Acute Medical Admissions of ELDERly Patients (ELDER)

NCT ID: NCT02395718

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-10-31

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.

Conditions

Geriatric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

QDU

Patients will undergo a fast track model for diagnostics and treatment with a goal of accomplishing a short-term hospitalisation. Patients will have immediate access to all diagnostic tests and treatments that will be carried out all day (24 hours) on demand from the responsible physician. The QDU is both organisationally and physically integrated in the ED. Point of care ultrasonography can be performed round the clock. Additionally the Department of Radiology provides the QDU with more advanced diagnostic procedures such as e.g. CT scans or MRI scans on a fast track basis. There is access to additional specialist evaluations from the ED staff or from various in house specialists, when needed. Simultaneously to the medical treatment, physical therapists and occupational therapists train and optimise patients' level of functioning, including prevention of loss of function.

Group Type: EXPERIMENTAL

QDU

Intervention Type: 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

Patients in the control group are treated as conventionally at one of seven wards at the DIM. After initial admission including initial diagnostics and treatment have been carried out in the ED, patients are transferred to the DIM. Usually patients are seen primarily by the on-call physician for evaluation of acute symptoms. The following day, a Chief physician will work out a plan for further diagnostics and treatment. Treatment by physiotherapists and occupational therapists is available on request from a physician. Analyses of blood samples are performed at the central laboratory and radiological procedures at the Department of Radiology.

Group Type: ACTIVE_COMPARATOR

DIM

Intervention Type: OTHER

Treatment at a ward at the DIM. Traditional inward hospitalisation

Interventions

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)

Intervention Type: OTHER

DIM

Treatment at a ward at the DIM. Traditional inward hospitalisation

Intervention Type: OTHER

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Zealand

OTHER

Sponsor Role: collaborator

Holbaek Sygehus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilla Stroem, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Holbæk, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29905758 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26931195 (View on PubMed)

Other Identifiers

ELDER

Identifier Type: -

Identifier Source: org_study_id