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

NCT07320651 | Recruiting DMC

• 1 other identifier: 2025-00733
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contraception; Menstrual Management

Keywords

decision aid; menstrual management; contraception; shared decision-making

Outcome Measures

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.

  immediately after the clinical encounter

Secondary Outcomes (9)

• Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (LL-DCS).

  at 3 months post-clinical encounter

• Patient knowledge.

  immediately after the clinical encounter

• Knowledge retention

  knowledge questionnaire at 3 months post-intervention

• Patient and healthcare provider satisfaction with the decision-making process

  immediately after the clinical encounter

• Patient involvement in decision-making

  immediately after the clinical encounter (10-point Likert scale).

Study Arms (2)

control group

ACTIVE COMPARATOR

Other: Standard counseling

intervention group

EXPERIMENTAL

Other: Encounter decision aid

Interventions

Encounter decision aid OTHER

The 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.

intervention group

Standard counseling OTHER

The control intervention consists of standard consultation with usual counseling.

control group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Central Study Contacts

Dehlia Moussaoui

CONTACT

+41 22 372 33 87; dehlia.moussaoui@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: January 6, 2026
• Study Start: September 2, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

CH (1)