The long-term effectiveness of glycemic control in a diabetes case management program and the challenges of diabetes care in Taiwan
Chih-Cheng Hsu, MD, DrPH1,2, Tong-Yuan Tai, MD, PhD3,4
1Division of Geriatrics and Gerontology, Institute of Population Health Sciences,
National Health Research Institutes, Zhunan, Taiwan
2Department of Health Services Administration, China Medical University, Taichung,
Taiwan
3Taipei Jen-Chi Relief Institution, Taipei, Taiwan 4Formosan Diabetes Care Foundation, Taipei, Taiwan
Running title: effectiveness and challenges of diabetes care in Taiwan
Corresponding author
Chih-Cheng Hsu, MD, DrPH
Division of Geriatrics and Gerontology, Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County, Taiwan Tel: +886-37-246-166 ext. 36336
Fax: +886-37-586-261 Email: cch@nhri.org.tw
Abstract
Aims
This study aims to evaluate the long-term effects on glycemic control of a domestic diabetes care program focusing on case management and to discuss the challenges in quality of diabetes care in Taiwan.
Methods
We randomized (clinic-based) 1060 study subjects recruited from the DMIDS
(Diabetes Management through an Integrated Delivery System) project in 2003–2005 into the intervention group (n=789 from 27 clinics) and control group (n=271 from 7 clinics). The quarterly self-care and nutrition education program in the intervention group was delivered by case managers, and usual care was given to the control group. The intervention program was provided from 2003 to 2007. A multivariable mixed model analysis was used to assess 3.5-year intervention effects on glycemic control.
Results
The glycated hemoglobin (HbA1c) in the intervention group (especially for those with baseline HbA1c in 7–9% and >9%) was significantly lower than that in the control group since the sixth month after recruitment and the intervention effects could sustain for 3 years.
Conclusions
The current study shows that the case management provided in the
pay-for-performance (P4P) diabetes care program in Taiwan is effective to improve glycemic control for at least 3 years. However, previous research indicated poverty is associated with not only higher diabetes incidence but inequality of diabetes care in Taiwan despite universal health coverage. The sicker were also shown less likely to be enrolled to the P4P diabetes care program. Additional cost-effectiveness studies and more health policy reform are needed to optimize diabetes care in Taiwan.
Introduction
The global prevalence of diabetes mellitus (DM) has been escalating in the past decade and is expected to continuously increase by about 55% over the next 20 years [1]. In Taiwan, like elsewhere in the world, DM is a major public health problem. Its prevalence increased by 48.0% from 2000 to 2008 in spite of a relatively stable age-adjusted incidence rate (by only 2.2% increase) seen for the same period [2]. The fact that diabetes could incur high mortality (since 1987 it has been the fourth or fifth-leading cause of death in Taiwan) and high healthcare costs (4.3 times higher for diabetes patients compared to those without diabetes) indicates that diabetes imposes significant health and financial burdens in Taiwanese society [3].
In response to the growing challenges of this devastating disease, the National Health Insurance Administration in Taiwan has initiated a multidisciplinary diabetes care program since 2001 aimed at bettering diabetes care [4]. As a result, the annual check-up rate of all recommended diabetes tests — including glycated hemoglobin (HbA1c), lipid profile, urine analysis, and fundus examination — has significantly increased in the past 10 years [2]. However, health providers have been reported less likely to enroll sicker patients to attend this pay-for-performance (P4P) diabetes care program [4,5]. A study also showed poverty was associated with inequality of
diabetes care despite the universal coverage policy implemented in Taiwan since 1995 [6]. Furthermore, to the best of our knowledge, there is only one randomized
controlled trial (RCT) demonstrating improved short-term (1-year) glycemic control after receiving the multidisciplinary management in the designated P4P program [7]. This study aimed to evaluate the long-term (≥ 3 years) effectiveness of the P4P program on glycemic control. We also wanted to discuss the current challenges to optimizing diabetes control in Taiwan.
Methods
We followed the recruited participants in the Diabetes Management through an Integrated Delivery System (DMIDS) project (NCT00288678 ClinicalTrial.gov) until December 2007. The project, which was sponsored by the National Health Research Institutes (NHRI) has been described elsewhere [7]. Briefly, we recruited 1209 type 2 diabetes patients from 40 community clinics during 2003–2005. For the current study, we excluded participants recruited from clinics with enrollment size fewer than 10 (n=70 from 13 clinics). Those who had incomplete data were also excluded (n=79). The remaining 1060 study subjects recruited from 27 clinics were selected for further
analysis. By study design, the participants in each clinic were randomized into 2 groups: the usual care group (n=537) and the NHRI-intervention (NHRI-I) group (n=523). The NHRI-I group underwent a quarterly self-care and nutrition education program delivered by NHRI-hired case managers. However, the physicians in 7 out of 27 clinics decided to hire a local case manager to provide case management for those (the Local-I group, n=266) originally allocated into the usual care group in their clinics. Therefore, we had 3 study groups: the NHRI-I group (n=523 from 27 clinics), the Local-I group (n=266 from 7 clinics), and the usual care group (n=271 from 20 clinics). The case management, carried out from recruitment through the end of 2007, in both the NHRI-I and Local-I groups followed the same protocol designated by the NHI Administration [4,7]. The only distinction between these two was the
sponsorship for the case management: the case managers in the NHRI-I group were hired by NHRI (5 case managers shared by 27 clinics), while the case managers in the Local-I group were hired by individual clinics (7 case managers serving a total of 7 clinics). All case managers in the NHRI-I and Local-I groups were qualified by the NHI Administration. For the purpose of analysis, we further regrouped those in the NHRI-I and the Local-I groups into the intervention group (n=789). As previously indicated, the baseline characteristics — including demographics and the biochemical profiles of the intervention and control groups — were comparable [7]. Finally, we stratified the participants into 3 classes according to their baseline HbA1c for subgroup analysis: < 7%, 7–9%, and > 9%. A multivariable mixed model analysis was used to assess intervention effects on HbA1c control. The covariates adjusted in the models included age, gender, education, DM duration, baseline HbA1c, and region. The clinic was treated as a random effect. Analyses were performed with SAS software, version 9.1 (SAS Institute, Cary, NC). A two-sided P value < 0.05 was considered statistically significant.
Results
Figure 1 (A) shows the HbA1c in the intervention group was significantly lower than that in the control group since the sixth month after recruitment and the intervention effects could last for at least 3 years. Figure 1 (B) indicates the levels of glycemic control in the NHRI-I and Local-I groups were both better than that in the control group; the HbA1cs after the sixth month in the Local-I group looked even lower, although not having reached a significant level, than that in the NHRI-I group throughout the 3-year intervention period. Figure 2 displays results from subgroup analysis. In general, the glycemic control in the intervention groups, regardless of their baseline status, was better than in the control group. The significant intervention
effects could last for 2.5 years and 3 years for those with baseline HbA1c > 9% and 7–9%, respectively. However, for those who had good glycemic control at recruitment (HbA1c < 7%), the intervention did not seem to be able to provide glycemic
improvement, except for a significantly lower HbA1c level seen in the 36th month.
Discussion
This is the first and also the only RCT study to date in Taiwan to demonstrate long-term effects on glycemic control in the NHI Administration-initiated P4P diabetes care program. This study is in accord with and even strengthens the results shown in our previous, small-scale research project focusing on the short-term (1-year)
glycemic effect of case management for the study subjects recruited in the city of Kaohsiung [7]. We previously reported the intervention group had greater
improvements than the control in fasting plasma glucose (-13.4 vs. 16.9 mg/dL, p=0.007) and HbA1c (-0.7% vs. -0.2%, p=0.034) at 12 months. The improvement of HbA1c in the intervention group (beta=0.100; SE=0.033; p=0.004) could further be independently explained by the reduction in carbohydrate intake (-31.24 ± 61.53 and 7.15 ± 54.09 grams/day for the intervention and control group, respectively). This RCT study demonstrates that the current P4P diabetes care program can effectively improve long-term glycemic control in type 2 diabetes in primary care clinics in Taiwan through the betterment of diet control.
In addition to implementing the P4P diabetes care program since 2001, the Ministry of Health and Welfare in Taiwan has been promoting nationwide public health campaigns aiming at improving diabetes care, such as diabetes-awareness initiatives, patient self-help organizations, and accreditation for diabetes care providers [8]. Through such efforts the health system in Taiwan has become
increasingly supportive of diabetes care. As a result, both diabetes patients’ self-care behaviors and health providers’ accountability have improved over the last decade [2,9]. That such endeavors are not fully sufficient by themselves, however, is
indicated by the fact that diabetic nephropathy accounts for more than 45% of cases of end-stage renal disease requiring dialysis in Taiwan [10]. The big challenges we are facing today and probably for the next decade include the rising prevalence of diabetes and the disparity in quality of diabetes care.
The barriers of healthcare accessibility were expected to be minimized after the NHI program implementation in 1995. But the universal and comprehensive coverage featured in this greatly appreciated nationwide single-payer health insurance program did not seem to be able to eliminate all concerns about inequality of
reimbursement design of the P4P diabetes care program may disparage the sicker and the elderly as unwelcome patients for program enrollment [4,5]. In one of our
previous studies [6], we also found that economically disadvantaged people were more likely to develop type 2 diabetes; their incidence density was estimated to be 20.4 per 1000 person-years, which was about 50% more than the general population (hazards ratio = 1.5; 95% CI = 1.3–1.7). Furthermore, compared to their middle-income counterparts, the poor with diabetes were more likely to get their first-time DM diagnosis during a course of hospitalization (adjusted odds ratio [aOR] = 2.2, P < 0.001) and less likely to visit diabetes clinics (aOR = 0.4, P < 0.001) after the
diagnosis was established. The poor with diabetes were also less likely than their middle-income counterparts to be prescribed for the test of HbA1c (aOR = 0.6; 95% CI = 0.4–0.9), low-density lipoprotein cholesterol (aOR = 0.4; 95% CI = 0.2–0.7), triglycerides (aOR = 0.5; 95% CI = 0.4–0.8), and retinopathy (aOR = 0.4; 0.2–0.9). All of these epidemiological features indicate that socioeconomic background is related to the vulnerability of diabetes development and the quality of diabetes care in Taiwanese society.
The current study provides some empirical evidence confirming the NHI Administration-initiated P4P diabetes care program is an effective model for glycemic control in Taiwan. However, several other studies also indicate that universal
coverage in the NHI program is not a silver bullet on its own. That less than 25% of diabetes patients are currently enrolled in the P4P diabetes care program indicates a need to promote it more. Facing the challenges of the rapid growth of diabetes prevalence, without further reforming health policy, we may not be able to optimize and equalize quality of diabetes care for all disadvantaged groups.
Acknowledgements
This project was supported by grants (96A1-HDPP08-017) funded by the National Health Research Institutes of Taiwan. We thank all co-investigators (Drs. Meng-Chuan Huang, Shyi-Jang Shin, Hung-Jen Yang, Chwen-Tzuei Chang, Chih-Jen Chang, Ching-Hui Loh, Mao-Tsu Fuh, and Hsing-Yi Chang) for their enthusiastic support. We also extend our deep appreciation to the 40 general practitioners and 1029 diabetes patients who participated in this study for their contributions.
Figure legends
Fig. 1
Comparison of mean HbA1c in different study groups in 0–42 months since
recruitment. (A) mean HbA1c in the intervention vs. control group. (B) mean HbA1c in the NHRI-I, Local-I, and control groups. A multivariable mixed model analysis was used to assess intervention effects on HbA1c control. The covariates adjusted in the models included age, gender, education, DM duration, baseline HbA1c, clinic, and region. * indicates P < 0.05 comparing the intervention group with the control group. Fig. 2
Comparison of mean HbA1c in the intervention vs. control group in 0–42 months since recruitment for different subgroups according to baseline HbA1c. (A) for those with baseline HbA1c < 7%, (B) for those with baseline HbA1c in 7–9%, and (C) for those with baseline HbA1c > 9%. A multivariable mixed model analysis was used to assess intervention effects on HbA1c control. The covariates adjusted in the models included age, gender, education, DM duration, baseline HbA1c, clinic, and region.* indicates P < 0.05 comparing the intervention group with the control group.
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