Implementing Australia’s psychotropic clinical practice guidelines in residential aged care: the EMBRACE helix counterbalanced randomised controlled trial comparing knowledge brokers with pharmacist education and passive distribution

Psychotropic medication use remains highly prevalent in dementia despite guidelines recommending against routine use. The Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE) trial evaluated the effectiveness and cost of using knowledge brokers to implement Australia’s Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications for People Living with Dementia and in Residential Aged Care. This 12-month helix-counterbalanced randomised controlled trial conducted between October 2023 and September 2024 evaluated three residential aged care facility (RACF)-level implementation strategies for antipsychotics, benzodiazepines and antidepressants. The strategies were: passive distribution of the Guideline (Level 1), quarterly pharmacist-led staff education (Level 2), and tailored implementation led by an onsite knowledge broker pharmacist (Level 3). Nineteen RACFs across four Australian states participated. The primary outcome was a composite measure of overall Guideline non-concordance for antipsychotics, benzodiazepines and antidepressants, comparing the Level 3 intervention with Level 1 and Level 2 at 6-months. Secondary outcomes included overall non-concordance at 3-, 9- and 12-months, and non-concordance with specific Guideline recommendations at all time points. Linear mixed models were used to analyse the primary and secondary outcomes. A cost consequence analysis was also conducted. Differences in overall non-concordance between intervention levels at 6 months (primary outcome) were not observed (Level 3 versus Level 2: −0.02 [95%CI −0.08 to 0.03], p = 0.43; Level 3 versus Level 1: −0.03 [95% CI −0.08 to 0.03], p = 0.34). There were no differences observed at other timepoints or for specific Guideline recommendations at any timepoint (secondary outcomes). There was a significant reduction in non-concordance per month for all three intervention strategies over the 12-month trial period (Level 1: −0.004 [95%CI: −0.009 to −0.001), Level 2: −0.006 [95%CI: −0.010 to −0.003], Level 3: −0.006 [95%CI: −0.010 to −0.003]). The mean (SD) cost ($AUD) of delivering the intervention per resident over the 12-months was Level 3: $207.53 ($186.60), Level 2: $61.23 ($37.58), and Level 1: $30.12 ($35.35). Guideline non-concordance decreased over time for all three interventions, but there was no difference between intervention strategies. Contamination between Levels may have diluted measurable effects, underscoring the need for future helix-counterbalanced trials to ensure clear delineation between implementation strategies and medication contexts. Australian New Zealand Clinical Trials Registry: ACTRN12623001141639. Registered 6 November 2023.