Original researchA cluster-randomized trial to estimate the effect of mobile screening and treatment feedback on HbA1c and diabetes-related complications in Tshwane primary health care clinics, South Africa
Introduction
More than 1.1 billion of the world’s population live on the African continent and this will increase to 2.4 billion by 2050. The greatest increase will be in the populations of sub-Saharan Africa. Life expectancy is predicted to rise and as the population grows, so too will the rates of obesity, cancer, heart disease and type 2 diabetes [1]. The International Diabetes Federation estimates that there will be a 109% increase in the prevalence of diabetes in Africa between 2013 and 2035. This rise in the prevalence of diabetes in Africa will be the largest in any continent in the world [2]. Health systems in Africa have already been severely weakened by diseases such as malaria, tuberculosis and HIV/AIDS and the continent is now faced with the rising burden of non-communicable diseases, which necessitates the need for innovative service delivery models to manage non-communicable diseases [1].
South Africa (SA) is an upper-middle income country, with a population of 54 million in 2014 and 62% of the population is urbanised [3]. Primary health care (PHC), delivered through a district health system which is mainly nurse-driven, forms the cornerstone of health care delivery. Primary health care is available at no cost to users. The essential drug lists and standard treatment guidelines with national policy documents drive the delivery of health care services [4]. Primary care services are provided by both provincial (clinics and community health centres) and local government (clinics).
The 2013 estimated prevalence of diabetes in Africa was 4% and in South Africa 9.3% [2]. The diabetes epidemic in SA is led by the Indian population, due to a genetic predisposition (9–11%), followed by 8–10% in the coloured community, 5–8% in the black community and 4% among whites [3], [5].
The management of diabetes is a challenge to health care systems worldwide. The United Kingdom Prospective Diabetes Study (UKPDS) showed that improved control of glucose and blood pressure resulted in significant reductions of diabetic complications [6]. Diabetic retinopathy and nephropathy are the leading causes of preventable blindness and end-stage kidney failure in the United States of America, and more than 60% of lower limb amputations occur in diabetics [7]. High prevalence rates for poor glycaemic and blood pressure control as well as diabetic complications have been reported for the diabetic population of the Tshwane district in Gauteng province, South Africa [8].
The quality of primary diabetes care is dependant on both multidisciplinary management and rigourous follow-up [9]. The Belgian Diabetes Project Group identified 34 indicators (31 process and three outcome) from five domains that is important for quality care, namely control of glycaemia, early detection of glycaemic complications, treatment of complications, cardiovascular disease and quality of life.
In the present study we investigated the effect of mobile screening and an expert review panel providing an individualised patient management plan on both the HbAc1 levels as outcome indicator as well as screening frequency for diabetes-related complications as process indicators of quality of care provided to diabetic patients at primary care level in South Africa.
Section snippets
Study design and setting
We conducted a cluster-randomised trial in primary care clinics in the Tshwane district of South Africa (Fig. 1). As a mobile unit was used to collect information, all patients at a facility had to be treated the same way to prevent bias, therefore we had to use clinics as the clusters and did not randomise at the individual level. A list was compiled where the 64 clinics providing PHC services were stratified by the three strata within the South African health system: 1. clinics managed by
Results
The Consort guidelines for reporting cluster randomised trials requires a flow diagram to indicate the flow of patients. (Fig. 1) [18].
The results of the intervention and control groups were tabulated regarding important variables at baseline (Table 1).
The mean age of participants was 58 years and 68.6% were female. The mean BMI was 30.7 kg/m2, regardless of gender. More than 80% of the patients were also reported to be hypertensive, and 72% were on oral diabetes medication only.
Loss to
Discussion
Diabetes care can no longer be regarded as glucose-centric, quality improvement efforts need to have a broader focus [19]. In our study, a comprehensive programme that integrated clinical evaluations, active screening and an individualised patient management plan did not lead to significant improvement in the HbA1c levels. Our study confirms very low goal-directed care aimed at improving clinical outcomes for diabetes in South Africa.
We found that screening for complications was low at
Limitations and strengths of the study
Our study had several limitations. One year could be too short to show a significant effect of shared care between primary and tertiary levels, as health systems can be slow to change. There was also no contact with the clinics, their health care providers, nor the patients, in the twelve months between the two rounds of the study by the investigators. The individualised patient management plans were shared with the clinics, with general feedback to the clinic managers, but no follow-up reviews
Conflict of interest
The authors state that they have no conflict of interest.
Acknowledgements
This study was funded by the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA), the African Population & Health Research Centre (APHRC) and research funds from the University of Pretoria. Novo Nordisk supplied and funded the mobile unit. Thank you to Prof P Roux, Head of Department Ophthalmology, University of Pretoria for the evaluation and grading of all retinal photographs. We are extremely grateful to the following physicians and family physicians for their
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