The effectiveness of a digital shared decision-making tool in hormonal contraception during clinical assessment: study protocol of a randomized controlled trial in Spain

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. 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)

Contraceptive counselling experiences in Spain in the process of creating a web-based contraceptive decision support tool: a qualitative study

“…Based on a pilot study, we are currently evaluating whether the use in consultation of “SHARECONTRACEPT”, a DST in hormonal contraception, corresponding to the 1st Phase of the “Contraception” DST, improves adherence to treatment, user satisfaction, decisional conflicts, counsellor or clinician satisfaction, and the knowledge acquired. This research project has received a grant from the European Regional Development Fund (ERDF) through competitive call FIS 18 for Health research projects, of the Carlos III Health Institute and has been recently published [ 53 ].…”

Design of the Maternal Website EMAeHealth That Supports Decision-Making During Pregnancy and in the Postpartum Period: Collaborative Action Research Study

“…Naturally, the website described here should not be seen as a substitute for personal attention [ 2 , 31 ]. Research shows that, in addition to regularly consulting the internet, women go to midwives and consider them their best source of information [ 12 , 13 , 51 ].…”

“…Pregnancy is a physiological stage in principle, but also a time when self-perception, parenting styles, and other elements are the most relevant variables, and in which other actors, such as partners and family members, with their own customs, convictions, or even ideologies (cultural and social baggage), are directly involved. Naturally, the website described here should not be seen as a substitute for personal attention [2,31]. Research shows that, in addition to regularly consulting the internet, women go to midwives and consider them their best source of information [12,13,51].…”

“…Health care tries to respond to increased demand and the current needs of users with the new resources available. In recent years, the examples of services that use new technologies in the care of patients with chronic pathology or multimorbidity have multiplied, and telemedicine has a widely understood potential for training and support in shared decision-making [ 1 , 2 ], using tools including video consultation, mobile messaging, and expert systems that issue responses from clinical practice guides or available resources. Sometimes they are accessible from platforms that are outside the health system but very widespread among the population, such as Facebook [ 3 ].…”

Development of two instruments for assessing maternity health needs: protocol of a clinimetric study

“…Given this reality, the use of e-health in ME as a support tool for health decision-making can be useful for women, professionals and the health system [11,12], as long as it is developed using an appropriate evidence-based methodology. The development of this tool must follow a strategy that considers both the resources and the needs and characteristics of the population which it is aimed at.…”