Clinical trial NCT03199768: Delirium in Geriatric Hospital Single-bed and Multibed Rooms
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Older Patients
Admittance to Single-bed Rooms or Multi-bed Rooms
Keywords: architecture
delirium
environment
hospital design and construction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2017-06-27
Enrollment: 1014
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Delirium
timeFrame: 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.
measure: Duration of delirium
timeFrame: 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:
measure: Use of Psychotropic drug
timeFrame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.
measure: Changes in medication - Opioid
timeFrame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.
measure: Changes in consumption of medicine
timeFrame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.
measure: Fixed guard at the patient
timeFrame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.
measure: Traumatic fall
timeFrame: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.
measure: Length of hospital stay (LOS)
timeFrame: First day at admission on the geriatric ward and until discharge. The average length of hospital stay is 7 days.
measure: Discharge to own home or institutionalization
timeFrame: At discharge from geriatric ward. 0-1 hours after discharge.
measure: Re-hospitalization
timeFrame: 0-30 days after discharge
measure: Death
timeFrame: 0-365 days after admission
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University of Aarhus, Health
Study officials:
affiliation: Department of Geriatrics , Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N
name: Else Marie Damsgaard, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.