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NCT Number: NCT07637747

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

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.

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Key information

Conditions

Shared Decision Making Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5450, Denmark

Location status: Recruiting

Location contact

Christensen

CONTACT

[email protected]

45 21254258

About this study

Shared decision-making (SDM) is a collaborative model for treatment decision-making and is widely regarded as a cornerstone of patient-centered care. In SDM, patients and healthcare professionals jointly review available treatment options and identify the solution that best aligns with the patient's preferences and values. Decision aids that are designed to support SDM by presenting treatment options and helping patients formulate and communicate their preferences, are often a central component of SDM. However, little is known about how healthcare professionals and patients understand and experience the use of decision aids in their clinical encounters. In particular, there is a lack of knowledge on the use of decision aids within mental healthcare.

This study aims to evaluate the impact of the Decision Helper™, when used in mental healthcare. The Decision Helper™ is developed as part of the broad implementation of SDM across all hospitals in the Region of Southern Denmark, but is not yet investigated within mental healthcare.

In the study, patients are randomized to either an intervention group or an active control group. In the intervention group, treatment consultations are conducted using the Decision Helper™, whereas in the control group, consultations follow SDM practices without the use of the decision aid. Additionally, the study seeks to explore patients' and mental healthcare professionals' understanding of, and experiences with, using the Decision Helper™ as part of the SDM practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared decision making

Other

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.

Primary outcomes

  1. Patient involvement in decision-making

    Time frame: 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.

Secondary outcomes

  1. Patient-perceived level of involvement in decision-making

    Time frame: Patient-assessed within two weeks after the treatment consultation.

    Patient-reported perceived involvement in decision-making, measured using the 9-item Shared Decision Making Questionnaire (SDM-Q-9). The SDM-Q-9 assesses the extent to which patients perceive themselves as being involved in decision-making. Patients rate their level of agreement with each of the 9 statements on a 6-point Likert scale. Raw scores range from 0 to 45 and are converted to a standardized score ranging from 0 to 100.

  2. Clinician-perceived level of involving the patient

    Time frame: Clinician-assessed within two weeks after the treatment consultation.

    Clinician-reported perceived level of patient involvement in decision-making, measured using the clinician version of the 9-item Shared Decision Making Questionnaire (SDM-Q-Doc). The SDM-Q-Doc assesses the extent to which clinicians perceive that they involve patients in the decision-making process. Clinicians evaluate each of the 9 items on a 6-point Likert scale. Raw scores range from 0 to 45 and are converted to scores ranging from 0 to 100. Higher scores indicate greater clinician-perceived involvement of patients in decision-making.

  3. Personal recovery

    Time frame: Patient-assessed within two weeks after the treatment consultation.

    Patient-reported measure of personal recovery, assessed using the Brief INSPIRE-O. The Brief INSPIRE-O is a 5-item self-rated measure of recovery, i.e., a patient-reported outcome measure (PROM), that assesses personal recovery from the patient's perspective.

    Each of the five statements is rated by the patient on a 5-point Likert scale ranging from 0 to 4. Item scores are summed and multiplied by 5 to generate a total score ranging from 0 to 100. Higher scores indicate higher levels of patient-perceived personal recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Korsbek, Associate Professor, PhD

CONTACT

[email protected]

45 21254258

Regina Christiansen, Assistant Professor, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

DAN-SHARE. Impact and Experiences of Using Decisions Aids in Hospital Outpatient Mental Health Settings. A Mixed Methods Study on Shared Decision-making Practice in the Danish Mental Healthcare

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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