NCT03199768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,014

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

July 6, 2018

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

June 1, 2017

Last Update Submit

July 4, 2018

Conditions

Keywords

architecturedeliriumenvironmenthospital design and construction

Outcome Measures

Primary Outcomes (2)

  • Delirium

    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.

    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.

  • Duration of delirium

    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.

    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.

Secondary Outcomes (9)

  • Use of Psychotropic drug

    First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.

  • Changes in medication - Opioid

    First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.

  • Changes in consumption of medicine

    First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.

  • Fixed guard at the patient

    First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.

  • Traumatic fall

    First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.

  • +4 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aarhus, Health

Aarhus, 8000, Denmark

Location

Related Publications (3)

  • Siddiqi N, Harrison JK, Clegg A, Teale EA, Young J, Taylor J, Simpkins SA. Interventions for preventing delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev. 2016 Mar 11;3(3):CD005563. doi: 10.1002/14651858.CD005563.pub3.

    PMID: 26967259BACKGROUND
  • Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

    PMID: 23992774BACKGROUND
  • Caruso P, Guardian L, Tiengo T, Dos Santos LS, Junior PM. ICU architectural design affects the delirium prevalence: a comparison between single-bed and multibed rooms*. Crit Care Med. 2014 Oct;42(10):2204-10. doi: 10.1097/CCM.0000000000000502.

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Else Marie Damsgaard, Professor

    Department of Geriatrics , Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 27, 2017

Study Start

September 15, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

July 6, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations