Start improving the quality of care for people with type 2 diabetes through a general practice support program: A cluster randomized trial

https://doi.org/10.1016/j.diabres.2009.12.012Get rights and content

Abstract

Aims

To evaluate the effectiveness of a two-arm quality improvement program (QIP) to support general practice with limited tradition in chronic care on type 2 diabetes patient outcomes.

Methods

During 18 months, we performed a cluster randomized trial with randomization of General Practices. The usual QIP (UQIP: 53 GPs, 918 patients) merged standard interventions including evidence-based treatment protocol, annual benchmarking, postgraduate education, case-coaching for GPs and patient education. The advanced QIP (AQIP: 67 GPs, 1577 patients) introduced additional interventions focussing on intensified follow-up, shared care and patient behavioural changes. Main outcomes were HbA1c, systolic blood pressure (SBP), and low density lipoprotein cholesterol (LDL-C), analyzed by generalized estimating equations and linear mixed models.

Results

In UQIP, endpoints improved significantly after intervention: HbA1c −0.4%, 95% CI [−0.4; −0. 3]; SBP −3 mmHg, 95% CI [−4; −1]; LDL-C −13 mg/dl, 95% CI [−15; −11]. In AQIP, there were no significant additional improvements in outcomes: HbA1c −0.4%, 95% CI [−0.4; −0.3]; SBP −4 mmHg, 95% CI [−5; −2]; LDL-C −14 mg/dl, 95% CI [−15; −11].

Conclusions

A multifaceted program merging standard interventions in support of general practice induced significant improvements in the quality of diabetes care. Intensified follow-up in AQIP with focus on shared care and patient behaviour changes did not yield additional benefit.

Introduction

Type 2 diabetes mellitus (T2DM) leads to severe micro- and macro-vascular complications, resulting in increased morbidity, but particularly in a two- to six-fold increased cardiovascular risk [1], [2]. Clinical evidence suggests that aggressive, timely, and multi-factorial interventions [3] aimed at controlling risk factors such as high blood pressure [4], blood lipids [5], [6], and glycaemia [7], [8] can reduce T2DM complications. General practice plays a key role in the management of diabetes, but the field suffers from clinical inertia. This inertia is characterized by insufficient adherence to guidelines aimed at reducing measures of glycaemia and cardiovascular risk factors to target values [9]. Additional barriers to clinical improvement are the absence of integrated mechanisms between primary and secondary care, and insufficient patient involvement during treatment [10].

High quality type 2 diabetes care is a complex matter. All over the world, quality improvement programs (QIPs) have been used to improve diabetes care [11], [12], [13], [14]. Many intervention programs do not succeed, or yield only small improvements [15], [16], [17]. Multifaceted interventions are more likely to exert positive effects than single interventions [18]. Nevertheless, the variety in QIP design and associated outcomes undermines clear conclusions about optimal program models, or how intensively the physician and patient population should be followed [19].

Before introducing a nation-wide QIP based on the principles of the chronic care model, the Belgian government requested a cluster randomized trial in the primary care setting. The mainly demand driven organization of care in Belgian makes the situation comparable to settings in the USA, France, Italy or Canada [10]. We compared the effects of “advanced quality improvement program” (AQIP) with “usual quality improvement program” (UQIP) on measured outcomes of care in people with T2DM. As they are valuable predictors of morbidity and mortality, we chose the following measures of care success: glycated haemoglobin (HbA1c), systolic blood pressure (SBP), and LDL-cholesterol (LDL-C). Using a set of standard interventions merged into a multifaceted general practice support program, UQIP implemented a treatment protocol whereby GPs aimed for evidence-based target values in their patients. These target values were set according to the standards of the American diabetes association (ADA), and are defined as: HbA1c of 7%, SBP of 130 mm Hg, and an LDL-C of 100 mg/dl. On top of UQIP, AQIP implemented a more elaborate and cost-intensive program with 3 supplementary focuses: (1) intensified, three-monthly follow-up of the GPs; (2) active stimulation to share care; (3) additional facilitation of patient behaviour changes, such as lifestyle habits and treatment compliance.

Section snippets

Study design

The Belgian National Institute for Health and Disability Insurance (NIHDI) sponsored this project, in an effort to examine the usefulness and feasibility of nation-wide implementation of such a program. To this end, NIHDI stipulated there be recruitment of at least 33% of available physicians in the region. Similar to other complex intervention evaluations [20], we organized an open pragmatic before/after study, with randomization of general practices in two intervention arms, AQIP and UQIP and

Physician profile, participant flow, and program participation

A total of 142 physicians from 90 practices agreed to participate and were randomized (Fig. 1). Within the first 30 days, 22 physicians dropped out (UQIP = 18, AQIP = 4, p < 0.001). Thus, only 120 physicians (36% of those available, 67 AQIP vs. 53 UQIP) registered baseline data. During the study there was negligible drop-out (AQIP = 0 and UQIP = 2, NS). We observed small differences in physicians’ characteristics for age (AQIP 46 vs. UQIP 43 years), the mean number of patient contacts (AQIP 97 vs. UQIP

Discussion

Previous research has shown that shared care improves both the delivery of diabetes care [29] and patient outcomes [30], whereas increased treatment adherence, weight loss and regular physical activity have a beneficial effect on the control of glycaemia, blood pressure and blood lipids [31], [32], [33]. The present study investigated whether improved patient outcomes could be achieved with a basic support program (UQIP), and whether intensified support of GPs and patients (AQIP) which paid

Conflicts of interest

The authors declare that they have no conflict of interest.

References (50)

  • M.K. Campbell et al.

    Sample size calculator for cluster randomized trials

    Comput. Biol. Med.

    (2004)
  • J.A. van Bruggen et al.

    Shared and delegated systems are not quick remedies for improving diabetes care: a systematic review

    Prim. Care Diabetes

    (2007)
  • Standards of medical care in diabetes—2007

    Diabetes Care

    (2007)
  • S.M. Haffner et al.

    Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction

    N. Engl. J. Med.

    (1998)
  • P. Gaede et al.

    Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes

    N. Engl. J. Med.

    (2003)
  • UK Prospective Diabetes Study Group

    Tight blood pressure control and risk of macrovascular and microvascular complications in type 2á diabetes: UKPDS 38

    BMJ

    (1998)
  • S. Colagiuri et al.

    Lipid-lowering therapy in people with type 2 diabetes

    Curr. Opin. Lipidol.

    (2002)
  • S. Vijan et al.

    Pharmacologic lipid-lowering therapy in type 2 diabetes mellitus: background paper for the American college of physicians

    Ann. Intern. Med.

    (2004)
  • I.M. Stratton et al.

    Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study

    BMJ

    (2000)
  • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)

    Lancet

    (1998)
  • P. O’Connor et al.

    Clinical inertia and outpatient medical errors

    Adv. Patient Saf.

    (2007)
  • C. Mathieu, F. Nobels, G. Peeters, P. Van Royen, K. Dirven, J. Wens, J. Heyrman, L. Borgermans, S. Swinnen, G. Goderis,...
  • M. Minkman et al.

    Performance improvement based on integrated quality management models: what evidence do we have? A systematic literature review

    Int. J. Qual. Health Care

    (2007)
  • D.C. Ziemer et al.

    An intervention to overcome clinical inertia and improve diabetes mellitus control in a primary care setting: Improving Primary Care of African Americans with Diabetes (IPCAAD) 8

    Arch. Intern. Med.

    (2006)
  • J. Szecsenyi et al.

    German diabetes disease management programs are appropriate for restructuring care according to the chronic care model: an evaluation with the patient assessment of chronic illness care instrument

    Diabetes Care

    (2008)
  • S.R. Majumdar et al.

    Controlled trial of a multifaceted intervention for improving quality of care for rural patients with type 2 diabetes

    Diabetes Care

    (2003)
  • J.M. Grimshaw et al.

    Effectiveness and efficiency of guideline dissemination and implementation strategies

    Health Technol. Assess.

    (2004)
  • K.G. Shojania et al.

    Effects of quality improvement strategies for type 2 diabetes on glycemic control: a meta-regression analysis

    JAMA

    (2006)
  • E. Vermeire et al.

    Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus

    Cochrane Database Syst. Rev.

    (2005)
  • Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies Volume 2—Diabetes Mellitus Care

    (2004)
  • L.A. Borgermans et al.

    Diversity in diabetes care programmes and views on high quality diabetes care: are we in need of a standardized framework?

    Int. J. Integr. Care

    (2008)
  • M. Campbell et al.

    Framework for design and evaluation of complex interventions to improve health

    BMJ

    (2000)
  • Standards of medical care for patients with diabetes mellitus

    Diabetes Care

    (2003)
  • L. Borgermans et al.

    A cluster randomized trial to improve adherence to evidence-based guidelines on diabetes and reduce clinical inertia in primary care physicians in Belgium: study protocol (NTR 1369)

    Implement Sci.

    (2008)
  • T. Bodenheimer et al.

    Improving primary care for patients with chronic illness

    JAMA

    (2002)
  • Cited by (36)

    • Organization of Diabetes Care

      2018, Canadian Journal of Diabetes
      Citation Excerpt :

      Many provinces and health regions also have developed diabetes strategies, diabetes service frameworks and support diabetes collaboratives. Some trials on diabetes-specific collaboratives have been shown to improve clinical outcomes (26,66,87). Provider incentives represent another area of health system support.

    • Organisation des soins du diabète

      2013, Canadian Journal of Diabetes
      Citation Excerpt :

      De nombreuses provinces et régions sanitaires ont également élaboré des stratégies, des cadres de service et des pratiques axées sur la collaboration pour la prise en charge du diabète. Certains essais sur la prise en charge du diabète favorisant la collaboration ont montré une amélioration des résultats cliniques (22,50,60), alors qu’une méta-analyse récente sur l’amélioration continue de la qualité ne montrait aucun avantage (12). Les incitatifs aux professionnels de la santé représentent une autre forme de soutien par le système de santé.

    • Organization of Diabetes Care

      2013, Canadian Journal of Diabetes
      Citation Excerpt :

      In a systematic review, evidence-based guideline interventions, particularly those that used interactive computer technology to provide recommendations and immediate feedback of personally tailored information, were the most effective in improving patient outcomes (51). A randomized trial using electronic medical record (EMR) decision support in primary care found improvement in A1C (52), and a cluster randomized trial of a QI program found that the provision of a clear treatment protocol—supported by tailored postgraduate education of the primary care physician and case coaching by an endocrinologist—substantially improved the overall quality of diabetes care provided, as well as major diabetes-related outcomes (50). Incorporation of evidence-based treatment algorithms has been shown in several studies to be an integral part of diabetes case management (10,26,30,31).

    View all citing articles on Scopus
    1

    Senior authors who contributed equally to this work.

    View full text