Impact and Experiences of Using Decisions Aids in Outpatient Mental Health.
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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Lisa Korsbek, Associate Professor, PhD
- 電話番号:45 21254258
- メール:lisa.korsbek.christensen@rsyd.dk
研究連絡先のバックアップ
- 名前:Regina Christiansen, Assistant Professor, PhD
- メール:reginachristiansen@health.sdu.dk
研究場所
-
-
-
Odense、デンマーク、5450
- 募集
- Odense University Hospital
-
コンタクト:
- Christensen
- 電話番号:45 21254258
- メール:lisa.korsbek.christensen@rsyd.dk
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
|
アクティブコンパレータ: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient involvement in decision-making
時間枠: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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient-perceived level of involvement in decision-making
時間枠: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
時間枠: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
時間枠: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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。