重度の股関節または膝関節症の患者にとって何が重要ですか? (PATI-Project)
重度の股関節または膝関節症の患者にとって何が重要ですか?意思決定の質、患者の関与、健康への影響
This clinical trial aims to investigate if shared decision-making, and the use of an in-consultation patient decision aid (PtDA), increases the decisional quality and therefore treatment satisfaction and outcome of patients with severe hip or knee osteoarthritis.
Finally, an evaluation will be conducted on patient-reported outcomes on pain, physical function, quality of life (QoL), and patient satisfaction, up to one year after surgery.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Osteoarthritis (OA) is the most common joint disease and a major cause of disability worldwide. The condition typically affects the hip or knee, and as the condition progresses it frequently causes debilitating pain and stiffness in the affected joints; thus impairing mobility, and decreasing function and quality of life(QoL).
Approximately 10,300 primary hip arthroplasties (THA) and 10,000 primary knee arthroplasties (TKA/UKA) were performed in Denmark in 2021.
For the majority of patients with severe osteoarthritis, evidence shows that joint replacement surgery is life-changing. Despite this documented effect, not all patients achieve optimal results. Patient dissatisfaction following THA and TKA has been reported as 7 % and 11-18%, respectively.
It is hypothesized that a lack of adequate information and patient involvement in the decision process might lead to the misalignment of patients' expectations and subsequent dissatisfaction. Considerable evidence shows that patients prefer more information and greater involvement. This strongly supports the concept that patients need to be actively involved in treatment decisions.
Accordingly, increasing patient involvement in healthcare decisions may be beneficial. Shared decision-making (SDM) supports patients' active involvement in the process and improves the quality of decisions. SDM can be facilitated using a PtDA, which has shown significant benefits in a range of patient groups. However, research on SDM and PtDAs in patients with severe hip or knee OA is lacking.
The overall aim of this project is to investigate if an in-consultation PtDA increases the decision quality for patients with severe OA of the hip or knee.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Odense、デンマーク、5000
- Odense University Hospital, OUH
-
Svendborg、デンマーク、5700
- Odense University Hospital, OUH
-
Vejle、デンマーク、7100
- Lillebaelt Hospital - Vejle
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Severe primary osteoarthritis eligible for primary total hip arthroplasty (THA) / primary total knee arthroplasty (TKA) / primary partial knee arthroplasty (UKA)
- Able to understand and read Danish
- Informed consent
Exclusion Criteria:
- Previous THA, TKA, or UKA on the contralateral side
- Cognitive impairment
- Non-OA-related reason for the visit
- No digital mailbox (E-boks)
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Shared decision-making (SDM)
Patients will be informed by a nurse before being consulted by the surgeon randomized to SDM and use the in-consultation PtDA during the consultation on patients with severe hip or knee osteoarthritis |
The intervention group has been involved in the development process of the PtDA. After receiving a training course in SDM and the use of a PtDA, the surgeons will practice SDM supported by an in-consultation PtDA during the consultations with the participant. |
|
介入なし：Usual practice
Patients will be informed by a nurse before being consulted by the surgeon randomized to usual practice during the consultation on patients with severe hip or knee osteoarthritis |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
時間枠：Within one week after inclusion in the consultation
|
Informed Patient-Centered (IPC) decision is calculated as the percentage of patients who are well-informed and received their preferred treatment. |
Within one week after inclusion in the consultation
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
時間枠：Within one week after inclusion in the consultation
|
Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making |
Within one week after inclusion in the consultation
|
|
Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire
時間枠：Within one week after inclusion in the consultation
|
HK-DQI, section 3, decision-making process: Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making |
Within one week after inclusion in the consultation
|
|
The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.
時間枠：Through study completion, an average of 1 year
|
The time duration will be documented by the surgeons |
Through study completion, an average of 1 year
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
時間枠：Three months and one year following surgery.
|
QoL: EuroQol (EQ-5D): Measuring the health-related quality of life. Presenting in three levels; Level 1: Indicating no problem, to Level 3: Indicating extreme problems |
Three months and one year following surgery.
|
|
The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire
時間枠：Three months and one year following surgery
|
Oxford Hip Score (OHS): Measuring function and pain with patients undergoing hip replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function). |
Three months and one year following surgery
|
|
The participant's pain and physical function after undergoing knee replacement surgery as measured by the Oxford Knee Score (OKS) questionnaire
時間枠：Three months and one year following surgery
|
Oxford Knee Score (OKS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function). |
Three months and one year following surgery
|
|
The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire
時間枠：Three months and one year following surgery.
|
Forgotten joint score (FJS): Measuring the participants' awareness of their artificial joint during activity of daily living (ADL). Minimum value: 0. Maximum value: 100. The higher score, the less the patient is aware of their affected joint. |
Three months and one year following surgery.
|
|
Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.
時間枠：Three months and one year following surgery.
|
The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret. |
Three months and one year following surgery.
|
|
Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)
時間枠：Three months and one year following surgery.
|
The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction. |
Three months and one year following surgery.
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Trine Ahlmann, PhD stud、Vejle Hospital
- スタディチェア：Claus Varnum, Ass.Prof.MD、Vejle Hospital
- スタディチェア：Martin Lindberg-Larsen, Ass.Prof.MD.、Odense University Hospital
- スタディチェア：Charlotte Myhre Jensen, Ass.Prof.RN、Odense University Hospital
- スタディチェア：Karina Dahl Steffensen, Prof.MD.、Vejle Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- S-20200137
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All data of the outcome measures will be available in an anonymized form if required by the scientific journal, in which the results of the trial will be published.
IPD 共有時間枠
Data will be available after the publication of the trial
IPD 共有アクセス基準
Data access will be reviewed by the author's group
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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