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Delirium in Geriatric Hospital Single-bed and Multibed Rooms

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ClinicalTrials.gov Identifier: NCT03199768
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )

Brief Summary:
To investigate whether single-bed rooms can prevent and reduce incidence and duration of delirium compared to multi-bed rooms in elderly patients admitted to a geriatric department. In addition, it is investigated whether single-bed rooms reduce the use of psychotropic drugs, opioids, parenteral medication, fixed guard, falls, hospitalization and discharge to institution among delirious patients. Furthermore, to study if delirium is associated with of re-hospitalization, traumatic fall, institutionalization and death within 30 days, compared to those who do not develop delirium.

Condition or disease
Delirium Older Patients Admittance to Single-bed Rooms or Multi-bed Rooms

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1014 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can the Hospital's Architectural Design Affect the Incidence and Treatment of Delirium in Geriatric Patients? A Comparison Between Single-bed and Multibed Rooms
Actual Study Start Date : September 15, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Single-bed rooms
Patients are admitted to single-bed rooms at the newly built hospital in the period 20th of March to the 1th of September 2017
Multi-bed rooms
Patients are admitted at multi-bed rooms with one to two fellow patients at the old hospital in the period 15th of September 2016 to the 19th of March 2017



Primary Outcome Measures :
  1. Delirium [ Time Frame: Repeated measurements twice a day at 7-11 AM and at 5-10 PM. From first day at admission on the geriatric ward until discharge. The average hospitalization period is 7 days. Longitudinal data collection. ]
    Delirium diagnosed using the Confusion Assessment Method (CAM) - Danish version. Incidence of delirium is measured by the first positive CAM score. Duration of delirium is defined by 1 or more consecutive positive CAM scores, and ends if there have been three consecutive negative CAM scores. Duration is measured in half days.

  2. Duration of delirium [ Time Frame: Repeated measurements twice a day at 7-11 AM and at 5-10 PM. From first day at admission on the geriatric ward until discharge. The average hospitalization period is 7 days. Longitudinal data collection. ]
    Delirium diagnosed by positive CAM test - Danish version. Incidence of delirium is measured by the first positive CAM score. Duration of delirium is defined by 1 or more consecutive positive CAM scores, and ends if there have been three consecutive negative CAM scores. Duration is measured in half days.


Secondary Outcome Measures :
  1. Use of Psychotropic drug [ Time Frame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days. ]
    By positive CAM: Use of Psychotropic drugs will be recorded from the medical chart.

  2. Changes in medication - Opioid [ Time Frame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days. ]
    By positive CAM: Changes in opioid will be recorded from the medical chart.

  3. Changes in consumption of medicine [ Time Frame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days. ]
    By positive CAM: Changes in the consumption of medicine will be recorded from the medical chart.

  4. Fixed guard at the patient [ Time Frame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days. ]
    By positive CAM: The patient must not be alone in the hospital room. Care staff will be with the patient all the time

  5. Traumatic fall [ Time Frame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days. ]
    By positive CAM:Traumatic fall under hospitalization will be reported to Danish Patient Safety Authority as an Unintended Event. Retrospective traumatic fall will be recorded

  6. Length of hospital stay (LOS) [ Time Frame: First day at admission on the geriatric ward and until discharge. The average length of hospital stay is 7 days. ]
    Calculated from admission to discharge from the geriatric ward

  7. Discharge to own home or institutionalization [ Time Frame: At discharge from geriatric ward. 0-1 hours after discharge. ]
    Recorded if the patients are discharge for home, nursing homes or sheltered housing facilities. Information will be recorded from the medical chart.

  8. Re-hospitalization [ Time Frame: 0-30 days after discharge ]
    Recorded if the patients are re-hospitalization

  9. Death [ Time Frame: 0-365 days after admission ]
    Date of death within 30, 90 and 365 days after admission



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Old patients (aged ≥75 years), acutely admitted to a geriatric ward at Aarhus University Hospital for both diseases that need medical and/or surgical treatment.
Criteria

Inclusion Criteria:

Patients 75 Years and older admitted to Geriatric ward and at Aarhus University Hospital in the period from the 15th of September 2016 to the 1th of September 2017.

Exclusion Criteria:

  • Patients who upon admission are dying assessed by a specialist in geriatrics
  • Patients with apoplexy where aphasia is present
  • Patients with severe dementia without language
  • Patients who are inability to understand or speak Danish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199768


Locations
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Denmark
University of Aarhus, Health
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
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Study Chair: Else Marie Damsgaard, Professor Department of Geriatrics , Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N

Publications of Results:
Other Publications:
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Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03199768     History of Changes
Other Study ID Numbers: Delirium in geriatric patients
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus ( Aarhus University Hospital ):
architecture
delirium
environment
hospital design and construction
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders