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Recruiting NCT07320651

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

No phase Interventional Contraception Menstrual Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Encounter decision aid, Standard counseling.
Who it may be relevant to
Registry conditions: Contraception, Menstrual Management. Basic parameters: 12 years — 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Encounter decision aid
    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.
  • Other Standard counseling
    The control intervention consists of standard consultation with usual counseling.

Primary outcome measures

  • Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS). [Time frame: immediately after the clinical encounter]
Secondary outcome measures (9)
  • Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (LL-DCS). [Time frame: at 3 months post-clinical encounter]
  • Patient knowledge. [Time frame: immediately after the clinical encounter]
  • Knowledge retention [Time frame: knowledge questionnaire at 3 months post-intervention]
  • Patient and healthcare provider satisfaction with the decision-making process [Time frame: immediately after the clinical encounter]
  • Patient involvement in decision-making [Time frame: immediately after the clinical encounter (10-point Likert scale).]
  • Patient involvement in decision-making [Time frame: immediately after the clinical encounter]
  • Participant treatment preference before the clinical encounter [Time frame: Baseline]
  • Participant treatment preference after the clinical encounter [Time frame: Immediately after the clinical encounter]
  • Medication continuation [Time frame: at 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 1 center
  • Geneva University Hospitals — Geneva

Identifiers

NCT: NCT07320651 · 2025-00733

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗