Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults: A Cluster-Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Geneva
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS).
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 25 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
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
- Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (LL-DCS).(at 3 months post-clinical encounter)
- Patient knowledge.(immediately after the clinical encounter)
- Knowledge retention(knowledge questionnaire at 3 months post-intervention)
- Patient and healthcare provider satisfaction with the decision-making process(immediately after the clinical encounter)
- Patient involvement in decision-making(immediately after the clinical encounter)
- Participant treatment preference before the clinical encounter(Baseline)
- Participant treatment preference after the clinical encounter(Immediately after the clinical encounter)
- Medication continuation(at 3 months)
- Patient involvement in decision-making(immediately after the clinical encounter (10-point Likert scale).)
Investigators
Dehlia Moussaoui
Principal investigator
University Hospital, Geneva