Clinical trial NCT02395718: Acute Medical Admissions of ELDERly Patients (ELDER)
Official title: Acute Medical Admission of ELDERly Patients (≥75yrs) to Either Fast Track or Traditional Inward Hospitalisation. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Disorder
Keywords: elderly
quick diagnostic unit
short stay unit
randomised controlled trial
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Region Zealand
First posted: 2015-03-24
Enrollment: 430
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated in a Quick Diagnostic Unit (QDU) compared to the Department of Internal Medicine (DIM). A QDU is a medical Short Stay Unit (SSU).

Detailed description: The Danish emergency care system is undergoing major changes; Emergency Departments (ED) are now centralised at fewer hospitals, thus the ED now serve as the single point of entry for all acute patients. Another initiative, has been the establishment of a Quick Diagnostic Unit (QDU) as a subunit in the ED. The QDU is a ward for fast track diagnostics and treatment of stable medical patients that is believed to optimise in-hospital care by quicker diagnosis and shorter hospitalisations, and minimise time for patients to return to their habitual health status. However, little evidence exists on the putative benefits for elderly patients treated in a QDU setting.

In this study, we will examine the benefits and drawbacks of treatment of elderly medical patients (≥75 years) in an acute treatment system with the possibility of fast-track admission and treatment, rather than treatment in the traditional medical system. We will randomise patients to treatment in either a fast track ward/short stay unit, the QDU, or to standard treatment at the Dept. of Internal Medicine (DIM).

We hypothesise that treatment in a QDU compared to DIM offers optimised care through immediate access to clinical staff and rapid diagnostic facilities, treatment and quicker rehabilitation.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 75 years
2. Admitted for in-hospital treatment for an internal medicine disease
3. Green tag triaged upon arrival in the ED

Exclusion Criteria:

1. Previous participation in this trial
2. Participation in other clinical trials
3. No QDU beds available
4. Subject does not have a Danish Civil Registration Number (CPR).
5. Subject resides abroad
6. Requires help using the toilet in daily life
7. Patients not aware of date, time and location, or their own data (name, birth date)
8. Informed consent cannot be obtained

Primary outcomes:
measure: All cause mortality
timeFrame: 90 days
Secondary outcomes:
measure: Length of stay in-hospital
timeFrame: Lenght of stay is assessed from date of randomization untill the date of discharge, date of death from any cause or whichever came first, assessed up to 100 weeks.
measure: Readmissions
timeFrame: 30 days
measure: In hospital Mortality
timeFrame: In hospital mortality is assessed from date of randomization untill the date of discharge, date of death from any cause or whichever came first, assessed up to 100 weeks.
measure: In-hospital Transfer
timeFrame: is assessed from date of randomization untill the date of discharge, date of death from any cause or whichever came first, assessed up to 100 weeks.
measure: Instrumental Activities of Daily Living
timeFrame: 90 days (± 2 days) from date of randomization
measure: Placement in a long-term-care home after hospitalisation.
timeFrame: 3 months (± 2 days)
measure: Complications of hospitalisation
timeFrame: is assessed from date of randomization untill the date of discharge, date of death from any cause or whichever came first, assessed up to 100 weeks.
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Dept. of Emergency Medicine, Holbaek Sygehus, Copenhagen University Hospital
Study officials:
affiliation: Dept. of Emergency Medicine, Holbaek Sygehus, Copenhagen University Hospital
name: Camilla Stroem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strom C, Rasmussen LS, Lowe AS, Lorentzen AK, Lohse N, Madsen KHB, Rasmussen SW, Schmidt TA. Short-stay unit hospitalisation vs. standard care outcomes in older internal medicine patients-a randomised clinical trial. Age Ageing. 2018 Nov 1;47(6):810-817. doi: 10.1093/ageing/afy090.
citation: Strom C, Rasmussen LS, Wistisen Rasmussen S, Benn Madsen KH, Ancher Sorensen HA, Andersen Schmidt T. Admission of elderly medical patients to fast track or standard hospitalisation: protocol for a randomised trial. Dan Med J. 2016 Mar;63(3):A5189.