Hip OsteoarthritisPATI-ProjectNCT05972525
What Matters to Patients With Severe Hip or Knee Osteoarthritis?
A study testing Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Vejle Hospital at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 3 sitesDenmark
- Study dates
- 11 Oct 2023to 11 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous THA, TKA, or UKA on the contralateral side
- Cognitive impairment
- Non-OA-related reason for the visit
- No digital mailbox (E-boks)
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Odense University Hospital, OUH
Odense, 5000
Odense University Hospital, OUH
Svendborg, 5700
Lillebaelt Hospital - Vejle
Vejle, 7100
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee
- Keywords
- Hip Osteoarthritis, Knee Osteoarthritis, Shared Decision Making, Total knee arthroplasty, Partiel knee arthroplasty, Total hip arthroplasty, Decision quality, HK-DQI
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or kneeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shared decision-making (SDM) | Experimental | 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 Receives: Behavioral: Shared decision-making supported by an in-consultation PtDA to patients with severe osteoarthritis in their hip or knee |
| Usual practice | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one week after inclusion in the consultation
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start11 Oct 2023
- Primary completion29 Nov 2024
- Study completion11 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Trine Ahlmann, PhD stud, Principal investigator, Vejle HospitalClaus Varnum, Ass.Prof.MD, Study chair, Vejle HospitalMartin Lindberg-Larsen, Ass.Prof.MD., Study chair, Odense University HospitalCharlotte Myhre Jensen, Ass.Prof.RN, Study chair, Odense University HospitalKarina Dahl Steffensen, Prof.MD., Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972525
- Sponsor's protocol ID
- S-20200137
- Acronym
- PATI-Project
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40597226