Cosa è importante per i pazienti con grave artrosi dell'anca o del ginocchio? (PATI-Project)
Cosa è importante per i pazienti con grave artrosi dell'anca o del ginocchio? Qualità decisionale, coinvolgimento del paziente e risultato sulla salute
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Odense, Danimarca, 5000
- Odense University Hospital, OUH
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Svendborg, Danimarca, 5700
- Odense University Hospital, OUH
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Vejle, Danimarca, 7100
- Lillebaelt Hospital - Vejle
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
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Nessun intervento: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
Lasso di tempo: Within one week after inclusion in the consultation
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
Lasso di tempo: 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
|
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Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire
Lasso di tempo: 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
|
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The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.
Lasso di tempo: Through study completion, an average of 1 year
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The time duration will be documented by the surgeons |
Through study completion, an average of 1 year
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
Lasso di tempo: Three months and one year following surgery.
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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.
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The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire
Lasso di tempo: Three months and one year following surgery
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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
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The participant's pain and physical function after undergoing knee replacement surgery as measured by the Oxford Knee Score (OKS) questionnaire
Lasso di tempo: Three months and one year following surgery
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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
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The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire
Lasso di tempo: Three months and one year following surgery.
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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.
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Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.
Lasso di tempo: Three months and one year following surgery.
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The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret. |
Three months and one year following surgery.
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Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)
Lasso di tempo: Three months and one year following surgery.
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The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction. |
Three months and one year following surgery.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Trine Ahlmann, PhD stud, Vejle Hospital
- Cattedra di studio: Claus Varnum, Ass.Prof.MD, Vejle Hospital
- Cattedra di studio: Martin Lindberg-Larsen, Ass.Prof.MD., Odense University Hospital
- Cattedra di studio: Charlotte Myhre Jensen, Ass.Prof.RN, Odense University Hospital
- Cattedra di studio: Karina Dahl Steffensen, Prof.MD., Vejle Hospital
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- S-20200137
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Data will be available after the publication of the trial
Criteri di accesso alla condivisione IPD
Data access will be reviewed by the author's group
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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