Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).

BACKGROUND: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION: Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

Health-care users, key community informants and primary health care workers' views on health, health promotion, health assets and deficits: qualitative study in seven Spanish regions.

BACKGROUND: Although some articles have analysed the definitions of health and health promotion from the perspective of health-care users and health care professionals, no published studies include the simultaneous participation of health-care users, primary health care professionals and key community informants. Understanding the perception of health and health promotion amongst these different stakeholders is crucial for the design and implementation of successful, equitable and sustainable measures that improve the health and wellbeing of populations. Furthermore, the identification of different health assets and deficits by the different informants will generate new evidence to promote healthy behaviours, improve community health and wellbeing and reduce preventable inequalities. The objective of this study is to explore the concept of health and health promotion and to compare health assets and deficits as identified by health-care users, key community informants and primary health care workers with the ultimate purpose to collect the necessary data for the design and implementation of a successful health promotion intervention. METHODS: A descriptive-interpretive qualitative research was conducted with 276 participants from 14 primary care centres of 7 Spanish regions. Theoretical sampling was used for selection. We organized 11 discussion groups and 2 triangular groups with health-care users; 30 semi-structured interviews with key community informants; and 14 discussion groups with primary health care workers. A thematic content analysis was carried out. RESULTS: Health-care users and key community informants agree that health is a complex, broad, multifactorial concept that encompasses several interrelated dimensions (physical, psychological-emotional, social, occupational, intellectual, spiritual and environmental). The three participants' profiles consider health promotion indispensable despite defining it as complex and vague. In fact, most health-care users admit to having implemented some change to promote their health. The most powerful motivators to change lifestyles are having a disease, fear of becoming ill and taking care of oneself to maintain health. Health-care users believe that the main difficulties are associated with the physical, social, working and family environment, as well as lack of determination and motivation. They also highlight the need for more information. In relation to the assets and deficits of the neighbourhood, each group identifies those closer to their role. CONCLUSIONS: Generally, participants showed a holistic and positive concept of health and a more traditional, individual approach to health promotion. We consider therefore crucial to depart from the model of health services that focuses on the individual and the disease toward a socio-ecological health model that substantially increases the participation of health-care users and emphasizes health promotion, wellbeing and community participation.

Beyond the consultation room: Proposals to approach health promotion in primary care according to health-care users, key community informants and primary care centre workers.

BACKGROUND: Primary health care (PHC) is the ideal setting to provide integrated services centred on the person and to implement health promotion (HP) activities. OBJECTIVE: To identify proposals to approach HP in the context of primary care according to health-care users aged 45-75 years, key community informants and primary care centre (PCC) workers. METHODS: Descriptive-interpretive qualitative research with 276 participants from 14 PCC of seven Spanish regions. A theoretical sampling was used for selection. A total of 25 discussion groups, two triangular groups and 30 semi-structured interviews were carried out. A thematic interpretive contents analysis was carried out. RESULTS: Participants consider that HP is not solely a matter for the health sector and they emphasize intersectoral collaboration. They believe that it is important to strengthen community initiatives and to create a healthy social environment that encourages greater responsibility and participation of health-care users in decisions regarding their own health and better management of public services and resources. HP, care in the community and demedicalization should be priorities for PHC. Participants propose organizational changes in the PCC to improve HP. PCC workers are aware that HP falls within the scope of their responsibilities and propose to increase their training, motivation, competences and knowledge of the social environment. Informants emphasize that HP should be person-centred approach and empathic communication. HP activities should be appealing, ludic and of proven effectiveness. CONCLUSIONS: According to a socio-ecological and intersectoral model, PHC services must get actively involved in HP together with community and through outreach interventions.

Evaluating the Implementation of a Multicomponent Intervention Consisting of Education and Feedback on Reducing Benzodiazepine Prescriptions by General Practitioners: BENZORED Hybrid Type I Cluster Randomized Controlled Trial.

BACKGROUND: General practitioners (GPs) in developed countries widely prescribe benzodiazepines (BZDs) for their anxiolytic, hypnotic, and muscle-relaxant effects. Treatment duration, however, is rarely limited, and this results in a significant number of chronic users. Long-term BZD use is associated with cognitive impairment, falls with hip fractures, traffic accidents, and increased mortality. The BENZORED IV trial was a hybrid type-1 trial conducted to evaluate the effectiveness and implementation of an intervention to reduce BZD prescription in primary care. The purpose of this qualitative study was to analyze the facilitators and barriers regarding the implementation of the intervention in primary care settings. METHODS: A qualitative interview study with 40 GPs from three Spanish health districts. Focus group meetings with GPs from the intervention arm of the BENZORED IV trial were held at primary healthcare centers in the three districts. For sampling purposes, the GPs were classified as high or low implementers according to the success of the intervention measured at 12 months. The Consolidated Framework for Implementation Research (CFIR) was used to conduct the meetings and to code, rate, and analyze the data. RESULTS: Three of the 41 CFIR constructs strongly distinguished between high and low implementers: the complexity of the intervention, the individual Stage of Change, and the key stakeholder's engagement. Seven constructs weakly discriminated between the two groups: adaptability in the intervention, external policy and incentives, implementation climate, relative priority, self-efficacy, compatibility, and engaging a formally appointed implementation leader. Fourteen constructs did not discriminate between the two groups, six had insufficient data for evaluation, and eleven had no data for evaluation. CONCLUSIONS: We identified constructs that could explain differences in the efficacy in implementation of the intervention. This information is relevant for the design of successful strategies for implementation of the intervention.