Modelling innovative interventions for optimising healthy lifestyle promotion in primary health care Prescribe Vida Saludable phase I research protocol

Modelling innovative interventions for optimising healthy lifestyle promotion in primary health care Prescribe Vida Saludable phase I research protocol BioMedCentral BMC Health Services Research Study protocol Modelling innovative interventions for optimising healthy lifestyle promotion in primary health care: "Prescribe Vida Saludable" phase I research protocol Alvaro Sanchez*1, Gonzalo Grandes1, Josep M Cortada2, Haizea Pombo1, Laura Balague3 and Carlos Calderon4 Address: 1Primary Care Research Unit of Bizkaia, Basque Health Service (Osakidetza), Bilbao, Spain, 2Deusto Health Centre, Basque Health Service (Osakidetza), Bilbao, Spain, 3Renteria Health Centre, Basque Health Service (Osakidetza), Renteria, Spain and 4Alza Health Centre, Basque Health Service (Osakidetza), Donostia-San Sebastian, Spain Email: Alvaro Sanchez* - alvaro.sanchez@osakidetza.net; Gonzalo Grandes - gonzalo.grandes@osakidetza.net; Josep M Cortada - nuriacortada@telefonica.net; Haizea Pombo - haizea.pomboramos@osakidetza.net; Laura Balague - laura.balaguegea@osakidetza.net; Carlos Calderon - carlos.calderongomez@osakidetza.net * Corresponding author Published: 18 June 2009 Received: 5 May 2009 Accepted: 18 June 2009 BMC Health Services Research 2009, 9:103 doi:10.1186/1472-6963-9-103 This article is available from: ? 2009 Sanchez et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: The adoption of a healthy lifestyle, including physical activity, a balanced diet, a moderate alcohol consumption and abstinence from smoking, are associated with large decreases in the incidence and mortality rates for the most common chronic diseases. That is why primary health care (PHC) services are trying, so far with less success than desirable, to promote healthy lifestyles among patients. The objective of this study is to design and model, under a participative collaboration framework between clinicians and researchers, interventions that are feasible and sustainable for the promotion of healthy lifestyles in PHC. Methods and design: Phase I formative research and a quasi-experimental evaluation of the modelling and planning process will be undertaken in eight primary care centres (PCCs) of the Basque Health Service – OSAKIDETZA, of which four centres will be assigned for convenience to the Intervention Group (the others being Controls). Twelve structured study, discussion and consensus sessions supported by reviews of the literature and relevant documents, will be undertaken throughout 12 months. The first four sessions, including a descriptive strategic needs assessment, will lead to the prioritisation of a health promotion aim in each centre. In the remaining eight sessions, collaborative design of intervention strategies, on the basis of a planning process and pilot trials, will be carried out. The impact of the formative process on the practice of healthy lifestyle promotion, attitude towards health promotion and other factors associated with the optimisation of preventive clinical practice will be assessed, through pre- and post-programme evaluations and comparisons of the indicators measured in professionals from the centres assigned to the Intervention or Control Groups. Discussion: There are four necessary factors for the outcome to be successful and result in important changes: (1) the commitment of professional and community partners who are involved; (2) their competence for change; (3) the active cooperation and participation of the interdisciplinary partners involved throughout the process of change; and (4) the availability of resources necessary to facilitate the change. Page 1 of 10 (page number not for citation purposes) BMC Health Services Research 2009, 9:103 The improvement of preventive clinical practice involves Background Although it is well known that the most common chronic the transferring and dissemination of effective and effi- diseases are caused by unhealthy behaviours such as cient interventions to real-world clinical conditions [21]. smoking and drinking alcohol, a sedentary lifestyle and The failure to date in translating identified effective clini- an unbalanced diet; in spite of primary health care (PHC) cal interventions into routine practice represents the gap services having many opportunities to intervene in those between what is avoidable or preventable via these inter- lifestyles; and despite the fact that its professionals are ventions and what is achieved in practice. Several types of convinced that healthy lifestyle promotion by health serv- quality improvement interventions have been developed ices has a potential impact that few other interventions with the objective of reducing this gap. In general, what could match; the truth is that healthy lifestyle promotion has been recommended is the use of multifaceted inter- is far from being an integrated element of clinical practice ventions that include several strategies such audits and in PHC [1]. The two main reasons for this are: a) insuffi- feedback, external facilitators, evidence-based educational cient evidence of the effect of interventions and active meetings with active participation and knowledge man- components on multiple risk behaviours [2,3]; and b) the agement. Specifically, in the area of optimisation of pre- difficulties in changing existing practice to include inno- vention services, efficient registration and reminding vative interventions under real-world conditions [4,5]. systems, a revision of professionals' roles, nursing-based programmes, the creation of multidisciplinary teams, To date, interventions on lifestyle modification in PHC integrated care services and collaboration with commu- nity resources, have shown positive results [22-34]. have shown mixed results [2,3]. There is solid evidence proving the effectiveness of brief advice given in PHC in achieving smoking cessation and reductions in alcohol However, the evidence on translation of effective preven- consumption [6-8]. In the case of physical activity, general tive interventions, strategies and programmes is at present advice has little effects, while, medical guidance in the insufficient or not conclusive [35]. On the one hand, the form of a written prescription for physical activity results effectiveness of the majority of these strategies is low or in small or moderate changes even in the long term moderate with a high variation in the degree of change [9,10]. However, concerning diet and the simultaneous achieved. On the other hand, interventions that have had approach of several behavioural risk factors, there is still some success are not easily incorporable to the real-world insufficient evidence on the effectiveness of the advice context of health centres [36]. This is why it has been rec- given in PHC [11-13]. Even for those lifestyles for which ommended that interventions for the optimisation of pre- there is evidence of effectiveness, it is not clear which are ventive clinical practice should be adapted to the real the effective components of the interventions, and there is context of each centre and health system: to their needs, high heterogeneity across the results obtained depending characteristics and identified barriers [37-39]. In line with on the context and the way in which the interventions are this, recent models concerning translation of evidence implemented [3]. into practice propose the optimisation of clinical practice through research [40-42]. Under this framework, research Changing people's lifestyles is not easy, because their should be used to optimise practice instead of using the practice context to attempt to demonstrate the relevance behaviour is determined by many personal, institutional and environmental factors, which operate and interact at of previous studies. Interventions should be designed in individual, interpersonal and community levels [14]. the same context in which they are going to be executed, with the active participation of the principle players [41]. Consequently, there is a growing recognition of the need to base lifestyle change interventions on relevant behav- iour change theories and to follow a suitable process link- There are many challenges in the design, evaluation and ing intervention techniques and strategies with this transfer of healthy lifestyle promotion to the clinical con- theory. This, as well as producing more effective interven- text, mainly due to the complexity of the interventions tions, should make it possible to identify which factors [43-45]. They are composed of a large number of elements work, how they work and why [15]. Classical planning and are focussed on a variety of interrelated levels: the models such as Precede-Proceed [16] or more modern patient as an individual, health professionals and the ones such as Intervention Mapping and Causal Modelling organisation that offers health services to the community, [17,18], as well as consensus techniques and constructs of in a context that is characterised by work overload and behaviour change [19] and guidelines such as those of lack of time. In 2000, the Medical Research Council NICE concerning the development of behaviour change (MRC) of the United Kingdom defined a theoretical and interventions [20], could facilitate this process of map- methodological framework for the design and evaluation ping and evaluation of theories and effective techniques. of this type of complex interventions in the clinical con- text [43]. This framework, updated in 2008 [45], uses simultaneously qualitative and quantitative techniques, Page 2 of 10 (page number not for citation purposes) BMC Health Services Research 2009, 9:103 , similar to those of sumption of alcoholic drinks), which are hypothetically clinical drug research, that could be executed in a sequen- effective, feasible and sustainable in routine PHC. tial or iterative manner: a) preclinical or theoretical phase: 2) To evaluate the changes associated with the planning establishment of theoretical fundamentals and identifica- tion of the active components in the evidence base; b) process in the actual healthy lifestyle promotion practice phase I or modelling phase: definition of intervention of PHC professionals, attitudes towards prevention and components, identification of potential barriers to change health promotion, and factors associated with the optimi- and of the mechanisms through which interventions sation of such clinical practice. should operate; c) phase II or exploratory trial: evaluation Design of the feasibility and optimisation of the intervention through the execution of quasi-experimental studies; d) A phase I formative research [43] will be performed in phase III or definitive randomised controlled trial, to ena- four PHC centres of the Basque Health Service – OSAKI- ble the controlled experimental evaluation of the inter- DETZA. In a first descriptive stage, a strategic needs assess- vention; e) phase IV or long term implementation phase ment will be carried out along with the prioritisation of under real-world conditions. To date, there have been sev- the areas of preventive practice to be optimised and selec- eral projects that have successfully applied the MRC tion of the aims of the programmes. In a second, creative framework for the design and evaluation of complex stage, specific objectives of intervention will be identified interventions [45]. The conclusions of these studies agree based on theoretical models of behaviour change and col- on the usefulness of the MRC framework as a tool for the laborative design of specific intervention actions for researchers in the designing, planning and evaluation of addressing and managing multiple risk behaviours will be innovative interventions to improve health. undertaken. In 2006, in order to tackle the problem of integrating Within the formative research, a quasi-experimental pre- health promotion into PHC, the Primary Care Research post evaluation study will be performed to compare the Unit of the Basque Health Service set up a multidiscipli- changes in indicators related to health promotion practice nary team of 12 health professionals: family doctors, pae- in the four PCCs assigned to the aforementioned forma- diatricians and nurses in PHC, specialists in preventive tive research process (Intervention Group) and those of medicine, public health, health education, epidemiolo- other four centres, matched in structural and population gists, psychologists and sociologists. Between 2006 and characteristics (Control group) [46]. Additionally, Nomi- 2007, this group undertook a first preclinical research nal Groups will be performed with professionals belong- phase on usefulness of various theoretical models and ing to intervention centres, in order to identify the intervention strategies for health behaviour change (sed- successes, strengths, weaknesses and shortcomings of the entary lifestyle, diet, smoking, alcohol), and identified process, as well as experiences concerning its usefulness, factors that make their integration in PHC difficult [1]. In and difficulties and barriers with respect to the coopera- line with the conclusions of this work, the objective of the tion between researchers and clinicians and between pro- research protocol reported here is the modelling and plan- fessions within the centres. ning of interventions which are hypothetically feasible and effective for healthy lifestyle promotion in PHC, fol- The project was approved by the Institutional Primary lowing four fundamental principles: (1) cooperation Care Research Committee of the Basque Health Service/ between primary care professionals, community partners Osakidetza, on 12th April 2007, by the Basque Country and researchers, from the design stage; (2) reorganisation Clinical Research Ethics Committee (Ref: 06/2008), and of the PCCs in order to facilitate the incorporation of evaluated and approved for funding by the Basque Gov- health promotion; (3) adoption of a socio-ecological ernment Department of Health (Ref: 2007111009). model, in which the health service plays an important role, complementary to that of other sectors and non- Participants health resources; and (4) use of an appropriate methodo- Eligibility criteria logical framework for the design and evaluation of com- The particular focus of this study, which aims to introduce plex interventions [1]. a process of change in health promotion practice in PHC under a framework of participative research with health professionals, community partners and researchers, deter- Methods mines the two characteristics that define the participants: Objectives 1) To design innovative programmes for promoting at (1) the intervention unit is the PCC; and (2) the centre least two healthy lifestyle behaviours (physical activity, must be especially interested in health promotion. The balanced diet, giving up smoking or the moderate con- creative work to be undertaken requires that the profes- sionals and health centres be positively motivated with Page 3 of 10 (page number not for citation purposes) BMC Health Services Research 2009, 9:103 : (1) previous history total of 30 community resources or agents were contacted, of participation or evaluation of programmes for health of which finally 18 agreed to collaborate, belonging to fol- promotion in the last 10 years, (2) previous initiatives of lowing fields: company doctors (2), citizen associations preventive practice optimisation and the promotion of (4), professionals from the educational sphere (4), from healthy lifestyles, (3) existence of programmes, resources, municipal organisations (6) and from sports centres or services or initiatives for health promotion in the commu- facilities (2). (Figure 1). nity or geographical area of reference, (4) positive attitude to working together and cooperation between the profes- Formative Research sionals of the centre, (5) centres in which it would be pos- It will entail the realisation of 12 sessions directed by sible to make some kinds of changes in the organisation external facilitators and fed with selected information of services, once the potential innovative strategies for (reviews of scientific evidence, selected published litera- approaching multiple risk behaviours have been deter- ture, etc.) depending on the objective of each session [see mined. The commitment of cooperation by a majority Additional File 1]. These sessions respond to different plus one of all the professionals of the centre for each of strategies for the optimisation of clinical practice: needs the professions (administrative officers, nurses, family assessment based on audit and feedback, prioritisation of doctors, paediatricians and others) was required to partic- areas of improvement using consensus techniques, evi- ipate in the project. dence-based education sessions, and participatory model- ling of interventions, by mapping and piloting of Recruitment process of the Health Centres and PHC professionals intervention components. The sessions will have a dura- The identification of the eligible centres was performed tion of approximately 90 minutes each and will be per- via the Medical Directors of the seven divisions of primary formed at intervals of at least 3 weeks, over the course of care services, under which the PHC of the Basque Health 12 months. In each centre, a coordinator will be identified Service – OSAKIDETZA is organised. Four of them to perform the necessary organisational tasks and they accepted to collaborate and they each selected two pri- will be person responsible for communication with the mary care centres with similar structural and population research team. Before each session, they will be given and characteristics. Project presentation sessions were given to will distribute to the rest of professionals a summary of the professionals of the selected centres, in which mem- the previous session and the objectives of the present one, bers of the research group explained the scientific and as well as selected documentation and support materials. methodological details of the project, and the work plan. After the execution of the sessions, synthesis documents Then, each of the professionals were invited to collaborate summarising the process undertaken, the content of the through the presentation of an informed consent form. discussions, and the results achieved, will be produced. In The majority of the professionals of each profession order to guarantee the accuracy of summaries, a circula- agreed to collaborate in eight of the centres; four of them tion system of these synthesis documents between collab- being assigned for convenience to the formative research orating professionals will be implemented, to allow process, and the other four forming the reference or Con- verification of the validity or to effect clarifications and trol Group. Finally, 130 professionals (82 in the Interven- changes in the content, results and conclusions obtained. tion Group and 48 in the Control Group), collaborated in The 12 sessions will be organised in two stages: a descrip- the project: 46 family doctors (29 in the Intervention and tive one (the first 4) and a creative one (the remaining 8) 17 in the Control), 45 nurses (26 in the Intervention and [see Additional File 1]. 19 in the Control), 27 administrative officers (18 in the Intervention and 9 in the Control), 10 paediatricians (8 in Descriptive Stage the Intervention and 2 in the Control), 3 midwives (2 in In order to prioritise areas for optimisation in healthy life- the Intervention and 1 in the Control group) and 1 social style promotion taking into account the real-world con- worker (Fig 1). text of the participating health centres, a process of strategic needs assessment will be carried out followed by Recruitment process of community partners a process for reaching consensus. The needs assessment in The professionals belonging to centres assigned to the each centre will be based on two sources of information. realisation of the formative process (Intervention Group), On the one hand, a transversal descriptive study of the were asked to identify partners and resources in their com- actual practice, skills, knowledge, perceived barriers and munity related to the promotion of healthy lifestyles. An resources in relation to healthy lifestyle promotion by initial list of resources and community partners for each health centre professionals. On the other hand, data anal- health centre was drawn up. The members of the research ysis will be performed on the prevalence of risk behav- Page 4 of 10 (page number not for citation purposes) BMC Health Services Research 2009, 9:103 Community School City council Matiena HC GP: 4 Citizen Nur: 5 Association Ped: 1 Sport Centre AS: 1 Community Community City Research Beasain HC La Merced council GP: 10 HC Unit GP, Nur, Epi, Company Nur: 11 GP: 5 Soc, Psi Ped: 1 Nur: 5 Doctors School AS: 6 Ped: 1 AS: 3 Citizen Associations Leioa HC GP: 10 Sport Citizen Nur: 7 Centre Association Ped: 4 AS: 7 City School council Community Figure 1 Operational organization of the formative process "Prescribe Vida Saludable" in the intervention centres. Note: HC, Health Centre; GP, General Practitioner; Nur, Nurse; Ped, Paediatrician; AS, Administrative Staff; Epi, Epidemiolo- gist; Soc, Sociologist; Psi, Psychologist. Participation in Control health centres, Beraun HC: GP (5), Nur (4), Ped (1), AS (2), Social worker (1); Markina HC: GP (5), Nur (5), AS (3); Berango HC: GP (2), Nur (2), Ped (1), AS (1); and Zurbaran HC: GP (5), Nur (8), AS (3). iours in the population and reception of preventive of proposals by each of the professionals of the centre and practice as reported by the users at the level of the health community partners involved, the prioritised selection of region of each collaborating centre, the information being one area of optimisation will be undertaken through two taken from the Health Surveys of the Basque Autonomous rounds of evaluation of the proposals on the basis of four Region in 2002 and 2007 [47,48]. The results of the needs dimensions: the magnitude of the problem, significance assessment will be presented and discussed with the pro- or potential impact, vulnerability and feasibility, follow- fessionals and the community partners of each centre to ing the method proposed by Hanlon [50]. The area prior- gather their opinions concerning the presented indicators, itised for optimisation in each centre will be the goal for the strengths, weaknesses, opportunities and threats for healthy lifestyle promotion, the object of the creative the centre and community, and possible areas for optimi- stage for the design and modelling of feasible and sustain- sation. able interventions. Subsequently a process for reaching consensus will be per- Creative stage formed to identify and prioritise areas for optimisation in In a second stage, we will proceed to the design and par- healthy lifestyle promotion focused on at least two risk ticipative modelling of innovative interventions for behaviours with high prevalence or high priority in a spe- addressing and managing multiple risk behaviours that cific target population. For this, the Nominal Group tech- could feasibly be implemented in a sustainable way in the nique [49] will be used in which, after the identification real context of PHC. For this, two communication ses- Page 5 of 10 (page number not for citation purposes) BMC Health Services Research 2009, 9:103 , in order to tion will be organised, supported by selected optimise their potential impact and sustainable integra- documentation derived from the reviews of the scientific tion. With respect to these intervention strategies and literature undertaken in the preclinical phase [51]. The actions, the key components and processes will be identi- sessions will have the following content: a) theoretical fied. Barriers and resources in relation to the context of models of healthy lifestyle modification; and b) evidence each centre (personal, material or organisational) that of effective intervention strategies, in which effective mod- make it easy or difficult to set the process of implementa- els and strategies for addressing and managing risk behav- tion in motion, and necessary changes and readjustments iours in PHC will be described. will also be identified. On the basis of the theoretical models and intervention On the basis of the feasibility evaluation regarding inter- strategies described in the aforementioned sessions, pro- vention actions and implementation strategies, and from fessionals of the centre will perform an analysis prior to the overall conclusions of the formative process under- the programme planning to identify the potential specific taken in each centre, a final selection and standardisation objectives – personal, interpersonal and environmental of the following intervention programme components factors that should be worked on to begin and maintain will be implemented: a) operational objectives of the pro- the process of behavioural and environmental change – as gramme; b) target population for the intervention (criteria well as potential concrete intervention actions – strategies for eligibility and exclusion) and mechanisms for address- or measures intended to modify these aforementioned ing them; c) personal factors and characteristics (socio- specific objectives or key factors [16-18]. demographic, biological, health status, risk status, life- style, beliefs and attitudes, family, etc.) essential to evalu- The proposal presented by the professionals concerning ate in order to adapt and guide the process and content of the specific intervention objectives and strategies will be the intervention; d) key components of the intervention: analysed, reworked, and completed by the members of strategies or processes; personnel involved; material or the research team. Afterwards, with the objective of con- organisational resources needed, with respect to the con- cluding the prior analysis of the programme, the profes- text of each centre; combination of these components; sionals of the centre and community partners will proceed and intensity of the intervention. to the determination of potential strategies for translating and sustainably introducing the plan to the real-world Comparison Groups conditions of the centre and the community. For this, the The professionals of the participating centres who have professionals of the centre and community partners been included in the Control Group will maintain the potentially involved in each intervention action will be usual standard care for healthy lifestyle promotion in the identified, as well as the necessary resources and the Basque Health Service – OSAKIDETZA and will not be the sequence of implementation of intervention: WHICH object of any formative process or intervention. action is to be undertaken by WHOM, HOW, WHEN and WHERE. To facilitate this exercise, the members of the Evaluation research team will produce selected documentation con- The primary outcome measure for the evaluation of the cerning action-research initiatives at an international level impact of the formative process will be the professionals' related to programmes for addressing risk behaviours in a self-reported healthy lifestyle promotion practice, clinical context, with the objective of serving as an exam- assessed through an updated version of the Preventive ple or suggesting new ways of translating research into Activities Questionnaire [52]. This same instrument will be practice, and of introducing and coordinating interven- used to assess the following factors associated to healthy tion strategies and actions. lifestyles promotion: attitude towards the promotion of healthy lifestyles, perceived barriers, knowledge, skills The essential active components of the preliminary pro- and confidence for addressing healthy lifestyles. Addition- gramme for healthy lifestyles promotion will be progres- ally, the organizational climate in the health centre will be sively piloted in the real-world conditions of the health assessed using a translated and culturally adapted version centres for a period of between one and three months. For of the Survey of Organizational Attributes for Primary Care this, the professionals of the centre will select intervention (SOAPC) [53]. objectives and actions to pilot on the basis of their impor- tance in the process of behavioural change, their innova- The Preventive Activities Questionnaire [52] was originally tive nature or uncertainty over their true feasibility. Then, developed in the framework of a research project whose pilot loops along with their associated evaluation sessions objective was to estimate how frequently preventive activ- will be undertaken. Subsequently, a structured group dis- ities recommended by the main consensus groups were cussion session will be organised to analyse the real feasi- put into practice in the PCCs of the Autonomous Region Page 6 of 10 (page number not for citation purposes) BMC Health Services Research 2009, 9:103 ; 4) resources for healthy life- naire, a panel of five experts in health promotion was style promotion in the consulting room/PCC; and 5) per- assembled from PHC professionals (family doctors and ceived barriers to health promotion. The translated and nursing personnel), epidemiologists, psychologists and culturally adapted version of the SOAPC comprises 19 sociologists. The expert panel revised the original ques- items which measure 5 relevant organisational factors: 1) tionnaire and suggested changes and new questions on communication: ability of the professional to work in a the basis of: 1) previous experience in application of the team when problems and differences arise; 2) practice- tool, for which the authors of the questionnaire were wide decision-making: participation of the professionals interviewed; 2) the results of the previous formative of the centre in decision-making; 3) nurses' participation research (preclinical phase) regarding the integration of in decision making: participation specifically of the nurs- healthy lifestyle promotion in PHC [1]; and 3) a rapid ing staff in decision-making; 4) stress/chaos: workload of review of tools for assessing preventive practices in the the professionals of the centre; and 5) history of change: context of PHC. The research team drew up a first version history of organisational changes and/or culture within of the questionnaire which was then submitted to the the centre. expert panel. They were asked to evaluate: the content validity, that is, whether the items within the question- The indicators related to the formative programme plan- naire were capable of evaluating all the dimensions ning process to be evaluated are based on the RE-AIM intended to be measured; the logical order of the ques- model: a) Reach: percentage of participating centres, pro- tions and the sections; their grammatical quality; and the fessionals and partners (among the eligible ones), and adequacy of the scales for each item punctuation. The their representativeness; b) Efficacy and evaluation of the questionnaire was reedited according to the contributions experience: impact of the formative process on healthy given by the expert panel. lifestyle promotion practice of the participating profes- sionals and their perception concerning the usefulness of For the evaluation of the centre as an organisation and, in the formative process and its results; c) Adoption and particular, the perception of the professionals of the implementation: degree of execution of the components organisational climate, a translated and culturally adapted of the formative process as planned: number and duration version of the SOAPC [53] will be used. A structured proc- of the sessions, number of participants in each session, ess of translation and back-translation of the original ver- etc.; d) Maintenance and monitoring: degree of continua- sion of the questionnaire was performed by two bilingual tion of the formative process components and changes researchers independently. This process yielded two trans- made; percentage of participants leaving the study, their lated versions that were quantitatively evaluated by each representativeness and impact on the Reach, Adoption of the members of the expert panel independently. Each and Efficacy of the formative process [54]. member had to judge the two versions on whether con- Analysis cepts expressed were equivalent, their clarity and the nat- uralness of the style of the writing. Subsequently a In order to evaluate the changes associated with the form- consensus meeting was used to reach agreement on a ative process, quantitative comparisons will be performed unique new version of the questionnaire, which was sub- between the professionals assigned to the Intervention sequently discussed with the authors of the original ques- Group and those from the Control Group, on an inten- tionnaire. tion to treat basis. The means of continuous variables will be compared using the Student's t test and the propor- A piloting of the two questionnaires was undertaken with tions using the Chi-square test. The differences between 21 professionals of the most representative professions of the two groups will be estimated and the 95% confidence the health centre (4 administrative officers, 10 nurses and interval calculated. The comparisons will be adjusted for 7 doctors). After the pilot trial, to obtain the final version, potential confounding factors by stratified analysis. the questionnaire was again submitted to evaluation by Finally, multivariate statistical models, linear for continu- the expert panel, and after the analysis, some questions ous variables and logistic for proportions, will be con- were rewritten and some others removed, for not return- structed in order to simultaneously account for possible ing relevant information. confounding effects, following a "forward strategy" guided by the aforementioned stratified analysis. The The updated version of the Preventive Activities Question- sample size of the present formative research study (130 naire (UIAPB) is divided into 7 sections. It consists of 120 health professionals, 30% in the control group) will pro- items and investigates the following dimensions: 1) atti- vide a greater than 80% power to detect as significant tude towards healthy lifestyle promotion in PHC; 2) cur- (alpha = 0.05) a difference of at least 20% (improvements rent self-reported practice of healthy lifestyle promotion; of 5% and 25% in the control and intervention groups, respectively) in the proportion of professionals that report 3) knowledge, skills and perceived effectiveness in Page 7 of 10 (page number not for citation purposes) BMC Health Services Research 2009, 9:103 ' contributions of their patients. GG and AS conceived the idea and are the study guaran- tors. They are primarily responsible for the study design and planning, obtained funding, will be responsible of Discussion This project tackles one of the most difficult challenges for project coordination and supervision, analysis and inter- the primary care services: changing the practice of heath pretation of results and manuscript preparation. JMC and promotion. Scientific literature about the change and the HP collaborated in the study design, obtained funding, optimisation of clinical practice agrees on highlighting and will be responsible for study coordination, interpreta- four factors that are important and necessary in achieving tion of results and manuscript preparation. LB and CC will be responsible for the analysis of results of the discus- this change: (1) the commitment of the professionals and partners involved; (2) their competence for change, such sion groups and critically reviewed the manuscript. All as new knowledge and analytical skills; (3) the active and contributors approved this version submitted for publica- tion to the BMC Health Services Research. participative cooperation of the interdisciplinary partners involved throughout the process of change; and (4) the necessary resources to facilitate this change [55-58]. Additional material The first two factors, commitment and competence, are Additional file 1 essential but not sufficient. The descriptive stage of the Table S1 – Operational design of the formative process for interven- present project as well as sessions 5 to 7 of the creative tion modelling and planning. Structured representation of the sessions stage, are directed towards those two factors. It includes that compose the "Prescribe Vida Saludable" formative process. the reflection induced by the study and discussion ses- Click here for file [] tion compared to the evaluation of current practice, the prioritisation of needs, the selection of a common aim for the whole centre, dissemination of the evidence-based knowledge, etc. In addition, the specific context, with Acknowledgements respect to the resources available and potential barriers for The project was supported by the Basque Government Health Department each centre in particular and for the health system in gen- (EXP: 2007111009) and by the Carlos III Institute of Health of the Spanish eral, is being taken into account, as recommended by the Ministry of Health, and co-financed by European Union FEDER funds (RET- experts. ICS G03/170 and RD06/0018/0018). We think that the most serious threats to the current References project are failing to maintain the active cooperation of 1. 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