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PLOS One logoLink to PLOS One
. 2012 Aug 27;7(8):e43870. doi: 10.1371/journal.pone.0043870

Effectiveness of Standardized Nursing Care Plans in Health Outcomes in Patients with Type 2 Diabetes Mellitus: A Two-Year Prospective Follow-Up Study

Juan Cárdenas-Valladolid 1,*, Miguel A Salinero-Fort 2, Paloma Gómez-Campelo 2, Carmen de Burgos-Lunar 3, Juan C Abánades-Herranz 4, Rosa Arnal-Selfa 5, Ana López- Andrés 6
Editor: Kaberi Dasgupta7
PMCID: PMC3428286  PMID: 22952794

Abstract

Background

Implementation of a standardized language in Nursing Care Plans (SNCP) allows for increased efficiency in nursing data management. However, the potential relationship with patientś health outcomes remains uncertain. The aim of this study was to evaluate the effectiveness of SNCP implementation, based on North American Nursing Diagnosis Association (NANDA) and Nursing Interventions Classification (NIC), in the improvement of metabolic, weight, and blood pressure control of Type 2 Diabetes Mellitus (T2DM) patients.

Methods

A two-year prospective follow-up study, in routine clinical practice conditions. 31 primary health care centers (Spain) participated with 24,124 T2DM outpatients. Data was collected from Computerized Clinical Records; SNCP were identified using NANDA and NIC taxonomies. Descriptive and ANCOVA analyses were conducted.

Results

18,320 patients were identified in the Usual Nursing Care (UNC) group and 5,168 in the SNCP group. At the two-year follow-up, the SNCP group improved all parameters except LDL cholesterol and diastolic blood pressure. We analyzed data adjustming by the baseline value for these variables and variables with statistically significant differences between groups at baseline visit. Results indicated a lowering of all parameters except HbA1c, but a statistically significant reduction was only observed with diastolic blood pressure results. However, the adjusted reduction of diastolic blood pressure is of little clinical relevance. Greater differences of control values for diastolic blood pressure, HbA1c, LDL-cholesterol and Body Mass Index were found in the SNCP group, but only reached statistical significance for HbA1c. A greater proportion of patients with baseline HbA1c ≥7 decreased to <7% at the two-year follow-up in the SNCP group than in the UNC group (16.9% vs. 15%; respectively; p = 0.01).

Conclusions

Utilization of SNCP was helpful in achieving glycemic control targets in poorly controlled patients with T2DM (HbA1c ≥7%). Diastolic blood pressure results were slightly improved in the SNCP group compared to the UNC group.

Trial Registration

ClinicalTrials.gov NCT01482481

Introduction

Type 2 Diabetes Mellitus (T2DM) is a chronic disease that has increased its prevalence and incidence rates in recent years [1], and some authors consider it the most important epidemic of the 21st century [2]. It is also associated with premature morbidity and mortality [3], [4] as well as with an increase in healthcare costs [5].

Glycated hemoglobin (HbA1c) is an important indicator of diabetic control, because it provides an average of all the blood glucose readings for the previous two-three months [6]. Several studies [7][9] have shown a relationship between the lack of glycemic control (HbA1c>7%) and chronic complications, so the relative risk for stroke or coronary heart disease is 1.18 for each 1-percent point increase in HbA1c (95% Confidence Interval [95% CI] = 1.10–1.26) in patients with T2DM [10].

Currently, the responsibility for the care of patients with diabetes has shifted to a primary health care setting, and, more specifically, to nurses. They have a central role in the treatment of patients with T2DM and have been implementing a wide range of interventions aimed at improving the provision of diabetes care and achieving better metabolic control [11].

In the last decade, there has been enormous development in the implementation of standardized languages in Nursing Care Plans (SNCP) for nursing diagnoses (North American Nursing Diagnosis Association -NANDA) [12] and interventions (Nursing Interventions Classification -NIC) [13]. In Spain since 1998, these taxonomies have been progressively incorporated into normal clinical practice and Computerized Clinical Records (CCR). However, there is still no common language in Spanish nursing practice [14].

The implementation of SNCP care plans allow for increased practicality and efficiency in nursing data management [15], but the potential relationship between nursing interventions and patientś health outcomes remains uncertain [16], [17].

The aim of the study was to evaluate the effectiveness of implementing SNCP in CCR registration in the improvement of metabolic, weight, and blood pressure control of patients with T2DM after two–year follow-up. The SNCP followed NANDA and NIC taxonomies.

Methods

Design

A two-year prospective follow-up study, carried out during the period from March 2008 to February 2010.

Sample

24,124 T2DM patients were potentially eligible to be included in the study. These patients were identified using the CCR and were comprised of patients who regularly visit (at least two records in the CCR over the past year) the 31 primary health care centers in the northeastern urban area of Madrid, Spain.

Eligibility criteria for patients were: over 30 years of age, with previously diagnosed T2DM (cardinal clinical, plus random blood glucose >200 mg/dl or oral glucose of >200 mg/dl at 2 h, twice or plasma fasting glucose of >126 mg/dl on two occasions or previously diagnosed). Patients were not included if they met any of the following exclusion criteria: gestational diabetes, patients involved in clinical trials, patients with life expectancy of less than one year (according to clinical judgment), and homebound patients. Figure 1 show the flowchart of the study.

Figure 1. Flow diagram of participants.

Figure 1

PCHC: Primary Health Care Center; T2DM: Type 2 Diabetes Mellitus; SNCP: Standardized Nursing Care Plans; UNC: Usual Nursing Care; CCR: Computerized Clinical Records; BP: Blood Pressure; HbA1c: Glycated hemoglobin; LDLc: Low-density lipoprotein cholesterol; BMI: Body Mass Index.

During February 2006- February 2008, the vast majority of nurses in the primary health care centers were trained in diagnostic reasoning based on NANDA and NIC taxonomies. Training consisted of eight classes of two hours, taught by a specialized nurse. 94.12% of nurses in the SNCP group and 24.39% of nurses in the UNC group attended the training. The implementation of NANDA and NIC taxonomies in the CCR by primary health care centers in Madrid began in March 2008.

Based on the types of nursing actions registered in the CCR, two groups of nurses were identified: those that used usual nursing care (UNC) and those that used SNCP.

The first group applied UNC which is defined as: direct nursing care, non standardized clinical interventions that contribute to the health or recovery of a patient. UNC for patients with T2DM are defined as: the treatment and monitoring of T2DM including interventions at different levels such as: controlling blood sugar levels, control of cardiovascular risk factors, drug therapy compliance, change in lifestyles, health education, and self-management [18]. UNC were identified in the CCR based on the non-standardized languages in nursing care or the standardized nursing cares based on other taxonomies.

The second group, SNCP group, applied UNC for patients with T2DM and SNCP based on NANDA and NIC taxonomieś. A SNCP describes the care to be provided to a specific group of patients and contains a diagnostic statement, nursing goals, implementation and evaluation [19]; based on up-to-date, evidence-based knowledge.

In the CCR, SNCP was identified based on the following three criteria:

- Criterion 1. The patient has a code that corresponds to the Gordon’s functional health patterns [20] in at least one of the following areas: health perception and health management; nutritional and metabolic; and activity and exercise.

- Criterion 2. The problems identified were described using codes nursing diagnosis statements based on NANDA taxonomy, used in T2DM patients (Table 1). A nursing diagnosis based on NANDA taxonomy is defined as a clinical judgment about individual, family or community responses to actual or potential health problems or life processes which provide the basis for the selection of nursing interventions to achieve patientś outcomes, for which, the nurse is accountable [12].

Table 1. Nursing diagnoses: domains, class, and titles.

Domain Class Nursing diagnoses
Nutrition Ingestion 00001 Imbalanced nutrition: more than body requirements
00002 Imbalanced nutrition: less than body requirements
00003 Risk for imbalanced nutrition: more than body requirements
Coping/stress tolerance Coping responses 00069 Ineffective coping
Life Principles Value/Belief/Action Congruence 00079 Non compliance
Health promotion Health management 00078 Ineffective self health management
00080 Ineffective family therapeutic Regimen Mangament
00081 Ineffective therapeutic regimen management
00082 Effective therapeutic regimen management
00162 Readiness for enhanced self-health management
00163 Readiness for enhanced nutrition
00084 Health-Seeking Behaviors: Management DM
Self Perception Self-Esteem 00120 Situational Low self-esteem
Perception/cognition Cognition 00126 Deficient knowledge
Activity/Rest Activity/Exercise 00168 Sedentary Lifestyle
Safety/Protection Physical injury 00046 Impaired skin integrity

- Criterion 3. The nursing intervention carried out was registered according to the codes of NIC taxonomy, used in T2DM patients [13] (Table 2).

Table 2. Nursing interventions: domains, class, and titles.

Domain Class Nursing interventions
Physiological: Basic and Complex Activity and exercise management 0200 Exercise promotion
1020 Diet Staging
1030 Eating Disorders: Management
1100 Nutrition Management
1160 Nutritional Monitoring
1240 Weight gain assistance
1260 Weight Management
1280 Weight Reduction Assistance
5246 Nutritional Counseling
Self-Care Facilitation 1803 Self-Care Assistance: Feeding
Electrolyte and Acid-Base Management 2120 Hyperglycemia management
2130 Hypoglycemia management
Behavioral Behavioral Therapy 4360 Behavior Modification
4410 Mutual Goal Setting
4420 Patient Contracting
4470 Self-Modification Assistance
Cognitive Therapy 4700 Cognitive Restructuring
Communication Enhancement 4920 Active Listening
Coping assistance 5210 Anticipatory Guidance
5220 Body Image Enhancement
5230 Coping Enhancement
5240 Counseling
5250 Decision-Making Support
5270 Emotional Support
5330 Mood Management
5390 Self-Awareness Enhancement
5400 Self-Esteem Enhancement
5440 Support System Enhancement
5480 Values Clarification
Patient education 5510 Health Education
5520 Learning Facilitation
5540 Learning Readiness Enhancement
5602 Teaching: disease process
5606 Teaching: individual
5612 Teaching: prescribed activity/exercise
5614 Teaching: prescribed diet
5616 Teaching: prescribed medication
5618 Teaching: procedure/treatment
5620 Teaching: psychomotor skills
Safety Crisis Management 6160 Crisis Intervention
Risk management 6520 Health Screening
6610 Risk Identification
6650 Surveillance
6680 Vital sings monitoring
Lifespan care 7140 Family Support
Health System Delivery System 7400 Health System Guidance
7460 Patient Rights Protection
Information Management 8180 Telephone Consultation
8190 Telephone Follow-up

Sources of Information

The CCR for primary health care in Madrid’s Health Service was used as the data source and was administered by OMI-AP® software. The CCR has been previously validated [21].

Data extraction of patient information was conducted at four time points: baseline, 12 and 18 months and after complete follow-up of the study (two-year follow-up). Data included variables and date on which data had been recorded in the CCR. The collection of variables was performed in routine clinical practice conditions.

For all the patients, the following variables were recorded: sociodemographic (age, gender), clinical variables (diabetes evolution time), personal health habits (smoking: cigarettes/day; drinking: alcohol units/week; physical activity: measured in hours per week with any exercise or activity outside of the patients’ regular job being considered, and recoded as sedentary, moderate-intensity, vigorous-intensity), associated morbidity (hypertension, dyslipidemia, coronary heart disease-CHD), diabetes mellitus complications (retinopathy, nephropathy, neuropathy), and the type of treatment prescribed (pharmacological and dietary). Additionally, biochemical–biological parameters were collected: body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and HbA1c. Only patients with laboratory values and anthropometric records in the CCR at baseline and at final visit were included to determine the effect of SNCP and achievement of control objectives. In some cases, loss of data was close to 50% (LDL cholesterol).

Blood pressure was measured according to the recommendations of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (2003) [22]; these recommendations were the most current at the start of this study.

The primary outcomes were those related to diabetes targets: glycemic control (HbA1c<7), blood pressure control (SBP<130 mm Hg, DBP<80 mmHg), lipid control (LDL cholesterol <130 mg/dl), and weight control (BMI<30 kg/m2) after the two-year follow-up.

The study was approved by the Institutional Review Board of the Committee on Human Research of the Hospital Ramón y Cajal (Madrid). The Committee for the Protection of Human Subjects determined that no informed consent was necessary in this type of study.

Statistical Analysis

First, a descriptive analysis was carried out for each variable included in this study, involving the mean and standard deviation for the quantitative variables and frequencies measured for the qualitative variables. Student’s t-test, or its nonparametric equivalent, was used for paired data (Wilcoxon test). Furthermore, the Pearson χ2 test was used for qualitative variables, and McNemar’s test was used for paired data.

Change (mean at the two-year follow-up value − mean baseline value) was calculated in both groups for the following variables: LDL cholesterol, HbA1c, SBP, DBP, and BMI. The variable Effect of the SNCP was determined for these variables using the formula: mean value of the change in SNCP− mean value of the change in UNC. Covariance analysis methodology (ANCOVA) proposed by Vickers was used to determine the adjusted effect of SNCP [23]. The covariables (adjustment variables) were: the baseline value for these variables and variables with statistically significant differences between groups at baseline visits (age, drinking, physical activity – sedentary, BMI, and type of treatment) or clinical relevance (gender). In order to adjust for significantly different variables at baseline and between both groups multivariate techniques (ANCOVA, logistic regression) were performed in order to adjust by variables imbalanced at baseline values between both groups.

In all instances, the accepted level of significance was 0.05 or less, with 95% CI. All the analyses were carried out using the intention-to-treat principle. Statistical analysis of the data was carried out with SPSS 17.0 (SPSS, Inc., Chicago, Illinois, USA).

Results

A total of 23,488 patients were included, of which 51.6% were female, mean age 69.7 years (SD = 14.5), and mean diabetes evolution time of 8.1 years (SD = 8.3). 18,320 patients were identified as part of the UNC group and 5,168 were identified as part of the SNCP group.

Table 3 show baseline characteristics of the study population. The two groups were homogeneous in gender, but not in age, and diabetes evolution time. Patients in the SNCP group had a higher prevalence of poorer personal health habits (drinking and sedentary physical activity), dyslipidemia and complications (retinopathy). Patients in the SNCP group also received more treatment for diabetes (oral antidiabetic and insulin) and for cardiovascular disease (ARB/calcium antagonist/statins/antiplatelets), with poorer HbA1c (7.25% vs. 7.12%; p<0.001), and better LDL cholesterol (115 mg/dl vs. 119 mg/dl; p<0.001), than patients of the UNC group.

Table 3. Baseline characteristics of the study population.

UNC (n: 18,320) SNCP (n: 5,168) p value
Sociodemographic variables
Female gender (%) 51.5 52.3 0.299
Age (yr) [mean ±SD] 69±12 70±13 0.000
Clinical variables
Diabetes evolution time (yr) [mean ±SD] 7.4±6.3 8.6±6.9 0.000
Personal health habits
Smoking (%) 19.4 18.7 0.268
Drinking (%) 20.9 23.4 0.000
Physical activity (sedentary) (%) 1.8 4.1 0.000
Biological parameters
BMI (Kg/m2) [mean ±SD] 30.1±5 29.8±4.7 0.004
DM treatment profile %
Drug-free 11.3 8 0.000
Oral antidiabetic 61.5 69.8 0.000
Insulin 18.6 22.6 0.000
Oral antidiabetic + Insulin 9.6 13.4 0.000
Others treatments %
Statins 47.7 52.3 0.000
Fibrates 3.7 3.5 0.585
Diuretics 27.9 26.5 0.054
Beta-blockers 16.7 15.6 0.066
Calcium antagonist 21.1 22.5 0.031
ACE Inhibitors 36.2 37.3 0.135
ARB 22.6 25.2 0.000
Antiplatelet 58.0 62.7 0.000
Associated morbidity %
CHD 13.3 13.2 0.949
Dyslipidemia 44.8 49.2 0.000
Hypertension 69.6 68.6 0.160
Complications %
Retinopathy 3.5 4.5 0.001
Nephropathy 6.8 7.1 0.351
Neuropathy 1.8 1.7 0.947

UNC: Usual Nursing Cares; SNCP: Standardized Nursing Care Plans; DM: Diabetes mellitus; BMI: Body mass index; ACE: Angiotensin-converting enzyme; ARB: Angiotensin receptor blockers; CHD: Coronary heart disease.

At the two-year follow-up, both groups experienced a modest decline in their parameter values (Table 4). The unadjusted effect of SNCP improved health outcomes, except for with LDL cholesterol and DPB. After adjusting for baseline parameter values and age, sex, type of treatment and physical inactivity, a lowering effect on all health outcomes was observed except for HbA1c. A statistically significant reduction was only observed with DBP. However, the reduction of DBP was of little clinical relevance.

Table 4. Mean values (SD) and changes of baseline and final parameters in both groups.

SNCP UNC Unadjusted SNCP effect (95% CI) Adjusted SNCP effect(95% CI)
Hba1c (%) mean (SD)
N patients 3,166 9,645
Baseline 7.25 (1.2) 7.12 (1.2)
Final 7.02 (1.1) 6.92 (1.1)
Change −0.23 (1.1) −0.20 (1.1) −0.02 (0.02–0.07) 0.03 (−0.01–0.06)
p value 0.26 0.14
LDL Cholesterol (mg/dl) mean (SD)
N patients 2,919 8,843
Baseline 115 (31) 119 (33)
Final 108 (30) 111 (31)
Change −7.14 (30) −8.04 (32) 0.90 (2.22–0.42) −0.68 (−1.76–0.39)
p value 0.18 0.21
SBP (mmHg) mean (SD)
N patients 4,354 13,680
Baseline 134 (16) 134 (17)
Final 132 (15) 132 (15)
Change −1.95 (19) −1.48 (18) −0.46 (−1.08–0.16) −0.07 (−0.56–0.42)
p value 0.15 0.78
DBP (mmHg) mean (SD)
N patients 4,354 13,680
Baseline 76 (10) 76 (10)
Final 75 (9) 74 (9)
Change −1.45 (11) −1.46 (11) 0.01 (0.37–0.36) −0.33 (−0.63–0.04)
p value 0.98 0.02
BMI (Kg/m2) mean (SD)
N patients 3,395 8,600
Baseline 29.8 (4.7) 30.1 (5)
Final 29.5 (4.7) 29.8 (5)
Change −0.22 (1.9) −0.22(1.8) −0.00 (−0.08–0.07) −0.02 (−0.10–0.05)
p value 0.99 0.54

UNC: Usual Nursing Cares; SNCP: Standardized Nursing Care Plans; Hba1c: Glycated hemoglobin; LDL: Low-density lipoprotein; SBP: Systolic Blood Pressure; DBP: Diastolic blood pressure; BMI: Body mass index.

Table 5 shows the proportion of patients who achieved the target of glycemic, blood pressure, lipid and weight control, at baseline, 12, 18 and 24 months, in both groups. There was a significant improvement (p<0.01) in the percentage of subjects who complied with control targets in both groups, at the two-year follow-up. The SNCP group showed greater change in control values than the UNC group, in DBP, HbA1c, LDL cholesterol and BMI, but only reached statistical significance for HbA1c. The UNC group performed better than the SNCP group in the degree of control of SBP (p<0.01).

Table 5. Percentage of subjects on-target for cardiovascular risk factors at baseline and at the two-year follow-up, stratified by group (UNC/SNCP).

N Baseline (%) 12 Months (%) 18 Months (%) 24 Months (%) p-value* Change (%) p-value
SBP<130 mmHg
UNC (%) 13,680 31.6 33.5 35.6 35.5 <0.01 3.9 <0.01
SNCP (%) 4,354 31.6 32.9 35.5 34.5 <0.01 2.9
DBP<80 mmHg
UNC (%) 13,680 50.6 53 55.7 55.9 <0.01 5.3 0.31
SNCP (%) 4,354 53.7 57 59.7 59.4 <0.01 5.7
HbA1c <7%
UNC (%) 9,645 54.4 59.2 61.2 60.3 <0.01 5.9 <0.01
SNCP (%) 3,166 47.6 51.8 56.4 55.2 <0.01 7.6
LDL c <130 mg/dl
UNC (%) 8,843 29.8 32.3 36.1 38.0 <0.01 8.2 0.61
SNCP (%) 2,919 33.4 34.9 38.2 41.9 <0.01 8.5
BMI <30 Kg/m2
UNC (%) 8,600 54.2 54.8 56.3 56.6 <0.01 2.4 0.21
SNCP (%) 3,395 56.8 58.2 59.6 59.6 <0.01 2.8

p*: p value of comparison of the two-year follow-up and baseline values, intragroup differences; Change: Final value (two-years)– Baseline values; UNC: Usual Nursing Cares; SNCP: Standardized Nursing Care Plans; SBP: Systolic Blood Pressure; DBP: Diastolic blood pressure. HbA1c: Glycated hemoglobin; LDL c: Low-density lipoprotein cholesterol; BMI: Body mass index.

There was a greater proportion of patients with baseline HbA1c ≥7 who decreased this value below 7% at the two-year follow-up in the SNCP group that in the UNC group (16.9% vs. 15%, respectively; p<0.01).

Finally, table 6 shows the factors associated with achieving glycemic control in patients with baseline HbA1c ≥7%. After adjusting by type of treatment, age and gender, the SNCP group showed a favourable trend toward target control (OR = 1.11; 95%CI = 0.99–1.24; p: 0.06). The variable more strongly associated with glycemic control was oral antidiabetic agents (OR = 2.41; 95% CI = 2.12–2.75; p<0.01).

Table 6. Associated factors with HbA1c <7% in 12,800 DM patients with baseline HbA1c≥7%: logistic regression model.

Variables Adjusted OR 95% CI p value
Group (SNCP/UNC) 1,11 0,99–1,24 0,06
Insulin treatment (yes/no) 1,20 1,06–1,36 <0,01
Oral antidiabetic agents (yes/no) 2,41 2,12–2,75 <0,01
Gender (male/female) 1,16 1,05–1,28 <0,01
Age, yr 0,99 0,98–1 0,17

UNC: Usual Nursing Cares; SNCP: Standardized Nursing Care Plans; HbA1c: Glycated hemoglobin.

In the SNCP group, average use of NANDA taxonomy in nursing diagnoses was 6.4 (DS = 1.9) and the most frequently used nursing diagnoses included: Effective Therapeutic Regimen Management (33.9%); Ineffective Therapeutic Regimen Management (22.4%); Impaired Skin Integrity (12.3%); Health-Seeking behaviors (9.9%); Imbalanced Nutrition: more than Body Requirements (3.7%); Readiness for Enhanced Self Health Management (3.1%); Deficient knowledge (2.2%) and Non compliance (2%).

Discussion

The present study showed that patients in the SNCP group reached a significant reduction in DBP, at the two-year follow-up, compared to patients in the UNC group. However, a reduction in DBP values has little clinical relevance. SNCP group demonstrated a favourable trend toward the glycemic control in previously poorly controlled patients, after adjusting for age, gender, and type of treatment. The main predictors variables were treatment with oral antidiabetic agents, and insulin treatment; that previously, in our country, had been associated with glycemic control [24].

Preceding studies have shown that the implementation of standardized languages in nursing care plans enhances the quality of documented patient assessments, the identification of commonly occurring diagnoses within similar settings, and coherence among nursing diagnoses, interventions and outcomes [17], [18], but that better documentation did not necessarily lead to better patient care outcomes [17].

Some studies in hospital settings, examined the relationship between the implementation of standardized languages and patient’s outcomes [25], [26]. However, there is a gap in the literature about the potential relationship between the implementation of standardized languages in nursing care plans and health outcomes for chronic patients in primary health care settings [16], [17]. One meta-analysis of nine trials that included 1,846 patients showed limited evidence that standardized electronic documentation of nursing diagnosis and related interventions led to better health outcomes [16].

The utilization of standardized languages in nursing care plans may be interpreted as an organizational intervention aimed at improving the process of care or patient outcomes. In a systematic review [27], which included nine studies of organizational interventions in patients with diabetes, there was no evaluation of the effectiveness of SNCP or nursing diagnoses. For this reason, our study cannot be compared with similar efficacy studies.

The patients in the SNCP group had a greater risk profile. This is consistent with the findings of Paans et al. [28] who identifies that one of the factors associated with the use of nursing diagnoses is the complexity of a patientś situation. For this reason, we adjusted for baseline differences with a multivariate analysis (ANCOVA), in spite of this there is still a possibility of bias in favor of the null hypothesis.

The study sample was composed of patients with T2DM who regularly visited primary health care centers. This may not be representative of the entire T2DM patient community. However, the prevalence of diabetes mellitus recorded in the 31 participating primary health care centers [21] is similar to that found in a population based study carried out in our city [29] (5.02% vs. 6.3%, respectively), so the potential selection bias would be of small magnitude.

Finally, the level of evidence from cohort studies is lower than clinical trials, so our results should be interpreted with caution.

Despite the limitations, this research analyzed a gap in the literature about the unclear relationship between the application of SNCP and patient outcomes. In conclusion, SNCP appears to be helpful in achieving target HbA1c levels in patients with T2DM with previously poorly controlled (HbA1c ≥7%). Other control parameters (blood pressure) are slightly improved compared to UNC. Clinical trials are needed to confirm our findings.

Acknowledgments

We thank the primary health care practitioners who took part in this study.

Funding Statement

Funding for the study was supplied by the “Instituto de la Salud Carlos III” (PI07/0865). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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