Five-year impact of a continuous quality improvement ... - CiteSeerX

Diabetes Care Publish Ahead of Print, published online October 16, 2007

Five-year impact of a continuous quality improvement effort implemented by a network of diabetes outpatient clinics

Club Diabete Sicili@* *The full list of the “Club Diabete Sicili@” Investigators’s is in the Appendix at the end of the paper.

Running title: Quality improvement in diabetes care

Corresponding Author: Antonio Nicolucci MD Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Via Nazionale, 66030 S. Maria Imbaro (CH), Italy. e-mail [email protected]

Received for publication 2 August 2007 and accepted in revised form 2 October 2007.

Copyright American Diabetes Association, Inc., 2007

Quality improvement in diabetes care

ABSTRACT Objectives: To evaluate the impact of a continuous quality improvement effort implemented by a network of diabetes outpatient clinics in Sicily, Italy. Research design and methods: Twenty-two clinics adopted the same electronic medical record system. Process and intermediate outcomes indicators were identified, and software was developed, enabling the extraction of the information needed for the profiling of quality of care. Data were centrally analyzed anonymously every year, and results were discussed in meetings with the participants. The performance of the different centres was ranked against the “best performers”, and the reasons for variation discussed. Results: From 2001 to 2005, 26.782 patients of age ≥18 years have been seen in the participating clinics. Rates of monitoring of HbA1c, blood pressure, lipid profile, and microalbuminuria constantly increased over the years. The percentage of individuals with HbA1c values ≤7.0% increased by 16.6%, while the proportion of patients with blood pressure ≤130/85 mmHg increased by 10.7%. The percentage of individuals with LDL cholesterol levels 20 mg/l on morning urine spot. Aspirin use was evaluated in individuals aged ≥40 years. Data are summarized as mean±standard deviation for continuous variables and percentages with 95% confidence limits for proportions. Information on variation for process and outcomes measures was displayed graphically using box-plots. Using these graphs, each centre was able to locate its own performance with respect to the overall picture.

had the possibility of obtaining the information on its performance directly from the electronic record system, using specific queries. Data were analyzed annually, from 2001 to 2005, and results were discussed once a year in ad hoc meetings involving the head of each of the diabetes clinics involved. On those occasions, the performance of the different centres was ranked against the “best performers”, the reasons for variation were openly discussed, and the possible solutions fully evaluated. In all the steps of the process anonymity was ensured. Following the plenary meetings, data were provided to each clinic to allow internal discussion, led by the head of the clinic, and involving all the personnel practicing in the structure (physicians, nurses, dieticians). The analyses of the data included all the patients aged ≥18 years who had had at least one encounter with the clinic during the index calendar year. Process measures included frequency of measurement of HbA1c, blood pressure, lipid profile (total and HDL cholesterol, triglycerides), and microalbuminuria. Process measures were expressed as percentages of patients monitored at least once during the previous 12 months. Intermediate outcome measures included mean HbA1c, blood pressure (BP), lipid profile, and BMI. In case of multiple records during the year, the last value was considered for the analyses. LDL cholesterol was estimated by the Friedwald equation. For selected outcomes, we also considered the proportion of patients with satisfactory values as well as the percentage of those with unacceptably high values. Outcomes were considered satisfactory if HbA1c levels were ≤7.0%, blood pressure values were ≤130/85 mmHg, and LDL cholesterol levels were ≤100 mg/dl. Unsatisfactory outcomes included HbA1c levels ≥8%, blood pressure values ≥140/90 mmHg, and LDL levels ≥130 mg/dl. Finally, the percentage of use of specific classes of drugs was calculated, including

RESULTS From January 2001 to November 2005, 26.782 patients have been seen at least once in the participating clinics; on average 12.000 patients have attended the centres every year (range 9.647-14.247). The mean age of the study population was of 65±12 years, while the proportion of males was of 49%. Rates of individuals who received processes of care for diabetes and drug prescriptions are reported in table 1, while intermediate outcomes attained are reported in table 2. Glycated haemoglobin. The proportion of patients with at least one measurement of HbA1c constantly increased across the years, from 56.6% in 2001 to 76.1% in 2005 (table 1). At the same time, the between centres variability in HbA1c monitoring decreased, as shown by the 4


two or more drugs also considerably raised across the years (table 1). Lipid profile. Monitoring of lipid profile showed a constant percentage increase over time (table 1), and was associated with a reduction in between centres variability in rates of lipid testing (figure 1, panel E). As for intermediate outcomes, a marked decrease in total cholesterol and LDL cholesterol levels were documented, while triglycerides and HDL cholesterol levels showed only marginal temporal variations. The proportion of individuals with LDL cholesterol levels on target also remarkably increased from 19.4% to 44.1% (table 2). The improvement in LDL levels did not translate into a reduction in between centres variability (figure 1, panel F). This finding can be explained by the fact that, within a general trend of improvement in mean LDL cholesterol levels, some clinics attained a markedly better result than others, thus increasing the between centres variability. The positive changes in total and LDL cholesterol levels were associated with a sharp increase in the use of statins, growing from 4.1% in 2001 to 27.5% in 2005. Among patients receiving statins, the percentage of those on target in 2005 was of 49.0% (46.9-51.1), while 26.5% (24.7-28.3) still had values ≥130 mg/dl. Similarly, among individuals’ not receiving statins only 41.7% (40.3-41.1) showed LDL levels below 100 mg/dl, while 26.5% (24.7-28.3) were not treated despite LDL values ≥130 mg/dl.

decreasing length of the boxes in figure 1, panel A. Mean HbA1c levels also progressively decreased from 7.8±1.7 in 2001 to 7.3±1.5 in 2005 (table 2). Between centres variability in HbA1c levels tended to decrease along the years as well (figure 1, panel B). When looking at the proportion of patients reaching specific therapeutic targets, it emerged that the percentage of individuals with HbA1c values ≤7.0% increased by over 15% (from 43.3% to 59.9%) during five years of observation (table 2). These positive changes in metabolic control were associated with a progressive decrease in the percentage of individuals on diet alone (from 11.9% in 2001 to 6.5% in 2005). In parallel, the proportion of patients treated with oral agents increased from 52.8% to 58.2%, while no major changes were detected in the use of insulin, alone or in association (table 1). Blood pressure. The proportion of individuals with at least one blood pressure reading during the year only slightly increased over time (table 1), and was associated with a decrease in between centres variability (figure 1, panel C). Small declines in mean systolic and diastolic blood pressure values were also documented, and were associated with an increasing rate of individuals with values on target (i.e. ≤130/85 mmHg), growing from 37.8% in 2001 to 48.5% in 2005 (table 2). Between centres variation in blood pressure levels was very small and did not substantially change during the study period (figure 1, panel D). Overall, the prevalence of individuals with hypertension slightly increased over the years (from 56.7% in 2001 to 68.4% in 2005), probably as a reflection of better reporting. The percentage of patients with hypertension treated with antihypertensive drugs substantially increased from 22.4% in 2001 to 72.9% in 2005 (table 1). Increasing rates of use of all antihypertensive agents were documented; the proportion of individuals treated with

Additional quality indicators. Monitoring of microalbuminuria, while showing an important trend of increase over the years, was still performed in only one-third of the patients in 2005 (table 1). Among individuals who had received the test, the proportion of those with MA progressively decreased from 30.5% in 2001 to 20.5% in 2005 (table 2). The use of Ace-inhibitors or ARBs in individuals with MA increased from 35.9% to 44.1% (table 1). Finally, mean BMI values remained unchanged, while the use of antiplatelet 5


similar, though less marked improvement, was documented for blood pressure monitoring, treatment and control. Improvement in blood pressure levels and targets achievement was less prominent notwithstanding a remarkable increase in use of antihypertensive agents. Improved reporting of medication prescription or suboptimal treatment are likely explanations for our findings. The need for more aggressive therapeutic approaches is further suggested by the fact that less than fifty percent of individuals with hypertension were treated with two or more antihypertensive agents. As for metabolic control, improvements in monitoring and HbA1c levels were particularly evident, but they were associated with only a moderate increase in the proportion of individuals treated with oral agents. The use of higher doses of oral agents or insulin might concur in explaining our findings, though we were unable to collect information on drug doses. Overall, temporal changes documented seem more pronounced of those documented in U.S. over 10 years (8), particularly for metabolic control, both in terms of mean HbA1c levels and proportion of patients with HbA1c levels below 7.0%. Furthermore, while no changes in blood pressure levels were documented across the years in U.S., the proportion of individuals at goal (i.e. ≤130/85 mmHg) constantly increased in our study. Another important information deriving from our study is represented by the reduction in practice variation, which is generally considered as an important source of inappropriate care as well as of resource consumption (14). We initially found a remarkable variation across centres, suggesting gross differences in the ability of specialist structures to provide adequate care for people with diabetes. After five years from the launch of the initiative, such a variability was substantially reduced for many process

agents in individuals over 40 years raised from 5.8% to 27.4% (table 2). CONCLUSIONS Our study shows that sharing an electronic health record system, has a significant potential for conducting practice-based quality-of-care studies across large numbers of outpatient practices. This was a preliminary, fundamental step for reaching a consensus in how to measure the quality of care in priority areas, promote critical evaluation of current practice, develop process improvements, and reduce practice variation. By adopting standardized process and outcomes measures, the study was able to document a tangible improvement in the quality of diabetes care provided by outpatient clinics in Sicily over five years. Recent quality improvement initiatives have consistently documented an improvement in processes of diabetes care, without a corresponding increase in treatment intensity (10) or an improvement in intermediate outcomes such as HbA1c levels (9-11), blood pressure control (9-10), or LDL levels (9,10). In our study, both process and intermediate outcome measures constantly improved over time, and the link between process and outcomes improvements is strongly supported by the information relative to intensity of treatment. One can in principle hypothesize that some of the improvements documented, particularly for process measures, be attributable to a more complete reporting of the information in the database during the years. Nevertheless, we found a strong consistency between increasing rates of monitoring, increasing drug prescription, and better levels of intermediate outcomes. This was particularly evident for the link between increased lipid monitoring, increased prescription of statins, and improved total and LDL cholesterol levels. That this is not an unspecific finding is further confirmed by the observation that triglycerides and HDL-cholesterol levels, less affected by statins treatment, only marginally changed across the years. A 6


results obtained so far, if maintained, would translate into a substantial reduction in the risk of major complications. Our study has some limitations. First, this is not a comparative study. Therefore, we cannot exclude that the positive changes in quality of care documented over five years be at least in part the results of a historical trend, rather than a specific effect of the quality improvement initiative. Nevertheless, substantial achievements have been obtained in a relatively short period of time, thus suggesting a more specific effect of the program. Second, the considerable success documented was obtained without allocation of extra resources or financial incentives, but simply through a physician-led effort, made possible by the commitment of the specialists involved. While this is a qualifying aspect of the initiative, it can at the same time represent a factor that might limit its generalizability to other areas where clinicians do not display a similar willingness to share their experiences with colleagues. In conclusion, the experience of the diabetes centres in Sicily open important perspectives. Over 300 diabetes outpatient clinics throughout Italy share now the same electronic health record system, and the list of process, intermediate outcomes, and treatment intensity indicators have been endorsed by the Associazione Medici Diabetologi. Starting from 2006, 90 centres have already agreed to implement the same process realized in Sicily, and information on over 120.000 patients has been collected for the calendar years 2005 and 2006. It will represent a major challenge to show that the same results obtained in a restricted, rather homogeneous area, can be replicated on a much larger scale. If so, substantial benefits can be foreseen for individuals with diabetes in Italy in the years to come.

and some of the intermediate outcome measures. Overall, our results support the concepts that direct measurement, feedback, and reporting of intermediate outcome levels or of level of medication management may enhance the effectiveness of care (9). A key feature of the continuous quality improvement effort implemented in Sicily is represented by the decision to use the “best performers” approach (15). In other words, clinicians did not face with theoretical standards, often perceived as unrealistic in their structural and organizational setting, but rather with the performance of centres operating in the same geographic area, under similar conditions. By comparing their own performance with that of centres reaching better overall results, specialists could easily realize the real margin of improvement made possible by simply increasing the level of attention to disease monitoring and treatment. Despite the satisfactory achievements, a substantial room for improvement in the care of diabetes still persists. One in three patients still has HbA1c levels ≥8% or LDL cholesterol levels ≥130 mg/dl, while one in two has blood pressure levels ≥140/90 mmHg. This situation is mirrored by the persistence of an elevated percentage of individuals not treated with statins or multiple antihypertensive agents, despite elevated LDL cholesterol and blood pressure levels. On the same line, monitoring of microalbuminuria is still unsatisfactory, and among individuals with microalbuminuria ACE-inhibitors and ARBs are underutilized. Getting more patients to goal thus represents an important priority of the initiative in the years to come. The inclusion of additional indicators representing broader aspects of diabetes care (i.e. eye and foot examination, education, influenza vaccine) as well as the addition of distal outcomes (i.e. cardiovascular events, severity of retinopathy) also constitute a necessary step to implement. Nevertheless, the

ACKNOWLEDGMENTS The study was supported by LifeScan Italia.

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American Diabetes Association: Standards of medical care in diabetes--2007. Diabetes Care 30 Suppl 1:S4-S41, 2007 Mayfield J: Who cares about the quality of diabetes care? Almost everyone. Diabetes Spectrum 16:161-167, 1998 Peters AL, Legorreta AP, Ossorio RC, Davidson MB: Quality of outpatient care provided to diabetic patients. A health maintenance organization experience. Diabetes Care 19:601-606 1996 Martin TL, Selby JV, Zhang D: Physician and patient prevention practices in NIDDM in a large urban managed-care organization. Diabetes Care 18:1124-1132, 1995 TRIAD Study Group: The Translating Research Into Action for Diabetes (TRIAD) study: a multicenter study of diabetes in managed care. Diabetes Care 25:386-389, 2002 Ilag LL, Martin CL, Tabaei BP, Isaman DJ, Burke R, Greene DA, Herman WH: Improving diabetes processes of care in managed care. Diabetes Care 26:2722-2727, 2003 Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM: A diabetes report card for the United States: quality of care in the 1990s. Ann Intern Med 136:565-574, 2002 Saaddine JB, Cadwell B, Gregg EW, Engelgau MM, Vinicor F, Imperatore G, Narayan KM: Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann Intern Med 144:465-474, 2006 Mangione CM, Gerzoff RB, Williamson DF, Steers WN, Kerr EA, Brown AF, Waitzfelder BE, Marrero DG, Dudley RA, Kim C, Herman W, Thompson TJ, Safford MM, Selby JV, TRIAD Study Group: The association between quality of care and the intensity of diabetes disease management programs. Ann Intern Med 145:107-116, 2006 Landon BE, Hicks LS, O'Malley AJ, Lieu TA, Keegan T, McNeil BJ, Guadagnoli E. Improving the management of chronic disease at community health centers. N Engl J Med 356:921-34, 2007 Chin MH, Cook S, Drum ML, Jin L, Guillen M, Humikowski CA, Koppert J, Harrison JF, Lippold S, Schaefer CT; Midwest cluster health disparities collaborative. Improving diabetes care in midwest community health centers with the health disparities collaborative. Diabetes Care 27:2-8, 2004. Kerr EA, Krein SL, Vijan S, Hofer TP, Hayward RA: Avoiding pitfalls in chronic disease quality measurement: a case for the next generation of technical quality measures. Am J Manag Care 7:1033-1043, 2001 Fleming BB, Greenfield S, Engelgau MM, Pogach LM, Clauser SB, Parrott MA: The Diabetes Quality Improvement Project: moving science into health policy to gain an edge on the diabetes epidemic. Diabetes Care 24: 1815–1820, 2001 Hayward RA, Hofer TP, Kerr EA, Krein SL: Quality improvement initiatives: issues in moving from diabetes guidelines to policy. Diabetes Care 27 Suppl 2:B54-60, 2004 Kiefe CI, Weissman NW, Allison JJ, Farmer R, Weaver M, Williams OD. Identifying achievable benchmarks of care: concepts and methodology. Int J Qual Health Care 10:443447, 1998

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Table 1. Proportion of patients who received processes of care for diabetes and drug prescriptions in the years 2001-2005. Data are percentages with their 95% confidence limits.

Process indicators HbA1c monitoring BP monitoring Lipid profile monitoring Microalbuminuria monitoring Diabetes treatment Diet alone Oral agents Insulin Insulin+OHA Statins ACE-Inhibitors/ARBs CCBs Diuretics Number of antihypertesive drugs 0 1 2 >2 ACE-Inhibitors/ARBs in individuals with MA Aspirin (pts. ≥40 years)

2001 56.6 (55.7-57.6) 63.4 (62.4-64.3) 39.2 (38.2-40.2) 7.2 (6.7-7.8)

2002 56.2 (55.3-57.1) 66.5 (65.6-67.3) 44.1 (43.3-45.0) 11.3 (10.7-11.9)

Calendar year 2003 58.9 (58.0-59.8) 64.7 (63.9-65.6) 51.2 (50.3-52.0) 14.9 (14.3-15.5)

2004 67.3 (66.5-68.0) 66.4 (65.7-67.2) 55.4 (54.5-56.2) 23.2 (22.5-23.9)

2005 76.1 (75.3-76.9) 70.0 (69.1-70.8) 63.3 (62.4-64.1) 30.8 (29.9-31.6)

11.9 (11.2-12.7) 52.8 (51.6-54.0) 23.5 (22.5-24.5) 11.8 (11.0-12.5) 4.1 (3.7-4.5) 7.3 (6.7-7.8) 2.4 (2.1-2.7) 2.9 (2.6-3.3)

9.3 (8.7-9.9) 58.8 (57.8-59.8) 20.6 (19.8-21.4) 11.4 (10.7-12.0) 6.9 (6.5-7.4) 11.9 (11.3-12.4) 3.7 (3.4-4.0) 5.1 (4.7-5.5)

8.5 (7.9-9.0) 60.4 (59.5-61.4) 20.3 (19.5-21.1) 10.8 (10.2-11.4) 12.1 (11.5-12.7) 20.6 (19.8-21.3) 6.6 (6.2-7.0) 9.5 (9.0-10.0)

7.0 (6.5-7.4) 60.2 (59.3-61.1) 21.0 (20.2-21.7) 11.8 (11.2-12.4) 19.5 (18.8-20.1) 28.6 (27.8-29.3) 9.9 (9.4-10.4) 14.5 (13.9-15.0)

6.5 (6.0-7.1) 58.2 (57.1-59.2) 22.3 (21.4-23.2) 13.0 (12.3-13.7) 27.5 (26.7-28.3) 34.7 (33.8-35.6) 11.2 (10.6-11.8) 17.4 (16.7-18.1)

77.6 (76.2-78.9) 9.8 (8.8-10.7) 8.2 (7.4-9.1) 4.4 (3.8-5.1)

65.8 (64.5-67.1) 14.3 (13.3-15.3) 12.5 (11.6-13.4) 7.4 (6.6-8.1)

45.5 (44.2-46.9) 21.9 (20.8-23.0) 19.9 (18.9-21.0) 12.6 (11.7-13.5)

31.9 (30.8-33.0) 24.6 (23.6-25.7) 24.8 (23.8-25.8) 18.6 (17.7-19.6)

27.1 (26.0-28.2) 26.9 (25.9-28.0) 25.6 (24.6-26.7) 20.3 (19.3-21.3)

35.9 (28.6-43.3)

32.5 (26.8-38.1)

28.3 (23.9-32.7)

37.7 (34.2-41.2)

44.1 (40.4-47.8)

5.8 (5.3-6.3)

10.0 (9.5-10.6)

16.5 (15.8-17.1)

22.7 (22.0-23.4)

27.4 (26.6-28.2)

BP = blood pressure OHA = oral hypoglycaemic agents ARBs = angiotensin receptor blockers CCBs = calcium channel blockers MA = micro/macroalbuminuria

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Table 2. Intermediate outcomes of diabetes care in the years 2001-2005. Data are mean±standard deviation or percentages with their 95% confidence limits.

Outcome indicators HbA1c (%) HbA1c ≤7.0% HbA1c ≥8.0% Systolic BP (mmHg) Diastolic BP (mmHg) BP ≤130/85 mmHg BP ≥140/90 mmHg BP ≥160/100 mmHg Total cholesterol (mg/dl) HDL cholesterol (mg/dl) Triglycerides (mg/dl) LDL cholesterol (mg/dl) LDL-C