BackgroundThere is a lack of evidence concerning the effectiveness of different strategies to engage healthcare professionals in collaborative processes that seek to optimise clinical practice. The PREDIAPS project aims to assess the effect of different primary health care (PHC) providers’ engagement procedures in the creation and execution of a facilitated interprofessional collaborative process to optimise the integration of the recommended clinical practice for the prevention of type-2 diabetes (T2D) in routine PHC.MethodsThis will be a randomised cluster type II hybrid implementation trial. Nine PHC centres from the Basque Health Service (Osakidetza) will be allocated to two different procedures to engage family doctors and nurses and create an interprofessional collaborative practice to optimise the integration of a T2D primary prevention programme. All centres and PHC professionals will receive training on current guidelines in primary prevention of T2D and effective interventions to promote healthy lifestyles. Headed by a local leader and an external facilitator, centres will conduct a collaborative structured process to model and adapt the intervention and its implementation to the specific context of professionals and centres. One of the groups will apply this strategy globally, promoting the cooperation of all health professionals from the beginning. The other will perform it sequentially, centred first on nurses, who will then seek the pragmatic cooperation of doctors. All patients without diabetes aged ≥ 30 years old who attend collaborating centres at least once during the study period and found to be at high risk of developing T2D will be eligible for programme inclusion. The main outcome measures focus on changes observed in indicators of T2D prevention clinical practice at centre level after 12 and 24 months, associated with the application of one or other engagement procedure. Secondary outcomes will compare their clinical effectiveness in changing eligible exposed patients’ main lifestyle behaviours and risk factors (physical activity and diet, weight, etc.) after 12 months.DiscussionThe PREDIAPS project will generate scientific knowledge on procedures for engaging PHC professional to facilitate feasible and effective adoption of proven interventions for the prevention of T2D in routine clinical practice through the application of implementation strategies.Trial registrationClinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017.
Women have the same social and family networks needs, regardless of cultural differences between Anglo-Saxon and Southern European countries. We recommend an perinatal education to empower women to manage their own health and that of their family and link the health system with other networks of personal and social support for women.
BackgroundThe ‘predictD algorithm’ provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression.Methods/DesignThis is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system.DiscussionTo our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations.Trial registrationClinicalTrials.gov identifier: NCT01151982
BackgroundAntenatal education needs to be renewed and adapted to the needs of women. Objectives: to assess women needs, identify factors that influence the desired outcomes, and propose a framework for developing new perinatal education based on the guidance published by the UK Medical Research Council for the development and evaluation of complex interventions in primary care.MethodsFor this study: (a) four focus group sessions were held from October to November 2010 in Bizkaia (Spain) with 30 women exploring their needs during pregnancy and postpartum; (b) two literature reviews were conducted on women’s needs at these times and theoretical models of healthcare education; and (c) seven discussion and consensus sessions were run with a group of experts composed of midwifes, gynaecologists, paediatricians, and paediatric and postpartum nurses.ResultsVarious areas for improvement were identified: needs assessment of each woman/family, consideration of pregnancy and childbirth as normal physiological processes, participation of fathers, establishment of social networks, continuity of postpartum care, better access to and training for midwives, and more flexible format and contents for the programme. We propose a woman-focused framework that includes three exploratory interviews during pregnancy, personalized interventions coordinated between professionals, empowerment to choose the type of birth, and postpartum activities.ConclusionNew perinatal education should be on-going and focused on each woman. It is necessary to assess the feasibility of implementing this type of programme, depending on the context, professionals’ readiness for change and characteristics of the proposed interventions. Then, its effectiveness and sustainability must be assessed.
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