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DAN-SHARE is a study on shared decision-making (SDM) in Danish mental healthcare that investigates the impact of a decision aid, the Decision Helperâ„¢, 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 Helperâ„¢ as part of decision-making 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. 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 Helperâ„¢, when used in mental healthcare. The Decision Helperâ„¢ 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 Helperâ„¢, 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 Helperâ„¢ as part of the SDM practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDM practice by using Decision Helper | Experimental |
| |
| SDM without Decision Helper | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared decision making | Other | Patients assigned to the intervention group will be exposed to the Decision Helperâ„¢ during consultations in which treatment decisions or related issues are addressed. The Decision Helperâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Korsbek, Associate Professor, PhD | Contact | 45 21254258 | lisa.korsbek.christensen@rsyd.dk | |
| Regina Christiansen, Assistant Professor, PhD | Contact | reginachristiansen@health.sdu.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | 5450 | Denmark |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| Shared decision making | Other | Patients assigned to the control group will not be exposed to the Decision Helperâ„¢ 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. |
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| 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. | 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. | Patient-assessed within two weeks after the treatment consultation. |