Clinical trial NCT05972525: What Matters to Patients With Severe Hip or Knee Osteoarthritis?
Official title: What Matters to Patients With Severe Hip or Knee Osteoarthritis? Decisional Quality, Patient Involvement and Health Outcome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Keywords: Hip Osteoarthritis
Knee Osteoarthritis
Shared Decision Making
Total knee arthroplasty
Partiel knee arthroplasty
Total hip arthroplasty
Decision quality
HK-DQI
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2023-08-02
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
timeFrame: Within one week after inclusion in the consultation
Secondary outcomes:
measure: Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
timeFrame: Within one week after inclusion in the consultation
measure: Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire
timeFrame: Within one week after inclusion in the consultation
measure: The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
timeFrame: Three months and one year following surgery.
measure: The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire
timeFrame: Three months and one year following surgery
measure: The participant's pain and physical function after undergoing knee replacement surgery as measured by the Oxford Knee Score (OKS) questionnaire
timeFrame: Three months and one year following surgery
measure: The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire
timeFrame: Three months and one year following surgery.
measure: Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.
timeFrame: Three months and one year following surgery.
measure: Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)
timeFrame: Three months and one year following surgery.
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, OUH
city: Svendborg
country: Denmark
facility: Odense University Hospital, OUH
city: Vejle
country: Denmark
facility: Lillebaelt Hospital - Vejle
Study officials:
affiliation: Vejle Hospital
name: Trine Ahlmann, PhD stud
role: PRINCIPAL_INVESTIGATOR
affiliation: Vejle Hospital
name: Claus Varnum, Ass.Prof.MD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Martin Lindberg-Larsen, Ass.Prof.MD.
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Charlotte Myhre Jensen, Ass.Prof.RN
role: STUDY_CHAIR
affiliation: Vejle Hospital
name: Karina Dahl Steffensen, Prof.MD.
role: STUDY_CHAIR
References: