Shared Decision MakingNCT07637747
Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings.
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
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. 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 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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: Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings. A Randomised Controlled Trial With a Qualitative Follow-up on Shared Decision-making in the Danish Mental Healthcare (the DAN-SHARE Study)
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.
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. 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.
- Conditions
- Shared Decision Making
- Being tested
- Shared decision making
- Keywords
- mental healthcare, shared decision making, patient decision aids, inpatient settings, patient involvement
- Medical subject headings
- Patient Participation
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 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.
Shared decision makingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SDM practice by using a Decision Helper-based PtDA | Experimental | Not described Receives: Other: Shared decision making |
| SDM without the Decision Helper-based PtDA | 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 completion30 Jun 2027 (estimated)
- Study completion29 Feb 2028 (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.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings. A Randomised Controlled Trial With a Qualitative Follow-up on Shared Decision-making in the Danish Mental Healthcare (the DAN-SHARE Study)
- ClinicalTrials.gov ID
- NCT07637747
- Acronym / sponsor ID
- DAN-SHARE
- Conditions
- Shared Decision Making
- Keywords
- mental healthcare, shared decision making, patient decision aids, inpatient settings, patient involvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDM practice by using a Decision Helper-based PtDA | Experimental | Other: Shared decision making |
| SDM without the Decision Helper-based PtDA | Active comparator | Other: Shared decision making |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- In treatment for a mental health disorder in one of the participating settings of the study
Key exclusion criteria (3 listed)
- Unable to understand Danish language
- Unable to provide verbal and written informed consent
- Diagnosed with cognitive impairment or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision makingPatients 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. | Other | SDM practice by using a Decision Helper-based PtDA |
| Shared decision makingPatients 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. | Other | SDM without the Decision Helper-based PtDA |
Primary outcome
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.
3 secondary outcomes
Patient-perceived level of involvement in decision-making
Time frame: Patient-assessed within two weeks after the treatment consultation.
Clinician-perceived level of involving the patient
Time frame: Clinician-assessed within two weeks after the treatment consultation.
Personal recovery
Time frame: Patient-assessed within two weeks after the treatment consultation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Regina Christiansen, Assistant Professor, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making in people with Shared Decision Making, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Korsbek, Associate Professor, PhD (45 21254258, lisa.korsbek.christensen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient involvement in decision-making (time frame: Throughout study completion, an average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.