Contemporary Clinical Trials Communications · 12 authors, 4 centres
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This is a protocol for a clustered randomized trial comparing team-based versus problem-based training for nursing home staff to deliver non-pharmacological care for residents with dementia. The trial will measure the effectiveness of these approaches on resident outcomes, particularly off-label antipsychotic use, and explore whether they are protective during the COVID-19 pandemic.
This manuscript presents the protocol for a pragmatic, clustered randomized trial that will compare two non-pharmacological approaches to dementia care in nursing homes: a team-based approach involving core training for all staff, and a problem-based approach leveraging professional healthcare providers' expertise. The study, originally initiated pre-pandemic with 80 nursing homes, was disrupted by COVID-19 and is now proceeding with 53 re-engaged facilities. Using a convergent mixed methods design, the trial will evaluate the comparative effectiveness of the two approaches on long-term resident outcomes, with the primary outcome being the percentage of residents using off-label antipsychotic medication. It will also assess whether either approach is protective against the negative consequences of COVID-19. Qualitative data from staff and family caregivers will be integrated with quantitative findings to contextualize results and explore implementation. The protocol acknowledges limitations, including reliance on a 7-day look-back period for medication data and the inability to capture residents' lived experiences. The results aim to provide evidence for healthcare providers, administrators, and policymakers to optimize dementia care training and inform responses to disruptive events.
