None listed
Conditions
Brief summary
This randomised controlled trial is attempting to better understand the effectiveness of education material provided to patients considering a surgical opinion for their knee osteoarthritis. The primary aim of this study is to determine whether a co-designed decision aid for people with knee osteoarthritis considering surgery in addition to standard care (intervention) increases the proportion of people who make a high quality decisions compared to standard care alone (control). Patients will be recruited from a public clinic or private rooms of surgeons in NSW. They will be screened for inclusion and randomised to receive the intervention or control. Education material will be provided to participants prior to attending an initial consultation with their surgeon. After attending their initial consultation, participants will be followed up 2 weeks, 6 months and 1 year later regarding if they made a high quality decision, the impact of educational material on their decision, consideration for surgery, satisfaction with treatment decision, decisional conflict, decision regret, function and quality of life. We hypothesise that the use of this co-designed decision aid will lead to greater rates of high quality decision-making reported by patients compared to those receiving standard care. Further, we hypothesise the use of this co-designed decision aid will lead to decreased decisional conflict, decision regret and rate of change from original decision compared to those receiving standard care. We also hypothesise that overall satisfaction and impact of education materials on treatment option chosen will be increased, and function and quality of life will be unchanged compared to those receiving standard care. Based on the fulfilment of these hypotheses, we expect patients to choose surgery less often when receiving the co-designed decision aid.
Interventions
A co-designed decision aid was created with the input from patients (pre- and post-knee arthroplasty), orthopaedic surgeons, rheumatologists, general practitioners and physiotherapists, along with up to date evidence from peer-reviewed literature. This decision aid covers many aspects of the decision including: 1) what is knee osteoarthritis; 2) what are the options for treatment; 3) what happens during a knee arthroplasty; 4) what do patients usually expect to achieve with surgery and if this a
A co-designed decision aid was created with the input from patients (pre- and post-knee arthroplasty), orthopaedic surgeons, rheumatologists, general practitioners and physiotherapists, along with up to date evidence from peer-reviewed literature. This decision aid covers many aspects of the decision including: 1) what is knee osteoarthritis; 2) what are the options for treatment; 3) what happens during a knee arthroplasty; 4) what do patients usually expect to achieve with surgery and if this actually happens; 5) how long an arthroplasty usually lasts; 6) when they can expect to see a benefit to their pain and function; 7) the possible harms and likelihood of them occuring; 8) what the benefits vs risks are for non-surgical and surgical treatment; and 9) questions they could ask their treating health professional. This decision aid was developed as per the International Patient Decision Aid Standards Collaboration guidelines (http://ipdas.ohri.ca/who.html; http://ipdas.ohri.ca/using.html). In this study, this co-designed decision aid will be randomly provided to patients in addition to the control (standard care). The patients randomised to this group will receive the decision aid at least 2 weeks prior to their intial consultation with the surgeon in either an electronic (PDF) or physical format (cardboard), based on their contact preference. Piloting indicated a strong patient preference for hardcopy, but with an option to receive an electronic version. This decision aid is theirs to keep forever with the only limitation being that it is for personal use only (patients will be allowed to request another copy if they lose the original). The anticipated time to completely read the material in one sitting is around 5 minutes, though patients may refer back to the material as many times as they wish. Adherence will be monitored by patient-reported use at 2 weeks following their initial consultation with the surgeon.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Primary diagnosis of osteoarthritis - Greater than or equal to 50 years old - Referred to an orthopaedic surgeon, presenting with knee pain - Considering whether to undergo knee arthroplasty
Exclusion criteria
- Use of any type of knee osteoarthritis treatment decision aid in the prior 12 months - A prior knee arthroplasty performed - Any other significant injury to lower limb (e.g. fracture, aseptic necrosis, etc.) in the prior 12 months - Cognitive impairment such that a patient is unable to independently consent to participate - Unable to access assistance to complete questionnaires in English while at home
Outcome results
None listed