Efficacy of a joint didactic intervention using the Junta De Andalucía School for Patients method to control prothrombin time in patients taking anticoagulants: protocol for a randomized controlled trial.

BACKGROUND: Oral anticoagulant drugs represent an essential tool in the prevention of thromboembolic events. The ones in widespread use are vitamin K antagonists, whose plasma level is monitored by measuring prothrombin time using the international normalized ratio. If its values are out of the recommended range, the patient will have a higher risk of suffering from thromboembolic or hemorrhagic complications. Previous research has shown that approximately 33% of patients keep having values at an inappropriate level. The purpose of the proposed study is to improve the international normalized ratio control results by a joint didactic intervention based on the Junta de Andalucía School for Patients method that will be implemented by anticoagulated patients themselves. METHODS: A randomized controlled trial will be undertaken at primary care centers from one healthcare area in Málaga (Andalusia, Spain). STUDY POPULATION: patients participating in an oral anticoagulant therapy program of vitamin K antagonists. First step: identification of patients in the oral anticoagulation therapy program with international normalized ratio control of the therapeutic level at 65% or less over total time. Second step: patients with international normalized ratio (INR) control figures under 2 or above 3 will be assigned to two different groups: Group 1 or joint intervention group: patients will be instructed in the joint didactic "from peer to peer," by a previously trained and expert anticoagulant patient. Group 2 or control group: the control group will receive the usual clinical practice. They will be evaluated by nurses about once a month, except for cases in which their INR figures are under 2 or above 3, and those patients will be evaluated more frequently. A total of 312 individuals will be required (156 in each group) to detect differences in INR figures equal to or higher than 15% between the groups. STUDY VARIABLES: time on therapeutic levels before and after the intervention; sociodemographic variables; vital signs; the existence of cardiovascular risk factors or accompanying diseases in the clinical records; laboratory test including complete blood counts, bleeding time, and prothrombin time or partial thromboplastin time; and blood chemistry, other prescribed drugs, and social support. A quasi-experimental analytic study with before-after statistical analysis of the intervention will be conducted. Linear regression models will be applied for the main variable results (international normalized ratio value, time on therapeutic level) inputting sociodemographic variables, accompanying diseases, and social support. TRIAL REGISTRATION: ClinicalTrials.gov NCT03647254 . Registered on 27 August 2018.

Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial.

UNLABELLED: Pressure ulcers represent a major current health problem and produce an important economic impact on the healthcare system. Most of studies to prevent pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids and to date, no studies have specifically examined the use of olive oil-based substances. METHODS AND DESIGN: Main objective: To assess the effectiveness of the use of olive oil, comparing it with hyperoxygenated fatty acids, for immobilised home-care patients at risk of suffering pressure ulcers. Design: Non-inferiority, triple-blind, parallel, multicentre, randomised clinical trial. Scope: Population attending Primary Healthcare Centres in Andalusia (Spain). Sample: 831 immobilised patients at risk of suffering pressure ulcers. RESULTS: The follow-up period was 16 weeks. Groups were similar after randomization. In the per protocol analysis, none of the body areas evaluated presented risk differences for pressure ulcers incidence that exceeded the 10% delta value established. Sacrum: Olive Oil 8 (2.55%) vs HOFA 8 (3.08%), ARR 0.53 (-2.2 to 3.26) Right heel: Olive Oil 4 (1.27%) vs HOFA 5 (1.92)%, ARR0.65 (-1.43 to 2.73). Left heel: Olive Oil 3 (0.96%) vs HOFA 3 (1.15%), ARR0.2 (-1.49 to 1.88). Right trochanter: Olive Oil 0 (0%) vs HOFA 4 (1.54%), ARR1.54 (0.04 to 3.03). Left trochanter: Olive Oil 1 (0.32%) vs HOFA 1 (0.38%), ARR0.07 (-0.91 to 1.04). In the intention to treat analysis the lower limit of the established confidence interval was never exceeded. DISCUSSION: The results obtained confirmed that the use of topical extra-virgin olive oil to prevent PU in the home environment, for immobilised patients at high risk, is not inferior to the use of HOFA. Further studies are needed to investigate the mechanism by which olive oil achieves this outcome. TRIAL REGISTRATION: Clinicaltrials.gov NCT01595347.

Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial.

BACKGROUND: Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. METHODS/DESIGN: The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. DISCUSSION: The regular use of olive-oil-based formulas should be effective in preventing pressure ulcers in immobilized patients, thus leading to a more cost-effective product and an alternative treatment. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01595347.

Effect of the Act on Promotion of Personal Autonomy and Care for dependent persons on their family caregivers.

BACKGROUND: The need of home care services is becoming an increasingly common scenario. These cares are mainly provided by the dependents' relatives specifically, by the women part of the family. This situation might take years, decreasing the physical and psychological health of the caregiver. In Spain, the Act of Promotion of Personal Autonomy and Care for dependent persons, guarantees those dependent persons and their caregivers to have access to social services or to financial grants. The aim of this study is to Know the possible effects of the benefits provided by this Act in regards to the mental health, the quality of life and use of health services by the family caregivers assisting their relatives in situation of dependency. METHODS AND DESIGN: A longitudinal descriptive study following-up a cohort of patients and caregivers. The study shall be carried out in Andalusia. It shall include the baseline assessment of the variables in those caregivers free from the exposure factor (reception of assistance pursuant to the Act). Following, once the benefits have been received, this cohort shall be followed-up.The study shall take three years, and the starting date for its development as well as its funding is January 2011. DISCUSSION: The longitudinal assessment of the rate of change of the variables studied shall allow us to know the implications which might be potentially generated as well as the natural evolution of those.

Perfil del tutor de practicas de alumnos de enfermería. Un estudio cualitativo / Profile of a trainee nurse mentor. The qualitative research

OBJETIVO/INTRODUCCIÓN: Las prácticas clínicas de alumnos de enfermería en Atención Primaria, son un factor clave en su formación. Este estudio intenta elaborar el perfil ideal del tutor de prácticas, investigando la opinión de todos los grupos implicados (tutores, profesores y alumnos). PARTICIPANTES Y METODOLOGÍA: Estudio observacional descriptivo, de investigación cualitativa mediante encuesta a "informadores clave". Análisis de los resultados mediante "foro de discusión". RESULTADOS: El perfil ideal del tutor es el siguiente: Diplomado en Enfermería, con estabilidad laboral, con al menos un curso de formación en el último año. Conocimientos sobre Pedagogía, artículos científicos publicados y alguna ponencia, comunicación o póster expuestos en Congresos. Con alguna (cualquier) experiencia docente. Que reúna los siguientes valores humanos: eficiente, responsable, abierto y liberal, inteligente lógica y racionalmente, creativo, imaginativo y flexible. Por último que le guste la docencia, tenga motivación personal, sea buen comunicador y tenga claras las características y funciones de su profesión. (AU)