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Trial registered on ANZCTR


Registration number
ACTRN12620001132932
Ethics application status
Approved
Date submitted
19/06/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study
Scientific title
Development and evaluation of informed consent procedures for recruitment into a placebo-controlled surgical trial of arthroscopic subacromial decompression
Secondary ID [1] 301166 0
Nil known
Universal Trial Number (UTN)
U1111-1251-2482
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 317297 0
Arthroscopic subacromial decompression surgery 317298 0
Condition category
Condition code
Musculoskeletal 315417 315417 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317474 0
Behaviour
Comparator / control treatment
Arm2: This group will receive consent material based on a hypothetical trial of ASD, This 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.
This will be delivered to participants via email, and 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, one-week after completion of the consent process. The duration of collection of trial outcome measures will be approximately 2 x 30-minutes sessions.
While reviewing the consent information, participants in both Arm1 and Arm2 will be provided with the opportunity to ask the clinical researcher any questions about the hypothetical study over the phone/video call. The clinical researcher will record any questions.

Control group
Active

Outcomes
Primary outcome [1] 323667 0
Proportion of people willing to opt into the hypothetical placebo-controlled surgical trial of ASD post consent scenario, measured by a study-specific telephone survey.
Timepoint [1] 323667 0
Immediately after completion of the consent scenario and again 1-week after completion of consent process.
Secondary outcome [1] 382529 0
Trial literacy assessed using the Therapeutic Misconception Scale
Timepoint [1] 382529 0
Immediately post participating in the informed consent process and one-week post completion of the consent process
Secondary outcome [2] 384768 0
A subset of purposively sampled participants that represent a range of ages and gender from each study arm (approximately 20 in total) will be invited to participate in a phone audio-recorded qualitative interview. After the collection of all other outcome data, these participants will be asked to review the consent material while verbalising their immediate responses to these materials, using a 'think aloud' technique. This will provide insight into how participants understand key concepts about the study design such as randomisation, blinding, and the use of placebo controls.
Timepoint [2] 384768 0
After the collection of outcome data at a follow-up time convenient to individual participants, within one month of completion of consent process.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Justification: As a feasibility study, no formal power calculation is needed (Rahman, Gemperle-Mannion et al. 2020). We have set a maximum target of 40 participants per arm (approximately 80 in total) to ensure adequate representation of males and females from both public and private hospital settings. These numbers will also be sufficient to enable the embedded qualitative evaluation.

Quantitative analysis: Categorical variables will be analysed using chi-square tests. For continuous variables we will employ (parametric) t-tests and (non-parametric) Mann-Whitney tests for symmetrically and asymmetrically distributed data, respectively. Analyses will be conducted on an intention-to-treat basis by a blinded statistician using Stata, version 14.0 (StataCorp, College Station, Texas).

Qualitative analysis: The qualitative interviews will gain further insight into how participants understand key study design concepts, and further the understanding of factors that contribute to participants’ willingness to opt-in to the hypothetical trial. The interviews will be audio recorded and transcribed data will be analysed using inductive thematic analysis to compare data from participants randomised to the two study arms. Concurrent with data collection, in the first stage of qualitative data analysis, two researchers will independently identify concepts relevant to the research question in the first five interview transcripts. The two researchers will meet to discuss a preliminary coding framework, which will continue to be refined and extended through analysis of subsequent interviews. When the researchers are confident that the coding framework captures all relevant interview responses and no new codes are identified in subsequent interviews, recruitment will cease. Data will be uploaded into a qualitative data management software (Nvivo data management package, version 12.0) and all transcripts will be coded using the refined framework. Codes will be grouped thematically for each of the two study arms and themes between each study arm will be compared and contrasted. Emerging interpretations will be challenged through discussion among the inter-disciplinary research team.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16691 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 30290 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 305610 0
University
Name [1] 305610 0
The University of Melbourne
Address [1] 305610 0
The University of Melbourne, Department of Surgery, Level 2 Clinical Sciences Building, 29 Regent Street
Fitzroy, VIC, 3065
Country [1] 305610 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Department of Surgery, Level 2 Clinical Sciences Building, 29 Regent Street
Fitzroy, VIC, 3065
Country
Australia
Secondary sponsor category [1] 306461 0
None
Name [1] 306461 0
Address [1] 306461 0
Country [1] 306461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305906 0
St Vincent's Hospital Melbourne - St Vincent's Hospital Melbourne Human Research Ethics Committee D
Ethics committee address [1] 305906 0
Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 305906 0
Australia
Date submitted for ethics approval [1] 305906 0
19/04/2020
Approval date [1] 305906 0
23/09/2020
Ethics approval number [1] 305906 0
Project ID: 62902, St Vincent’s Local Reference Number: LRR 069/20

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102014 0
A/Prof Michelle Dowsey
Address 102014 0
The University of Melbourne, Department of Surgery, Level: 02 Room: 203, Clinical Sciences Building, 29 Regent Street
Fitzroy, VIC, 3065
Country 102014 0
Australia
Phone 102014 0
+61 3 9231 3955
Fax 102014 0
Email 102014 0
mmdowsey@unimelb.edu.au
Contact person for public queries
Name 102015 0
A/Prof Michelle Dowsey
Address 102015 0
The University of Melbourne, Department of Surgery, Level: 02 Room: 203, Clinical Sciences Building, 29 Regent Street
Fitzroy, VIC, 3065
Country 102015 0
Australia
Phone 102015 0
+61 3 9231 3955
Fax 102015 0
Email 102015 0
mmdowsey@unimelb.edu.au
Contact person for scientific queries
Name 102016 0
A/Prof Michelle Dowsey
Address 102016 0
The University of Melbourne, Department of Surgery, Level: 02 Room: 203, Clinical Sciences Building, 29 Regent Street
Fitzroy, VIC, 3065
Country 102016 0
Australia
Phone 102016 0
+61 3 9231 3955
Fax 102016 0
Email 102016 0
mmdowsey@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent for data sharing has not been obtained and ethics approval would be required from the study institution for future use of patient level data.
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8277 0
Ethical approval
Citation [1] 8277 0
Link [1] 8277 0
Email [1] 8277 0
Other [1] 8277 0
Type [2] 8279 0
Informed consent form
Citation [2] 8279 0
Link [2] 8279 0
Email [2] 8279 0
Other [2] 8279 0
Summary results
No Results