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

NCT07637747 | Recruiting DMC

• 1 other identifier: DAN-SHARE
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shared Decision Making

Keywords

Mental health; Share decision making; decision aids

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout study completion, an average of 3 months.

Secondary Outcomes (3)

• Patient-perceived level of involvement in decision-making

  Patient-assessed within two weeks after the treatment consultation.

• Clinician-perceived level of involving the patient

  Clinician-assessed within two weeks after the treatment consultation.

• Personal recovery

  Patient-assessed within two weeks after the treatment consultation.

Study Arms (2)

SDM practice by using Decision Helper

EXPERIMENTAL

Other: Shared decision making

SDM without Decision Helper

ACTIVE COMPARATOR

Other: Shared decision making

Interventions

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.

SDM practice by using Decision Helper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• In treatment for a mental health disorder in one of the participating settings of the study

You may not qualify if:

• Unable to understand Danish language
• Unable to provide verbal and written informed consent
• Diagnosed with cognitive impairment or dementia

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Odense University Hospital

Odense, 5450, Denmark

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Lisa Korsbek, Associate Professor, PhD

CONTACT

45 21254258; lisa.korsbek.christensen@rsyd.dk

Regina Christiansen, Assistant Professor, PhD

CONTACT

reginachristiansen@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: June 10, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (1)