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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Behavioral: Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee

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 Type: Interventional
• Enrollment (Actual): 615
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital, OUH
  • Svendborg, Denmark, 5700
    • Odense University Hospital, OUH
  • Vejle, Denmark, 7100
    • Lillebaelt Hospital - Vejle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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
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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Collaborators: Odense University Hospital
• Investigators: Principal Investigator: Trine Ahlmann, PhD stud, Vejle Hospital; Study Chair: Claus Varnum, Ass.Prof.MD, Vejle Hospital; Study Chair: Martin Lindberg-Larsen, Ass.Prof.MD., Odense University Hospital; Study Chair: Charlotte Myhre Jensen, Ass.Prof.RN, Odense University Hospital; Study Chair: Karina Dahl Steffensen, Prof.MD., Vejle Hospital

Publications and helpful links

General Publications

• Pedersen TA, Lindberg-Larsen M, Jensen CM, Timm S, Steffensen KD, Varnum C. Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis - a study protocol for a multicentre, cluster randomised controlled trial (PATI-study). BMC Musculoskelet Disord. 2025 Jul 2;26(1):584. doi: 10.1186/s12891-025-08856-w.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Actual): November 29, 2024
• Study Completion (Estimated): July 11, 2026

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Hip Osteoarthritis; Total hip arthroplasty; Knee Osteoarthritis; Shared Decision Making; Partiel knee arthroplasty; Decision quality; HK-DQI
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: S-20200137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available after the publication of the trial
• IPD Sharing Access Criteria: Data access will be reviewed by the author's group
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No