Geriatric DisorderELDERNCT02395718
Acute Medical Admissions of ELDERly Patients (ELDER)
A study testing QDU and DIM in people with Geriatric Disorder, run by Holbaek Sygehus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- QDU and DIM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 75 years
- Admitted for in-hospital treatment for an internal medicine disease
- Green tag triaged upon arrival in the ED
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Emergency Medicine, Holbaek Sygehus, Copenhagen University Hospital
Holbæk, 4300
About this study
Official title: Acute Medical Admission of ELDERly Patients (≥75yrs) to Either Fast Track or Traditional Inward Hospitalisation. A Randomised Controlled Trial
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).
Read the 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
- Being tested
- QDU, DIM
- Keywords
- elderly, quick diagnostic unit, short stay unit, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QDUOther
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)
DIMOther
Treatment at a ward at the DIM. Traditional inward hospitalisation
| Study group | Role | What they receive |
|---|---|---|
| QDU | Experimental | 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. Receives: Other: QDU |
| DIM | Active comparator | 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. Receives: Other: DIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (7)
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
Measured: 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.
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).
Measured: 30 days
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 90 days (± 2 days) from date of randomization
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).
Measured: 3 months (± 2 days)
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Region Zealand
- Responsible party
- Sponsor
- Investigators
- Camilla Stroem, MD, Principal investigator, Dept. of Emergency Medicine, Holbaek Sygehus, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395718
- Sponsor's protocol ID
- ELDER
- Acronym
- ELDER
- Status last verified
- Feb 2017
- First submitted
- 7 Jan 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29905758Strom 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.
PubMed 26931195
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Medical Admission of ELDERly Patients (≥75yrs) to Either Fast Track or Traditional Inward Hospitalisation. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02395718
- Acronym / sponsor ID
- ELDER / ELDER
- Conditions
- Geriatric Disorder
- Keywords
- elderly, quick diagnostic unit, short stay unit, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Region Zealand
- Study start
- Jan 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QDU | Experimental | Other: QDUPatients 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. |
| DIM | Active comparator | Other: DIMPatients 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 75 years
- Admitted for in-hospital treatment for an internal medicine disease
- Green tag triaged upon arrival in the ED
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QDUTreatment 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) | Other | QDU |
| DIMTreatment at a ward at the DIM. Traditional inward hospitalisation | Other | DIM |
Primary outcome
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.
7 secondary outcomes
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.
Readmissions
Time frame: 30 days
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.
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.
Instrumental Activities of Daily Living
Time frame: 90 days (± 2 days) from date of randomization
Placement in a long-term-care home after hospitalisation.
Time frame: 3 months (± 2 days)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 29905758Strom 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.
- Derived from this study: PubMed 26931195Strom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Stroem, MD principal investigator
Dept. of Emergency Medicine, Holbaek Sygehus, Copenhagen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QDU and DIM in people with Geriatric Disorder, run by Holbaek Sygehus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.