What Matters to Patients With Severe Hip or Knee Osteoarthritis?

Knee Osteoarthritis Clinical Trial

— PATI-Project  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972525
• Other study ID #: S-20200137
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: July 11, 2026

Study information

• Verified date: May 2024
• Source: Vejle Hospital
• Contact: Trine Ahlmann, PhD stud
• Phone: +4561164836
• Email: trine.alman.pedersen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 551
• Est. completion date: July 11, 2026
• Est. primary completion date: October 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital, OUH	Odense
Denmark	Odense University Hospital, OUH	Svendborg
Denmark	Lillebaelt Hospital - Vejle	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Vejle Hospital	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)	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.
Other	The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire	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
Other	The participant's pain and physical function after undergoing knee replacement surgery as measured by the Oxford Knee Score (OKS) questionnaire	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
Other	The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire	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.
Other	Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.	The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret.	Three months and one year following surgery.
Other	Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)	The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction.	Three months and one year following surgery.
Primary	The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).	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
Secondary	Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire	Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making	Within one week after inclusion in the consultation
Secondary	Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire	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
Secondary	The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.	The time duration will be documented by the surgeons	Through study completion, an average of 1 year