Acute Medical Admissions of ELDERly Patients (ELDER)

Geriatric Disorder Clinical Trial

— ELDER  

Official title:

Acute Medical Admission of ELDERly Patients (≥75yrs) to Either Fast Track or Traditional Inward Hospitalisation. A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395718
• Other study ID #: ELDER
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: February 2, 2017
• Start date: January 2015
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Disorder

Intervention

Other:
• QDU
Treatment in a QDU. Intervention being fast track model for diagnostics and treatment with a goal of accomplishing a short-term hospitalisation (see description QDU arm)
• DIM
Treatment at a ward at the DIM. Traditional inward hospitalisation

Locations

Country	Name	City	State
Denmark	Dept. of Emergency Medicine, Holbaek Sygehus, Copenhagen University Hospital	Holbaek

Sponsors (2)

Lead Sponsor	Collaborator
Holbaek Sygehus	Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Number of participants that die by any cause within 90 days after the day of admission, data will be retrieved from The Danish Civil Registration system 90 days after admission. Accounted as dead or alive.	90 days
Secondary	Length of stay in-hospital	Length of stay in-hospital per participant, defined as the duration of a single episode of hospitalisation including day of admission, and day of discharge. Length of stay will be calculated by subtracting the day of admission from day of discharge as registered in the patient's hospital chart. Accounted in days	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.
Secondary	Readmissions	Number of participants that are readmitted within 30 days from date of discharge (defined as the proportion of patients readmitted no more than 30 days post initial discharge as registered in the patient's hospital chart. Accounted as yes or no).	30 days
Secondary	In hospital Mortality	Number of participants that die In-hospital (defined as patients that have died at any time during hospitalisation as registered in the patient's hospital chart. Accounted as dead or alive).	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.
Secondary	In-hospital Transfer	Number of participants that are transferred to other wards while in hospital (defined as patients that have been transferred to any other ward in the hospital apart from the Department of Radiology at any time during hospitalisation as registered in the patient's hospital chart. Accounted as yes or no).	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.
Secondary	Instrumental Activities of Daily Living	Number of participants with change in Instrumental activities of daily living-score (iADL- score) within 90 days from admission (defined as any decrease or increase in iADL score within 90 days from admission. Accounted in score increase, score decrease or no-change).	90 days (± 2 days) from date of randomization
Secondary	Placement in a long-term-care home after hospitalisation.	Number of participants that are placed in a long-term-care home after hospitalisation within 90 days from admission (defined by placement in any kind of long-term-care home after hospitalisation from the first day of admission to day 90 after admission. Accounted as yes or no).	3 months (± 2 days)
Secondary	Complications of hospitalisation	Number of participants with complications of hospitalisation (defined as an injury caused by medical management (rather than the disease process).; Complications of hospitalisation are one or more of the following: Nosocomial infection; Medication error; Deep venous thrombosis; Pulmonary Embolism; Delirium; Decubitus ulcers; Post-procedural haemorrhage; In-hospital fractures or falls; Gastrointestinal haemorrhage; Cerebral infarction	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.