Efficacy and cost-effectiveness of a community-based model of care for older patients with complex needs: a study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design.

BACKGROUND: 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.

INTERVENTION: A comprehensive, multidimensional geriatric assessment with care coordination was performed in a community setting-Older Persons ENablement And Rehabilitation for Complex Health conditions (OPEN ARCH).

OBJECTIVES: This study will assess the acceptability and determine the impact of the OPEN ARCH intervention on the health and quality of life outcomes, health and social services utilisation of older people with multiple chronic conditions and emerging complex care needs. An economic evaluation will determine whether OPEN ARCH is cost-effective when compared to the standard care.

METHODS/DESIGN: This multicentre randomised controlled trial uses a stepped wedge cluster design with repeated cross-sectional samples. General practitioners (GPs; n ≥ 10) will be randomised as 'clusters' at baseline using simple randomisation. Each GP cluster will recruit 10-12 participants. Data will be collected on each participant at 3-month intervals (- 3, 0, 3, 6 and 9 months). The primary outcome is health and social service utilisation as measured by Emergency Department presentations, hospital admissions, in-patient bed days, allied health and community support services. Secondary outcomes include functional status, quality of life and participants' satisfaction. Cost-effectiveness of the intervention will be assessed as the change to cost outcomes, including the cost of implementing the intervention and subsequent use of services, and the change to health benefits represented by quality adjusted life years.

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.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000198325p . Registered on 6 February 2017.