Acute Medical Admissions of ELDERly Patients (ELDER)

NCT02395718 | Completed DMC

• 1 other identifier: ELDER
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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).

Conditions

Geriatric Disorder

Keywords

elderly; quick diagnostic unit; short stay unit; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Length of stay in-hospital

  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

  30 days

• In hospital Mortality

  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

  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

  90 days (± 2 days) from date of randomization

Study Arms (2)

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.

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.

Other: DIM

Interventions

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)

QDU

DIM OTHER

Treatment at a ward at the DIM. Traditional inward hospitalisation

DIM

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holbaek Sygehus: lead
• Region Zealand: collaborator

Study Sites (1)

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

Holbæk, 4300, Denmark

Location

Related Publications (2)

• 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.

  PMID: 29905758 DERIVED

• 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.

  PMID: 26931195 DERIVED

Study Officials

• Camilla Stroem, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

DK (1)