OBJECTIVE: To evaluate the effects of a patient decision aid for people considering shoulder surgery.
METHODS: Participants with shoulder pain considering shoulder surgery (n = 425) were recruited online and randomised to (i) a decision aid outlining the benefits and harms of shoulder surgery and non-surgical options (then randomised to a side-by-side vs. top-and-bottom display of options); and (ii) general information about shoulder pain from the NHS. Outcomes included treatment intention (primary), knowledge, attitudes, informed choice, and decisional conflict. Linear and logistic regression models were used to evaluate between-groups differences in outcomes.
RESULTS: 409 participants (96%) had post-intervention data. Mean age was 41.3 years, 44.2% were female. There was no between-group difference in post-intervention treatment intention (MD -0.2, 95% CI: -3.3 to 2.8) and likelihood of intending to have shoulder surgery (OR 0.7, 95% CI: 0.3-1.5). The decision aid slightly improved knowledge (MD 4.4, 95% CI: 0.2-8.6), but not any other secondary outcomes. The display of options did not influence any outcome.
CONCLUSIONS: In this online trial, a co-designed patient decision aid had no effect on treatment intention, attitudes, informed choice, and decisional conflict, but a small effect on improving knowledge.
PRACTICE IMPLICATIONS: Research is needed to understand reasons for the lack of anticipated effects.
TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12621000992808).