Abstract

BackgroundOlder adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient’s home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care.MethodsThe ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit.Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient’s own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively.DiscussionRising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT.Trial registrationThe trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020.

Highlights

  • Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission

  • The authors of all systematic reviews included in this umbrella review recommend that more high quality randomised controlled trial (RCT) need to be conducted in this area

  • All clinical and research staff will be fully equipped with Personal Protective Equipment (PPE) and are accustomed to Dissemination plan The results of this feasibility trial will inform the design of the anticipated definitive trial, rather than directly inform clinical decision-making, since clinical and cost effectiveness cannot be determined at this level

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Summary

Methods

Trial design This is a parallel group pilot RCT with a 1:1:1 allocation ratio. In order to ensure standardised conduct and reporting, the Standard Protocol Items for Intervention Trials (SPIRIT) guidelines will be used [40]. The SOLAR team (consisting of a consultant in geriatric medicine/geriatric specialist registrar, specialist geriatric nurse, senior pharmacist, senior physiotherapist, senior occupational therapist and senior medical social worker) in the ED will assess all participants in the intervention group and perform CGA. ED PLUS incorporates the most recent evidence on physical activity and falls prevention, duration of physical activity programmes, management of multimorbidity and physical exercise interventions for improving measures of physical function in older adults [31, 52, 55,56,57]. Provisions for post‐trial care A detailed letter describing the ED PLUS programme will be sent to the general practitioner (GP) and other HSCPs as required for all intervention group participants discharged directly from the ED. These data alongside the qualitative interviews will be used to measure adherence and to assess whether any modifications are required to improve engagement

Discussion
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