BackgroundIn subjects with hypercholesterolaemia, cholesterol values remain above guideline levels. One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence. The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients, consisting of a combined strategy that would include the delivery of printed information, treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner’s practice.Methods/DesignA randomised, parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain’s Autonomous Regions (Comunidades Autónomas), covering a total of 358 subjects aged 18 years or over with diagnosis of hypercholesterolaemia. Patients in the intervention group will be supplied with printed material with information on the disease and its management, mobile-telephone text messages with guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance, and self-report cards to check compliance with recommendations. Both groups -intervention and control- will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the measurements to be made, the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24 months. The secondary variables are as follows: adherence to recommendations on lifestyle and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels; appearance of cardiovascular events; physical activity; food consumption; smoking habit; anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents; socio-demographic data; beliefs and expectations about preventive recommendations; and degree of satisfaction with the combined strategy.DiscussionShould this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia. It is a simple, relatively inexpensive intervention.Trial registrationClinicalTrials.gov: NCT02314663.
BackgroundPatient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience.Our study aims to achieve the following:- Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.- Find and analyze educational tools to improve patient safety culture in primary care.- Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care.Design and methodsDesignExperimental unifactorial study of two groups, control and intervention.Study populationTutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain.SampleFrom the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned.InterventionResidents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group-either intervention or control-through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After the intervention has ended, the survey will once again be provided to all participants.Outcome measuresChange in safety culture as measured by Hospital Survey on Patient Safety CultureCONSORT Extension for Non-Pharmacologic Treatments 2008 was applied.DiscussionThe most significant limitations on the project are related to selecting a tool to measure the safety environment, the training calendar of residents in Family and Community Medicine in last year of studies and the no-answer bias inherent to research conducted through self-administered surveys.The development and application of a safety culture in the health sector, specifically in primary care, is as yet limited. Thus, identifying the strengths and weaknesses in the safety environment may assist in designing strategies for improvement in the primary care health centers of our region.Trial registrationISRCTN: ISRCTN41911128
BackgroundFostering a culture of safety is an essential step in ensuring patient safety and quality in primary care. We aimed to evaluate the effectiveness of an educational intervention to improve the safety culture in the family and community medicine teaching units in an Atlantic European Region.MethodsRandomized study conducted in family and community medicine teaching units in Galicia (Spain). Participants were all fourth-year residents and their tutors (N = 138). Those who agreed to participate were randomized into one of two groups (27 tutors/26 residents in the intervention group, 23 tutors/ 23 residents in the control one).All were sent the Survey on Patient Safety Culture. After that, the intervention group received specific training in safety; they also recorded incidents over 15 days, documented them following a structured approach, and had feedback on their performance. The control group did not receive any action. All participants completed the same survey four months later. Outcome measures were the changes in safety culture as quantified by the results variables of the Survey: Patient Safety Grade and Number of events reported.We conducted bivariate and adjusted analyses for the outcome measures. To explore the influence of participants’ demographic characteristics and their evaluation of the 12 dimensions of the safety culture, we fitted a multivariate model for each outcome.ResultsTrial followed published protocol. There were 19 drop outs. The groups were comparable in outcome and independent variables at start. The experiment did not have any effect on Patient safety grade (− 0.040) in bivariate analysis. The odds of reporting one to two events increased by 1.14 (0.39–3.35), and by 13.75 (2.41–354.37) the odds of reporting 3 or more events. Different dimensions had significant independent effects on each outcome variable.ConclusionA educational intervention in family and community medicine teaching units may improve the incidents reported. The associations observed among organizational dimensions and outcomes evidence the complexity of patient safety culture measurement and, also, show the paths for improvement. In the future, it would be worthwhile to replicate this study in teaching units from different settings and with different health professionals engaged.Trial registrationIt was retrospectively registered with (ISRCTN41911128, 31/12/2010).Electronic supplementary materialThe online version of this article (10.1186/s12875-018-0901-8) contains supplementary material, which is available to authorized users.
BackgroundIn patients treated with oral anticoagulants, subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding, although the effectiveness of the vaccine has only been proven for intramuscular injection. The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants.Methods/designWe present a prospective, double blinded, clinical trial comparing two groups of patients with oral anticoagulants: one group was administered tetanus-diphtheria vaccine by intramuscular injection, while the other was administered the same vaccine by subcutaneous injection. Allocation to each group was randomized and the duration of the study was six years.Study population: all patients treated with oral anticoagulants, who had been administered with at least one dose of vaccine, at 15 Health Centres in Vigo (Spain), and who agreed to participate in the study. The sample size was 115 patients in each group. The main variables for the safety analysis were the measurement of the brachial diameter, the appearance of basic injuries at the vaccine administration site, the appearance of pain and systemic reactions. The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed. Details will be classified according to the administration route, while within each group a 3-tiered stratification will be defined by the administered number of doses. As a measure of association, relative risk will be estimated; the reduction of relative risk will also measured. For safety and to control the confounder effect, a logistic regression analysis will be carried out. As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT 2010 guidelines were applied for reporting parallel group randomised trials.DiscussionThe most significant difficulties on the project are related to the large number of participating centres, required to obtain a viable study population sample size, and the coordination given the scattering of the centres and researchers.Trial registrationISRCTN69942081.
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