Impact and Experiences of Using Decisions Aids in Outpatient Mental Health.
ConditionShared Decision Making
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
In treatment for a mental health disorder in one of the participating settings of the study
Disqualifiers
Unable to understand Danish language
Unable to provide verbal and written informed consent
Diagnosed with cognitive impairment or dementia
Trial design
Design model
Parallel
Treatments tested in this trial
Shared decision making
Other interventionPatients 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 making
Other interventionPatients 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: SDM practice by using Decision HelperExperimental treatment 1 intervention
Group B: SDM without Decision HelperActive comparator 1 intervention
Trial outcomes
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.
Time frame
Throughout study completion, an average of 3 months.Secondary outcomes
1
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.2
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.3
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.Sponsors and contacts
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Source ClinicalTrials.gov