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Recruiting Not applicable

Impact and Experiences of Using Decisions Aids in Outpatient Mental Health.

NCT07637747 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2026-04-15
Last updated
2026-06-10

Condition(s) studied

Shared Decision Making

Investigational drug(s) / intervention(s)

Shared decision makingShared decision making

Shared decision making: Patients assigned to the intervention group will be exposed to the Decision Helper™ during consultations in which treatment decisions or related issues are addressed. The Decision Helper™ used in these consultations follows a five-step process based on the core principles of shared decision-making: (1) framing the situation and explaining the purpose of the consultation; (2) clarifying the patient's preferred level of information; (3) exploring what matters most to the patient in the decision-making process; (4) presenting the available treatment options, including their advantages and disadvantages; and (5) asking whether the patient is ready to make a decision regarding their preferred treatment option.

Shared decision making: Patients assigned to the control group will not be exposed to the Decision Helper™ during treatment consultations in which decisions are made. However, because all healthcare professionals in the participating settings have received training in shared decision-making, the control group constitutes an active control condition, as patients will still be exposed to the general principles of SDM during decision-making consultations.

Study summary

DAN-SHARE is a study on shared decision-making (SDM) in Danish mental healthcare that investigates the impact of a decision aid, the Decision Helper™, on patient involvement in treatment decision-making in hospital outpatient mental health settings. The study also explores patients' and healthcare professionals' understanding and experiences of using the Decision Helper™ as part of decision-making practice in mental healthcare.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * In treatment for a mental health disorder in one of the participating settings of the study Exclusion Criteria: * Unable to understand Danish language * Unable to provide verbal and written informed consent * Diagnosed with cognitive impairment or dementia

Primary outcome measure(s)

  • Patient involvement in decision-making — Throughout study completion, an average of 3 months.
    Observed level of patient involvement in decision making according to the OPTION 12 scale. OPTION 12 measures the level of patient involvement in decision-making by assessing recordings of treatment consultations on a 5-point Likert scale (0 to 4). Raw score rangs from 0 to 48 and is converted to a score ranging from 0 to 100. Higher scores indicate a higher level of patient involvement.

Trial sites (1)

FacilityCityRegionStatus
Odense University Hospital Odense Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07637747 on ClinicalTrials.gov ↗ ← All trials in Denmark