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Completed

NCT Number: NCT02395718

Acute Medical Admissions of ELDERly Patients (ELDER)

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).

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Key information

Conditions

Geriatric Disorder

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Emergency Medicine, Holbaek Sygehus, Copenhagen University Hospital

Holbæk, 4300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

QDU

Other

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

Other

Treatment at a ward at the DIM. Traditional inward hospitalisation

Primary outcomes

  1. All cause mortality

    Time frame: 90 days

    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.

Secondary outcomes

  1. Length of stay in-hospital

    Time frame: 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.

    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

  2. Readmissions

    Time frame: 30 days

    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).

  3. In hospital Mortality

    Time frame: 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.

    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).

  4. In-hospital Transfer

    Time frame: 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.

    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).

  5. Instrumental Activities of Daily Living

    Time frame: 90 days (± 2 days) from date of randomization

    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).

  6. Placement in a long-term-care home after hospitalisation.

    Time frame: 3 months (± 2 days)

    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).

  7. Complications of hospitalisation

    Time frame: 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.

    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

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • Region Zealand

Registry information

Official study title

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

Acronym: ELDER

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2015
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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