An interventional study of Shared decision making and Shared decision making in Shared Decision Making, sponsored by University of Southern Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment
The DAN-SHARE study evaluates the use of DECISION HELPER™-based patient decision aids (PtDAs) in mental healthcare by exploring the impact of using a DECISION HELPER™ in-consult PtDA on patient involvement in decision-making. The study compares treatment consultations that use a PtDA with treatment consultations in which SDM is practiced without the use of a PtDA and hypothesises that the use of an in-consult PtDA will increase patient involvement in decision-making. Additionally, the study explores how patients and clinicians in mental healthcare understand and experience SDM and the use of the PtDA as part of the SDM practice in mental healthcare.
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. Patient decision aids (PtDAS) 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 patient decision aids in their clinical encounters. In particular, there is a lack of knowledge on the use of patient decision aids within mental healthcare.
This study aims to evaluate the impact of Decision Helper™-based PtDAs, when used in mental healthcare. Decision Helper™-based PtDAS are PtDAS designed by using a generic template known as the DECISION HELPER™. They are mandatory to develop and use as part of the implementation of SDM across all hospitals in the Region of Southern Denmark. However, there is a lack of knowledge of whether these PtDAs enhance SDM practices in psychiatric treatment consultations and supports people using mental health services in achieving greater involvement in treament decision-making.
In the study, patients are randomised to either an intervention group or an active control group. In the intervention group, treatment consultations are conducted using the Decision Helper™-based PtDA, whereas consultations in the control group follow SDM practices without the use of the PtDA. Additionally, the study explores patients' and mental healthcare professionals understanding and experiences the PtDAs as part of their SDM practice.
409 studies on the registry are indexed under Patient Participation; 101 are open to participants now.
This study's planned enrollment of 62 is below the median of 128 across 322 interventional studies indexed under Patient Participation.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Shared decision making
Other: Shared decision making
Patients assigned to the intervention group will be exposed to a Decision Helper™-based PtDA during consultations in which treatment decisions or related issues are addressed. The Decision Helper™-based PtDAS 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.
Patients assigned to the control group will not be exposed to the Decision Helper™-based PtDA during treatment consultations in which decisions are made. However, because all healthcare professionals in the participating settings have received training in SDM, the control group constitutes an active control condition, as patients will still be exposed to the general principles of SDM during decision-making consultations.
Patient involvement in decision-making
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.
Time frame: Throughout study completion, an average of 3 months.
Patient-perceived level of involvement in decision-making
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.
Time frame: Patient-assessed within two weeks after the treatment consultation.
Clinician-perceived level of involving the patient
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.
Time frame: Clinician-assessed within two weeks after the treatment consultation.
Personal recovery
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.
Time frame: Patient-assessed within two weeks after the treatment consultation.
Plan to share: Yes
Supporting information: Study protocol
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