Nursing Department, Campus Catalunya, Universitat Rovira i Virgili, Av/ Catalunya, 35, 43002, Tarragona, Spain.
Medicine Department, Universitat Rovira i Virgili, C/ Dr. Mallafrè Guasch, 4, 43005, Tarragona, Spain.
BMC Public Health. 2019 Sep 4;19(1):1224. doi: 10.1186/s12889-019-7572-9.
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.
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.
Clinical Register number ISRCTN5827994 . Date: 15/04/2019 (Retrospectively registered).
决策工具代表了临床医生和用户/患者之间关系的范式转变。它们的一些优点包括患者承诺、促进偏好和价值观以及提高治疗依从性。本研究方案旨在评估一种避孕决策工具（SHARECONTRACEPT）的有效性，具体涉及：a）改善医疗咨询中的激素避孕咨询，表现在降低决策冲突和提高对可用避孕选择的了解；b）改善治疗依从性，表现在：选择治疗的持续时间、剂量或使用程序的遵守情况，以及处理与避孕方法使用相关事件的能力；并减少意外怀孕和自愿终止妊娠。SHARECONTRACEPT 工具由本项目的前几个阶段开发，可在以下网址获得：http://decisionscompartides.gencat.cat/en/decidir-sobre/anticoncepcio_hormonal/METHODS/DESIGN：一项纵向、前瞻性、随机、对照的社区临床试验，在西班牙 6 个自治区的临床避孕咨询单位进行，设有实验组和对照组。干预描述：参与的卫生专业人员将被随机分配到两组中的一组。分配到实验组的临床医生将使用 SHARECONTRACEPT 辅助进行避孕咨询，而对照组的临床医生将按照其临床单位提供的常规避孕咨询进行。计划研究 1708 名使用者（对照组 n=854 名，干预组 n=854 名），从参加卫生专业人员咨询的女性中招募。选定的使用者将随访一年。数据将通过专门的问卷和验证工具收集，用于测量决策冲突和治疗依从性。
本研究方案的结果将提供共享决策工具 SHARECONTRACEPT 有效性的证据，这可能为用户和专业人员提供一种有用的工具，以促进避孕方法的依从性。
临床登记号 ISRCTN5827994。日期：2019 年 4 月 15 日（回顾性注册）。
