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Efficacy and cost-effectiveness of a community based model of care for older patients with complex needs: a study protocol for a multicentre randomized controlled trial using a stepped wedge cluster design
Expand descriptionBackground: Community dwelling older persons with complex care needs may deteriorate rapidly and require hospitalisation if they receive inadequate support for their conditions in the community. This trial aims to assess the acceptability, impact and cost-effectiveness of a comprehensive, multidimensional geriatric assessment with care coordination (the OPEN ARCH intervention) in a community setting. Methods/Design: This multicentre randomised controlled trial uses a stepped wedge cluster design with repeated cross sectional samples. General Practitioners (GPs; n=12) will be randomised as ‘clusters’ at baseline using simple randomisation. Each GP cluster will then recruit 10-12 participants. Data will be collected on each participant at three-month interval (-3, 0, 3, 6 and 9 months). The primary clinical outcomes are Emergency Department (ED) presentations, acute hospital admissions, in-patient bed days, health service (including allied health) and community support service utilization. Secondary outcomes include functional status, Quality of Life (QoL) and participants’ satisfaction. Cost effectiveness of the intervention will be assessed as a change to cost outcomes, including the cost of implementing the intervention and subsequent use of health services; and, the change to health benefits, represented by quality adjusted life years (QALYs). Discussion: The results will have direct implications for the design and wider implementation of this new model of care for community dwelling older persons with complex care needs. Additionally, it will contribute to the evidence base on acceptability, efficacy, and cost-effectiveness of the intervention for this high-risk group of older people.