Molina-Férnandez et al. BMC Public Health (2019) 19:1224 https://doi.org/10.1186/s12889-019-7572-9 STUDY PROTOCOL Open Access The effectiveness of a digital shared decision-making tool in hormonal contraception during clinical assessment: study protocol of a randomized controlled trial in Spain Maria Inmaculada de Molina-Férnandez1, Laia Raigal-Aran1* , Miriam de la Flor-Lopez2, Paula Prata3, Isabel Font-Jimenez1, Francesc Valls-Fonayet4, Gemma March-Jardi5, Ramon Escuriet-Peiro6 and Lourdes Rubio-Rico1 Abstract Background: Decision-making tools represent a paradigm shift in the relationship between the clinician and the user/patient. Some of their advantages include patient commitment, the promotion of preferences and values, and increased treatment adherence. This study protocol aims to assess the effectiveness of a decision-making tool in contraception (SHARECONTRACEPT) concerning: a) Improvement in counselling on hormonal contraception at the medical consultation, measured in terms of decreasing decisional conflict and improving knowledge of available contraceptive options; b) Improvement in adherence to treatment measured in terms of: persistence in the chosen treatment, compliance with dose or procedure of use, and ability to deal with incidents related to the use of the contraceptive method; and decreasing unwanted pregnancies and voluntary interruption of pregnancy. The SHARECONTRACEPT tool, developed by previous phases of this project, is available at: http://decisionscompartides. gencat.cat/en/decidir-sobre/anticoncepcio_hormonal/ Methods/design: A longitudinal, prospective-type, randomized, controlled community clinical trial, carried out in the clinical contraceptive counselling units of 6 autonomous regions in Spain, with an experimental group and a control group. Description of the intervention: The health professionals participating will be randomly assigned to one of the two groups. Clinicians assigned to the experimental group will perform contraceptive counselling assisted by SHARECONTRACEPT, and those of the control group will follow the conventional contraceptive counselling provided in their clinical unit. It is planned to study 1708 users (control group n = 854 and intervention group n = 854), recruited from women who attend the consultations of the health professionals. The selected users will be followed up for one year. The data will be collected through ad-hoc questionnaires, and validated instruments for measuring decisional conflict and adherence to treatment. (Continued on next page) * Correspondence: laia.raigal@urv.cat 1 Nursing Department, Campus Catalunya, Universitat Rovira i Virgili, Av/ Catalunya, 35, 43002 Tarragona, Spain Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Molina-Férnandez et al. BMC Public Health (2019) 19:1224 Page 2 of 8 (Continued from previous page) Discussion: The results of this study protocol will offer evidence of the effectiveness of a shared decision- making tool, SHARECONTRACEPT, which may prove a useful tool for users and professionals to promote adherence to contraceptive methods. Trial registration: Clinical Register number ISRCTN5827994. Date: 15/04/2019 (Retrospectively registered) Keywords: Study protocol, Clinical trial, Contraception, Treatment adherence, E-health, Shared decision-making tool Background used, but also to other methods such as the progestogen In Spain, nine out of ten women of childbearing age, pill (used by 0.1%), combined injectable contraceptives between 15 and 49 years, report that they have had (used by 0.2%), patches (used by 0.7%), and the combined sex, at some time, and two out of ten report having hormonal vaginal ring (used by 2.9%). Long-acting revers- had sex without using any method of contraception. ible contraception (LARC) methods, including intrauter- In other words, some two million women would currently ine devices (IUDs) and the subdermal implant, are the be exposed to an unwanted pregnancy in our country most effective as regards avoiding unwanted pregnancies (SEC) [1]. In this regard, in 2015 a report was published (Pearl index for implants, the Levonorgestrel IUD and the that stated that approximately 35% of pregnancies in Spain copper IUD of 0.05, 0.2 and 0.8–2 pregnancies per 100 were unwanted (some 190,000 unwanted pregnancies/ women/year, respectively) [5]. Based on the latest results year) [2]. of the SEC, in 2018, an increase can be seen in the last Half of these unwanted pregnancies in Spain end in year in the use of LARC (9.6% of total users), with respect voluntary termination (VTP), 93,131 in 2016, according to the 2016 survey (7.7% of total users) [1, 6]. to a report on these terminations by the Spanish Ministry According to the results of the latest survey on the use of Health. The report highlights a decline in VTPs in recent of contraceptives in Spain, 1% used an implant, 4.3% had years and although it would be nice to think that this is due a hormonal IUD and 4.3% had a copper IUD [1]. These to better use of contraceptives, the fact that only 10.4% of methods, in addition to their excellent cost-effectiveness total VTPs were due to medical reasons is worrying [3]. ratio and comfort and safety for the health of women, Also, it should not be forgotten that the role being played are highly efficient as they do not influence non-com- by emergency (post-coital) contraception to reduce un- pliance with or the misuse of the method by the user. wanted pregnancies and the subsequent reduction in the This aspect differentiates them from other hormonal rate of VTPs is not known; according to the latest survey of methods, which, while highly effective in theory, their 2018, presented by the SEC, 30% of respondents reported effectiveness is reduced by the lack of adherence to resorting to emergency contraception, at some time [1]. treatment [1, 4, 7]. The condom is the most popular form of contraceptive The term adherence includes two concepts: compli- in Spain: it is used by 29.6% of the population, compared ance with doses (taken correctly in accordance with the with 17.3% of women who use combined hormonal con- drug posology) and persistence in the duration of the traceptives (CHC), the most commonly used hormonal prescribed treatment (constant use of treatment over method of contraception across all age brackets. The time) [8]. The lack of adherence to contraceptive treat- population continues to rely, therefore, on the condom, a ments generally compromises their effectiveness and good way to avoid possible contagion by sexually trans- results in many of the unwanted pregnancies and mitted diseases (STDs), but one that is not a very effective VTPs, with an estimated annual cost of approximately contraceptive in practice when compared with other hor- 80 million euros to the national health system [2]. monal methods due to its inconsistent and/or incorrect In a recent review, it was found that in Spain, non- use [1]. Each year, eighteen out of every 100 women con- compliant use of contraceptives among users of CHC is dom users get pregnant during their first year of use com- common, between 65 and 70% of users forget or delay a pared to nine out of 100 women users of CHC per year, pill more than once a month, but moreover, 18% did not according to Pearl indices corresponding to each method, use any additional method subsequently and 43% were as published recently by the World Health Organization distressed by the possibility of getting pregnant that (WHO) [4]. month, showing a lack of skills and knowledge as to how In the last 30 years, new hormonal contraceptives have to act in the event of an oversight or non-compliance been added to the range of existing contraceptive devices, [8]. In addition, there is a high dropout rate from CHC drugs or technologies. Most of these additions have within 12 months of the start of treatment, with figures involved modifications or a variety of alternatives to oral close to 50%, which are due to the onset of side effects hormonal contraception, the best-known and most widely and/or the lack of adherence to treatment [9]. Molina-Férnandez et al. BMC Public Health (2019) 19:1224 Page 3 of 8 The low use of LARC is not influenced by the lack of their increasing occurrence, were followed [13, 14]. These adherence, but could be explained by problems related criteria, grouped in a checklist of 30 items, establish the to: a lack of knowledge of such methods, accessibility to three blocks for inclusion in SDMTs: clinical content, de- them, and the bleeding pattern they present that is not velopment process and evaluation of effectiveness [13, 15]. accepted by all women, as they are not informed of it For the SHARECONTRACEPT development process, [1, 4, 5, 10]. In this regard, recent SEC survey data show the stages described by the National Health System (NHS) that 45.6% of women acknowledged that their doctor or Agency for Evaluation, Technology and Performance were midwife did not offer them the contraceptive option of followed for SDMT evaluation and validation [15]. Then, a LARC during their counselling consultation, despite the the development process is described in stages (Study fact that in several of the autonomous communities par- framework flowchart of the design of SHARECONTRA- ticipating in the population survey, this type of long-acting CEPT, Fig. 1). contraception is financed wholly or in part [1, 10]. The data set out above show the need to encourage Clinical trial of SHARECONTRACEPT the population of potential users of contraceptive methods Hypothesis to get access to balanced and objective information on the Advice on hormonal contraception at the physician’s different contraceptive methods based on the latest scien- office, with the support of the SHARECONTRACEPT tific evidence to help them choose the most suitable to their SDMT, encourages dialogue and the exchange of informa- health status and their personal situation [4]. Dehlendorf, tion between the woman and the clinician, which can help the author of an interesting review of how contraceptive ad- select a contraceptive method more in accordance with vice should be given, stresses the need for clinicians, before her preferences, needs, priorities and characteristics, thus such demand, to establish a close and trusting relationship improving adherence to the method of choice. with users. In recent years, the patient has acquired a more active Aims and objectives and responsible role in relation to the management of The purpose of this project is to evaluate the effectiveness their health and in the clinical practice. On a daily basis, of the SHARECONTRACEPT SDMT during contracep- patients and healthcare professionals face situations in tive counselling in six autonomous communities of Spain which decisions related to the diagnostic process and/or different treatment options should be taken jointly [11, 12]. 1. To determine whether the use of To facilitate this, shared decision-making tools (SDMT) SHARECONTRACEPT improves adherence to have been developed, that promote discussion between the chosen contraceptive treatment, in relation patients and healthcare professionals concerning the to compliance with dose or method of use and various treatment options [11–13]. persistence in the duration of the prescribed The purpose of this study protocol is to evaluate the treatment, effectiveness of an SDMT in open access online digital 2. To assess whether SHARECONTRACEPT increases hormonal contraception during contraceptive counselling the ability to cope with incidents related to the use consultation, according to the needs of the population. of the method, 3. To assess the social impact of using Methods/design SHARECONTRACEPT in relation to decreasing Study framework unwanted pregnancies and voluntary termination The SDMT in hormonal contraception, SHARECON- of pregnancy (VTP), TRACEPT, was previously devised by the authors De 4. To analyse whether SHARECONTRACEPT Molina, Rubio and De la Flor. decreases the woman’s conflict in view of the In August 2018, it was published on the “Decisions choice of contraceptive method, Compartides” website of the Department of Health of the 5. To assess whether the use of SHARECONTRACEPT Generalitat (Government) of Catalonia, in Spanish, Catalan helps clinicians to better understand the various and English: http://decisionscompartides.gencat.cat/en/ hormonal contraceptive options available and their decidir-sobre/anticoncepcio_hormonal/index.html). characteristics (risks, benefits and consequences), and. Below, we set out how it was produced, as we consider 6. To analyse whether the use of SHARECONTRACEPT it relevant as a reference framework for the study: changes the pattern of use of hormonal contraception For the design of the SHARECONTRACEPT SDMT, in the population towards more effective methods. the criteria of the International Patient Decision Aid Standards (IPDAS), an international group of researchers Design and health professionals set up in 2003 to determine the The research is approached as a longitudinal, prospective standard criteria for the development of SDMT in view of community clinical trial. While in the conventional format Molina-Férnandez et al. BMC Public Health (2019) 19:1224 Page 4 of 8 Fig. 1 Study framework of the development of the Shared Decision-Making Tool following the stages described by the National Health System (NHS) Agency for Evaluation, Technology and Performance of clinical trials allocation is performed on the participat- Clusters sample ing subjects themselves, in the community format, clusters Firstly, the clusters were selected. The researchers are assigned to which the units of analysis belong. responsible for each of the six autonomous communities In this research, the clusters are the professionals of in Spain recruited them by means of convenience the Clinical Units of the six participating Spanish sampling. During the first quarter of 2019, professional autonomous communities: Madrid, Aragon, Galicia, the clinicians giving contraceptive counselling (gynaecologists, Basque Country, Valencia and Catalonia (see Fig. 2). The midwives, family doctors and/or nurses) from the different units of analysis are the women attending the con- Spanish autonomous communities participating were in- sultation of the professionals between 1 July 2019 and vited to take part. One hundred and sixty-four (164) pro- 30 June 2020. fessionals agreed to participate and they were randomly Molina-Férnandez et al. BMC Public Health (2019) 19:1224 Page 5 of 8 In addition, through documents and videos, they will get access to the contents of the different subjects (see Table 1), depending on whether they are professionals assigned to EG (they will be able to view the six subjects from the beginning) or CG (during the fieldwork they will only be able to view subjects 2 and 6, although they will be able to get access to the rest once sample collec- tion has finished). 2- user registration Having reviewed the course con- tents, the professional will be requested to register with the data collection platform. 3-platform Finally, via this icon, access to the data col- lection base is granted, using a username and personal Fig. 2 Map of participating communities where the clusters were password, to start inputting cases (units of analysis). selected. Created by the author Unit analysis sample assigned using the EPIDAT program (single sampling), to Sample size one of two groups: In a second stage the units of analysis are recruited. A sample of 1708 women is established (Table 2). The cal- 1- Experimental Group (EG), professionals who will culation was performed using the EPIDAT program to perform counselling with the support of the test hypotheses in a model of comparison of proportions SHARECONTRACEPT SDMT, and in independent groups. A possible loss of 25% of the 2- Control group (CG), professionals who will perform sample is estimated, and so by applying the correction clinical counselling as they had until then factor where R is the expected proportion of losses, the (conventional contraceptive counselling). following sample size is finally envisaged: Starting from this context, it was decided to create the Sample selection criteria The sample will be selected Web page: Sharecontracept.com, through which the pro- from the women attending the practice of one of the fessionals can easily access the three different environ- professionals from either CG or EG requesting counsel- ments in which they are to participate. ling on contraception or when such need is found du- ring the stipulated period (1 July 2019 to 30 June 2020) and who fulfil the following inclusion criteria: have 1-virtual campus In order, insofar as possible, to completed their primary education and be competent in standardize the procedure to be followed given that the Spanish and/or Catalan (the languages of SHARECON- different professional profiles and broad geographical TRACEPT, although it is also in English); be between 16 spread, the Foundation of the Rovira i Virgili University and 49 years of age, have internet access, and agree to in Tarragona (Spain) designed a 60-h online course for participate voluntarily in the study. Women are ex- the professionals involved in the project. cluded who wish to have children within one year of the This course is to be implemented prior to starting the date of consultation or have a history of: stroke, fieldwork. There are two courses, one for the CG and acute myocardial infarction, thrombosis, breast the other for EG. The professionals of each group will cancer (< 5 years), liver cirrhosis or liver tumour. receive an email with a link in order to access the corre- sponding SHARECONTRACEPT virtual course with a Table 1 Moodle course table of contents username and a password. Once inside the course, and Theme 1 The shared decisions model after a brief presentation, they will be asked to perform a Theme 2 The SHARECONTRACEPT project test of knowledge on contraception at the beginning and Theme 3 Which are the WHO’s eligibility criteria at the end of the course, to assess whether SHARECON- TRACEPT improves the knowledge of the professionals Theme 4 Keys to giving good counselling who use it. After the first test, the system will allow Theme 5 Videos with examples of how to counsel with the them access to the rest of the course environment, support of SHARECONTRACEPT where, among others, they will find forums through Theme 6 Instructions on how to implement the information collection platform of the SHARECONTRACEPT Project which they can contact the research team. Molina-Férnandez et al. BMC Public Health (2019) 19:1224 Page 6 of 8 Table 2 Study sample size calculated using the EPIDAT Table 3 Variables collected in the study program Main variable Adherence to treatment: Power (%) Sample size* (+ correction factor for expected losses) • Compliance with dose and method of EG CG Total administration and 80.0 854 854 1708 • Persistence in the duration of the prescribed treatment Sample sizes to apply the χ2 test with Yates continuity correction *An α risk of 0.05 and a β risk of 0.2 (80% power) are assumed, standard values Secondary variables Woman’s sociodemographic characteristics: in such studies • Age • Level of education Information collection questionnaires Information on • Occupation each of the women will be collected at four times during a year, from two online questionnaires developed ad • Marital status/partner hoc: an in-person survey and a telephone survey (to be Contact details conducted 3 times: at one month, at 6 months, and one • Telephone year following the in-person consultation). • Telephone 2 The main variable is adherence to treatment (compliance Medical history: with the dose and method of administration and persist- • Smoker ence in the duration of the prescribed treatment) and the secondary variables include the woman’s sociodemographic • HBP characteristics, her medical, obstetrical and gynaecological • Uterine malformations history, her contraceptive method, decisional conflict, and Obstetric and gynaecological history: variables of the professional (see Table 3). • Menstrual pattern The statistical approach will consist of a set of biva- • Miscarriage riate and multivariate descriptive analyses and the appli- • VTP cation of logistic regression models to determine the extent to which the likelihood of changing birth control • Living children method and the likelihood of choosing one particular Contraceptive method method are linked to certain specified variables. Losses • Contraceptive method considered by the are considered as women that do not complete the patient before counselling follow-up of the protocol to which they were assigned or • Experiences with other methods that do not to remain until the end of the analysis. • Woman’s attitude towards compliance (Morisky-Green treatment adherence test) Study limitations • Contraceptive finally chosen The fact that the two groups (EG and CG) may come • Incidents with the chosen method into contact at the same health centre or unit could result • Incident management in professionals who must continue to provide counselling Decisional conflict in a conventional manner (CG) potentially modifying how they behave if they find out about or get access to SHARE- The woman’s decisional conflict in view of the choice of contraceptive method CONTRACEPT due to comments by their EG peers. To (O’Connor Scale) avoid this insofar as possible, during training EG will be https://decisionaid.ohri.ca/eval_dcs.html asked to keep absolute confidentiality. And of the professional: Different autonomous communities, different sexual • Satisfaction with the counsellor or clinician with and reproductive healthcare policies, different funding the use of the digital SDMT (Likert scale) schemes for contraceptive methods, different profes- • Test of knowledge prior to and after fieldwork sionals giving counselling with different levels of training (midwives, nurses, gynaecologists and family physicians) could be limitations, and so these variables must be duly method and according to their needs in order to promote taken into account when analysing the results. adherence to the chosen contraception and advise in the event of the occurrence of side effects, among others [16]. Discussion Before choosing a particular method there are aspects It is recommended, during counselling on contraception, related to the potential user and the characteristics of to use a shared decision-making approach focusing on each of the methods that must be clearly defined. To ascertaining the user’s values and preferences, which begin with, there is a need for a good anamnesis includ- helps facilitate qualified information on each contraceptive ing the woman’s age, previous knowledge of the subject, Molina-Férnandez et al. BMC Public Health (2019) 19:1224 Page 7 of 8 information about her sexual partner, the purpose of participated in its design, performance, coordination and community contraception, personal preferences and predisposing engagement. All authors have given their final approval of the version submitted for publication. factors for poor compliance in accordance with the method [17]. Regarding the method, the woman must Funding be familiar with the main features of the existing methods; This study has undergone peer-review by the funding body Instituto de their effectiveness, side effects and safety, reversibility, Salud Carlos III - ISCIII (Spanish Government), in the 2018 call under the Health Strategy Action 2013–2016, within the National Research Programme possible non-contraceptive benefits, ease or complexity of oriented to Societal Challenges, within the Technical, Scientific and Innovation use, impact on intercourse, and price, among others [18]. Research National Plan 2013–2016, with reference PI18/00915, co-funded with Dehlendorf warns that many women express dissatis- European Union European Regional Development Fund (ERDF) funds. These sources of funding did not play a role in the Spanish study design, faction with the counselling they receive from clinicians data collection, study management, data analysis, interpretation of the data, [16], and other studies have found that clinicians show writing of the report, or in the decision to submit the report for publication. inaccurate knowledge of contraceptive methods and/or The authors declare that they have no competing interests. possess outdated information [16, 19, 20]; it would also Availability of data and materials appear that the decision made by women is strongly in- The study is ongoing. fluenced by the mention or recommendation of specific Data will be available when the study ends (31/12/2021). methods by the clinicians providing counselling, in a pa- Ethics approval and consent to participate ternalistic healthcare environment [11, 16]. SDMTs have Participants will be informed about the content, purpose, and procedure of been created to change this. Specifically, SHARECON- the study by means of a written form of informed consent. No negative TRACEPT has been devised to help clinicians and users impact on the study participants is expected. The study will be conducted in accordance with the principles of the in the processes of learning, counselling and choice of Helsinki Declaration, and will follow Spain’s best practice guidelines (Buena the contraceptive method that best suits each person Práctica Clínica). Data confidentiality will be protected under the Spanish law and situation. governing the protection of personal data (Ley Orgánica 3/2018 de Protección de Datos de Carácter Personal). This project enables testing by users and clinicians in Ethics approval was obtained from the Ethics Committee of Institut the daily practice and within the health system whether d’Atenció Primària Jordi Gol (reference coder: P18/208) and from the Institut this SDMT in hormonal contraception is effective, giving d’Investigacions Sanitàries Pere Virgili (reference code CEIM: 186/2018). These Ethical Approvals cover all the participating sites included in this study. them all an opportunity to review it and comment on it, which are key aspects of the development process of an Consent for publication SDMT [15]. Not applicable as the manuscript does not contain any individual person’s data which is not from the research group. Abbreviations CG: Control group; CHC: Combined hormonal contraception; EG: Experimental Competing interests group; IPDAS: International Patient Decision Aid Standards; IUD: Intrauterine The authors declare that they have no competing interests. devices; LARC: Long-Acting Reversible Contraception; SDMT: Shared Decision- Making Tools; SEC: Sociedad Española de Contracepción (Spanish Society of Author details Contraception); STD: Sexually transmitted diseases; VTP: Voluntary termination 1 Nursing Department, Campus Catalunya, Universitat Rovira i Virgili, Av/ of pregnancy; WHO: World Health Organization Catalunya, 35, 43002 Tarragona, Spain. 2Medicine Department, Universitat Rovira i Virgili, C/ Dr. Mallafrè Guasch, 4, 43005 Tarragona, Spain. 3Escola Acknowledgements Superior de Enfermagem do Porto, Portugal, Rua Bernardino de Almeida, The authors gratefully acknowledge the support of the study participants 4200-072 Porto, Portugal. 4Universitat Rovira i Virgili, Campus Catalunya, and partner organizations. Universitat Rovira i Virgili, Av/ Catalunya, 35, 43002 Tarragona, Spain. 5Institut Study group members from the project PI18/00915 who are involved in the Català de la Salut, Primary Care Unit. CAP Jaume I, C/ Jaume i, 45-49, 43005 implementation of the clinical trial: Dr. Cristina Martinez Bueno1, Ms. Maria Tarragona, Spain. 6Àrea d’Atenció Sanitària. Gerència de Salut i Atenció Dolores Martinez-Romero2, Dr. Lucia Martinez-Villarejo3, Ms. Montserrat Integrada, Servei Català de la Salut | Generalitat de Catalunya, Travessera de Moharra-Frances4, Prof Jose Cruz Quilez-Conde5, Ms. Anna Rodriguez- les Corts, 131-159 | Pavelló Ave Maria, |08028 Barcelona, Spain. Martinez6, Dr. Federico Villagrasa-Rocher7, Ms. Demetria Patricio-Peña 8, Ms. Dolores Creus-Pujol9. Received: 16 August 2019 Accepted: 29 August 2019 1 Institut Català de la Salut. Barcelona. Spain. 2 Dirección general de asistencia sanitaria SERGAS. Santiago de Compostela. Spain. References 3 Midwifery training unit. Madrid. 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