What Matters to Patients With Severe Hip or Knee Osteoarthritis?

Not Applicable

Active, not recruiting

• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Interventions: Behavioral: Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee

• Registration Number: NCT05972525
• Lead Sponsor: Vejle Hospital

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.

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 Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-02
• Study Start: 2023-10-11
• Primary Completion: 2024-11-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Study Completion: 2026-07-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 615

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shared decision-making (SDM)	Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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

Trial Locations

Locations (2)

Odense University Hospital, OUH; 🇩🇰 Svendborg, Denmark

Lillebaelt Hospital - Vejle; 🇩🇰 Vejle, Denmark