Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.

BACKGROUND: Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. METHODS: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. DISCUSSION: EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

[Profile and evolution of chronic complex patients in a subacute unit]. / Perfil y evolución de pacientes crónicos complejos en una unidad de subagudos.

OBJECTIVE: To improve the management of geriatric pluripathologic patients in Catalonia, the identification of chronic complex patient (PCC) or patients with advanced chronic disease (MACA) has been promoted. Patients with exacerbated chronic diseases are promoted to be admitted in subacute units (SG) located in intermediate hospitals and specialized in geriatric care, as an alternative to acute hospital. The results of the care process in patients identified as PCC/MACA in SG have not been evaluated. DESIGN: Descriptive-comparative, cross-sectional, and quantitative study. LOCATION: SG located in intermediate care hospital. PARTICIPANTS: Consecutive patients admitted in the SG during 6months. MAIN MEASUREMENTS: We compared baseline characteristics (demographic, clinical and geriatric assessment data), results at discharge and 30days post-discharge between PCC/MACA patients versus other patients. RESULTS: Of 244 patients (mean age±SD=85,6±7,5; 65.6%women), 91 (37,3%) were PCC/MACA (PCC=79,1%, MACA=20,9%). These, compared with unidentified patients, had greater comorbidity (Charlson index=3,2±1,8 vs 2,0; p=0,001) and polypharmacy (9,5±3,7 drugs vs 8,1±3,8; p=0,009). At discharge, the return to usual residence and mortality were comparable. PCC/MACA had higher mortality adding the mortality at 30day post-discharge (15,4% vs 8%; p=0,010). In a multi-variable analysis, PCC/MACA identification (p=0,006), as well as a history of dementia (p=0,004), was associated with mortality. Although PCC/MACA patients had higher readmission rate at 30day (18,7% vs 10,5%; p=0,014), in the multivariable analyses, only male, polypharmacy, and heart failure were independently associated to readmission. CONCLUSIONS: Despite having more comorbidity and polypharmacy, the outcomes of patients identified as PCC/MACA at discharge of SG, were comparable with other patients, although they experienced more readmissions within 30days, possibly due to comorbidity and polypharmacy.

Opportunistic screening for atrial fibrillation versus detecting symptomatic patients aged 65 years and older: A cluster-controlled clinical trial. / Cribado oportunista de fibrilación auricular frente a detección de pacientes sintomáticos de 65 años o más: ensayo clínico controlado por clúster.

OBJECTIVE: The goal of this study was to assess the effectiveness of opportunistic screening through pulse palpation in the early detection of atrial fibrillation in subjects aged≥65 years versus detection through an active search for patients with symptoms and/or complications and sequelae associated. MATERIAL AND METHODS: This was a cluster randomized controlled trial performed in 48 primary care centers of the Spanish National Healthcare System. A total of 368 physicians and nurses were randomized. The researchers in the experimental group (EG) performed opportunistic screening for auricular fibrillation, whereas the researchers in the control group (CG) actively searched for symptomatic patients. An ECG was performed on patients found to have an irregular heartbeat to confirm the diagnosis of auricular fibrillation. RESULTS: A total of 5,465 patients with a mean age of 75.61 years were recruited for the EG, and 1,525 patients with a mean age of 74.07 years were recruited for the CG. Of these, 58.6% were female, without significant differences between groups. Pulse was irregular in 4.3 and 15.0% of the patients in the EG and the CG, respectively (P<.001). A total of 164 new cases of atrial fibrillation were detected (2.3%), 1.1% in the EG and 6.7% in the CG (adjusted OR: 0.29; 95% CI 0.18-0.45). CONCLUSIONS: Case finding for atrial fibrillation in patients aged≥65 years with symptoms or signs suggestive of atrial fibrillation is a more effective strategy than opportunistic screening through pulse palpation in asymptomatic patients. TRIAL REGISTRATION: The trial is registered in ClinicalTrials.gov (NCT01291953; February 8, 2011).

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

BACKGROUND: Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. METHODS/DESIGN: An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). DISCUSSION: If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. TRIAL REGISTRATION: The study is registered as NCT01291953 (ClinicalTrials.gob).