Effectiveness of a multi-component programme for managing depression in primary care: a cluster randomized trial. The INDI project.

BACKGROUND: There are significant shortcomings in the management and clinical outcomes of depressed patients. The objective is to assess the effectiveness of a multi-component programme to improve the management of depression in primary care. METHODS: This is a cluster-randomized controlled trial, conducted between June 2007 and June 2010. Twenty primary care centres were allocated to intervention group or usual care group. The intervention consisted of a multi-component programme with clinical, educational and organizational procedures including primary care nurses working as case-managers. Outcomes were monitored by a blinded interviewer at 0, 3, 6 and 12 months. TRIAL REGISTRATION: ISRCTN16384353, at http://isrctn.org. RESULTS: In total, 338 adult patients with major depression (DSM-IV) were assessed at baseline. At 12 months, 302 patients were assessed, 172 in the intervention group and 130 in the control group. The severity of depression (mean Patient Health Questionnaire-9 score) was 1.76 points lower in the intervention group [7.15 vs. 8.78, 95% CI=-3.53 to 0.02, p=0.053]. The treatment response rate was 15.4% higher in the intervention group than in the controls [66.9% vs. 51.5%, odds ratio 1.9, 95% CI=1.2 to 3.1, p=0.011)], and the remission rate was 13.4% higher [48.8% vs. 35.4%, odds ratio 1.8, 95% CI=1.1 to 2.9, p=0.026)]. LIMITATIONS: Unblinded physicians diagnosed depression in their patients and decided whether to include them in the study, so we cannot discount a hidden selection bias. CONCLUSIONS: The programme for managing depression leads to better clinical outcomes in patients with major depression in primary care settings.

Nutrition education intervention for dependent patients: protocol of a randomized controlled trial.

BACKGROUND: Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions.The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. METHODS/DESIGN: Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0-6-12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin.Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient's nutritional status using the MNA test, diet, anthropometry, and biochemical parameters.Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention.The SPSS/PC program will be used for statistical analysis. DISCUSSION: The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers' education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. TRIAL REGISTRATION NUMBER: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775.

Improving the role of nursing in the treatment of depression in primary care in Spain.

PURPOSE: We describe a multicomponent program for the systematic evaluation and treatment of depression in primary care. CONCLUSION: Primary-care nurses trained in clinical and therapeutic aspects of depression play a central role in care management, patient education, treatment adherence, and clinical monitoring. PRACTICE IMPLICATIONS: Diverse interventions, including organizational changes and the enhancement of the role of nurses, have been effective in improving depression outcomes in primary-care settings.

Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement).

BACKGROUND: Most depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management. DESIGN: A cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression. SETTING: 20 primary care centres in the province of Tarragona (Spain) SAMPLE: 400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV) and who need to initiate antidepressant treatment INTERVENTION: A multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface. MEASUREMENTS: The patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial). These interviews will be given at 0, 3, 6 and 12 months. MAIN VARIABLES: Severity of the depressive symptoms, response rate and remission rate. ANALYSIS: Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster. DISCUSSION: The effectiveness of caring for depression in primary care can be improved by various strategies. The most effective models involve organisational changes and a greater role of nurses. However, these models are almost exclusively from the USA, and this randomized clinical trial will determine if this approach could be effective to improve the outcomes of depression in primary care in the Spanish health care system. TRIAL REGISTRATION: ISRCTN16384353.

Effect of influenza vaccine status on winter mortality in Spanish community-dwelling elderly people during 2002-2005 influenza periods.

This study assessed the relationship between the reception of conventional inactivated influenza vaccine and winter mortality in a prospective cohort that included 11,240 Spanish community-dwelling elderly individuals followed from January 2002 to April 2005. Annual influenza vaccine status was a time-varying condition and primary outcome was all-cause death during study period. Multivariable Cox proportional-hazard models adjusted by age, sex and co-morbidity were used to evaluate vaccine effectiveness. Influenza vaccination was associated with a significant reduction of 23% in winter mortality risk during overall influenza periods. The attributable mortality risk in non-vaccinated people was 24 deaths per 100,000 persons-week within influenza periods, the prevented fraction for the population was 14%, and one death was prevented for every 239 annual vaccinations (ranging from 144 in Winter 2005 to 1748 in Winter 2002).