PATI-Project: What Matters to Patients With Severe Hip or Knee Osteoarthritis?

Sponsor

Vejle Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972525

Collaborator

Odense University Hospital (Other)

551

Enrollment

Locations

Arms

Anticipated Duration (Months)

183.7

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis Knee Osteoarthritis	Behavioral: Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

551 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The group of hip and knee surgeons at Vejle, Odense, and Svendborg hospitals will be randomized 1:1 either to continue standard consultation or to practice SDM supported by the in-consultation PtDA.The group of hip and knee surgeons at Vejle, Odense, and Svendborg hospitals will be randomized 1:1 either to continue standard consultation or to practice SDM supported by the in-consultation PtDA.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

What Matters to Patients With Severe Hip or Knee Osteoarthritis? Decisional Quality, Patient Involvement and Health Outcome

Anticipated Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Jul 11, 2024

Anticipated Study Completion Date :

Mar 11, 2026

Arms and Interventions

Arm	Intervention/Treatment
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	Behavioral: Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee 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.
No Intervention: 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

Arm

Intervention/Treatment

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

Behavioral: Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee

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.

No Intervention: 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

Outcome Measures

Primary Outcome Measures

The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI). [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.

Secondary Outcome Measures

Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire [Within one week after inclusion in the consultation]
Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making
Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire [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
The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire [Three months and one year following surgery]
Oxford Knee Score (OHS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function).
The participant's pain and physical function after undergoing knee replacement surgery as measured by Oxford Knee Score (OKS) questionnaire [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).
The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire [Three months and one year following surgery.]
Forgotten joint score (FJS): Measuring the participants' awareness of their artificial joint during ADL. Minimum value: 0. Maximum value: 100. The higher score, the less the patient is aware of their affected joint.
Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D) [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
The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA. [Through study completion, an average of 1 year]
The time duration will be documented by the surgeons
Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire. [Three months and one year following surgery.]
The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret.
Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ) [Three months and one year following surgery.]
The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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