Admission of elderly medical patients to fast track or standard hospitalisation: protocol for a randomised trial

Abstract

Introduction: Emergency department-based short stay units (SSUs) are increasingly being introduced to provide accelerated care. The effects of treatment in SSUs for elderly medical patients are not well-studied.

Methods: The ELDER trial is a single-blinded, randomised parallel trial with 1:1 allocation between hospitalisation in an SSU (intervention) and the Department of Internal Medicine (standard care). The study is conducted at Holbaek Hospital, Denmark. Elderly patients are screened for inclusion if an emergency physician assesses that treatment in an SSU is possible. Eligible participants are patients aged ≥ 75 years needing in-hospital treatment of an acute medical problem and who are stable upon admission. The primary outcome is 90-day all-cause mortality. Secondary outcomes include: length of stay in hospital, incidence of complications during hospitalisation, rate of unplanned readmissions and change in instrumental activities of daily living. We aim at recruiting 430 patients based on an estimated effects size of reducing mortality by 10%. All outcome measures will be assessed in an intention-to-treat analysis. Recruitment started on 5 January 2015. By 16 October 2015, we have enrolled 203 patients. An interim safety analysis is scheduled.

Conclusion: In the ELDER trial, we explore benefits and harms related to treatment in an SSU for elderly medical patients compared with standard hospitalisation.

Funding: Region Zealand's Forskningsfond, the Tryg Foundation and University of Copenhagen.

Trial registration: clinicaltrials.gov identifier: NCT02395718.