¿Qué les importa a los pacientes con osteoartritis severa de cadera o rodilla? (PATI-Project)
¿Qué les importa a los pacientes con osteoartritis severa de cadera o rodilla? Calidad decisional, participación del paciente y resultado de salud
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Odense, Dinamarca, 5000
- Odense University Hospital, OUH
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Svendborg, Dinamarca, 5700
- Odense University Hospital, OUH
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Vejle, Dinamarca, 7100
- Lillebaelt Hospital - Vejle
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
Periodo de tiempo: Within one week after inclusion in the consultation
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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
Periodo de tiempo: Within one week after inclusion in the consultation
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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.
Periodo de tiempo: 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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Trine Ahlmann, PhD stud, Vejle Hospital
- Silla de estudio: Claus Varnum, Ass.Prof.MD, Vejle Hospital
- Silla de estudio: Martin Lindberg-Larsen, Ass.Prof.MD., Odense University Hospital
- Silla de estudio: Charlotte Myhre Jensen, Ass.Prof.RN, Odense University Hospital
- Silla de estudio: Karina Dahl Steffensen, Prof.MD., Vejle Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- S-20200137
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will be available after the publication of the trial
Criterios de acceso compartido de IPD
Data access will be reviewed by the author's group
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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