TY - JOUR
T1 - The effectiveness of a digital shared decision-making tool in hormonal contraception during clinical assessment
T2 - Study protocol of a randomized controlled trial in Spain
AU - De Molina-Férnandez, Maria Inmaculada
AU - Raigal-Aran, Laia
AU - De La Flor-Lopez, Miriam
AU - Prata, Paula
AU - Font-Jimenez, Isabel
AU - Valls-Fonayet, Francesc
AU - March-Jardi, Gemma
AU - Escuriet-Peiro, Ramon
AU - Rubio-Rico, Lourdes
N1 - Funding Information:
This study has undergone peer-review by the funding body Instituto de Salud Carlos III - ISCIII (Spanish Government), in the 2018 call under the Health Strategy Action 2013–2016, within the National Research Programme oriented to Societal Challenges, within the Technical, Scientific and Innovation Research National Plan 2013–2016, with reference PI18/00915, co-funded with European Union European Regional Development Fund (ERDF) funds. These sources of funding did not play a role in the Spanish study design, data collection, study management, data analysis, interpretation of the data, writing of the report, or in the decision to submit the report for publication. The authors declare that they have no competing interests.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/9/4
Y1 - 2019/9/4
N2 - 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. 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.
AB - 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. 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.
KW - Clinical trial
KW - Contraception
KW - E-health
KW - Shared decision-making tool
KW - Study protocol
KW - Treatment adherence
UR - http://www.scopus.com/inward/record.url?scp=85071749543&partnerID=8YFLogxK
U2 - 10.1186/s12889-019-7572-9
DO - 10.1186/s12889-019-7572-9
M3 - Article
C2 - 31484579
AN - SCOPUS:85071749543
VL - 19
JO - BMC public health
JF - BMC public health
IS - 1
M1 - 1224
ER -