Effectiveness of the multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) for diabetic microvascular complications: A population-based cohort study

doi:10.1016/j.diabet.2016.07.030

Diabetes & Metabolism

Volume 42, Issue 6, December 2016, Pages 424-432

https://doi.org/10.1016/j.diabet.2016.07.030 Get rights and content

Abstract

Aim

To evaluate the effectiveness of the multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) in reducing the risks of microvascular complications.

Methods

This prospective cohort study was conducted with 29,670 propensity-score-matched RAMP-DM participants and diabetes patients under the usual primary care (14,835 in each group). Study endpoints were the first occurrence of any diabetic microvascular complications, non-proliferative diabetic retinopathy/preproliferative diabetic retinopathy (NPDR/prePDR), sight-threatening diabetic retinopathy (STDR) or blindness, nephropathy, end-stage renal disease (ESRD), neuropathy and lower-limb ulcers or amputation. Log-rank tests and multivariable Cox proportional-hazards regressions were employed to estimate between-group differences in incidences of study endpoints.

Results

After a median follow-up of 36 months with > 41,000 person-years in each group, RAMP-DM participants had a lower incidence of microvascular complications (760 vs 935; adjusted hazard ratio [HR]: 0.73; 95% confidence interval [CI]: 0.66–0.81; P < 0.001) and lower incidences of all specific microvascular complications except neuropathy (adjusted HR: 0.94; 95% CI: 0.61–1.45; P = 0.778). Adjusted HRs for the RAMP-DM vs control group for ESRD, STDR or blindness, and lower-limb ulcers or amputation were 0.40 (95% CI: 0.24–0.69; P < 0.001), 0.55 (95% CI: 0.39–0.78; P = 0.001) and 0.49 (95% CI: 0.30–0.80; P = 0.005), respectively.

Conclusion

The RAMP-DM intervention was associated with lower incidences of all microvascular complications except neuropathy over a 3-year follow-up. These encouraging results constitute evidence that structured risk assessment and risk-stratified management provided by a multidisciplinary team is effective for reducing microvascular complications in diabetes patients.

Clinical trial registry

NCT02034695, www.ClinicalTrials.gov.

Introduction

Diabetes mellitus (DM) is one of the most common chronic diseases in the world. Its worldwide prevalence is estimated to reach 592 million by 2035, with an increase of 54.2% in total case numbers compared with 2013 [1]. China has the largest number of diabetes patients, and the number is estimated to exceed 129 million by 2030, accounting for more than one-fourth of total diabetes cases in the world [2]. In Hong Kong, around one in 10 people has DM [3], and its prevalence is increasing [4]. DM patients have an increased risk of developing microvascular complications, including retinopathy, nephropathy and neuropathy. Prevalences of retinopathy and neuropathy are estimated to be 22% and 13%, respectively, in newly diagnosed DM patients [5]. The prevalence of proliferative retinopathy is 2% in DM patients of < 5 years’ duration, and increases to 25% in patients with DM for ≥ 25 years [6]. Diabetic nephropathy develops in 25% of type 2 DM patients within 10 years of diagnosis [7], and end-stage renal disease (ESRD) develops in 14% of type 1 DM patients of 10 years’ duration [8].

Due to the insidious progress of microvascular complications in DM, patients may go undetected or be left untreated in early-stage disease, which can lead to devastating impacts on quality of life and life expectancy once clinically significant complications have developed, including ESRD, sight-threatening diabetic retinopathy (STDR) and limb amputation. Several modifiable risk factors, including HbA_1c, blood pressure and estimated glomerular filtration rate (eGFR), are found in association with the development of microvascular complications [9], [10], [11]. Early screening and intervention at earlier stages of microvascular complications and modifiable risk factors are critical for preventing or delaying the progress of disease severity. In recent years, guidelines have recommended risk-factor screening and risk-stratified disease management [12], [13], [14] by setting personalized treatment goals based on patients’ individual risks of complications. Personalized management is advocated as a means of translating the evidence from randomised controlled trials to real-world settings [15]. However, there is a lack of studies of the effectiveness of risk-stratification-based personalized management [15].

Two previous studies of the short-term effectiveness of risk-stratification interventions have been conducted in the US [16] and UK [17]. Both studies reported increases in the percentages of subjects achieving target HbA_1c and blood-pressure levels in the intervention groups. However, the long-term effectiveness of the interventions were not reported. In Asia, an attempt at risk-stratified management was made by the Joint Asia Diabetes Evaluation (JADE) Program [18]. Clinicians had access to a web-based comprehensive risk-stratification model using an electronic portal and, during 2007–2009, 3687 people with diabetes across seven Asian countries, including Hong Kong, were enrolled [19]. However, the implications of such structured care and effectiveness of the model compared with the usual care remain unclear.

To enhance the management of DM patients in a primary-care setting in Hong Kong, the multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) has been operating in public-sector general outpatients’ clinics since August 2009. Details of the intervention have been reported elsewhere [20]. Compared with DM subjects under usual care, the RAMP-DM group showed significant improvements in achieving HbA_1c targets, controlling blood pressure and reducing the incidence of cardiovascular events at both 12 months [21] and 36 months [22] of follow-up.

The RAMP-DM intervention included systematic comprehensive screening for risk factors and early-stage diabetic microvascular complications at enrolment, including retinal photographic examination, foot assessment, renal function tests and urinary albumin-to-creatinine ratio measurement. Nevertheless, it remains unclear as to whether the RAMP-DM intervention is associated with a reduction in microvascular complications. Therefore, the present study aimed to investigate the effectiveness of the RAMP-DM intervention on microvascular complications compared with the usual primary care over a 3-year follow-up. It was hypothesized that RAMP-DM participants would have significantly lower incidences of microvascular complications, especially in advanced stages of disease.

Section snippets

Study design

This prospective cohort study compared the risks of developing different stages of three subtypes of diabetic microvascular complications over 3 years in DM patients managed under RAMP-DM and in those receiving the usual primary care.

RAMP-DM intervention

The RAMP-DM is a territory-wide primary-care service component for patients with DM in public primary-care clinics in Hong Kong. Launched in August 2009 by the Hong Kong Hospital Authority (HA), it is the sole public healthcare provider in Hong Kong. Details of

Baseline characteristics

From 1 August 2009 to 31 July 2010, a total of 18,459 DM subjects under primary care were enrolled in RAMP-DM. Of these, 47,148 were identified as potential control subjects who met inclusion criteria for the study. Subjects with any pre-existing microvascular complications were excluded in each group, leaving 17,804 and 44,809 subjects in the RAMP-DM and control groups, respectively. Limiting eligibility to only those with complete baseline data reduced the sample to 17,528 and 16,180 in the

Discussion

To the best of our knowledge, this was the first study to investigate the long-term effectiveness of multidisciplinary risk-stratification-based DM management on microvascular complications in a Chinese population. With more than 41,000 person-years of follow-up in each group, this population-based cohort study found that the RAMP-DM intervention was associated with reduced incidences of all the studied DM microvascular complications except neuropathy. RAMP-DM was more effective for lowering

Conclusion

Our prospective comparative efficacy study in a public primary-care setting has found that RAMP-DM is associated with a lowered risk for first occurrences of retinopathy, STDR, nephropathy, ESRD and lower-limb ulcers or amputation over a 3-year follow-up. These findings add to the effectiveness of RAMP-DM, and provide empirical translatable evidence of the efficacy of multidisciplinary risk-stratified management for people with DM.

Disclosure of interest

The authors declare that they have no competing interest.

Acknowledgements

This study of enhanced primary care was funded by the Food and Health Bureau and the government of the Hong Kong Special Administrative Region (Project No. EPC-HKU-2). The authors wish to acknowledge the contributions of the RAMP-DM teams (including Ms Dorothy Lam and Mr Jackey Chan) and the Statistics and Workforce Planning Department (including Ms Eva Tsui, Mr Peggo Lam and Mr Choi-Fan Yiu) of the Hong Kong Hospital Authority. Also, we would like to thank all the cluster coordinators and

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Original articleEffectiveness of the multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) for diabetic microvascular complications: A population-based cohort study

Abstract

Aim

Methods

Results

Conclusion

Clinical trial registry

Introduction

Section snippets

Study design

RAMP-DM intervention

Baseline characteristics

Discussion

Conclusion

Disclosure of interest

Acknowledgements

Diabetes Res Clin Pr

Diabetes Res Clin Pr

Kidney Int

Am J Kidney Dis

J Clin Epidemiol

Diabetes Atlas

The prevalence of diabetes, association with cardiovascular risk factors and implications of diagnostic criteria (ADA 1997 and WHO 1998) in a 1996 community-based population study in Hong Kong Chinese

Diabetic Med

Diabetic complications and their implications on health care in Asia

Hong Kong Med J

The Wisconsin Epidemiologic Study of Diabetic Retinopathy: II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years

Arch Ophthalmol

Risk of end-stage renal disease in diabetes mellitus: a prospective cohort study of men screened for MRFIT

JAMA

Individual risk assessment and information technology to optimise screening frequency for diabetic retinopathy

Diabetologia

Diabetic microvascular complications: can patients at risk be identified? A review

Int J Clin Pract

Standards of Medical Care in Diabetes 2013

Diabetes Care

Type 2 diabetes National clinical guideline for management in primary and secondary care (update)

Clinical practice guidelines for the prevention and management of diabetes in Canada

Can J Diabetes

Management of hyperglycemia in type 2 diabetes: evidence and uncertainty

Cardiovass Diabetol

A systematic approach to risk stratification and intervention within a managed care environment improves diabetes outcomes and patient satisfaction

Diabetes Care

Original article
Effectiveness of the multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) for diabetic microvascular complications: A population-based cohort study