O que importa para pacientes com osteoartrite grave de quadril ou joelho? (PATI-Project)
O que importa para pacientes com osteoartrite grave de quadril ou joelho? Qualidade decisória, envolvimento do paciente e resultado em saúde
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.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
Prazo: 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
Prazo: 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.
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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)
Prazo: 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
- Cadeira de estudo: Claus Varnum, Ass.Prof.MD, Vejle Hospital
- Cadeira de estudo: Martin Lindberg-Larsen, Ass.Prof.MD., Odense University Hospital
- Cadeira de estudo: Charlotte Myhre Jensen, Ass.Prof.RN, Odense University Hospital
- Cadeira de estudo: Karina Dahl Steffensen, Prof.MD., Vejle Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S-20200137
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Data will be available after the publication of the trial
Critérios de acesso de compartilhamento IPD
Data access will be reviewed by the author's group
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
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