CuidaCare: effectiveness of a nursing intervention on the quality of life's caregiver: cluster-randomized clinical trial.

BACKGROUND: In Spain, family is the main source of care for dependent people. Numerous studies suggest that providing informal (unpaid) care during a prolonged period of time results in a morbidity-generating burden. Caregivers constitute a high-risk group that experiences elevated stress levels, which reduce their quality of life.Different strategies have been proposed to improve management of this phenomenon in order to minimize its impact, but definitive conclusions regarding their effectiveness are lacking. METHODS/DESIGN: A community clinical trial is proposed, with a 1-year follow-up period, that is multicentric, controlled, parallel, and with randomized allocation of clusters in 20 health care centers within the Community of Madrid. The study's objective is to evaluate the effectiveness of a standard care intervention in primary health care (intervention CuidaCare) to improve the quality of life of the caregivers, measured at 0, 6, and 12 months after the intervention.One hundred and forty two subjects (71 from each group) ≥65 years, identified by the nurse as the main caregivers, and who provide consent to participate in the study will be included.The main outcome variable will be perceived quality of life as measured by the Visual Analogue Scale (VAS) of EuroQol-5D (EQ-5D). The secondary outcome variables will be EQ-5D Dimensions, EQ-5D Index, nursing diagnosis, and Zarit's test. Prognostic variables will be recorded for the dependent patient and the caregiver.The principle analysis will be done by comparing the average change in EQ-5D VAS value before and after intervention between the two groups. All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account. DISCUSSION: Assistance for the caregiver should be integrated into primary care services. In order to do so, incorporating standard, effective interventions with relevant outcome variables such as quality of life is necessary. Community care nurses are at a privileged position to develop interventions like the proposed one. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov under code number NCT 01478295.

Cluster randomized trial to evaluate the effect of a multimodal hand hygiene improvement strategy in primary care.

OBJECTIVE: To evaluate the effectiveness of a multimodal intervention in primary care health professionals for improved compliance with hand hygiene practice, based on the World Health Organization's 5 Moments for Health Hygiene. DESIGN: Cluster randomized trial, parallel 2-group study (intervention and control). SETTING: Primary healthcare centers in Madrid, Spain. PARTICIPANTS: Eleven healthcare centers with 198 healthcare workers (general practitioners, nurses, pediatricians, auxiliary nurses, midwives, odontostomatologists, and dental hygienists). Methods. The multimodal hand hygiene improvement strategy consisted of training of healthcare workers by teaching sessions, implementation of hydroalcoholic solutions, and installation of reminder posters. The hand hygiene compliance level was evaluated by observation during regular care activities in the office visit setting, at the baseline moment, and 6 months after the intervention, all by a single external observer. RESULTS: The overall baseline compliance level was 8.1% (95% confidence interval [CI], 6.2-10.1), and the healthcare workers of the intervention group increased their hand hygiene compliance level by 21.6% (95% CI, 13.83-28.48) compared with the control group. CONCLUSIONS: This study has demonstrated that hand hygiene compliance in primary healthcare workers can be improved with a multimodal hand hygiene improvement strategy.

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BACKGROUND: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. METHODS/DESIGN: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. DISCUSSION: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Validation of diabetes mellitus and hypertension diagnosis in computerized medical records in primary health care.

BACKGROUND: Computerized Clinical Records, which are incorporated in primary health care practice, have great potential for research. In order to use this information, data quality and reliability must be assessed to prevent compromising the validity of the results.The aim of this study is to validate the diagnosis of hypertension and diabetes mellitus in the computerized clinical records of primary health care, taking the diagnosis criteria established in the most prominently used clinical guidelines as the gold standard against which what measure the sensitivity, specificity, and determine the predictive values.The gold standard for diabetes mellitus was the diagnostic criteria established in 2003 American Diabetes Association Consensus Statement for diabetic subjects. The gold standard for hypertension was the diagnostic criteria established in the Joint National Committee published in 2003. METHODS: A cross-sectional multicentre validation study of diabetes mellitus and hypertension diagnoses in computerized clinical records of primary health care was carried out. Diagnostic criteria from the most prominently clinical practice guidelines were considered for standard reference.Sensitivity, specificity, positive and negative predictive values, and global agreement (with kappa index), were calculated. Results were shown overall and stratified by sex and age groups. RESULTS: The agreement for diabetes mellitus with the reference standard as determined by the guideline was almost perfect (κ=0.990), with a sensitivity of 99.53%, a specificity of 99.49%, a positive predictive value of 91.23% and a negative predictive value of 99.98%.Hypertension diagnosis showed substantial agreement with the reference standard as determined by the guideline (κ=0.778), the sensitivity was 85.22%, the specificity 96.95%, the positive predictive value 85.24%, and the negative predictive value was 96.95%. Sensitivity results were worse in patients who also had diabetes and in those aged 70 years or over. CONCLUSIONS: Our results substantiate the validity of using diagnoses of diabetes and hypertension found within the computerized clinical records for epidemiologic studies.

Evaluación del cumplimiento de higiene de las manos en un área de atención primaria de Madrid / Evaluation of hand hygiene compliance in a Primary Health care area of Madrid

Introducción La higiene de las manos (HM) es la medida más eficiente para la prevención de infecciones nosocomiales. Nuestro estudio pretende estimar su cumplimiento en atención primaria. Métodos Estudio transversal en el que se ha recogido información sociodemográfica de 198 profesionales. Se evaluó el cumplimiento de HM según los criterios de la Organización Mundial de la Salud. Resultados El cumplimiento de HM fue del 8,1% (intervalo de confianza al 95%: 6,2–10,1). La experiencia laboral de más de 20 años se asoció significativamente a muy bajos niveles de cumplimiento. Conclusión La atención primaria presenta un cumplimiento de HM excesivamente bajo. Es necesario desarrollar programas formativos que aumenten el cumplimiento así como facilitar el acceso a las soluciones hidroalcohólicas (AU)

Introduction Hand hygiene is the most effective measure for preventing infections related to healthcare. This study aims to evaluate the Hand hygiene compliance in Primary Health Care. Methods A cross-sectional study was carried out, collecting socio-demographic data and the hand hygiene compliance from 198 Primary Health Care workers. Their hand hygiene compliance was evaluated according to WHO criteria. Results The level of hand hygiene compliance was 8.1% (95% CI 6.2–10.1). Employment experience of over 20 years was significantly associated with low levels of compliance .Conclusion Primary Health Care workers have a low hand hygiene compliance. Training programs need to be introduced to increase compliance and facilitate access to hydro-alcoholic solutions (AU)

[Evaluation of hand hygiene compliance in a Primary Health Care area of Madrid]. / Evaluación del cumplimiento de higiene de las manos en un área de atención primaria de Madrid.

INTRODUCTION: Hand hygiene is the most effective measure for preventing infections related to healthcare. This study aims to evaluate the Hand hygiene compliance in Primary Health Care. METHODS: A cross-sectional study was carried out, collecting socio-demographic data and the hand hygiene compliance from 198 Primary Health Care workers. Their hand hygiene compliance was evaluated according to WHO criteria. RESULTS: The level of hand hygiene compliance was 8.1% (95% CI 6.2-10.1). Employment experience of over 20 years was significantly associated with low levels of compliance. CONCLUSION: Primary Health Care workers have a low hand hygiene compliance. Training programs need to be introduced to increase compliance and facilitate access to hydro-alcoholic solutions.

Effectiveness of a training programme to improve hand hygiene compliance in primary healthcare.

BACKGROUND: Hand hygiene is the most effective measure for preventing infections related to healthcare, and its impact on the reduction of these infections is estimated at 50%. Non-compliance has been highlighted in several studies in hospitals, although none have been carried out in primary healthcare. MAIN OBJECTIVE: To evaluated the effect of a "Hand Hygiene for the reduction of healthcare-associated infections" training program for primary healthcare workers, measured by variation from correct hand hygiene compliance, according to regulatory and specific criteria, 6 months after the baseline, in the intervention group (group receiving a training program) and in the control group (a usual clinical practice). SECONDARY OBJECTIVES: -To describe knowledges, attitudes and behaviors as regards hand hygiene among the professionals, and their possible association with "professional burnout", stratifying the results by type of group (intervention and usual clinical practice).-To estimate the logistic regression model that best explains hand hygiene compliance. METHODS/DESIGN: Experimental study of parallel groups, with a control group, and random assignment by Health Center.Area of study.- Health centers in north-eastern Madrid (Spain).Sample studied.- Healthcare workers (physicians, odontostomatologists, pediatricians, nurses, dental hygienists, midwife and nursing auxiliaries).Intervention.- A hand hygiene training program, including a theoretical-practical workshop, provision of alcohol-based solutions and a reminder strategy in the workplace.Other variables: sociodemographic and professional knowledges, attitudes, and behaviors with regard to hand hygiene. STATISTICAL ANALYSIS: descriptive and inferential, using multivariate methods (covariance analysis and logistic regression). DISCUSSION: This study will provide valuable information on the prevalence of hand hygiene non-compliance, and improve healthcare.