Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-25
SponsorUniversity Hospital, Geneva
About this trial
Decision aids are educational tools designed to help people participate in decision-making about health care choices, by providing evidence-based information, promoting patient-centered care, and supporting patient autonomy and engagement. Our research team developed an Encounter Decision Aid (EDA) exploring treatment options for menstrual management in adolescents and young adults (AYAs), in accordance with the latest International Patient Decision Aids Standards and the Ottawa Decision Support Framework.
In this cluster-randomized controlled trial, we aim to evaluate the effectiveness of this EDA on patient-centered outcome measures in AYAs considering treatment for menstrual management and/or contraception compared to standard counseling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adolescents and young adults aged 12-25 years old
presenting to an outpatient consultation at "Unité de policlinique de gynécologie" or "Consultation de gynécologie pédiatrique" at HUG
considering initiation or switch to hormonal medication for menstrual management and/or contraception
able to give informed consent as documented by signature or accompanied by a legal guardian who can provide consent if required.
Disqualifiers
individuals who cannot read and understand French to a degree that would prevent participation in informed consent and study-related materials.
individuals who have major sensory disability, such as visual or hearing impairment, that would compromise their ability to give written informed consent and use the EDA, in the absence of their legal guardian.
individuals with cognitive or psychiatric conditions significantly impairing decision making capacity, unless accompanied by a legal guardian.
patients currently participating in another clinical trial related to contraceptive decision-making, to avoid potential interference.
Trial design
Design model
Parallel
Treatments tested in this trial
Encounter decision aid
Other interventionThe intervention will involve the use of an encounter decision aid (EDA) during the clinical encounter. This paper-based tool was developed through an iterative process at HUG by our multidisciplinary team, comprising clinicians, specialized nurses, clinical researchers, graphic designer, stakeholders and patient representatives.
Standard counseling
Other interventionThe control intervention consists of standard consultation with usual counseling.
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: control groupActive comparator 1 intervention
Group B: intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS).
Decisional conflict is defined as a state of uncertainty about a course of action and is measured by the Decisional Conflict Scale. It is recognized as a core component of the quality of the decision-making process. The Decisional Conflict Scale low literacy (LL-DCS) is a validated score that includes 10 items which are scored on a 0 to 4 scale; the items scores are summed, divided by 10, and then multiplied by 25. The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.
Time frame
immediately after the clinical encounterSecondary outcomes
1
Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (LL-DCS).
Decisional conflict is defined as a state of uncertainty about a course of action and is measured by the Decisional Conflict Scale. It is recognized as a core component of the quality of the decision-making process. The Decisional Conflict Scale low literacy (LL-DCS) is a validated score that includes 10 items which are scored on a 0 to 4 scale; the items scores are summed, divided by 10, and then multiplied by 25. The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.
Time frame
at 3 months post-clinical encounter2
Patient knowledge.
Score on a 7-item true/false questionnaire on hormonal treatment and contraception, assessed right after the clinical encounter.
Time frame
immediately after the clinical encounter3
Knowledge retention
Reassessment of knowledge using the same questionnaire (score on a 7-item true/false questionnaire on hormonal treatment and contraception) at 3 month-follow up.
Time frame
knowledge questionnaire at 3 months post-intervention4
Patient and healthcare provider satisfaction with the decision-making process
* Patient satisfaction rated on a 5-point Likert scale, indicating how strongly they would recommend the decision-making approach. * Clinician satisfaction rated on a 5-point Likert scale (where higher scores indicating greater satisfaction). Satisfaction will be defined as the proportion scoring ≥4 ("very satisfied" and extremely satisfied").
Time frame
immediately after the clinical encounterSponsors and contacts
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Source ClinicalTrials.gov