The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil

The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil

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Contents lists available at ScienceDirect

Primary Care Diabetes journal homepage: http://www.elsevier.com/locate/pcd

Original research

The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil Michelly Georgia da Silva Marinho a , Annick Fontbonne b,∗ , Jessyka Mary Vasconcelos Barbosa a , Heloisa de Melo Rodrigues c , Eduardo Freese de Carvalho a , Wayner Vieira de Souza a , Eduarda Angela Pessoa Cesse a a

Department of Community Health, Aggeu Magalhães Research Centre, Oswaldo Cruz Foundation (Fiocruz), Recife, Brazil b UMR 204 Nutripass, Institute of Research for Development (IRD), Montpellier University, Montpellier, France c Department of Statistics, Federal University of Pernambuco (UFPE), Recife, Brazil

a r t i c l e

i n f o

a b s t r a c t

Article history:

Aims: To evaluate the results of a structured intervention in primary healthcare to improve

Received 30 January 2017

type 2 diabetes management.

Received in revised form

Methods: The intervention was implemented in 2011–2012 in two cities in the State of Per-

30 May 2017

nambuco, Brazil, and evaluated in 2013 by interviewing healthcare professionals about their

Accepted 3 June 2017

practices in all primary care facilities of these two cities (intervention group), and of two

Available online xxx

paired control cities (control group). Comparisons between the intervention and control groups were made using standard parametric tests.

Keywords:

Results: The percentage of professionals who measured adherence to treatment, developed

Diabetes mellitus

educational actions to control high-risk situations or prevent complications, or declared

Primary healthcare

that they “explained” the disease to the patients, was higher in the control group (p < 0.05).

Family Health Strategy

Multidisciplinary involvement, requests for electrocardiograms and referrals to specialists

Evaluation

were also more frequent in the control group (p < 0.01). The only differences favoring the

Brazil

intervention group were the higher proportion of nurses (p < 0.05) and community health workers (p < 0.01) trained for diabetes management and a greater frequency of discussing the cases of diabetic patients at team meetings (p < 0.01). Conclusions: These negative results raise questions about the effectiveness of actions aiming to improve diabetes management in primary care, and reinforce the need for careful evaluation of their impact. © 2017 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Abbreviations: CCM, Chronic Care Model; FHS, Family Health Strategy. Corresponding author at: UMR 204 Nutripass, Centre IRD of Montpellier, 911 avenue Agropolis, BP 64501, 34394 Montpellier Cedex 5, France. E-mail address: [email protected] (A. Fontbonne). http://dx.doi.org/10.1016/j.pcd.2017.06.002 1751-9918/© 2017 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved. ∗

Please cite this article in press as: M.G. da Silva Marinho, et al., The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil, Prim. Care Diab. (2017), http://dx.doi.org/10.1016/j.pcd.2017.06.002

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1.

Introduction

Chronic diseases are today the leading cause of death and disability worldwide. More than 80% of mortality from chronic diseases worldwide now occurs in low and middle-income countries, with cardiovascular diseases, cancer, chronic lung disorders, and diabetes as their foremost causes [1,2]. This constitutes one of the major challenges to public health systems, because the present fragmented and reactive healthcare model, designed primarily to cope with acute conditions and acute exacerbation of chronic conditions, has not been successful in appropriately managing chronic diseases [3,4]. The care of individuals with chronic diseases requires a different organizational approach that provides timely diagnosis, regular monitoring and adequate control of risk factors for complications or the exacerbation of conditions [5]. Studies have demonstrated the importance of strengthening health systems in this regard, as a way of achieving effective management and preventive actions for people with chronic diseases, as part of primary healthcare, particularly in lowand middle-income countries [6–9]. One of the models that advocates and guides the implementation of this type of healthcare system modification is the Chronic Care Model (CCM) [10,11]. It includes six components: health system organization, support for clinical decisions, care system design, self-management support, community resources and policies, and clinical information systems. Experiences of CCM implementation to improve management of people with diabetes have demonstrated some degree of effectiveness in several countries [9,12,13]. In Brazil, an intervention for improving diabetes care in primary healthcare along the lines of the CCM, the QualiDia project, was implemented by the Ministry of Health from August 2011 to July 2012 as a pilot experience in nine cities from three Brazilian States (Pernambuco, Rio de Janeiro, Santa Catarina) and the city of Anchieta, in the State of Espirito Santo. The aim was to strengthen multidisciplinary care of type 2 diabetes mellitus in primary healthcare, focusing on reorganization of the municipal health system and improvement of the practices of care of the Family Health Strategy (FHS) professionals. Within the Brazilian Unified Health System (Sistema Único de Saúde, SUS), publicly funded and built along the model of the British National Health Service, the FHS forms the core of primary healthcare, conducting health promotion, prevention, diagnosis and control of communicable and non-communicable diseases, including diabetes mellitus. A FHS team comprises one physician, one nurse, one nursing technician and several lay community health workers, and is responsible for the primary care of all the population in a specific geographical area. This generally represents around 3000 persons with about 100 diabetic patients. Every family in the area receives regular home visits from their community health worker. Diabetic patients are usually referred to the FHS dispensary every two months for medical check; they are also invited to participate in educational groups, gathering hipertensive and diabetic subjects (HIPERDIA groups [14]). Diabetes care includes active early detection, management, monitoring and prevention of complications related to the disease, and is described in details in a “Diabetes Mellitus”

handbook within a collection of “Basic Care Handbook” possessed by all FHS teams [15]. A specific study was conducted in 2013 in the state of Pernambuco to evaluate the impact of the QualiDia project on both professionals and patients in the two cities where the intervention was thoroughly implemented, comparing them with the practices in two control cities in the same state. The present paper reports the results of this study concerning the evaluation of the impact on FHS professionals’ practices, regarding the management of patients with type 2 diabetes.

2.

Methods

2.1.

Description of the intervention

The QualiDia project (“Health Education for Self-care and Continuous Assessment of Quality of Diabetes Care in Brazil”) was launched by the Brazilian Ministry of Health in 2011. The intervention began with representatives of the selected cities signing a contract with the Ministry of Health to share responsibility for the QualiDia project intervention. The technical team of the Ministry of Health then conducted one awareness-raising workshop with the heads of the municipal Health Departments of the selected cities, with extensive participation of FHS health professionals. A local management team was constituted, and its first task was to identify where the municipal health system needed reorganization and to develop a plan of action to improve diabetes care, thus answering the “health system organization” component of the CCM. This plan could include, for instance, hiring of experts to provide clinical support for primary care teams, extension of the offer and number of clinical tests for people with diabetes, organization of the referral system at other levels of care and/or implementation of the Ministry of Health’s clinical protocol for type 2 diabetes mellitus care [15]. Clinical laboratories were organized to provide regular screenings and check-ups and the professionals of each FHS team developed a plan of action for the care of diabetes; these local plans included actions to identify new cases of diabetes, and to use risk stratification for scheduling visits and educational groups for self-management support. To help with clinical decisions, also a key component of the CCM, three learning sessions for FHS professionals (nurses, physicians, dentists, nutritionists, community health workers, nursing assistants) were conducted on themes such as screening for new cases of diabetes and risk stratifying, and health teams were encouraged to use “Plan-Do-Check-Act” cycles to improve actions [16]. Provided with this information and municipal technical support, the FHS teams were left free to implement the organizational changes they deemed necessary to improve diabetes management in the territory they covered.

2.2.

Evaluation of the intervention

The QualiDia project intervention in Pernambuco was evaluated in 2013. The evaluation consisted of a non-randomized comparative cross-sectional survey, the INTERDIA Study (“Evaluation of INTERvention strategies for the management

Please cite this article in press as: M.G. da Silva Marinho, et al., The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil, Prim. Care Diab. (2017), http://dx.doi.org/10.1016/j.pcd.2017.06.002

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Table 1 – Characteristics of the intervention and control cities (2010 census).

Total population % men % less than 15 years of age % 65 years of age or more Human development index

São Lourenc¸o Medium-size Intervention

Abreu e Lima Medium-size Control

Itamaracá Small-size Intervention

Sairé Small-size Control

102,895 48.6% 24.9% 6.2% 0.653

94,429 47.8% 23.8% 6.4% 0.679

21,884 57.4% 23.0% 5.0% 0.653

11,240 49.2% 25.7% 10.3% 0.585

of patients with DIAbetes in primary care”). It was conducted between April and September 2013. The study covered the two cities where the QualiDia intervention was implemented, Ilha de Itamaracá (small-sized, <20.000 inhabitants) and São Lourenc¸o da Mata (medium-sized, >20.000 and <100.000 inhabitants), and two control cities, Sairé (small-sized) and Abreu e Lima (medium-sized). All four cities are situated in the metropolitan region of Recife, capital of the State. The two control cities were paired by population size, geographic proximity and percentage of population covered by the Family Health Strategy. With a view to ensuring the representativeness of practices for the care of diabetes in the FHS, all FHS teams in the four cities were investigated, which totalled 29 teams in the intervention cities, and 32 teams in the control cities. Investigation was based on the interview of the team’s physician or nurse. Standardized forms were used, addressing issues relating to the FHS team composition, work processes, training for diabetes care and actions provided for diabetes care based on the Ministry of Health standards. The interviews were conducted by trained personnel. All participants signed an informed consent form before being interviewed. The INTERDIA Study was approved by the Research Ethics Committee of the Aggeu Magalhães Research Center—FIOCRUZ (registration n◦ 35/2011) and the Brazilian National Research Ethics Commission (CONEP).

2.3.

Statistical analysis

Variables were selected from the forms completed by the FHS health professionals to describe the composition of the FHS team, the training of healthcare workers with respect to diabetes mellitus, and current practices regarding the monitoring of diabetic patients, support for self-care, use of clinical guidelines, and referral to specialists, test requests and clinical examinations. Answers were compared between the intervention and the control groups by applying the chi-square test for comparison of proportions and the Student’s t-test for comparison of means. The level of statistical significance was set at 0.05. The Statistical Package for the Social Sciences (SPSS) Version 19 was used for all analyses.

3.

Results

3.1. cities

Characteristics of the intervention and control

Main characteristics of the cities are shown in Table 1. Medium-sized intervention and control cities were similar in

terms of population and demographics. There were more differences between small-sized intervention and control cities, in terms of percentage of men and elderly people. The difference was probably due to the presence of a penitentiary on the Ilha de Itamaracá, with a mostly male and young population, and there should not be such a difference when considering the free population.

3.2.

Characteristics of the health teams

Table 2 summarizes the characteristics of the FHS teams in the intervention and the control groups. There were 29 and 32 FHS teams in the intervention and control groups, respectively. As already said, in each team either the physician or the nurse were interviewed, but the great majority of interviewees were nurses (90.2%). All teams in the control group had a physician, a nurse and a nursing assistant. One team in the intervention group had no appointed physician and not all had a nursing assistant, which was a significant difference compared to the control group (p = 0.009). The intervention group had a higher number of nurses and community health workers trained for diabetes management, with a significant difference only for the latter (p = 0.002).

3.3.

Management of type 2 diabetic patients

Table 3 presents a comparison of the intervention and control groups regarding various actions required for the correct management of diabetic patients in primary healthcare. A larger percentage of professionals in the intervention group reported discussing cases of people with diabetes at team meetings (p = 0.003). However, multidisciplinary involvement in diabetes management was significantly more frequent in the control than in the intervention group (p = 0.002). The proportion of teams who declared evaluating adherence to treatment when visiting the patients was higher in the control than in the intervention group (p = 0.023), but there was no difference for the check on medication use, nor for the other questions concerning planification or conduction of visits. Requests for complementary examinations were not significantly different between the groups, except for electrocardiogram, which was very unfrequently requested in the intervention group (7.4% vs. 56.3% in the control group, p < 0.001). Referrals to specialists were significantly more frequent in the control than in the intervention group, except for endocrinologists where the difference was not significant.

Please cite this article in press as: M.G. da Silva Marinho, et al., The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil, Prim. Care Diab. (2017), http://dx.doi.org/10.1016/j.pcd.2017.06.002

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Table 2 – Characteristics of the Family Health Strategy teams in the intervention and control groups. Intervention

Control

p Value

Interviewee Physician Nurse

2 (6.8) 27 (93.2)

4 (12.5) 28 (87.5)

0,198

Team composition Physician Nurse Nursing assistant Dentist Dental assistant Dental hygienist Community health workers (number)

28 (96.6) 29 (100) 23 (79.3) 22 (75.9) 20 (69.0) 3 (10.3) 7±5

32(100) 32 (100) 32 (100) 22 (68.8) 21 (65.6) 5 (15.6) 5±2

0.475 – 0.009 0.536 0.781 0.710 0.169

Trained for diabetes management Nurses Community health workers (at least 50%)

17 (60.7) 22 (81.5)

10 (35.7) 10 (40.0)

0.064 0.002

Note: All results expressed as n (%) except for row “community health workers (number)”, which is mean ± SD.

Table 3 – Management of type 2 diabetic patients in the intervention and control groups. Intervention

Control

p Value

General Use of guidelines for management of diabetes Discussion of cases at team meetings Multidisciplinary involvement in diabetes care

10 (37.0) 27 (96.4) 17 (58.6)

5 (17.9) 21 (65.6) 29 (93.5)

0.207 0.003 0.002

Visits Monitoring through monthly home visits Planned according to patient’s need or level of risk Active patient search in case of missed visit Test for fasting glucose in all patients Evaluation of treatment adherence Check of medication use

29 (100) 8 (27.6) 25 (89.3) 27 (96.4) 3 (10.3) 21 (72.4)

28 (87.5) 10 (31.2) 27 (84.4) 30 (93.8) 11 (35.5) 24 (77.4)

0.051 0.756 0.580 0.638 0.023 0.657

Requests Cholesterol blood tests Triglycerides blood tests Creatinine blood tests Fasting blood glucose tests Urea blood tests Glycated hemoglobin Electrocardiogram

26 (96.3) 26 (96.3) 23 (85.2) 27 (100) 22 (100) 14 (51.9) 2 (7.4)

31 (96.9) 31 (96.9) 28 (87.5) 31 (96.9) 26 (100) 21 (65.6) 18 (56.3)

0.903 0.903 0.798 0.358 – 0.287 <0.001

Referral Cardiologist Ophthalmologist Nephrologist Endocrinologist Nutritionist Dentist

10 (35.7) 13 (46.4) 5 (17.9) 24 (85.7) 12 (42.9) 5 (17.9)

24 (75.0) 28 (87.5) 14 (43.8) 22 (68.8) 30 (93.8) 15 (46.9)

0.002 0.001 0.033 0.124 <0.001 0.018

Note: All results expressed as n (%). Bold value shows statistically significant p values for differences between intervention and control groups.

3.4. Education and counseling for type 2 diabetic patients Table 4 presents educational and counseling activities, in groups or individually, carried out by the FHS teams, comparing the intervention and the control groups. The proportion of teams who developed educational activities regarding the control of high-risk situations (p = 0.016) or the prevention of complications (p = 0.008) was higher in the control than in the intervention group. Furthermore, the professionals in the control group were more likely to report that issues relating to the disease (diabetes) were covered during

visits (p = 0.028). There were no statistically significant differences between the two groups on lifestyle counseling. It was focussed on healthy eating and physical activity, and guidance for footcare and tobacco cessation was very unfrequently offered.

4.

Discussion

Diabetes control and management in Brazil, as in many other places in the world, are known to be sub-optimal [17–21] and this may be, to a significant degree, related to the inadequa-

Please cite this article in press as: M.G. da Silva Marinho, et al., The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil, Prim. Care Diab. (2017), http://dx.doi.org/10.1016/j.pcd.2017.06.002

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Table 4 – Education and counseling for type 2 diabetic patients in the intervention and control groups. Intervention

Control

p Value

Education in general (support groups) Presence of educational material Educational activities to control high-risk situations Educational activities for prevention of complications

12 (41.4) 22 (75.9) 21 (72.4)

14 (43.8) 31 (96.9) 31 (96.9)

0.853 0.016 0.008

Educational topics covered during the visit Use of medication The disease itself The prognosis of the disease Risk factors (sedentarity, smoking, diet, etc.)

22 (75.9) 9 (31.0) 20 (69.0) 21 (72.4)

24 (75.0) 19 (59.4) 18 (56.3) 17 (53.1)

0.938 0.028 0.310 0.124

Guidance and counseling Encouragement of physical activity Guidance on healthy eating Guidance on tobacco cessation Guidance on foot care

23 (79.3) 29 (100) 2 (6.9) 6 (20.7)

26 (83.9) 30 (96.8) 6 (19.4) 10 (32.3)

0.651 0.333 0.160 0.315

Note: All results expressed as n (%). Bold value shows statistically significant p values for differences between intervention and control groups.

cies of the current model of care for tackling chronic diseases [4,10,22]. The QualiDia intervention was one of the first initiatives of the Brazilian Ministry of Health to implement the Chronic Care Model in primary healthcare, with the aim of improving diabetes care. As it is recognized that assessment of the impacts of targeted interventions for chronic disease care facilitates planning of health system responses, especially in low to middle income countries [8,9,23], the impact of the QualiDia intervention was evaluated, in Pernambuco, by way of the INTERDIA Study. This comparative evaluation of diabetes care practices demonstrated that, paradoxically, although training for diabetes management was logically more frequent in the two cities where the intervention took place, the overall results were more favorable in the control group. The only positive way to interpret this result would be to assume that professionals in the intervention group have become more critical and more aware of the discrepancies between the recommendations and their practices. This effect of intervention has been shown in other studies. In Brazil, Torres et al. [24] showed that educational workshops for primary healthcare professionals stimulated their reflective, critical and creative potential in the planning and organization of care for people with diabetes. In Soweto, South Africa, an intervention based on the CCM had an impact on the knowledge of primary care nurses, making them more critical of their working conditions and health actions regarding hypertension and people with diabetes [12]. Unfortunately, since the present study did not include direct observation of the professionals’ practices in diabetes management, it was not possible to test this assumption by comparing the interviewees’ responses with their actual practices. Despite this possibility, our conclusion would rather be that the QualiDia project, at best, had no impact on professionals’ diabetes management practices. In contrast to the probable lack of impact suggested by the present analysis, studies of CCM implementation carried out in countries with similar characteristics to Brazil, especially with regard to insufficient resources for the public health system, generally found favorable impacts on the practices of health professionals regarding diabetes care. This is the case in South Africa, where

Katz et al. [12] noted the improvement of the professionals’ practices with regard to the early detection of cases and referral to experts, and a positive impact on nurses’ knowledge of the management of diabetes cases. In Saudi Arabia, it was found that, after the implementation of an intervention at primary care level, quality indicators for professional practices improved in terms of guidance, registration of risk factors and appropriate requests for tests [25]. In Pakistan, an intervention promoting self-management support and delivery system design was proposed to type 2 diabetes patients; it showed improvement in knowledge, better adherence to treatment, and provided a sound basis on which to promote self-management [26]. In high-income countries that have implemented interventions based on the Chronic Care Model for more than two decades, improvements have also been shown. Most studies have shown that interventions which contained one or more CCM elements had beneficial effects on care processes [27–30], although with mixed results for clinical outcomes [31,32]. The negative results of the QualiDia intervention could be attributed to the short duration of implementation (one year). Successful interventions generally take at least three years [13,25–27,30,33]. Moreover, these interventions conducted many multidisciplinary integrated diabetes management actions in communities, including some aiming to reorganize the care delivery system [13,33,34]; and facilitators had well defined roles, helped nurses with patient education, provided “self-management”, monitored the overall system including the scheduling of patients and reviewed charts for the chronic diseases register [25,31,33,34]. The QualiDia project implementation strategy, on the other hand, was based mainly on workshops, and the number of local facilitators supporting the FHS professionals was small. Another explanation for the absence of effect of the QualiDia intervention is the change of the municipal Department of Health management team after the 2012 municipal elections. Rapid staff turnover and poor employment security have been referred to as one of the main problems for the achievement of a comprehensive healthcare model in the Brazilian public system [35–37]. There is therefore a need to effect

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changes regarding labor contracts, to allow health workers and managers to continue their activities regardless of changes in local government. Furthermore, studies have suggested that several factors including supporting reflective healthcare practice and ensuring that leaders support the implementation and sustainability of interventions may have been just as important as Chronic Care Model’s components in contributing to the improvements in healthcare practice [27]. A last possibility for negative results would be contamination, but it is unlikely because the control cities were absolutely unaware of an intervention going on and when they were investigated, and thus made aware of this intervention, it was already over in the intervention cities. Whatever the explanation, the results of the present study point to the importance of bearing in mind that interventions in health services or systems occur within a pre-existing context with political characteristics, institutional settings and actors that influence the development and the impact of these interventions. As the implementation of interventions based on CCM is a complex process, knowledge of these characteristics [9,11] and of the barriers imposed by the health system model [12,25,38,39] are necessary for the application process and to obtain successful results. The present study also identified that the guidelines for diabetes care in primary health care [15] were insufficiently complied with by health professionals. As in other studies, a low percentage of professionals reported actions relating to foot care [21,40], used clinical diabetes management guidelines handbooks or planned visits according to the patient’s level of risk [17–19,41].

4.1.

Despite these limitations, the INTERDIA study is, to the best of our knowledge, the first in Brazil to evaluate the impact of a CCM-based intervention on health professionals’ practices using a comparison group, with inclusion criteria similar to the intervention group.

5.

Conclusions

The INTERDIA study responds to the growing need for research and dissemination of knowledge regarding chronic illness care practices, especially in developing countries with underfunded public health systems. In view of the steady increase in the prevalence of chronic diseases in all regions of the world, the search for more promising interventions in public health to deal with them is a major concern in the political agendas of countries and international organizations. In low and middle income countries, evaluation of interventions to improve diabetes care and the education of doctors and nurses is crucial for the success of programs [9]. Results from this evaluation show that a complex intervention aiming at changing practices mostly by making primary healthcare professionals aware of the challenges in caring and organizing effective care for diabetic patients can have no detectable impact, despite what has certainly been an enormous investment in money and manpower. This raises important questions regarding how to develop viable actions to improve the care of diabetes and other chronic conditions in primary healthcare and reinforce the importance of research embedded in the practical context of decision-making in order to contribute to the development of more effective public policies.

Limitations and strengths

The INTERDIA study, similar to many studies in the field of process evaluation, has limitations. The intervention and control groups were not randomized, and no data were available regarding practices prior to the intervention; however, there was no difference between the intervention and control groups in terms of respondents’ characteristics and involvement of doctors and nurses in the FHS team composition, suggesting that differences found in care practices are unlikely to derive from systematic differences in baseline characteristics. Another common limitation to the field of process evaluation is the need for rapid results, as if often required by decision-makers [2,6,7,42], resulting in a short time span between the intervention and its assessment (one year after implementation in the case of INTERDIA). This period may have been insufficient to reveal the full effect of the intervention on the professionals’ practices. Other limitations include the absence of data about the actual changes in organization made by the FHS teams in the intervention cities, which leaves open the possibility that nothing had changed; this would however mean that the QualiDia project was not efficient in driving beneficial changes and would not alter the conclusion about its negative results. Finally, no objective measures, such as laboratory tests, were performed to assess the effect of the intervention, but in this context of a complex intervention with no detectable impact on practices, it would have been highly unlikely to elicit differences on clinical outcomes, and yet more difficult to interpret them, had there been any.

Conflict of interest The authors state that they have no conflict of interest.

Funding The INTERDIA study was supported by the National Council for Technological and Scientific Development (CNPq), Brazil [grant number 563911/2010-7].

Acknowledgments The authors wish to thank Family Health Strategy institutions, administrators and personnel in the participating municipalities in the State of Pernambuco; they are also grateful to the interviewers, the Public Health Residents and Master’s students and all personnel who contributed to data collection, data management and statistical analysis.

references

[1] World Health Organization, Global status report on noncommunicable diseases, 2014. Available at: http://apps.who.int/iris/bitstream/10665/128038/1/ 9789241507509 eng.pdf?ua=1 (Accessed 26 January 2017).

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Please cite this article in press as: M.G. da Silva Marinho, et al., The impact of an intervention to improve diabetes management in primary healthcare professionals’ practices in Brazil, Prim. Care Diab. (2017), http://dx.doi.org/10.1016/j.pcd.2017.06.002