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Trial registered on ANZCTR


Registration number
ACTRN12621000992808
Ethics application status
Approved
Date submitted
24/06/2021
Date registered
28/07/2021
Date last updated
28/07/2021
Date data sharing statement initially provided
28/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a patient decision aid reduce people's intentions to have shoulder surgery
Scientific title
Can a patient decision aid reduce people’s intentions to undergo subacromial decompression surgery or rotator cuff repair surgery for their shoulder pain?
Secondary ID [1] 304617 0
NHMRC Investigator Grant APP1194105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 322537 0
Condition category
Condition code
Musculoskeletal 320164 320164 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A patient decision aid outlining the options of having surgery for shoulder pain (subacromial decompression surgery or rotator cuff repair surgery) and not having surgery, and the benefits and harms of each, with the options (non-surgical options vs. surgery) displayed in two formats:
- side-by-side
- top-and-bottom

The two patient decision aid formats will be delivered as two separate intervention arms (i.e. participants will be randomly allocated to view only one format).
The patient decision aid was co-developed with patients and health professionals specifically for this trial (i.e. it is not publicly available yet) and incorporates the best available evidence on subacromial decompression surgery and rotator cuff repair surgery from the most recent Cochrane reviews of these surgeries. Information in the decision aid is presented under the following headings:
• Who should read this decision aid?
• What are the treatment options covered in this decision aid?
• What are the likely benefits of surgery compared to non-surgical options?
• What are the likely complications of surgery?
• Summary of benefits, harms, and other practical issues
• Questions to consider when talking with a health professional

Participants in the intervention group will view the patient decision aid online for a minimum of 3 minutes before being directed to complete questionnaires assessing knowledge, attitudes, treatment intentions and decisional conflict. The patient decision aid will be displayed for a minimum of 3 minutes to ensure participants do not skip reading the patient decision aid.
Intervention code [1] 320965 0
Behaviour
Comparator / control treatment
Information for patients with subacromial pain syndrome developed by the Therapies Department National Health Service (NHS) East Kent Hospitals University.

Participants in the control group will view this material online for a minimum of 3 minutes before being directed to complete questionnaires assessing knowledge, attitudes, treatment intentions and decisional conflict. The control material will be displayed for a minimum of 3 minutes to ensure participants do not skip reading the information presented.
Control group
Active

Outcomes
Primary outcome [1] 328047 0
The primary outcome will be treatment intentions as a continuous and dichotomous variable. Treatment intentions will be assessed with the following question: ‘If your surgeon or doctor asked you right now to make a choice between having surgery and trying non-surgical options (e.g. medication, exercise, physiotherapy), please show where you would be on the scale below by moving the slider’. The scale ranges from 1 (definitely wish to try non-surgical options) to 15 (definitely wish to have surgery). Participants who score greater than 7 will be classified as intending to try surgery, while those who score less than or equal to 7 will be classified as intending to not try surgery. This outcome has sufficient test retest reliability (Pearsons r = 0.95 for intentions as a continuous outcome and 0.91 for intentions as a dichotomous outcome), is sensitive to change (as a dichotomous outcome), and discriminates between interventions (as a dichotomous outcome).
Timepoint [1] 328047 0
Immediately following the intervention
Secondary outcome [1] 397332 0
Knowledge (continuous outcome). Knowledge will be assessed using an 8-item questionnaire that assesses participant’s conceptual and numerical understanding of shoulder pain and various treatment options (range: 0 to 8). Questions were developed for the purpose of this study and were based on information presented in the decision aid (intervention).
Timepoint [1] 397332 0
Immediately following the intervention
Secondary outcome [2] 397333 0
Attitudes (continuous outcome). Attitudes will be assessed using a 3-item questionnaire with each item scored from 1 to 7 (range 3-21). This questionnaire was adapted from previous studies:

1. Smith SK, Trevena L, Simpson JM, et al. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial. BMJ. 2010;341:c5370.
2. Nagle C, Gunn J, Bell R, et al. Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458]. Bjog. 2008;115(3):339-47.
3. Björklund U, Marsk A, Levin C, et al. Audiovisual information affects informed choice and experience of information in antenatal Down syndrome screening – A randomized controlled trial. Patient Education and Counseling. 2012;86(3):390-5.
4. Korfage IJ, Fuhrel-Forbis A, Ubel PA, et al. Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. Breast Cancer Res. 2013;15(5):R74-R.
5. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expectations. 2001;4(2):99-108.
Timepoint [2] 397333 0
Immediately following the intervention
Secondary outcome [3] 397334 0
Informed choice will be a binary outcome. Informed choice is a composite measure of knowledge, attitudes and treatment intentions. Participants will be considered to have made an informed treatment choice when they have sufficient knowledge (greater than or equal to 4 out of 8 score on the Knowledge questionnaire), and attitudes that align with their treatment intentions.

Attitudes align with treatment intentions when:
• A participant has positive attitudes towards surgery (greater than or equal to 12 on Attitudes questionnaire) and intends to try surgery
• A participant has negative attitudes towards surgery (<12 score on Attitudes questionnaire) and intends to not try surgery

Participants with insufficient knowledge, or attitudes that do not align with their treatment intentions will be considered as making an uninformed choice.

This approach to assessing informed choice has been done previously:

1. Hersch J, Barratt A, Jansen J, et al. The effect of information about overdetection of breast cancer on women's decision-making about mammography screening: study protocol for a randomised controlled trial. BMJ Open. 2014;4(5):e004990.
2. Coxeter PD, Del Mar CB, Hoffmann TC. Preparing Parents to Make An Informed Choice About Antibiotic Use for Common Acute Respiratory Infections in Children: A Randomised Trial of Brief Decision Aids in a Hypothetical Scenario. Patient. 2017;10(4):463-74.

Timepoint [3] 397334 0
Immediately following the intervention
Secondary outcome [4] 397335 0
Decisional conflict (continuous outcome). Decisional conflict will be assessed using the 18-item Decisional Conflict Scale, with items ranging in score from 1 (strongly agree) to 5 (strongly disagree).
Timepoint [4] 397335 0
Immediately following the intervention

Eligibility
Key inclusion criteria
Qualtrics (market research company; www.qualtrics.com) will recruit 396 participants who
(a) self-identify as currently having shoulder pain
(b) rate their shoulder pain over the past week as 1 or more on a scale of 0-10
(c) did not have a traumatic shoulder injury, and
(d) self-identify as currently considering surgery to treat their shoulder pain
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Being <18 years old
Not able to read and type English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised through the online survey platform Qualtrics (1:1 ratio; concealed to investigators).
Randomisation will occur automatically once a participant enters the survey. Those recruiting participants via email will not be aware of the randomisation sequence. Hence, allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 ratio for decision aid vs. control material, and 1:1 ratio for side-by-side display decision aid vs. top-and-bottom display decision aid. Randomisation will be performed via computerised sequence generation through the online platform Qualtrics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be performed as intention-to-treat. The researcher analysing the data will be blind to group allocation. Descriptive statistics (means and standard deviations or medians and ranges, as appropriate) will summarise participant characteristics and outcome data. A one-way independent ANCOVA (or Kruskal-Wallis test, as appropriate) will evaluate between-group differences in treatment intentions, knowledge, attitudes, and decisional conflict (continuous variables), adjusted for baseline values. Logistic regression – adjusted for baselines values – will evaluate between-group differences in the proportion of participants that intend to undergo surgery and make an informed choice. We will use multiple imputation for participants with missing outcome data

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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23848 0
United States of America
State/province [1] 23848 0
Country [2] 23849 0
United Kingdom
State/province [2] 23849 0
Country [3] 23850 0
New Zealand
State/province [3] 23850 0
Country [4] 23851 0
Canada
State/province [4] 23851 0

Funding & Sponsors
Funding source category [1] 308977 0
Government body
Name [1] 308977 0
National Health and Medical Research Council
Address [1] 308977 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 308977 0
Australia
Primary sponsor type
Individual
Name
Joshua Zadro
Address
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 309912 0
None
Name [1] 309912 0
Address [1] 309912 0
Country [1] 309912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308869 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 308869 0
Level 3, Administration Building (F23), Corner of Eastern Avenue and City Road, The University of Sydney, Camperdown NSW 2006
Ethics committee country [1] 308869 0
Australia
Date submitted for ethics approval [1] 308869 0
13/01/2021
Approval date [1] 308869 0
15/06/2021
Ethics approval number [1] 308869 0
2021/081

Summary
Brief summary
Subacromial decompression surgery and rotator cuff repair surgery are often performed to treat shoulder pain, but recent evidence suggests these surgeries provide little-to-no benefit to patients over non-surgical options and may cause harm. The aim of this study is to evaluate whether a patient decision aid outlining the benefits and harms of these surgeries can reduce people’s intentions to undergo surgery. Secondary outcomes include knowledge of the benefits and potential harms of surgery compared to non-surgical options, attitudes towards surgery, the proportion of people who are equipped to make an informed choice, and decisional conflict.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112166 0
Dr Joshua Zadro
Address 112166 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 112166 0
Australia
Phone 112166 0
+61 449906121
Fax 112166 0
Email 112166 0
joshua.zadro@sydney.edu.au
Contact person for public queries
Name 112167 0
Dr Joshua Zadro
Address 112167 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 112167 0
Australia
Phone 112167 0
+61 449906121
Fax 112167 0
Email 112167 0
joshua.zadro@sydney.edu.au
Contact person for scientific queries
Name 112168 0
Dr Joshua Zadro
Address 112168 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 112168 0
Australia
Phone 112168 0
+61 449906121
Fax 112168 0
Email 112168 0
joshua.zadro@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Baseline and post-intervention data as required
When will data be available (start and end dates)?
Following publication of this study (anticipated Feb 2022). There is no end date. Data will be kept in perpituaty.
Available to whom?
Anyone who requests it with a reasonable reason and will put in a formal ethics request to use the data
Available for what types of analyses?
To be decided based on the request
How or where can data be obtained?
Through contacting the principal investigator, Dr Joshua Zadro, via email joshua.zadro@sydney.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results