None listed
Conditions
Brief summary
Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment is common in clinical trials, and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure?; ii) Optimisation: Can patients’ willingness to enrol in, or understanding of, such a trial be improved by the consent process; and iii) Exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved? Participants will include patients consented for shoulder impingement surgery with one of the orthopaedic surgeons from St Vincent’s Public Hospital Melbourne (SVHM). It is expected that a total of number of 80 participants will be recruited to this study. The primary outcome will be the proportion of people willing to opt in to the proposed hypothetical placebo surgery trial of arthroscopic subacromial decompression (ASD) post each consent scenario. The focus of this feasibility study is how to optimise patient recruitment to a future trial comparing ASD of the shoulder joint to anaesthetic and skin incision only. Outcomes from this study will inform a future placebo-controlled surgical trial for ASD.
Interventions
A consent process for a hypothetical placebo-controlled surgical trial of arthroscopic subacromial decompression (ASD). In this trial, there will be two different groups (Arm1 and Arm2), with the only difference between the groups being how the information about the hypothetical trial is presented. Both consent processes will clearly explain trial participation to a hypothetical trial in plain English. Content for the hypothetical trial is based on previously published placebo-controlled trials
A consent process for a hypothetical placebo-controlled surgical trial of arthroscopic subacromial decompression (ASD). In this trial, there will be two different groups (Arm1 and Arm2), with the only difference between the groups being how the information about the hypothetical trial is presented. Both consent processes will clearly explain trial participation to a hypothetical trial in plain English. Content for the hypothetical trial is based on previously published placebo-controlled trials of ASD and informed by qualitative interviews with orthopaedic patients about their understanding of and attitude towards placebo-controlled surgical trials. The consent process will invite participants to take part in a hypothetical placebo-controlled trial of ASD. It will describe: the procedure, the need for further research, what a placebo-controlled surgical trial involves, and trial participation requirements. It will also describe key concepts such as equipoise, placebo-effects, randomisation, and blinding. The intervention will be delivered to participants individually, and will be delivered once in detail with the clinical researcher, lasting approximately 20-minutes duration. Participants who have consented to the study will be delivered the study informed consent procedure for the hypothetical trial (Arm1 or Arm2) via email. Trial outcome measures will be collected by a clinical researcher via video-call or over the phone immediately after participating in the informed consent process and at a second time point, approximately one-week after completion of the consent process. The duration of collection of trial outcome measures will be approximately 2 x 30-minutes sessions. Monitoring adherence to the intervention will require the clinical researcher to ensure participants have reviewed the consent material in full. To ensure this, after randomisation participants will be provided with a copy of the relevant study information (Arm1 or Arm2) and will be instructed to not review this information until a rescheduled time with the clinical researcher. During this time the researcher will record any questions participants may have.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be considered for inclusion if they are aged 18 years or older; have consented for arthroscopic subacromial decompression (ASD) with one of the orthopaedic surgeons from St Vincent's Hospital Melbourne (SVHM) or have consented to surgery at the private rooms of a surgeon who conducts surgery at SVHM; have a mastery of the English language.
Exclusion criteria
i) Patients undergoing revision surgery ii) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia) iii) Unable to provide informed consent without the aid of an interpreter.
Outcome results
None listed