Delirium in Geriatric Hospital Single-bed and Multibed Rooms

NCT ID: NCT03199768

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1014 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-15

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Design:

The project will be conducted as an observational prospective cohort study. Patients hospitalized in the period from the 15th September 2016 to the 1th September 2017 which meet the criteria are included

Inclusion Criteria:

Patients 75 Years and older admitted to Geriatric ward at Aarhus University Hospital.

Exclusion Criteria:

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

Data collection:

All patients who meet the inclusion criteria will be examined for state of delirium by using the Confusion Assessment Method (CAM).

The primary outcome is delirium, diagnosed with positive CAM, which is measured morning and evening every day of the week. Duration of delirium is defined by 1 or more consecutive positive CAM scores, and ends if there have been three consecutive negative CAM scores. During hospitalization, it is registered if the patient is staying in a single or a multi-bed room.

Additionally, it is registered, if the old patient has infections, anemia, hypo-natremia, constipation and urinary retention. In the event of delirium, the consumption of psychiatric drugs and changes in drug administration, need for fixed guard and fall episodes are recorded. In the event of delirium, the consumption of psychiatric drugs and changes in drug administration, need for fixed guard and fall episodes are recorded. Length of hospital stay is calculated and it is recorded if the patients are discharge for home, nursing homes or sheltered housing facilities. Follow-up is 30 days after discharge. Traumatic fall is registered in Emergency Department, housing change, re-hospitalization and death is recorded.

Primary outcome is collected prospectively and secondary outcome is collected retrospectively from the electronic patient journal.

Settings: The daily assessment of delirium is part of the regular procedure in the Geriatric Department.

Halfway through the data collection period, The department of Geriatric moves from old hospital buildings to newly built hospital. At the old hospital there are 2.5% single rooms and at the new 100% single rooms.

Patients are included using civil registration number. They may be hospitalized once at both at the old and the new, but they can not be included twice in the same type of hospital.

Sample size: The power calculation is based on an observation study by Caruso et al. Incidence of delirium in single and multi-beds rooms in intensive patients (mean age 59 years) is compared. The incidence of delirium in single-bed rooms is 6.8% versus 15.1% in multi-bed rooms. With a power of 90% and a significance level of 5%, we need 320 patients in each group (N = 640).

Time frame: On average there are admitted 75 older patients pr. months. We expect that 10% are re-hospitalized. When calculating vacation and re-hospitalization, the data collection period is expected to last 12 months.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Else Marie Damsgaard, Professor

Role: STUDY_CHAIR

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

Locations

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University of Aarhus, Health

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 26967259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23992774 (View on PubMed)

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.

Reference Type RESULT
PMID: 25226117 (View on PubMed)

Other Identifiers

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Delirium in geriatric patients

Identifier Type: -

Identifier Source: org_study_id

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