Start improving the quality of care for people with type 2 diabetes through a general practice support program: A cluster randomized trial
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.
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Senior authors who contributed equally to this work.