Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial.

BACKGROUND: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. METHODS/DESIGN: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundació Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. DISCUSSION: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice. TRIAL REGISTRATION: NCT 02514538.

A quality improvement plan for hypertension control: the INCOTECA Project (INterventions for COntrol of hyperTEnsion in CAtalonia).

BACKGROUND: Different studies have shown insufficient blood pressure (BP) control in hypertensive patients. Multiple factors influence hypertension management, and the quality of primary care is one of them. We decided therefore to evaluate the effectiveness of a quality improvement plan directed at professionals of Primary Health Care Teams (PHCT) with the aim to achieve a better control of hypertension. The hypothesis of the study is that the implementation of a quality improvement plan will improve the control of hypertension. The primary aim of this study will be to evaluate the effectiveness of this plan. DESIGN: multicentric study quasi-experimental before - after with control group. The non-randomised allocation of the intervention will be done at PHCT level. SETTING: 18 PHCT in the Barcelona province (Spain). SAMPLE: all patients with a diagnosis of hypertension (population based study). EXCLUSION CRITERIA: patients with a diagnosis of hypertension made later than 01/01/2006 and patients younger than 18 years. INTERVENTION: a quality improvement plan, which targets primary health care professionals and includes educational sessions, feedback to health professionals, audit and implementation of recommended clinical practice guidelines for the management of hypertensive patients. MEASUREMENTS: age, sex, associated co-morbidity (diabetes mellitus type I and II, heart failure and renal failure). The following variables will be recorded: BP measurement, cardiovascular risk and antihypertensive drugs used. Results will be measured before the start of the intervention and twelve months after the start of the study. Dependent variable: prevalence of hypertensive patients with poor BP control. ANALYSIS: Chi-square test and Student's t-test will be used to measure the association between independent qualitative and quantitative variables, respectively. Non-parametric tests will be used for the analysis of non-normally distributed variables. Significance level (alpha) will be set at < 0.05. Outcomes will be analysed on an intention-to-treat basis. DISCUSSION: The implementation of a quality improvement plan might benefit the coordination of different professionals of PHCTs and may also improve blood pressure control. TRIAL REGISTRATION: This protocol has been registered at clinicaltrials.gov with the ID number MS: 1998275938244441.

Intervention for control of hypertension in Catalonia, Spain (INCOTECA Project): results of a multicentric, non-randomised, quasi-experimental controlled intervention study.

OBJECTIVE: The purpose of this study was to assess the effectiveness of a quality improvement (QI) plan aimed at primary healthcare teams (PHCTs) to optimise hypertension control and to compare it with standard clinical care. METHODS: Design Multicentric, non-randomised, quasi-experimental controlled intervention study. Setting 5 PHCTs in the intervention and 13 in the standard care group in the province of Barcelona, Catalonia, Spain. Participants This is a population-based study in which all patients over 18 years of age with a diagnosis of hypertension before 1 January 2006 were included (n=9877 in the intervention group and n=21 704 in the control group). Intervention A QI plan that targeted primary care professionals. The plan included training sessions, implementation of recommended clinical practice guidelines for the management of hypertensive patients and audit and feedback to health professionals. Main outcome measure Prevalence of hypertensive patients with an adequate blood pressure (BP) control. RESULTS: The adjusted difference between intervention and standard care groups in the odds of BP control was 1.3 (95% CI 1.1 to 1.6, p=0.003). Results of the mixed model on repeated measures showed that, on average, an individual in the intervention group had an increase of 92% in the odds of BP control (OR 1.9, 95% CI 1.7 to 2.1). CONCLUSIONS: The implementation of a QI plan can improve BP control. This strategy is potentially feasible for up-scaling within the existing PHCTs. TRIAL REGISTRATION: ClinicalTrials.gov MS: 1998275938244441.