Open access Research BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and health professionals: EIRA study (phase II) Mariona Pons-Vigués, 1,2,3 Anna Berenguera, 1,2 Núria Coma-Auli,1 Sebastià March,4 Haizea Pombo,5 Barbara Masluk,6 Montserrat Pulido-Fuentes,7 Carmela Rodriguez,8 Juan A Bellón,9,10 Enriqueta Pujol-Ribera1,2,3 To cite: Pons-Vigués M, Abstract Berenguera A, Coma-Auli N, Strengths and limitations of this study Objective To evaluate the implementation and development et al. Qualitative evaluation of a complex intervention on health promotion and changes of a complex intervention to ►► The sampling method of the qualitative evaluation in health-promoting behaviours in primary healthcare implement health promotion might only have captured the experiences and views according to healthcare attendees and health professionals. activities according to of the professionals and attendees more involved healthcare attendees and Design Descriptive qualitative evaluation research and positive with regard to the intervention and to health professionals: EIRA conducted with 94 informants. Data collection techniques health promotion. study (phase II). BMJ Open consisted of 14 semistructured individual interviews, 9 ►► The rigour procedures applied (methodological ade- 2019;9:e023872. doi:10.1136/ discussion groups, 1 triangular group and 6 documents. quacy, triangulation of techniques and analysis and bmjopen-2018-023872 Three analysts carried out a thematic content analysis reflexivity of the interdisciplinary research team) en- with the support of ​Atlas.​ti software. This evaluation was ►► Prepublication history for sured the validity and reliability of the findings. this paper is available online. modelled on Proctor and colleagues’ concept of outcomes for ►► The richness and complementarity of the information To view these files, please visit implementation research. generated by healthcare attendees and health pro- the journal online (http://​dx.​doi.​ Setting 7 primary care centres from seven Spanish regions: fessionals from seven distinct regions will contribute org/​10.​1136/​bmjopen-​2018-​ Andalusia, Aragon, Balearic Islands, Basque Country, Castilla- to the adaptation of the intervention to the various 023872). La Mancha, Castilla-Leon and Catalonia. settings to ultimately achieve feasible, sustainable Participants The study population were healthcare Received 2 May 2018 integration in everyday primary care practice. attendees (theoretical sampling) and health professionals Revised 8 February 2019 (opportunistic sampling) who had participated in the Accepted 12 February 2019 exploratory trial of the EIRA intervention (2015). Results Healthcare attendees and professionals had a person-focused care.1 It is considered the positive perception of the study. Healthcare attendees ideal setting to implement individual, group even reported that they would recommend participation to and community health promotion interven- family and friends. Health professionals became aware of tions. However, these implementations face the significance of the motivational interview, especially barriers and challenges set up by the system, for health promotion, and emphasised social prescribing of the professionals and the public.2 3 physical activity. They also put forward recommendations Since it is very common for the same to improve recruitment, screening and retention of participants. Healthcare attendees modified behaviours person to accumulate inter-related unhealthy and health professionals modified working practices. To behaviours, complex interventions are achieve sustainability, health professionals believe that it is increasingly used in studies of behavioural crucial to adapt agendas and involve all the staff. change. In addition, first-hand knowledge © Author(s) (or their Conclusions The discourses of all stakeholders on the of the setting where health promotion takes employer(s)) 2019. Re-use intervention must be taken into consideration for the place is crucial when evaluating its effect. permitted under CC BY-NC. No successful, setting-specific implementation of adequate, Complexity results from the number of inter- commercial re-use. See rights and permissions. Published by acceptable, equitable and sustainable strategies aimed at acting components, namely the amount and BMJ. health promotion and well-being. difficulty of behaviours required by those For numbered affiliations see delivering or receiving the intervention, end of article. Background the number of groups or organisational Correspondence to Primary healthcare (PHC), the most acces- levels targeted, the number and variability Dr Mariona Pons-Vigués; sible and most frequently used health of outcomes and the degree of flexibility of ​mponsv@​idiapjgol.​info service, provides comprehensive, long-term the intervention.4 5 The main directives for Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 1 Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Figure 1 Second phase (development of an exploratory trial) of the EIRA Project, which follows the UK Medical Research Council framework for complex interventions. the design, implementation and evaluation of complex of an intervention, assesses its quality and fidelity, clari- interventions were developed by the Medical Research fies causal mechanisms and identifies contextual factors Council (MRC)4 6 7 using a mixed-method approach with associated with variation in outcomes.4 11 Qualitative five sequential phases: (1) definition of the theoretical methodology has a unique role in understanding the foundation (preclinical phase), (2) construction of a implementation process of an intervention12: interest- model (phase I), (3) development of a pilot study (phase ingly, qualitative research can be used concurrently with II), (4) completion of the definitive trial (phase III) and a pilot trial, for instance, to optimise recruitment and (5) long-term implementation (phase IV). informed consent strategies, to identify acceptability of The EIRA Project started in Spain in 2012 with the the intervention, to provide insights into processes of objective to modify unhealthy behaviours in primary change and to help interpret findings.13 Accordingly, the care patients following the MRC framework for complex qualitative evaluation of the intervention implementation interventions.6 7 To date, the first three phases have been process is able to identify determinants of clinical practice completed.2 3 8–10 Specifically, the objective of the EIRA such as barriers and facilitators that influence the adop- Project was to design, conduct and evaluate a complex, tion of organisational and professional change.14 This multirisk intervention to enhance adherence to the qualitative evaluation facilitates understanding of how Mediterranean diet, increase insufficient physical activity and why the different components of the intervention and reduce smoking, cardiovascular risk factors and risk are successfully or unsuccessfully implemented; it also of depression in people aged 45–75 years that contact contributes to identify predictive factors of success and PHC services with at least two of these behaviours or generates useful knowledge for advancing the implemen- risk factors. Participants receive individual recommen- tation of scientific evidence.15 In addition, the qualitative dations on their behaviour and risk factors, and they are methodological perspective might transcend the main offered to attend group sessions and social prescription limitations of the quantitative approach that prevails in of health promoting community assets. The person-cen- clinical trials and provides essential information on the tred approach uses the motivational interview, and the evaluation of interventions, since it involves the different attendee becomes an active agent in her own life. Partic- stakeholders, which actively convey their experiences, ipants allocated to the control group receive the usual opinions, needs and suggestions for improvement. care (figure 1). This qualitative evaluation presents the results of the A key question in evaluating a complex intervention second phase (development of an exploratory trial) is actual effectiveness. However, the process itself is of the EIRA Project. The objective was to evaluate: (1) also important: what happens, how, when and why. The the process of implementation and development of a process evaluation in trials explores the implementation complex intervention on health promotion in primary 2 Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. care according to healthcare attendees and health profes- the summer of 2015; one triangular group (a meeting sionals and (2) changes in health-promoting behaviours. of three people to discuss together a topic or issue with the aim of ascertaining the range and intensity of their views)17; and one individual interview with a community Methods agent. In addition, we collected the written reports of six Design professionals who could not attend the discussion groups Descriptive qualitative research based on the experiences because of scheduling conflict (two documentary tech- of participants was used to evaluate the exploratory trial niques in February and four in summer). Table 1 details of the EIRA complex intervention. the main characteristics of the 81 PHC professionals who participated in the study. Setting and study population Semistructured individual interviews were used to Seven primary care centres (PCCs) included in the inter- collect information from healthcare attendees. We vention group of the EIRA Project from seven Spanish initially planned a semistructured individual interview regions (one PCC per region) participated: Andalusia, for each of the 15 profiles of informant; however, two Aragon, Balearic Islands, Basque Country, Castilla-La semistructured individual interviews could not take place Mancha, Castilla-Leon and Catalonia. The control group because the participants could not be contacted after the of the exploratory trial did not participate in the qualita- end of the study. We finally held 13 interviews with health- tive evaluation. care attendees. Table 2 shows the characteristics of these The study population were: (A) PHC professionals from 13 participants. participating PCC (including family physicians, primary In total, data collection techniques consisted of 14 care nurses, social workers and administrative staff) and semistructured individual interviews, 9 discussion groups, assistant researchers (in charge of performing baseline 1 triangular group and 6 documents. Semistructured and 6-month measurements and questionnaires); and individual interviews, discussions groups and triangular (B) healthcare attendees aged 45–75 years who partici- group followed a topic guide with open-end questions, pated and completed the EIRA study. with some adaptations according to type of informant and study period (box 1). The topic guides were based on Sample design and participant selection strategy a review of the literature and the objectives of the study. PHC professionals from participating PCC and assistant After obtaining informed consent from the participants, researchers were selected by means of opportunistic all interviews were audio or audio and video recorded. sampling.16 The site investigator of each PCC contacted The discussion groups took place in the PCC with one all professionals who participated in the EIRA study to moderator and one observer and lasted between 90 min book group interviews 2–3 months after the beginning and 120 min. Semistructured individual interviews took of recruitment (February 2015 in three centres) and at place in a setting accessible for the healthcare attendees the end of the intervention (summer of 2015 in the seven and lasted between 15 min and 60 min. The field work centres of the intervention group). The decision of PHC was carried out in each region by qualified interviewers professionals to participate in the group interviews was with experience in qualitative research. Informative rich- voluntary. For healthcare attendees, we applied theoret- ness for a deeper understanding of the development and ical sampling based on a prior definition of participants’ implementation of the intervention was achieved. characteristics to obtain optimal variety and discursive wealth.16 Fifteen informant profiles emerged from the Data analysis discursive variants sex, age, educational level and type All interviews and discussion groups were transcribed of intervention (the approach to the first component of verbatim and deidentified by trained personnel.18 A the intervention was decided by the participant). Next, thematic content analysis was carried out19 20 with the two of these profiles were randomly allocated to each support of A ​ tlas.​ti software. The data were analysed as PCC included in the intervention group of the EIRA follows by three researchers (NCA, MPV and EPR, who Project; one PCC had three profiles. At the end of the are a nurse, a pharmacist and a physician, respectively): intervention (summer 2015), the site investigator of each (1) formulation of preanalytical intuitions after succes- PCC contacted by phone the healthcare attendees partic- sive readings of the transcriptions and the notes from ipating in the EIRA Project who met the specific infor- documentary techniques; (2) creation of an initial analyt- mant profile for the PCC to explain the objectives of the ical plan and text codification; (3) creation of categories qualitative evaluation and invited them to participate in by grouping the codes according to the analogy criterion an interview. The voluntary aspect of participation was based on Proctor and colleagues’ model of outcomes for also emphasised to healthcare attendees. implementation research21 and new elements from the discourses; (4) analysis of each category and relation- Data collection and generation techniques ship with the others; and (5) elaboration of the new text Conversational techniques were used for PHC profes- with the main results. These results were presented and sionals: three discussion groups in February 2015 and discussed in a meeting with all research members of the six discussion groups at the end of the intervention, in EIRA Project (January 2016). Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 3 4 Table 1 Description of participating healthcare professionals according to study period and region Open access Date Region Technique* Participants Age Sex Occupation February 2015 Balearic Islands 1 DG 13 Six aged 30–49 years. 9 female. 1 administrative staff. Seven aged 50–65 years. 4 male. 5 nurses. 5 physicians. 2 psychologists and one assistant researcher. Castilla-La Mancha 1 DG 6 One aged under 30 years. 5 female. 6 nurses. One aged 30–49 years. 1 male. Four aged 50–65 years. 2 DT 2 Missing information. 2 female. 2 assistant researchers (nurses). Catalonia 1 DG 8 Seven aged 30–49 years. 7 female. 6 nurses. One aged 50–65 years. 1 male. 2 physicians. Summer 2015–end of Andalusia 1 DG 5 One aged 30–49 years. 1 female. 5 physicians. intervention Four aged 50–65 years. 4 male. Aragon 1 DG 4 Two aged 30–49 years. 3 female. 3 nurses. Two aged 50–65 years. 1 male. 1 physician. Balearic Islands 1 DG 9 Four aged. 30–49 years. 7 female. 1 administrative staff. Five aged 50–65 years. 2 male. 1 assistant researcher (psychologist). 3 nurses. 4 physicians. 1 DT 1 One aged 30–49 years. 1 female. 1 assistant researcher (psychologist). Basque Country 1 DG 11 Two aged under 30 years. 10 female. 1 administrative staff. Three aged 30–49 years. 1 male. 1 assistant researcher. Six aged 50–65 years. 4 nurses. 5 physicians. 1 SI 1 One aged 30–49 years. 1 female. 1 community agent. Castilla-León 1 DG 9 Two aged under 30 years. 8 female. 6 nurses. One aged 30–49 years. 1 male. 3 physicians. Six aged 50–65 years. Castilla-La Mancha 1 TG 3 One aged 30–49 years. 3 female. 3 nurses. Two aged 50–65 years. Catalonia 1 DG 6 Six aged 30–49 years. 5 female. 4 nurses. 1 male. 2 physicians. 3 DT 3 Three aged 30–49 years. 2 female. 1 assistant researcher (psychologist). 1 male. 2 nurses. Most people taking part in the various techniques in February 2015 took also part at the end of the intervention (summer 2015). The data are aggregated for confidentiality reasons. Anonymity, confidentiality and data protection were guaranteed. It is impossible to identify participants; for example, Catalonia is a Mediterranean region with more than 7 million of inhabitants. *Technique: discussion groups (DG); semistructured interview (SI); triangular group (TG) and documentary technique (DT). Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Table 2 Description of participant healthcare attendees by region (summer 2015, end of the intervention) Risks at the start of the study Region (intervention on risk: yes/no) Sex Educational level Age (years) Andalusia Diet (yes); cardiovascular risk (yes). Male Primary education 70 Physical activity (yes); diet (yes); depression Female Primary education 58 risk (no). Aragon Physical activity (yes); diet (yes). Male Primary education 51 Diet (yes); physical activity (no); cardiovascular Male Secondary education 64 risk (no). Basque Country Physical activity (yes); depression risk (yes). Female Primary education 75 Physical activity (yes); cardiovascular risk (yes). Female Secondary education 62 Castilla-León Depression risk (yes); diet (yes); physical Female Secondary education 69 activity (yes). Physical activity (yes); smoking (yes); Female Primary education 58 cardiovascular risk (yes). Castilla-La Mancha Physical activity (yes); diet (yes); smoking (yes). Female Primary education 49 Depression risk (yes), diet (yes); smoking (yes). Female Primary education 52 Catalonia Diet (no); physical activity (no); smoking (yes). Female No education 47 Physical activity (yes); diet (yes), cardiovascular Male Primary education 59 risk (yes); smoking (no). Physical activity (yes); diet (yes); depression Female Secondary education 55 risk (yes). No semistructured interviews with healthcare attendees took place in the Balearic Islands. Anonymity, confidentiality and data protection were guaranteed. It is impossible to identify participants; for example, Catalonia is a Mediterranean region with more than 7 million of inhabitants. Rigour and quality criteria Results To guarantee quality and rigour, we adhered to the The results are classified in five categories: acceptability, following recommendations22 23: description of the inter- appropriateness and feasibility, sustainability, penetration vention, the context, the participants and the research (changes implemented) and suggestions for improve- process; methodological adequacy; working with different ment. Table 3 shows the definitions of these categories actors; triangulation of techniques (comparison of data complemented with illustrative quotations from the obtained by means of different information collection discussions. techniques) and analysis (contrasting and comparing the data analyses performed by different analysts to Acceptability strengthen the credibility and confirmability of the study In general, healthcare attendees and health profes- results); and reflexivity of the interdisciplinary research sionals reported satisfaction with their participation, and team. Sufficient data were collected to meaningfully their final evaluation was positive. Healthcare attendees answer the research question. The authors guarantee the described being thankful to the professionals for their accuracy, transparency and honesty of the data and infor- support, and they explained that they felt more confi- mation contained in the study. dent making decisions about the process of change. All healthcare attendees interviewed would recommend Ethical considerations participating in the study to family and friends, and in This study followed the tenets of the Declaration of fact some had already done it. They affirmed that partici- Helsinki. All participants signed the informed consent pation requires being ready to pay attention, to listen and form. Anonymity, confidentiality and data protection to reflect. were guaranteed. Health professionals believed in health promotion and while they did not consider the contents of the interven- Patient and public involvement tion innovative, they indicated that it changes working Study participants were not involved in the development practices, notably the systematisation of recommenda- of the research question or the outcome measures nor tions and the boost of social prescription. However, they the design of the study. The results will be presented to remained critical and underscored that the project was study participants and citizens through informative activ- too ambitious, too long, somehow unclear and unorgan- ities and the media. ised, which led to confusion during implementation. Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 5 Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Box 1 Topic guide for the data generation techniques Box 1 Continued based on type of informant and study period ►► Have you found useful the resources related to the EIRA Project such Primary healthcare professionals and assistant as the webpage, SMS and so on? researchers (February 2015) ►► What could we improve? ►► We will start talking about recruitment: in your experience, what do ►► Would you recommend participation in a similar study to your family you suggest to enhance recruitment? and friends? ►► Based on your experience, how can we improve the suggested ►► How do you evaluate your participation in the EIRA Project? screening strategy? ►► What is your experience with the algorithm of prioritisation and what do you suggest to improve it? They specifically highlighted difficulties in the approach ►► What is your overall assessment of the proposed intervention? to risk of depression. Moreover, in some primary care ►► What do you suggest to improve the feasibility of each component of teams tension emerged between professionals that partic- the intervention (diet, physical activity, smoking, cardiovascular risk ipated and their non-participating colleagues. and depression risk)? ►► What are your views and experiences on the resources and ma- Appropriateness and feasibility terials of the intervention (web for professionals, web for patients, The results have been categorised according to the phases patient information leaflets, SMS other ICTs)? ►► How does the target population accept each aspect of the study of the study. (how do they feel, ask and talk about their difficulties with regard to Training behavioural change)? ►► How could we boost participation in the study (consent at recruit- Although some professionals considered that the training ment, follow-up …)? conducted prior intervention was appropriate and ►► What do you suggest to improve the coordination of the project? provided new concepts, they maintained that it was insuf- ►► Finally, how do you perceive your participation in this project? ficient for the actual implementation of the intervention, specifically concerning the motivational interview and Primary healthcare professionals and assistant the approach to risk of depression. There was no practical researchers (summer 2015) training in the use of online case report forms (CRF), and ►► What is your overall assessment of the intervention? in one of the centres, the training was provided too early. ►► Has your participation in this study been useful to modify any aspect Some theoretical aspects could not be translated into of clinical practice? Do you think that it has been useful for patients? ►► What are your suggestions to improve the feasibility of each compo- practice due to lack of time or skills. nent of the intervention? Coordination ►► Concerning each component of the intervention: would you keep them in the definitive trial? Would you keep them at each level of With regard to coordination, the professionals found the intervention? How does the population accept them? (How do they meetings with the research team useful. However, it was feel, ask and talk about their difficulties with regard to behavioural sometimes unclear how to proceed, how to give appoint- change?) ments and refer healthcare attendees for follow-up or ►► What are your views on the relevance and usefulness of the resourc- who was responsible for reviewing the study tests. In addi- es and materials of the intervention (web for professionals, web for tion, some procedures were changed after the start of the patients, patient information leaflets, SMS and other Information study. Reiteration of questions and lost to follow-up were and communications technology - ICTs-)? generated by the complexity of circuits and the lack of ►► How could we improve the coordination of the project? communication between professionals. ►► How do you assess the feasibility of expanding this project to other primary care centres? Recruitment ►► How do you evaluate your participation in this project? Most professionals agreed that recruitment involved a ►► Finally, do you have any comment on recruitment, screening strate- higher workload than anticipated and that it took place gy and prioritisation algorithm? in a short timeframe. They explained that it was diffi- Healthcare attendees (summer 2015) cult to explain the study and to encourage healthcare ►► Could you please explain your overall experience with the EIRA attendees to participate, and they believed that many study? enrolled because they felt commitment to their profes- ►► Which activities have you carried out during your participation sionals. Healthcare attendees explained that they partic- in the study? (If none, ask about group interventions and social ipated because they thought it was interesting, they had prescription.) time and they felt commitment to their regular health ►► Do you think that you have participated in decision making about professionals. your own health? How was your experience? Professionals pointed at a selection bias caused ►► Has this study contributed to adopt healthier behaviours? Has any by the recruitment of frequent attenders, patients aspect of your life changed since you entered the study? Do you think that it is feasible to integrate the recommendations and ac- generally better controlled and more motivated. No tivities suggested by primary care professionals into your daily life? random systematic sampling was applied, and any reason for consultation was accepted. Several profes- Continued sionals from the selected PCC declined participation. 6 Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 Table 3 Verbatim quotations of participants Acceptability Perception among implementation stakeholders that a given treatment, service, practice or innovation is agreeable, palatable or satisfactory. ‘Actually, I’d say that many health care attendees, not 100%, or even 50%, rather 30% to 40%, are very happy. Not just happy, but very very happy… We are talking about individual interviews, aren’t we? With health care attendee and health professional’ (female physician, Basque Country). ‘Feeling more confident about it yes, because probably I was not confident at all, see? I was talking about that. I have integrated it now, because I felt a bit insecure, and now, well, now I know I’m doing the right thing’ (woman, 52*, healthcare attendee, Castilla-La Mancha). ‘I think it’s fine. The questions I’m asked, the blood tests with results that I know very well and that other issue’. (man, 70, healthcare attendee, Andalusia). ‘Generally speaking I’m happy with the intervention, I believe that with the EIRA project I have acquired tools to evaluate my daily work. They have been useful to us professionals because it has helped to structure, plan and prioritize our intervention. Motivation and decision-making with the patient have really contributed to achieve the objectives’ (female nurse, 40 years, Catalonia). ‘I have found it truly interesting, but also very long and difficult to implement with our current work overload’ (female physician, 42 years, Catalonia). Appropriateness and feasibility Appropriateness is the perceived fit, relevance or compatibility of the innovation or evidence based practice for a given practice setting, provider or consumer; and/or perceived fit of the innovation to address a particular issue. Feasibility is the extent to which a new treatment or innovation can be successfully used within a given agency or setting. Training conducted prior intervention ‘I think that the training on motivational interviewing has been interesting’ (female physician, 42 years, Catalonia). ‘I would say no, we did not learn anything new. If it was meant to provide the same baseline for everybody, well, then fine. But we did not see it as what we actually had to deliver for the project, I mean, we saw it as something that they tell you and then you have to face the real thing’ (female nurse, 61 years, Castilla-La Mancha). ‘Well, whenever we receive specific training we benefit, we become aware of many things that we don’t do… we become more aware, we realise that we overlook some issues, in this sense it has been useful, sure’ (female physician, 42 years, Balearic Islands). Coordination ‘Let’s see, I really believe that this was planned top-down, and as a research project, well, it has been carried out in a hurry like all research projects, so the truth is we need more time for reflection’ (female nurse, 62 years, Aragon). ‘I think that in our health centre all this work has mainly focused on the nurses… we have not been as involved… I think that we should have coordinated better, I think that’s a fair point’ (male physician, Basque Country). Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 Recruitment ‘The recruitment bit was the worst, seeing the patients between consultations, explaining about consent, that took a long time, and sometimes they did not even participate’ (female nurse, 39 years, Catalonia). ‘The recruitment should be different, another model, because the participants are regular attendees, and they manage, they more or less manage their health’ (female nurse, 61 years, Castilla-La Mancha). Baseline visit of allocated health ‘And what did you decide to work on? Mainly, the diet to lower cholesterol. And I have succeeded’ (man, 59 years, healthcare attendee, Catalonia). professional ‘Some have started with one and then become involved and used to it… this here started walking and exercising and he finally has come for quitting smoking, he is a multiplier. I really think that this approach is very useful, to make them commit, when we talked about contract. The contract is crucial, when they realise that they have to sign the commitment form’ (male physician, 61 years, Andalusia). ‘I thought it was fantastic, very good, wonderful, having a tool (ie, prioritisation algorithm) like that to assist you’ (female nurse, 26 years, Castilla-León). Individual intervention ‘… but the test of arteries and all that, they were really delighted with this. And also the people got confused, like with depression, mainly in patients with diabetes or that have been advised on diet and lifestyles for ages, they also mixed this with the study’ (female professional, 39 years, assistant researcher, Balearic Islands). ‘I think it has been too short, basically a short question. Just a couple of interviews and that’s it’ (man, 51 years, healthcare attendee, Aragon). Group intervention ‘For sharing and all that. It’s wonderful. I think that in these matters the people benefit from the group’ (woman, 75 years, healthcare attendee, Basque Country). ‘… the conflict of some doctors that have not quite grasped why the nurse went for a walk and protested “now I don’t have a nurse, I want her to stay here”, and these apparent trifles that if all perhaps… just having patients from 5 GPs out of 11 has not worked out very well, maybe… the whole health centre should have participated…’ (male physician, 42 years, Balearic Islands). Community intervention ‘And in relation to community activities, like other times, it’s always the same, it’s difficult to get them started, it was hard to get them going, but it is eventually rewarding because they already ask when they will be happening again’ (female physician, Basque Country). ‘Yes, but now it has stopped because it’s unpredictable, it depends on the policies of the council, so now we have it and later we don’t, and now they even have changed coordinator so my expectations…’ (male nurse, 40 years, Catalonia). ‘And the community assets should be better exploited. Here in our neighbourhood there are things available that we don’t know about and then maybe talking I learn that a neighbourhood association organises fitness sessions. And the Council, they also have initiatives, the City Council has a programme with a doctor, let’s say in charge of the programme, they have done it for a while and sometimes they have wanted to come, they even came here’ (male physician, 62 years, Castilla-León). Patient information leaflets ‘That on depression too, what is anxiety, how to manage sleeplessness, patients have found it very interesting’ (female physician, 43 years, Andalusia). ‘The information is very good, that on sleeplessness is outstanding’ (male physician, 61 years, Andalusia). Continued Open access 7 BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. 8 Table 3 Continued SMS and webpage to support advice ‘Yes, yes, yes. Because it’s a reminder that… that is good, and it’s there. I don’t delete it, it’s there and sometimes I say, come on, I’ll go and have a look. Yes, it’s a reminder that’s available. For me provided it’s quite…good’ (woman, 52 years, healthcare attendee, Castilla-La Mancha). Open access ‘Well, I very well, because I read that and really integrated that information. Sometimes I even laughed’ (woman, 47 years, healthcare attendee, Catalonia). ‘Just being as thoughtful as to send an encouraging message, it’s great because sometimes it reaches you just when you most need it’ (woman, 55 years, healthcare attendee, Catalonia). ‘Even with the mobile phone and messages, the mobile phone, “my mobile is only to phone and to receive calls, no messages”. Well, it’s more difficult than anticipated’ (female nurse, 45 years, Aragon). ‘Text messaging is really good, it’s a very good idea and I think it has been used a great deal… the platform was meant for an age group of health care attendees with not very advanced IT skills. I really believe that our health care attendees, very few will have used this platform because they are not used to, they don’t know how to use it and therefore, the platform has probably not been very useful, what do you think? I mean, you receive the message and you see it, and it seems that the mobile is easier to manage, while internet access… If you don’t have internet access at home where are you going to read it?’ (female nurse, 31 years, Castilla-La Mancha). Case Report Form (CRF) ‘You cannot register the commitment with the patient in the CRF, it’s not even practical. It is not adapted to the commitment you make with the patient and that suggested is so cumbersome that it’s impossible to see it through, that of physical exercise planned the, the objectives attainable in a week, during the week, during every day of the week’ (physician, Balearic Islands). Follow-up ‘Many have refused to undertake the final evaluation because they had the baseline evaluation and did not implement the intervention or maybe, perhaps at the time they had problems to come to the health centre or had something else going on and they already disconnected, you and the patient, from the study and the evaluation and follow up never took place; and others that dropped out because they are not interested, they say not now because it’s complicated, I have problems etc., I don’t want to do it or…’ (female professional, 39 years, assistant researcher, Balearic Islands). Evaluation of intervention (baseline ‘… [I]t is essential to remain within the centre (laughs) because otherwise we left things undone and the possibility to be face to face, talking with them about things that I’m missing, that need and final). Role of assistant completing…the coordination with them has worked well’ (female professional, 39 years, assistant researcher, Balearic Islands). researchers ‘I’m also having trouble with the internet connection because I don’t have my own password and I don’t have my own physical workspace, which results in work overload’ (female professional, assistant researcher, Castilla-La Mancha). Sustainability The extent to which a newly implemented treatment is maintained or institutionalised within ongoing, stable operations of a service setting. ‘Yes, I really think so, I think that with time it’s doable’ (female nurse, Castilla-León). ‘If you specifically mean this project, I think that I would consider depression separately’ (female physician, 55 years, Aragon). ‘I liked it, well it’s my opinion, it’s one of these things that, I enjoyed doing and I would like to continue because there are aspects that, I don’t know, that I find very positive’ (female nurse, Balearic Islands). ‘We have talked about this in the Community Health Meeting that has just taken place and it seems that it mainly hinges on political will … to include purposefully the activities in the portfolio of services, some proposals suggested to include community health in the portfolio of services, because otherwise it’s always some kind of favour and that the… and therefore I believe that the top management should really rally behind it, to be able to expand, I think’ (female nurse, 62 years, Aragon). ‘The project can be extended to other centres, but it’s crucial to adapt the schedule of the professionals that are in charge of these interventions, which might cause conflict with other professionals or additional burden for participants. Best to carry out the project with the whole team’ (female nurse, Catalonia). Penetration: changes implemented by healthcare attendees and professionals after the intervention. Integration of a practice within a service setting and its subsystems. Healthcare attendees ‘… every now and then it’s good to get it out even if it’s by answering questions …. I used to think about the questions that he asked, which since my life is so hectic I had not even considered’ (woman, 55 years, healthcare attendee, Catalonia). ‘I feel very well, very well. More fit and all that. Well, at first to climb to the eight floor was so very challenging. I feel better. All in all, it has worked for me’ (woman, 62 years, healthcare attendee, Basque Country). ‘… it has helped, before I used to smoke anything I could find and now I smoke 5 or 6 or 7 more or less. But before I used to smoke much more’ (woman, 47 years, healthcare attendee, Catalonia). ‘Yes, let’s see, before I didn´t have nuts and now I know that they are good for me. So now I feel good when I eat them, because I eat them now. Fruit? Well, I didn’t have that much and… and now I eat more’ (woman, 52 years, healthcare attendee, Castilla-La Mancha). ‘Do you think that all this has been helpful? I think so, more so because I lacked willpower, and taking all literally and it has been like a push, a push’ (man, 59 years, healthcare attendee, Catalonia). ‘Yes, it has helped… it also helped a lot mentally, for my own reflection. I needed it badly, because I felt very unhappy, unemployed, I carried a lot of luggage. My family far away, I was suffering… I still have lots to do, it was very very very useful’ (woman, 47 years, healthcare attendee, Catalonia). ‘I even spoke to my children after that (…) and I told them: If you are going to give me something give it to me while I’m alive, love, affection… don’t do, you don’t have to do anything for me’ (woman, 55 years, healthcare attendee, Catalonia). ‘About walking, I’ve tried, it has been a very complicated period because I’ve had very difficult family issues… but I’ve tried to walk a bit more’ (Woman, 58 years, healthcare attendee, Castilla-León). Health professionals ‘… to be more aware maybe toward the patient. I think it has been useful, perhaps not for everybody, I don’t know, the feeling is that, we act sensibly and that yes, that we have to encourage it more, but I don’t know how’ (female physician, 42 years, Balearic Islands). These quotations were translated by a professional scientific bilingual translator. Anonymity, confidentiality and data protection were guaranteed. It is impossible to identify participants; for example, Catalonia is a Mediterranean region with more than 7 million of inhabitants. Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. In particular, few admission staff chose to take part, especially those about diet or mental health. Health- and their involvement was often hurried and uncoor- care professionals considered that the leaflets were dinated, which increased the workload of the profes- a useful tool, particularly regarding diet, and even sionals involved in the study. patients who did not participate in the study received them. They also believed that healthcare attendees First visit with the health professional (prioritisation of behaviours appreciate written information. to modify and intervention plan) Most healthcare attendees evaluated positively their SMS and health education webpage involvement in decision making and many explained that Few healthcare attendees agreed to receive SMS, but they participated in the prioritisation of behaviours and those that accepted explained that SMS were helpful risks that needed changing. Patients asserted that trust in and encouraging. Professionals considered SMS useful the health professional facilitates change. Health profes- reminders. The webpage was hardly accessed, for which sionals evaluated positively the patients’ assessment of healthcare attendees and professionals provided various their own risk behaviours followed by the decision about reasons: lack of recommendation, no access to computers/ which behaviours to modify. Professionals also indicated Internet, lack of motivation and feeling uncomfortable that the prioritisation algorithm was useful. sitting in front of a screen. Individual intervention Online CRF Healthcare attendees believed that the advice was useful The professionals believed that the study online CRF and applicable, and they felt that health professionals was too complicated, too slow and that it was difficult really cared and listened to them. They emphasised that to register personalised agreements. Also, since the in comparison with usual visits health professionals had programme was separate from the electronic health more time to attend to them without rush and to do a records, they had to work with both programmes simulta- holistic valuation. The healthcare attendees that received neously. In addition, poor internet connection slowed the health promotion recommendations in regular prac- work of some professionals. tice mixed them up with the intervention advice of the study. They also mixed up the clinical intervention with Follow-up the collection of information for the clinical trial. They Health professionals indicated that follow-up data such thought that the follow-up period should be extended as adherence rates were somewhat unclear and would and include more people. The professionals were posi- be interested in learning about the final results. They tive about the person-centred approach and have become believed that retention of participants might be deter- more aware of the significance of the motivational inter- mined by difficulties in attending the intervention visits, view and of health promotion. loss of interest and the perception that no added value is attached to these interventions. Group intervention Group activities focused on physical activity and nutri- Evaluation of the intervention (baseline and final): role of the tion. Healthcare attendees explained that sharing assistant researchers experiences was positive; they established new rela- Generally, healthcare attendees evaluated positively tionships and organised walking groups. Some profes- the questionnaires and tests carried out by the assistant sionals reported that these activities are difficult to researchers (blood tests, evaluation of vascular health and implement due to lack of time. For others, these activ- so on) because they felt listened to and had more time to ities do not fall within their duties (they considered talk. The professionals believed that healthcare attendees them additional activities or simply going for a stroll felt well cared for because they spent sufficient time with with healthcare attendees). the interviews. The assistant researchers indicated that they had to administer too many questionnaires. They Community intervention also pointed at the following issues: insufficient informa- Although few centres used activities already popular tion, lack of their own working space, irregular access to in the neighbourhood, social prescription was very the CRF and lack of authorisation to consult the medical positively evaluated both by healthcare attendees and history of healthcare attendees. professionals. Most physical activities prescribed were organised by the town councils. For professionals, Sustainability social prescription was a novel concept, and they Some professionals considered that it is important to emphasised that adherence is unknown since atten- extend this intervention to other PCC but underscored dance was not registered. the need for the support of institutions, for extended consultation length and the involvement of all profes- Health education leaflets sionals. In addition, risk of depression remains a contro- Healthcare attenders favoured personal contact versial component of the intervention. Some professionals over patient information leaflets. However, the would exclude it altogether, while others believed that it few comments received on leaflets are all positive, needs a different approach. Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 9 Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Penetration: changes implemented by healthcare attendees multibehavioural intervention as an endorsement of the and professionals after the intervention definitive trial of the EIRA Project. However, we acknowl- Healthcare attendees reported increased motivation and edge that the current version of this intervention cannot knowledge of healthy behaviours and feeling more posi- yet be integrated in primary care practice until funda- tive towards change. Those working with physical activity mental organisational changes that ensure feasibility and and nutrition explained that they implemented changes sustainability in real-world conditions take place. Even and described high levels of satisfaction: they walked though the intervention was adapted and implemented more, got less tired and felt fitter, ate healthier (smaller following the recommendations of healthcare attendees amounts, more vegetables, fruit and nuts and use of olive and health professionals obtained in prior phases of the oil) and some stated that they drank less alcohol. They EIRA Project,2 3 8–10 further adjustments are required. also stated that they smoked less cigarettes. Professionals For instance, in the EIRA Project, we concluded that for agreed that healthcare attendees made an effort to health promotion, it is essential to involve most primary meet their objectives, to implement changes and to start care professionals, including administrative staff, to avoid healthier habits. tension and to challenge the notion that health promo- The barriers for change according to healthcare tion is voluntary or based on personal preference. It is also attendees were: family responsibilities (care of the sick, important to reduce the work overload (objectively high), care of grandchildren, house chores and so on), life–work to simplify recruitment and screening questionnaires and imbalance, weather conditions and lack of willpower. to modify the approach to emotional discomfort and risk The professionals agreed with these barriers and added of depression. However, it is crucial to participate in the financial issues and unawareness of the need to change. dissemination of social prescription and to continue the Facilitators of change according to healthcare attendees research in implementation strategies focusing on equity were: group activities and trust in health professionals. and on improving overall results. It has also been observed For health professionals, the healthcare attendees should that primary care professionals require more resources, decide which behaviours to modify because their commit- time, skills and motivation to reach out and work with the ment implies autonomy and empowerment and facilitates community in health promotion.24 change. Healthcare attendees reported high levels of satisfac- The professionals reflected on how to approach health tion with the study because they felt that professionals promotion in primary care: with a holistic view of health- gave them enough time and listened to their needs and care attendees, providing evidence-based advice, being preferences. They also felt supported during the process more purposeful, using motivational interview, involving of change and were able to initiate sustainable healthy the family and prioritising social prescription. Participa- behaviours. We might thus conclude that the intervention tion in the intervention facilitated a deeper knowledge of encouraged a holistic, person-centred approach under- healthcare attendees and extended consultation length. scoring the key role of the primary care professional Professionals reported improvement in the assessment and of the motivational interview as a useful strategy to and register of activities in the electronic health records. promote behavioural change.25 The motivational inter- view requires training and extended consultation times,26 Suggestions for improvement and although health professionals received basic training Table 4 shows the discourses and suggestions for improve- (4 hours at the beginning of the study), most agree that ment of participants. further training is required. Although some health professionals underscored the pivotal role of PHC to manage risk of depression, many Discussion worried about lack of skills, attitudes, tools and experi- Overall, health professionals and healthcare attendees ence, in agreement with others authors.27 In addition, shared a positive perception of their participation in the some healthcare attendees had a positive opinion about study. Indeed, healthcare attendees would even recom- the opportunity to know their depression risk.28 To some mend it to family and friends. Health professionals real- extent, the recommendations to manage emotional ised the significance of the motivational interview, in discomfort in primary care take all these views into particular with regard to health promotion. They also account.29 The real objective of the first approach is to underscored the potential of social prescribing in relation ascertain the nature of the emotional discomfort by means to physical activity. In addition, health professionals put of active listening, probing and empathy to understand forward suggestions to improve recruitment, screening the meaning, adaptability and problem solving skills of and retention of participants. Healthcare attendees each person to avoid chronification and medicalisation. modified behaviours and health professionals revised This project encourages participation in community working practices. According to health professionals, the activities, particularly physical activity, even though many continuity of this programme is contingent on adapting participants did not follow these recommendations. In agendas and involving all staff. agreement with the results of the systematic review by We regard the positive attitude of healthcare attendees March et al, which shows that in primary care preventive and health professionals towards this health promotion interventions, the community might be more effective 10 Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 Table 4 Suggestions for improving the intervention according to participating healthcare attendees and professionals Primary healthcare professionals and Healthcare attendees assistant researchers Quotations Training More practical training, in particular, regarding ‘I think that the concepts were explained, they talked about nutrition, this and the online case report form. that… but not with the platform and we needed to do it in front of the platform. More training on motivational interview and on More practical workshop, practice it before starting and for all of us to do the the approach to risk of depression. same’ (female nurse, 61 years, Castilla-La Mancha). Organisation and Improve the flow of information and ‘Regarding the project coordination for doctors and nurses, maybe the area of coordination communication within institutions and work community prescription with other organisations and entities’ (male physician, groups. Specify the responsibilities of each 62 years, Castilla-León). professional (what, how, when and where). ‘It is important that we get involved and that the authorities get on board Create a shared agenda. to disseminate the healthy lifestyles, what we have now with food in the Involve all staff in the PCC. supermarkets, to label fat and sugars much more clearly, in short, we need to Guarantee connectivity and computers in send the message that nutrition is crucial. This will determine if we are more or working order. less sick in the future, and the same goes for depression. I mean, if we do not Shift current agenda to commit more time to take it seriously now we will end up with wonderful medicines to patch up all health promotion. these diseases but…’ (female physician, 43 years, Andalusia). Actively involve community and institutions. Recruitment Extended period avoiding peak times. ‘And the recruitment has been hard, because when we have got 60, it means Extend consultation length. that we have seen 120. Or even more than that. And of course, and this within Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 Involve all staff in the PCC. the daily schedule is hard. In fact, it’s not even feasible. You can only do this for a short while’ (female nurse, 61 years, Castilla-La Mancha). Individual Continuity of follow-up. Availability of referral specialists for each ‘Well… I’d say that… it’s working fine with these improvements I’ve just intervention Increase frequency of type of behaviour (each professional should mentioned … extend length of consultation… give direct advice…’ (man, visits to be able to talk. manage the behaviours where she feels more 51 years, healthcare attendee, Aragon). More specific advice. competent). ‘I would add some manner of social assessment, some evaluation of social Promote the motivational interview. interaction… of going out, if she socialises… For instance, I would include more Social assessment of participant. questions on prevention of social isolation…’ (female nurse, 62 years, Aragon). Consider the results perceived by the people. Continuity of follow-up. Promote the role of nursing in the follow-up. Group Enhance group Enhance group activities. ‘Actually… the… the topic… I think it is well presented… maybe what I missed intervention activities. was… well… what I mean with a meeting… not with a big group… perhaps six or eight people… for each person to be able to talk about what they want to talk… what they do… (man, 64 years, healthcare attendee, Aragon). Community Reaching out to the community. ‘I really believe that we need to change, we need to completely rethink intervention nursing, because it should become more community oriented, we should reach out more. It is already happening in other countries like Great Britain and others, where the nurse spends more time in the community than inside the consultation room of the surgery, that’s why I reckon that they’ll need to rethink, I don’t know, it’s just my opinion’ (female physician, Balearic Islands). Continued Open access 11 BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. 12 Table 4 Continued Open access Primary healthcare professionals and Healthcare attendees assistant researchers Quotations Patient Review patient information leaflets on physical ‘… with stretching exercises, with… an idea of the type of exercise information activity and depression. recommended for them, I think. Some more guidance, because I’m not an leaflets expert on this, I know very little about it, really, as a professional, and as a patient it’s even worse’ (female nurse, Basque Country). SMS Pay attention to time ‘Yes, about that… once I got an SMS at 12.30 at night, at 12.30 at night it does when sending SMS. not make any sense, I’m on standby for my father and the phone might ring’ (man, 59 years, healthcare attendee, Catalonia). Webpage More dynamic, user-friendly and practical. ‘And after the ICT tool, I would like to see a warning like a summary with a very clear idea of what you have to do next, you know “book an appointment in a month” or “no”, you know?’ (female physician, 45 years, Balearic Islands). Online case Easier and more practical. ‘Yet again, this platform does not allow you to register the commitment of the report form Possibility during follow-up to register priority patient and it is not practical. It does not reflect the agreement that you reach changes in the behaviours or risks to be with the patient and the one suggested is so cumbersome that it is impossible modified. to fulfil…’ (male physician, Balearic Islands). Systematic recording of drop-outs and causes. Evaluation of Explain results of Structured support for the assistant ‘That the assistant researchers were here on a permanent basis. For the whole the intervention questionnaires and researchers. duration of the study. Not just come one day and we’ll see. Here during our (assistant tests during the visit. Move the 3-month blood test to 6 months. same working hours’ (female nurse, 31 years, Castilla-La Mancha). researchers) Project Use of various Use of various strategies to disseminate to the ‘I’d say that mainly, for instance mmm.… How can I put it? Go some day to dissemination strategies to community the different phases of the project places like a marketplace, you know, to talk to people’ (woman, 47 years, disseminate to the and the results. healthcare attendee, Catalonia). community the ‘… to promote it, so that people know it exists, and of its purpose when they different phases of the see it, listen what is this in that case I’d like, I mean, for people to see that this project and the results. study is happening, experimental or pilot or whatever you call it, but that they can access that programme, that screening’ (female nurse, 60 years, Castilla-La Mancha). These quotations were translated by a professional scientific bilingual translator. Anonymity, confidentiality and data protection were guaranteed. It is impossible to identify participants; for example, Catalonia is a Mediterranean region with more than 7 million of inhabitants. Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. than the individual approach,30 health professionals One strength of the study is the use of the MRC underscored a more systematic use of social prescription approach for the design, implementation and evalua- in regular practice, which indicates an interest in imple- tion of complex interventions.4 6 7 The following phase menting a more biopsychosocial model.31 This qualitative of the intervention (definitive trial) will more specifi- assessment suggests that despite early resistance, profes- cally adapt to the people and setting and will be more sionals and healthcare attendees became eventually aware sustainable thanks to the richness and complementarity of the importance of the community components of health of the information generated by healthcare attendees promotion interventions. In addition, the feasibility of and professionals from these seven regions. The evalu- community recommendations is suggested as a selection ation process was also analysed by quantitative methods criteria of PCC with capability to develop complex health (paper under construction), but considering the limited promotion interventions based on networks that identify, sample of the pilot trial and the low response rate to ques- promote and evaluate local health assets.32 In contrast, tionnaires, qualitative evaluation has proven crucial to despite the growing holistic, psychological and collective understand how healthcare attendees and professionals conception of health,9 the persistence of the biomedical perceive the intervention. Moreover, the rigour proce- paradigm is shown by the positive evaluation of medical dures applied ensured the validity and reliability of the tests by healthcare attendees. findings. Although the authors of the current evaluation Most professionals and healthcare attendees consid- are also members of the EIRA research team, positive and ered SMS, a low cost method that preserves privacy, negative information on the intervention was rigorously useful for people with mobile phones. This outcome is collected to deepen understanding on the components consistent with other studies that suggest that SMS are that need improvement (see table 4). effective in health promotion interventions, particularly regarding quitting smoking and physical activity, where SMS can be used to provide positive feedback in order to Conclusions effect and maintain behavioural change.33–35 In contrast, The discourses of all stakeholders with regard to the inter- the webpage was not considered useful for participants, vention must be taken into consideration for a successful, in agreement with other studies that stress the relevance setting-specific implementation of the most adequate, of the patient–health professional relationship.35 36 acceptable, equitable and sustainable strategies for health promotion and well-being. Limitations and strengths In the EIRA Project, healthcare attendees and health Author affiliations professionals provided information and were consulted 1 Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi about the development and evaluation of the interven- Gol i Gurina (IDIAPJGol), Barcelona, Spain 2 tion. However, further steps towards deeper changes in Universitat Autònoma de Barcelona, Barcelona, Spain 3 Departament d'Infermeria, Universitat de Girona, Girona, Spain research practice should involve more effective participa- 4 Primary Care Research Unit of Mallorca, Balearic Health Services-IbSalut, Palma, tion in decision making.37 Spain Despite the use of theoretical sampling for healthcare 5 Primary Care Research Unit of Bizkaia, Basque Health Service-Osakidetza, Bilbao, attendees, the voice of participants with higher education Spain 6 qualifications (only 6% in the pilot trial) was insufficient. Psychology and Sociology Department, University of Zaragoza, Zaragoza, Spain 7 Facultad de Terapia Ocupacional, Logopedia y Enfermería, Universidad de Castilla- Also, the voluntary character of participation of health- La Mancha, Talavera de la Reina, Spain care attendees and professionals in this qualitative evalu- 8 Primary Care Research Unit, The Alamedilla Health Centre, Castilla and León Health ation might imply that only the experiences and opinions Service (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Salamanca, of people with a positive view of the intervention and of Spain 9 health promotion were collected. However, the detailed Health District of Primary Care Málaga-Guadalhorce, SAS, Málaga, Spain 10 Biomedical Research Institute of Malaga (IBIMA), Málaga, Spain description of less successful aspects, the polarisation of professionals regarding the benefits of the study and the Acknowledgements We are grateful to all healthcare attendees and professionals suggestions for improvement point at a diversity of stand- who participated in the study and shared their experiences. We would also like to points. We believe that it is nonetheless fundamental to thank Anna Moleras, Bonaventura Bolíbar, Joan Llobera, José Ángel Maderuelo, add the perspective of less motivated professionals and Rosa Magallón, Vicente Martínez, Elena Melús, Emma Motrico, Fernando Salcedo, Marc Casajuana, Edurne Zabaleta and Tomas López for their contributions and of participants that dropped out or that simply decided Eulàlia Farré for the English translation. not join the study. Although participants of this qualita- Contributors MP-V, AB and EP-R designed the study and wrote the protocol. tive study and of the EIRA Project comprise people from EP-R, MP-V, AB, BM, MP-F, SM, HP, CR and JAB participated in data collection and various geographical origins, the contribution of partic- generation techniques. MP-V, NC-A and EP-R conducted the analysis. All authors ularly vulnerable individuals (female carers, immigrants contributed to the interpretation of results. MP-V, AB and EP-R wrote the first draft of the manuscript. All authors read, contributed and approved the final version of and people with precarious employment) remains inad- the manuscript. equate. This subpopulation probably lack sufficient time Funding This project has been funded by the Carlos III Health Institute (Ministry of and need more attention regarding health promoting Economy and Competitiveness, Spain) with a grant for Research Projects on Health behaviour. More research is needed to further under- (PI12/01914; PI12/001616; PI12/02608; PI12/01974; PI12/02774; PI12/02635; standing of vulnerable patients. PI12/02379; and P15/00114) through the Network for Prevention and Health Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872 13 Open access BMJ Open: first published as 10.1136/bmjopen-2018-023872 on 23 March 2019. Downloaded from http://bmjopen.bmj.com/ on November 16, 2020 by guest. Protected by copyright. Promotion in Primary Care (redIAPP, RD12/0005/0001; RD16/0007/0001) and by 15. Palinkas LA, Aarons GA, Horwitz S, et al. Mixed method designs in European Union European Regional Development Fund (ERDF) funds (European implementation research. Adm Policy Ment Health 2011;38:44–53. Regional Development Fund). 16. Moser A, Korstjens I. Series: Practical guidance to qualitative research. Part 3: Sampling, data collection and analysis. Eur J Gen Competing interests None declared. Pract 2018;24:9–18. 17. Conde F. Los grupos triangulares como espacios transicionales para Patient consent for publication Obtained. la producción discursiva. In: Huelva L, ed. Culturas e identidades Ethics approval The study was approved by the Research Ethics Committee of the urbanas. Sevilla: Junta de Andalucia-Fundación El Monte, IDIAP Jordi Gol (2013; P12/073). The authors guarantee the accuracy, transparency 1996:275–307. and honesty of the data and information contained in the study. 18. MacLean LM, Meyer M, Estable A. Improving accuracy of transcripts in qualitative research. Qual Health Res Provenance and peer review Not commissioned; externally peer reviewed. 2004;14:113–23. 19. Morse JM, Richards L. Readme first for a user’s guide to qualitative Data sharing statement No additional data are available. methods: Sage, 2002. Open access This is an open access article distributed in accordance with the 20. Pope C, Ziebland S, Mays N. Qualitative research in health care. Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which Analysing qualitative data. BMJ 2000;320:114–6. permits others to distribute, remix, adapt, build upon this work non-commercially, 21. Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement and license their derivative works on different terms, provided the original work is challenges, and research agenda. Adm Policy Ment Health properly cited, appropriate credit is given, any changes made indicated, and the use 2011;38:65–76. is non-commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. 22. Tuckett AG. Part II. rigour in qualitative research: complexities and solutions. Nurse Res 2005;13:29–42. 23. Calderón C. Evaluación de la calidad de la investigación cualitativa en salud: criterios, proceso y escritura. Forum Qual Sozialforsch / References Forum Qual Soc Res 2009;10. 1. Starfield B, Shi L, Macinko J. Contribution of primary care to health 24. Cabeza E, March S, Cabezas C, et al. [Healthcare promotion in systems and health. Milbank Q 2005;83:457–502. primary care: if Hippocrates were alive today…]. Gac Sanit 2016;30 2. Rubio-Valera M, Pons-Vigués M, Martínez-Andrés M, et al. Barriers Suppl 1:81–6. and facilitators for the implementation of primary prevention and 25. Miller WR, William R, Rollnick S. Motivational interviewing: helping health promotion activities in primary care: a synthesis through meta- people change: Guilford Press, 2013. ethnography. PLoS One 2014;9:e89554. 26. Söderlund LL, Madson MB, Rubak S, et al. A systematic review 3. Moreno-Peral P, Conejo-Cerón S, Fernández A, et al. Primary care of motivational interviewing training for general health care patients' perspectives of barriers and enablers of primary prevention practitioners. Patient Educ Couns 2011;84:16–26. and health promotion-a meta-ethnographic synthesis. PLoS One 27. Dowrick C, May C, Richardson M, et al. The biopsychosocial 2015;10:e0125004. model of general practice: rhetoric or reality? Br J Gen Pract 4. Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating 1996;46:105–7. complex interventions: the new Medical Research Council guidance. 28. Bellón JÁ, Moreno-Peral P, Moreno-Küstner B, et al. Patients' BMJ 2008;337:a1655. opinions about knowing their risk for depression and what to do 5. Petticrew M. When are complex interventions 'complex'? When are about it. The predictD-qualitative study. PLoS One 2014;9:e92008. simple interventions 'simple'? Eur J Public Health 2011;21:397–8. 29. Castelló M, Fernández de Sanmamed MJ, García J, et al. Atenció A 6. Campbell M, Fitzpatrick R, Haines A, et al. Framework for design les persones amb malestar emocional relacionat amb condicionants and evaluation of complex interventions to improve health. BMJ socials a l’ atenció primària de salut. Barcelona: Fòrum Català 2000;321:694–6. d’Atenció Primària, 2016. 7. Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating 30. March S, Torres E, Ramos M, et al. Adult community health- complex interventions to improve health care. BMJ 2007;334:455–9. promoting interventions in primary health care: a systematic review. 8. Zabaleta-del-Olmo E, Bolibar B, García-Ortíz L, et al. Building Prev Med 2015;76:S94–104. interventions in primary health care for long-term effectiveness in 31. March S, Ripoll J, Jordan Martin M, et al. Factors related to health promotion and disease prevention. A focus on complex and the development of health-promoting community activities in multi-risk interventions. Prev Med 2015;76:S1–4. Spanish primary healthcare: two case-control studies. BMJ Open 9. Pons-Vigués M, Berenguera A, Coma-Auli N, et al. Health-care users, 2017;7:e015934. key community informants and primary health care workers' views 32. Cofiño R, Aviñó D, Benedé CB, et al. [Health promotion based on on health, health promotion, health assets and deficits: qualitative assets: how to work with this perspective in local interventions?]. study in seven Spanish regions. Int J Equity Health 2017;16:99. Gac Sanit 2016;30(Suppl 1):93–8. 10. Berenguera A, Pons-Vigués M, Moreno-Peral P, et al. Beyond 33. Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for the consultation room: proposals to approach health promotion health: a systematic review of reviews. Annu Rev Public Health in primary care according to health-care users, key community 2015;36:393–415. informants and primary care centre workers. Health Expect 34. Whittaker R, McRobbie H, Bullen C, et al. Cochrane Tobacco 2017;20:896–910. Addiction Group. Mobile phone-based interventions for smoking 11. Moore GF, Audrey S, Barker M, et al. Process evaluation of cessation. Cochrane Database Syst Rev 2016;17. complex interventions: medical research council guidance. BMJ 35. Berenguera A, Molló-Inesta À, Mata-Cases M, et al. Understanding 2015;350:h1258. the physical, social, and emotional experiences of people with 12. Ludvigsen MS, Meyer G, Hall E, et al. Development of clinically uncontrolled Type 2 diabetes: a qualitative study. Patient Prefer meaningful complex interventions - the contribution of qualitative Adherence 2016;10:2323–32. research. Pflege 2013;26:207–14. 36. Carmona-Terés V, Moix-Queraltó J, Pujol-Ribera E, et al. 13. Cooper C, O'Cathain A, Hind D, et al. Conducting qualitative Understanding knee osteoarthritis from the patients' perspective: a research within clinical trials units: avoiding potential pitfalls. qualitative study. BMC Musculoskelet Disord 2017;18:225. Contemp Clin Trials 2014;38:338–43. 37. Boote J, Baird W, Beecroft C. Public involvement at the design stage 14. Nilsen P. Making sense of implementation theories, models and of primary health research: a narrative review of case examples. frameworks. Implement Sci 2015;10:53. Health Policy 2010;95:10–23. 14 Pons-Vigués M, et al. BMJ Open 2019;9:e023872. doi:10.1136/bmjopen-2018-023872