Open access Protocol Effectiveness and cost-­effectiveness of a virtual community of practice to improve the empowerment of patients with ischaemic heart disease: study protocol of a randomised controlled trial Ana Isabel González-­González ‍ ‍,1,2 Lilisbeth Perestelo-­Pérez,3,4 Débora Koatz,5,6 Marta Ballester ‍ ‍,5,6 Valeria Pacheco-­Huergo,5,7 Vanesa Ramos-­García ‍ ‍,8 Alezandra Torres-­Castaño,8 Amado Rivero-­Santana,3,4 Ana Toledo-­Chávarri,4,8 Cristina Valcárcel-­Nazco,8 Juana Mateos-­Rodilla,9 Juan Carlos Obaya-­Rebollar,10 Javier García-­García,11 Santiago Díaz-­Sánchez,12 Luis Morales-­Cobos,13 Josep María Bosch-­Fontcuberta,14,15 Nuria Vallejo-­Camazón,16 Ana Rodríguez-­Almodovar,17 José Carlos del Castillo,18 Marcos Muñoz-­Balsa,19 Yolanda del Rey-­Granado,19 Sofía Garrido-­Elustondo,20 María-­Eugenia Tello-­Bernabé,21 Ana Belén Ramírez-­Puerta,19 Carola Orrego ‍ ‍5,6 To cite: González-­González AI, Perestelo-­Pérez L, Koatz D, ABSTRACT et al. Effectiveness and Strengths and limitations of this study Introduction Virtual Communities of Practice (VCoP) or cost-­effectiveness of a virtual knowledge-­sharing virtual communities offer ubiquitous community of practice to ►► We will experimentally test an innovative learn- access to information and exchange possibilities for people in improve the empowerment ing intervention based on a Virtual Community of of patients with ischaemic similar situations, which might be especially valuable for the Practice (VCoP) for patient empowerment, for which heart disease: study self-­management of patients with chronic diseases. In view the literature lacks experimental evaluations. protocol of a randomised of the scarce evidence on the clinical and economic impact of ►► VCoP can enhance communication between com- controlled trial. BMJ Open these interventions on chronic conditions, we aim to evaluate munity members in different geographic locations 2020;10:e037374. doi:10.1136/ the effectiveness and cost-­effectiveness of a VCoP in the and even from different time zones. bmjopen-2020-037374 improvement of the activation and other patient empowerment ►► Participation rate can be low as similar experienc- ►► Prepublication history and measures in patients with ischaemic heart disease (IHD). es have shown; we will include the active role of additional material for this paper Methods and analysis A pragmatic randomised controlled a community manager, weekly emails as reminders is available online. To view these trial will be performed in Catalonia, Madrid and Canary Islands, and a gamified competitive score system to boost files, please visit the journal Spain. Two hundred and fifty patients with a recent diagnosis participation. online (http://​dx.​doi.​org/​10.​ of IHD attending the participating centres will be selected ►► Since all randomised patients will be required a min- 1136/​bmjopen-​2020-​037374). and randomised to the intervention or control group. The imum level of digital literacy so, the results could not Received 04 February 2020 intervention group will be offered participation for 12 months be generalised to all patients. Revised 17 August 2020 in a VCoP based on a gamified web 2.0 platform where there ►► Patients belonging to the control group and inter- Accepted 26 August 2020 is interaction with other patients and a multidisciplinary vention group could receive a different type of self-­ professional team. Intervention and control groups will receive management support depending on the centres usual care. The primary outcome will be measured with the where the care is provided. Patient Activation Measure questionnaire at baseline, 6, 12 © Author(s) (or their employer(s)) 2020. Re-­use and 18 months. Secondary outcomes will include: clinical permitted under CC BY-­NC. No variables; knowledge (Questionnaire of Cardiovascular Risk University Hospital in Madrid, Nuestra Señora de Candelaria commercial re-­use. See rights Factors), attitudes (Self-­efficacy Managing Chronic Disease University Hospital in Santa Cruz de Tenerife and IDIAP Jordi and permissions. Published by Scale), adherence to the Mediterranean diet (Mediterranean Gol in Barcelona. The results will be disseminated through BMJ. Diet Questionnaire), level of physical activity (International workshops, policy briefs, peer-­reviewed publications, local/ For numbered affiliations see Physical Activity Questionnaire), depression (Patient Health international conferences. end of article. Questionnaire), anxiety (Hospital Anxiety Scale-­A), medication Trial registration number ​ClinicalTrials.​gov Registry adherence (Adherence to Refill Medication Scale), quality of life (NCT03959631). Pre-­results. Correspondence to (EQ-­5D-­5L) and health resources use. Data will be collected Dr Ana Isabel González-­ González; from self-­reported questionnaires and electronic medical ​gonzalezgonzalez@​ records. INTRODUCTION allgemeinmedizin.​uni-​frankfurt.​ Ethics and dissemination The trial was approved by In Western countries, ischaemic heart de Clinical Research Ethics Committee of Gregorio Marañón disease (IHD) is a major public concern, González-­González AI, et al. BMJ Open 2020;10:e037374. doi:10.1136/bmjopen-2020-037374 1 Open access and although mortality from IHD has been significantly There is little research on the effect of VCoP in terms reduced since 2000, it remains as a leading cause of death of their clinical and economic impact and on the empow- (50.6 deaths/100 000 inhabitants in Spain and 106.6 erment of patients with chronic diseases, especially with deaths/100 000 inhabitants in the USA in 2016).1 In IHD.19 20 We propose to address this gap and, thus, Spain, 32 325 people died from IHD in 2017, according present the protocol of a randomised controlled trial, to the National Institute of Statistics.2 Patients with IHD which mainly aims to evaluate the effectiveness and cost-­ may have a stable disease or an acute coronary syndrome, effectiveness of a VCoP to improve the activation and which could present with or without ST segment eleva- other measures related with patient empowerment in tion. In addition, some patients may have left ventricular patients with IHD. dysfunction and heart failure.3–5 For the treatment of IHD, in addition to the phar- macological treatment and, if necessary, interventional METHODS AND ANALYSIS procedures, it is essential to manage cardiovascular risk This protocol has been prepared in accordance with the factors such as smoking cessation, blood pressure, lipids Standard Protocol Items: Recommendations for Inter- and diabetes control, adherence to a Mediterranean ventional Trials checklist (online supplemental addi- diet, active lifestyle and prevent obesity. Moreover, for tional file 1).21 the secondary prevention of IHD, cardiac rehabilita- tion programmes are beneficial for patients, improving Study design exercise capacity, quality of life and psychological well-­ We plan a pragmatic randomised controlled multicentre being.6–8 The active role of the patient is crucial, along trial (e-­mpodera2), with two parallel arms and 18-­month with the support of healthcare providers to achieve a follow-­up. successful secondary prevention of IHD. The empowerment and self-­management of patients Study setting with chronic conditions are becoming one of the main The setting of the intervention will be a virtual setting. objectives in healthcare, especially in primary care (PC). Usual care will be provided at primary care practices The European EMPATHiE project9 defines the empow- (PCPs) and outpatient specialised clinics in Catalonia, ered patient as one who ‘has control over the manage- Madrid and Canary Islands in Spain. ment of the conditions of their daily life, actively tries Eligibility criteria to improve his/her quality of life and has the necessary Patients with a recent diagnosis of IHD will be screened knowledge, skills, attitudes and self-­perception to adjust for the following eligibility criteria: his/her behaviour and work in partnership with others when necessary, to achieve optimal well-­being’. Inclusion criteria One of the domains included in patient empower- Age ≥18 years; active diagnosis in the electronic medical ment is the level of patient activation. Patient activation record (EMR) of IHD (International Classification of incorporates a combination of knowledge about the Primary Care Second Edition - ICPC-2 codes K74-76; illness, ability and self-­ confidence in the management or International Classification of Diseases 9th Edition - of the medical conditions.10 It is associated with healthy ICD-9 codes 410, 411, 411.8, 413, 414 and 414.9) in the behaviours, good chronic disease metrics and reduced year prior to inclusion in the study; internet at home or morbidity and unplanned hospitalisations.11–15 smartphone; be able to follow the requirements of the Interventions aimed at empowerment are intended to study (eg, digital literacy); have signed the informed provide patients (and their informal caregivers, when consent (online supplemental additional file 2). appropriate) with the ability to participate in decisions related to their illness to the extent they wish, develop Exclusion criteria self-­confidence, self-­esteem and skills to face the physical, Institutionalised, terminal illness, physical or mental emotional and social impact of the disease in their daily disability that limits the ability to answer the question- lives.16 17 naires or when telephone/email contact is not available Virtual Communities of Practice (VCoP) offer ubiquitous in the PCPs/hospitals’ databases. access to information and exchange possibilities for people in similar situations, which is especially valuable in patients Interventions with chronic diseases. A CoP is a group of individuals who VCoP group participate in a common activity and experience and create ‘e-­mpodera2’ is a gamified VCoP on a web 2.0 platform a shared identity and deepen their knowledge and expe- based on the exchange of experiences and knowledge rience in the area through a continuous interaction that through participatory learning.22 It will provide educa- strengthens their relationships.18 In this context, a group tional, playful elements and tools that will facilitate the of patients with the same illness such as IHD, could benefit learning and transfer of knowledge and attitudes among from an intervention of these characteristics where they can patients with IHD and with healthcare professionals. The share resources and information in addition to having the structure and components will be designed according to possibility of receiving peer and professional support. the needs and specifications of patients with IHD recruited 2 González-­González AI, et al. BMJ Open 2020;10:e037374. doi:10.1136/bmjopen-2020-037374 Open access in an earlier stage using a cocreation methodology with professionals combined with information from the face-­to-­ face sessions and virtual activities (forums and EMR. interactions) that incorporated a personalised itinerary— ►► Knowledge about the disease will be assessed through Patient Journey Map—(published elsewhere) and with a self-­administered online questionnaire based on the use of various types of content including readings, the Questionnaire of Cardiovascular Risk Factors,26–28 resources, videos, games and virtual sessions.22 previously translated from the English version and Patients will have access to multidisciplinary profes- adapted to the Spanish population. sional support as needed and according to what was iden- ►► Patients’ attitudes to self-­care will be evaluated using tified in the content-­design stage (published elsewhere) the self-­administered Self-­efficacy Managing Chronic that will potentially include general practitioners, cardi- Disease Scale (SMCDS),29 translated into Spanish30 ologists, psychologists, self-­care and self-­management and used in patients with heart failure.31 specialists, nutritionist and others as necessary. Various ►► Adherence to the Mediterranean diet will be assessed thematic areas related to the empowerment of patients with the Mediterranean diet questionnaire,32 vali- and self-­care of IHD will be progressively covered: health dated in the Spanish population in the PREDIMED competence, self-­ efficacy and activation improvement, (Prevención con Dieta Mediterránea) study.33–35 behavioural changes, lifestyle/signs/symptoms moni- ►► Physical activity will be measured using the Interna- toring, technical skills, chronic disease acceptance and tional Physical Activity Questionnaire (IPAQ), trans- shared decision-­making. Special emphasis will be given to lated and adapted to the Spanish language.36 Patients the changes recommended by European Guidelines23 for will be classified into three categories (low, medium self-­management of IHD including monitoring changes and high) according to the index of physical activity in symptoms, stress management, mental health and (product of the intensity—in Metabolic Equivalents, adherence to medication, diet, exercise plans, sodium METs—by the frequency) and the duration of the cholesterol, and alcohol restriction and tobacco absti- activity. nence. The active role of a community manager, weekly ►► Depressive disorders will be detected by the Patient emails as reminders and a gamified competitive score Health Questionnaire-9 (PHQ-9),37 validated in system will boost participation. Spanish with similar behaviour to the original and good acceptance.38 Usual care group ►► Anxiety will be assessed using the Hospital Anxiety Patients allocated to both the intervention and the and Depression Scale (HADS scale),39 a 14-­ item control group will continue with their usual self-­care and questionnaire validated in PC in Spain,40 41 with professional care according to the local guidelines.3–5 special interest and usefulness in the context of PC. It is a measure composed of two subscales (HADS-­A: anxiety and HADS-­D: depression), of 7 items each Outcomes measures that are scored from 0 to 3. The authors recom- Primary outcome mend a threshold of eight points to detect possible The primary outcome will be the patient activation level cases of anxiety. One of the main virtues of this tool using the Patient Activation Measure (PAM) question- is the suppression of somatic symptoms. However, naire that assesses activation in patients with chronic in patients with IHD, it underestimates people with diseases.12 The questionnaire consists of 13 items that depression,42 while the subscale HADS-­A has good assess knowledge, skills and confidence of people for specificity and predictive value for measuring anxiety self-­ care, measured by a Likert 1–4 scale with a total in this PC.43 score between 0 and 100 (100 identifies the patients ►► Adherence to medication will be assessed with the with the highest level of activation). The Spanish trans- Adherence Refill and Medication Scale (ARMS),44 lated version has been validated in patients with chronic validated in Spain and used to measure adherence diseases and has demonstrated a similar behaviour to to medication in patients with chronic diseases. It the original instrument with good validity and reliability consists of 12 questions and there is no cut-­off point, properties.24 It has been used in previous studies by this the lower the score, the better the adherence. To research team.25 quantify adherence, a value of 1–4 (never, sometimes, almost always or always) is assigned to each of the Secondary outcomes responses according to a Likert-­type scale. For the effectiveness of the VCoP, we will record the ►► Quality of life related to health (HRQoL) will be following secondary measures: described and assessed with the EQ-­5D-­5L index,45 46 a ►► Clinical variables such as body mass index, lipid profile generic and standardised instrument developed by the (High-­density lipoprotein cholesterol - HDL-­C, Low-­ EuroQoL Group, and prepared in several languages, density lipoprotein cholesterol - LDL-­ C), smoking including Spanish, and used in PC.47 It relates the status, number and frequency of angina episodes will HRQoL with the amount of life and offers a score be collected through researcher developed online for the gains in health, the Quality Adjusted Life Year questionnaire that will be fulfilled by healthcare (QALY). The descriptive EQ-­5D-­5L system comprises González-­González AI, et al. BMJ Open 2020;10:e037374. doi:10.1136/bmjopen-2020-037374 3 Open access five dimensions (mobility, personal care, daily activi- is 200 patients (100 per arm). Assuming a 20% loss to ties, pain/discomfort and anxiety/depression). follow-­up, the required sample increases to 250 (125 per arm). Explanatory and adjustment variables Sociodemographic: age, sex, nationality, Autonomous Recruitment Community of residence (Catalonia, Madrid or Canary Patient recruitment will be organised on each Autono- Islands), marital status (married/partner, single, sepa- mous Community (Catalonia, Madrid or Canary Islands). rated/divorced, widowed), living alone (yes/no), educa- The recruitment will be supported by informative meet- tional level (incomplete primary education, complete ings with directors and healthcare professionals (general primary education, secondary education, university practitioners, nurses, cardiologists) from the partici- or equivalent studies), income level and employment pating centres. In these meetings, a 10-­minute presen- status.48 tation describing the study aim, planned time frame Morbidity-­related: type of IHD (stable angina, unstable and tasks to be carried out by healthcare professionals, angina, myocardial infarction), duration of IHD expected resources utilisation and funding procedures (months), current diagnosis of heart failure in EMR will be detailed. Patients that fulfil inclusion criteria will (K86), left ventricular ejection fraction (≤ ‍ ‍30%, 30%–35%, be actively encouraged by their healthcare professionals 35%–45%, >45%), New York Heart Association (NYHA) to participate by providing information about the trial functional classification (I–IV), number and description and collecting their informed consent and contact details of chronic concomitant diseases,49 pharmacological treat- (eg, phone number/email). The research team will invite ment (acetylsalicylic acid or clopidogrel/ticagrelor/pras- potential participants via phone and mail to access the ugrel, beta-­blockers, statins, ACE inhibitors, angiotensin ‘e-­mpodera2’ platform where they will be provided with II receptor blockers, other treatments), cardiac catheter- a unique registration code (figure 1). Patients will be isation (yes/no) and participation in a cardiac rehabil- consecutively included in the study; recruitment will be itation programme before and during the study period continuous until the sample size is reached. (yes/no). ►► Use of healthcare resources: primary care (PC) visits, Allocation and blinding visits to the emergency department, visits to specialists, Two hundred and fifty patients will be randomly assigned number of hospitalisations, lengths of stay, prescribed to the intervention (VCoP) or control group. The rando- medications, use of diagnostic tests. misation, stratified by centre, will be central and automat- ►► Loss of productivity: self-­administered questionnaire ically performed by the online ‘e-­mpodera2’ platform and about work absences related to the illness. the assigned group will be communicated to the patient ►► Use of the VCoP: number of logins into the platform once he or she has entered the platform and completed and time spent using the platform. baseline assessment (figure 1). Lack of knowledge of the This information will be collected online from a patient randomisation sequence by the professionals who partic- self-­reported questionnaire that the research team will ipate in the recruitment of patients will, therefore, be elaborate combined with information from the EMR. ensured. The intervention group will be taken directly to VCoP use data will be collected through the platform the registration page of ‘e-­mpodera2’ VCoP, where they database. will receive a personalised message to welcome them into the platform. To warrant patient participation and coop- Adverse events eration, this type of intervention cannot be blinded to All significant adverse events as well as unintended patients. Data analysis will be blinded to the assignment consequences for each group will be collected and of the intervention. described by the site researcher, nominated for each PCP and hospital, and reported to the core team. A Data management special form to report trial-­related adverse events has In order to maintain participant confidentiality, all infor- been developed and distributed. mation will be stored with anonymised ID code numbers. The ID code numbers will be unrelated to participants’ Participant timeline identifiers, except in a central file with the participants’ Primary and secondary outcome measures will be contact details. All data will be stored on an electronic collected before the start of the VCoP intervention and at database management system located on a secure server 6, 12 and 18 months. See table 1. with password-­ controlled access provided for research data collection. Databases will be designed to avoid down- Sample size loading inappropriate values for every variable. Trial Assuming an alpha error of 0.05 and power of 80%, the monitoring will be the responsibility of the core research necessary number of patients to detect, by means of inde- team in charge of all quality control activities, assessing pendent two-­sample t-­test, an average minimal important adherence to the trial protocol: timely work plan execu- difference of 4 points (SD 10) in the PAM question- tion and comprehensiveness of data acquisition and data naire12 24 between the intervention and usual care group, quality. 4 González-­González AI, et al. BMJ Open 2020;10:e037374. doi:10.1136/bmjopen-2020-037374 Open access Table 1 Schedule of enrolment, interventions, and assessments (SPIRIT checklist) Study period Preallocation Postallocation Close-­out Timepoint Enrolment Baseline 6 months 12 months 18 months Eligibility screen X         Informed consent X         Interventions            VCoP            Usual care           Assessments            PAM   X X X X  Sociodemographic and clinical variables   X X* X* X*  Knowledge   X X X X  SMCDS   X X X X  Mediterranean Diet Questionnaire   X X X X  IPAQ   X X X X  PHQ-9   X X X X  HADS-­A   X X X X  ARMS-­e   X X X X  EQ-­5D-­5L   X X X X  Use of resources     X X X  Use of VCoP            Adverse events           *Follow-­up of just clinical variables. ARMS-­e, Adherence Refill and Medication Scale; HADS, Hospital Anxiety and Depression Scale; IPAQ, International Physical Activity Questionnaire; PAM, Patient Activation Measure; PHQ-9, Patient Health Questionnaire; SMCDS, Self-­efficacy Managing Chronic Disease Scale; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; VCoP, Virtual Community of Practice. The Research Ethics Committees, the representatives Between-­ group differences at each time-­ point will be of the Health Authority in matters of inspection and compared by means of Wald’s χ2 test. the personnel authorised by the Promoter, may only We will perform the analyses on an intention-­to-­treat access to check personal data, clinical study procedures basis (a sensitivity analysis on the per-­protocol popula- and compliance with the rules of good clinical practice tion will be also performed). Multiple imputation will be (always maintaining the confidentiality of information). used for missing data, if applicable (Markov Chain Monte Carlo multivariate imputation algorithm, with 10 imputa- Statistical analysis tions per variable). Analyses will be carried out with the Sociodemographic and clinical baseline variables for statistical software R V.4.0.2 (http://www.​R-​project.​org/). both groups will be analysed by descriptive methods (mean (SD), median (range), n (%)). The VCoP effect Cost-effectiveness analysis of the VCoP on the primary and secondary outcomes will be examined We will carry out an economic evaluation, from base- by means of multilevel linear regression, with the inter- line to 18-­month follow-­up, in which the costs and the vention, measurement time (0, 6, 12 and 18 months) results of the VCoP will be compared with the usual care and their interaction as fixed effects (along with other following the recommendations of the guidelines for the potential covariates), random intercepts for patients management of patients with IHD,3–5 during the period and general practitioner (GP), and unstructured covari- of the clinical trial. The accepted analytical methods by ance to account for within-­subject correlations. We will the scientific community will be followed.50 The analysis also analyse the three-­ way interaction intervention×- will take both the perspective of the National Health time×centre, since usual care could vary between centres, System and of the social perspective. Therefore, direct leading to differential intervention effects. We expect to healthcare costs and indirect costs will be included. recruit a sufficient number of GPs to allow their inclusion The direct costs per patient will be calculated based in the model as a random intercept, but we will perform on the use of healthcare resources, and the indirect a sensitivity analysis as well as excluding this component. costs will be estimated, focusing on productivity losses González-­González AI, et al. BMJ Open 2020;10:e037374. doi:10.1136/bmjopen-2020-037374 5 Open access Figure 1 Flow of participants. ARMS, Adherence Refill and Medication Scale; CdPV, Comunidad de Práctica Virtual; HADS-­A, Hospital Anxiety and Depression Scale; IPAQ, International Physical Activity Questionnaire; PAM, Patient Activation Measure; PHQ-9, Patient Health Questionnaire; SMCDS, Self-­efficacy Managing Chronic Disease Scale. 6 González-­González AI, et al. BMJ Open 2020;10:e037374. doi:10.1136/bmjopen-2020-037374 Open access due to IHD, applying the human capital approach. receive written information of the proposed research In addition to including the short-­term costs (devel- project, including information regarding the aims of the opment and implementation of the VCoP), the costs project, the duration of the participants’ involvement, the observed during the follow-­ up will be included. We expected benefits to the participant and the procedures do not plan to consider opportunity costs in our cost-­ involved in the participation. Recruiters will emphasise effectiveness analysis from the social perspective, as that enrolment in the study is voluntary and that partici- we understand that patients will use their free time on pants can withdraw at any moment of the project and that the VCoP and therefore they will not spend work or any decision they take in this respect will have no bearing productive time not generating a cost for the system. on the medical care received. Once patients have signed The use of resources will be obtained from a patient the written informed consent, a researcher from the ‘e-­m- self-­reported questionnaire described in the outcome podera2’ team will contact them via phone and/or mail section. In addition, information about work absences to provide further information along with the necessary related to the illness will be requested. The classic costs data (username and password) to login into the online estimation approach will be followed, multiplying the platform. Additionally, recruiters will highlight that infor- use of resources by their unit cost. The unit costs will mation generated by the study will be published, but no be obtained from the eHealth cost database (Oblikue identification details will be divulged. Patients and health- Consulting) and from public sources such as rates and care providers will be informed of whom to contact in retail prize. The main outcome measure will be the case of any query and research staff will be available to incremental cost per gained QALY. The utilities for the answer questions. estimation of the QALYs will be obtained through the We will prepare presentations to disseminate the study EQ-­5D-­5L questionnaire45 that will be completed by findings to healthcare stakeholders and patients, and the patient at the beginning of the study and at each at relevant national and international conferences. We follow-­up visit. Results of the cost-­effectiveness analysis aim to publish the results of the trial in peer-­reviewed will be summarised as the incremental cost-­effectiveness journals. ratio (ICER). ICER is the ratio of the differences in costs to the differences in observed effects. Non-­parametric TRIAL STATUS methods based on bootstrap simulations will be used The recruitment of patients in each region will start in to calculate CIs in the ICER. The same non-­parametric September 2020. The estimated end date of the recruit- methods will be used to calculate the acceptability curve ment for this study is December 2020. that represents the probability that each choice will be cost-­effective for different cost-­effectiveness thresholds. Author affiliations The willingness-­to-­pay threshold is defined at Euro 25 1 Goethe-­Universitat Frankfurt am Main Institut fur Allgemeinmedizin, Frankfurt am 000/QALY on the basis of the values most recently Main, Hessen, Germany 2 reported in the Spanish literature.51 Finally, determin- Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Gerencia Asistencial de Atención Primaria, Servicio Madrileño de Madrid, Madrid, istic sensitivity analyses (one, two or several ways) will be Spain carried out in order to assess the impact of the parame- 3 Servicio de Evaluación y Planificación del Servicio Canario de la Salud, Tenerife, ters on the cost-­effectiveness results of the VCoP. Spain 4 Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Patient and public involvement Tenerife, Spain 5 This protocol was developed without patient or public Avedis Donabedian Research Institute (FAD), Barcelona, Spain 6 Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), involvement. A group of patients with IHD will actively Barcelona, Spain participate in a content-­ design previous stage using a 7 Centro de Atención Primaria Turó, Instituto Catalán de la Salud, Barcelona, Spain cocreation methodology with face-­ to-­ face sessions and 8 Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, virtual activities. Spain 9 Escuela Madrileña de Salud, Dirección General de Humanización y Atención al Paciente, Madrid, Spain 10 Centro de Salud Chopera, Gerencia Asistencial de Atención Primaria, Madrid, ETHICS AND DISSEMINATION Spain Informed consent will be obtained from each partici- 11 Unidad de Calidad y Seguridad del Paciente. Hospital Universitario Nuestra Señora pant before randomisation. The project received ethics de Candelaria, Tenerife, Spain 12 approval from the local Committees at each participating Centro de Salud Pintores, Gerencia Asistencial de Atención Primaria, Madrid, Spain Autonomous Community: Clinical Research Ethics 13 Centro de Salud Las Américas, Gerencia Asistencial de Atención Primaria, Madrid, Committee of Gregorio Marañón University Hospital Spain in Madrid, Nuestra Señora de Candelaria University 14 Centro de Atención Primaria Encants, Instituto Catalán de la Salud, Barcelona, Hospital in Santa Cruz de Tenerife and from the coordi- Spain 15 nating centre IDIAP Jordi Gol in Barcelona (19/053-­P). Departament de Medicina Area de Medicina, Universitat Autonoma de Barcelona, Barcelona, Catalunya, Spain Patients will be personally informed by their physicians 16 Hospital Germans Trias i Pujol, Badalona, Catalunya, Spain or nurses about the study and the possibility to partici- 17 UGC Cardiología, Hospital Universitario Reina Sofía, Códoba, Spain pate during a programmed consultation. They will 18 Cardiovascular Area, Hospital San Juan de Dios, Tenerife, Canarias, Spain González-­González AI, et al. BMJ Open 2020;10:e037374. doi:10.1136/bmjopen-2020-037374 7 Open access 19 Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio 12 Skolasky RL, Green AF, Scharfstein D, et al. Psychometric properties Madrileño de Salud, Madrid, Spain of the patient activation measure among multimorbid older adults. 20 Centre Family and Community Care Teaching Multiprofessional Unit, Comunidad Health Serv Res 2011;46:457–78. 13 Salyers MP, Matthias MS, Spann CL, et al. The role of patient de Madrid Consejeria de Sanidad, Madrid, Spain activation in psychiatric visits. Psychiatr Serv 2009;60:1535–9. 21 Centro de Salud El Naranjo, Gerencia Asistencial Atención Primaria, Servicio 14 Schmittdiel J, Mosen DM, Glasgow RE, et al. Patient assessment Madrileño de Salud, Madrid, Spain of chronic illness care (PACIC) and improved patient-­centered outcomes for chronic conditions. J Gen Intern Med 2008;23:77–80. Twitter Marta Ballester @Inst_Donabeidan 15 Mosen DM, Schmittdiel J, Hibbard J, et al. Is patient activation associated with outcomes of care for adults with chronic conditions? Contributors AIG-­G wrote the initial draft of the protocol. CO is the guarantor J Ambul Care Manage 2007;30:21–9. of the trial. AIG-­G, CO, LP-­P, DK, VP-­H and MB conceived the project. SG-­E, AR-­R 16 Náfrádi L, Nakamoto K, Schulz PJ. Is patient empowerment the and CV-­N provided the methodological guidance. AT-­C, VR-­G, AT-­C, JM-­R, JCO-­R, key to promote adherence? A systematic review of the relationship SD-­S, LM-­C, JG-­G, NV-­C, AR-­A, JCdC, JMB-­F, M-­ET-­B, MMB, YdR-­G and ABR-­P are between self-­efficacy, health locus of control and medication adherence. PLoS One 2017;12:e0186458. co-­supervisors of this project, providing advice at all stages of the development of 17 Risling T, Martinez J, Young J, et al. Evaluating patient Empowerment the protocol, and contributed to the revision of the manuscript. All authors read and in association with eHealth technology: Scoping review. J Med approved the final manuscript. Internet Res 2017;19:e329. Funding This study has been funded by Instituto de Salud Carlos III through the 18 Li LC, Grimshaw JM, Nielsen C, et al. Evolution of Wenger's concept of community of practice. Implement Sci 2009;4:11. project ‘PI18/01404, PI18/01397, PI18/01333’, Co-­funded by European Regional 19 Oliva A. Psychosocial intervention 2013;22:15–23. Development Fund, (ERDF) ‘A way of shaping Europe’. 20 Pinilla J, Barber P BG. El coste de la enfermedad potencialmente Competing interests None declared. prevenible en España. Madrid; 2017. 21 Chan A-­W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation Patient and public involvement Patients and/or the public were involved in the and elaboration: guidance for protocols of clinical trials. BMJ design, or conduct, or reporting, or dissemination plans of this research. Refer to 2013;346:e7586–7. the Methods section for further details. 22 Bermejo-­Caja CJ, Koatz D, Orrego C, et al. Acceptability and feasibility of a virtual community of practice to primary care Patient consent for publication Not required. professionals regarding patient empowerment: a qualitative pilot Provenance and peer review Not commissioned; externally peer reviewed. study. BMC Health Serv Res 2019;19:403. 23 National Clinical Guideline Centre. MI - Secondary Prevention: Open access This is an open access article distributed in accordance with the Secondary Prevention in Primary and Secondary Care for Patients Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which Following a Myocardial Infarction: Partial Update of NICE CG48. permits others to distribute, remix, adapt, build upon this work non-­commercially, London Royal College of Physicians; 2013. and license their derivative works on different terms, provided the original work is 24 Moreno-­Chico C, González-­de Paz L, Monforte-­Royo C, et al. properly cited, appropriate credit is given, any changes made indicated, and the use Adaptation to European Spanish and psychometric properties of the is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. patient activation measure 13 in patients with chronic diseases. Fam Pract 2017;34:627–34. 25 González-­González AI, Orrego C, Perestelo-­Perez L, et al. 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