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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Shared decision making
  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-ma
• Другое Shared decision making
  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.

Первичные конечные точки

• Patient involvement in decision-making [Срок оценки: Throughout study completion, an average of 3 months.]

Вторичные конечные точки (3)

• Patient-perceived level of involvement in decision-making [Срок оценки: Patient-assessed within two weeks after the treatment consultation.]
• Clinician-perceived level of involving the patient [Срок оценки: Clinician-assessed within two weeks after the treatment consultation.]
• Personal recovery [Срок оценки: Patient-assessed within two weeks after the treatment consultation.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Odense University Hospital — Odense

Идентификаторы

NCT: NCT07637747 · DAN-SHARE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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