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NCT Number: NCT07320651

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

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.

Recruiting

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Key information

Conditions

Contraception Menstrual Management

Age range

12 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Dehlia Moussaoui

CONTACT

[email protected]

+41 22 372 33 87

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard counseling

Other

The control intervention consists of standard consultation with usual counseling.

Primary outcomes

  1. Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS).

    Time frame: immediately after the clinical encounter

    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.

Secondary outcomes

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

    Time frame: at 3 months post-clinical encounter

    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.

  2. Patient knowledge.

    Time frame: immediately after the clinical encounter

    Score on a 7-item true/false questionnaire on hormonal treatment and contraception, assessed right after the clinical encounter.

  3. Knowledge retention

    Time frame: knowledge questionnaire at 3 months post-intervention

    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.

  4. Patient and healthcare provider satisfaction with the decision-making process

    Time frame: immediately after the clinical encounter

    • 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").

  5. Patient involvement in decision-making

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

    measured by the self-reported collaboRATE scale (three brief questions that patients complete following the clinical encounter)

  6. Patient involvement in decision-making

    Time frame: immediately after the clinical encounter

    assessed via the OPTION-5 instrument (where independent observer rate clinician behaviors on a standardized scale (0-100), applied to a video recording of the clinical encounter).

  7. Participant treatment preference before the clinical encounter

    Time frame: Baseline

    self-reported answer to the question: "Which treatment would you like to start?"

  8. Participant treatment preference after the clinical encounter

    Time frame: Immediately after the clinical encounter

    self-reported answer to the question: "Which treatment would you like to start?"

  9. Medication continuation

    Time frame: at 3 months

    self-reported answer to the question: "if a medication was prescribed following your previous gynecological appointment, are you still currently using it?" yes or no

Study contacts

Contact information is provided by the study sponsor or research team.

Dehlia Moussaoui

CONTACT

[email protected]

+41 22 372 33 87

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults: A Cluster-Randomized Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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