specialist, under evaluation. Moreover, intermediate outcome and process indicators could be at least partially dependent on unmeasured patient factors and unsatisfactory process and intermediate outcomes may not only result from out-of-standard medical interventions [41]. Not to be underestimated is also the frequently evolving treatment targets and management strategies advocated by guidelines panels that make it difficult for general practitioners and clinical diabetologists as well to change consolidated habits and adapt to new therapeutic options. As a matter of fact, enhancement in the processes and outcomes of care is not a painless process and acceptance of being audited by external sources implies a willing attitude to improve compliance to guidelines. In fact, the true utility of quality measurement lies in its ability to inspire quality improvement in clinical care and delivery of equitable and cost-effective diabetic care and improvement of health outcomes is the ultimate goal of any healthcare system.
Funding No extramural funding was used to support this work. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Conflict of interest statement The authors state that they have no conflict of interest.
Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
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Please cite this article in press as: A. Modesti, et al., Health care delivery in type 2 diabetes. A survey in an Italian primary care practice, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.04.008
