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

N/ARecruitingNCT07320651

University Hospital, Geneva252 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

252

Conditions

Contraception Menstrual Management

Interventions

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.

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: immediately after the clinical encounter

Secondary Outcomes

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.

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

Time frame: 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.

Time frame: 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").

Time frame: 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)

Time frame: 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).

Time frame: 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?"

Time frame: Baseline

Participant treatment preference after the clinical encounter

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

Time frame: 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

Time frame: at 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts