Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults

University Hospitals (UH)

Status: Enrolling

Conditions: Contraception; Menstrual Management

Treatments: Other: Encounter decision aid; Other: Standard counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT07320651

2025-00733

Details and patient eligibility

About

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.

Enrollment: 252 estimated patients

Sex: Female

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

252 participants in 2 patient groups

control group

Active Comparator group

Treatment:

Other: Standard counseling

intervention group

Experimental group

Treatment:

Other: Encounter decision aid