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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Contraception; Menstrual Management
• Intervention / Treatment: Other: Standard counseling; Other: Encounter decision aid

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dehlia Moussaoui; Phone Number: +41 22 372 33 87; Email: dehlia.moussaoui@hug.ch

Study Locations

• Switzerland
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • Recruiting
      • Geneva University Hospitals
      • Contact: Dehlia Moussaoui; Phone Number: +41 22 372 33 87; Email: dehlia.moussaoui@hug.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Other: Standard counseling; The control intervention consists of standard consultation with usual counseling.
Experimental: intervention group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (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.	at 3 months post-clinical encounter
Patient knowledge.	Score on a 7-item true/false questionnaire on hormonal treatment and contraception, assessed right after the clinical encounter.	immediately after the clinical encounter
Knowledge retention	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.	knowledge questionnaire at 3 months post-intervention
Patient and healthcare provider satisfaction with the decision-making process	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").	immediately after the clinical encounter
Patient involvement in decision-making	measured by the self-reported collaboRATE scale (three brief questions that patients complete following the clinical encounter)	immediately after the clinical encounter (10-point Likert scale).
Patient involvement in decision-making	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).	immediately after the clinical encounter
Participant treatment preference before the clinical encounter	self-reported answer to the question: "Which treatment would you like to start?"	Baseline
Participant treatment preference after the clinical encounter	self-reported answer to the question: "Which treatment would you like to start?"	Immediately after the clinical encounter
Medication continuation	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	at 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: August 31, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: contraception; decision aid; shared decision-making; menstrual management
• Other Study ID Numbers: 2025-00733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No