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

Sponsor
University Hospital, Geneva
Study ID
NCT07320651
Status
Recruiting
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Conditions

  • Contraception
  • Menstrual Management

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 25 Years
Healthy Volunteers
Not accepted

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.
  • Standard counseling — OTHER
    The control intervention consists of standard consultation with usual counseling.

Study Details

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.

Key Dates

First listed
Jan 6, 2026
Start date
Sep 2, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: control group
  • Experimental: intervention group

Primary Outcome Measure

Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS). [ Time Frame: immediately after the clinical encounter ]

Central Contacts

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