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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator |
| |
| intervention group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dehlia Moussaoui | Contact | +41 22 372 33 87 | dehlia.moussaoui@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | Canton of Geneva | 1205 | Switzerland |
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| Standard counseling | Other | The control intervention consists of standard consultation with usual counseling. |
|
| 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 |
| 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 |