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

9 juin 2026 mis à jour par: University of Southern Denmark

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

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.

Aperçu de l'étude

Statut

Recrutement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

62

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

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

Exclusion Criteria:

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: SDM practice by using Decision Helper
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.
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.
Comparateur actif: SDM without Decision Helper
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient involvement in decision-making
Délai: 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.

Throughout study completion, an average of 3 months.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient-perceived level of involvement in decision-making
Délai: Patient-assessed within two weeks after the treatment consultation.
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.
Patient-assessed within two weeks after the treatment consultation.
Clinician-perceived level of involving the patient
Délai: Clinician-assessed within two weeks after the treatment consultation.
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
Délai: Patient-assessed within two weeks after the treatment consultation.

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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 avril 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

1 mai 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

10 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DAN-SHARE

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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