Shared Decision MakingNCT07637747
Impact and Experiences of Using Decisions Aids in Outpatient Mental Health.
A study testing Shared decision making in people with Shared Decision Making, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shared Decision Making
- What is being tested?
- Shared decision making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Apr 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- In treatment for a mental health disorder in one of the participating settings of the study
Who cannot join
- Unable to understand Danish language
- Unable to provide verbal and written informed consent
- Diagnosed with cognitive impairment or dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Regina Christiansen, Assistant Professor, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5450
Christensen, 45 21254258, lisa.korsbek.christensen@rsyd.dk
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Shared Decision Making
- Being tested
- Shared decision making
- Keywords
- Mental health, Share decision making, decision aids
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision makingOther
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 makingOther
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 group | Role | What they receive |
|---|---|---|
| SDM practice by using Decision Helper | Experimental | Not described Receives: Other: Shared decision making |
| SDM without Decision Helper | Active comparator | Not described Receives: Other: Shared decision making |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout study completion, an average of 3 months.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Patient-assessed within two weeks after the treatment consultation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shared Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637747
- Sponsor's protocol ID
- DAN-SHARE
- Status last verified
- Jun 2026
- First submitted
- 1 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes