Increasing the capacity of community managed organisations to provide chronic disease preventive care to people with a mental health condition: protocol for a cluster-randomised controlled trial
Abstract
Comprehensive and routine provision of preventive care for modifiable risk factors within mental health community managed organisations (CMOs) is variable. This protocol describes a planned cluster-randomised controlled trial to support the delivery of such care within a large Australian CMO. A model of care and implementation support strategies will be co-designed and delivered across six months, with 12 CMO sites randomised to intervention or control groups. The model of care referred to as ‘The Live Well and Flourish Framework’ will guide staff in intervention sites through support conversations about modifiable risk factors (stopping or reducing smoking/vaping, healthy eating, limiting alcohol, and being physically active), supported through implementation strategies delivered throughout the intervention. The primary outcome is the proportion of people accessing CMO services who report being connected to health behaviour change support and resources for ‘Living Well Activities’. The resources required to develop and implement the model of care and implementation strategies will inform a cost-effectiveness evaluation of the intervention. Findings from this trial will inform future care delivery and initiatives within CMOs to provide support for modifiable chronic disease risk factors. Prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12625000322437) on 17/04/2025.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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