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Can a patient decision aid reduce people's intentions to have shoulder surgery

Can a patient decision aid reduce people’s intentions to undergo subacromial decompression surgery or rotator cuff repair surgery for their shoulder pain?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000992808
Enrollment
425
Registered
2021-07-28
Start date
2021-09-01
Completion date
2021-10-28
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 decisio

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.

Sponsors

Joshua Zadro
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Being <18 years old Not able to read and type English.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 18, 2026