DeliriumNCT03199768
Delirium in Geriatric Hospital Single-bed and Multibed Rooms
An observational study of Delirium and Older Patients, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Delirium, Older Patients, Admittance to Single-bed Rooms or Multi-bed Rooms
- How many people
- 1,014 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Keywords
- architecture, delirium, environment, hospital design and construction
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
By positive CAM: Use of Psychotropic drugs will be recorded from the medical chart.
Measured: 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
By positive CAM: Changes in opioid will be recorded from the medical chart.
Measured: 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
By positive CAM: Changes in the consumption of medicine will be recorded from the medical chart.
Measured: 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
By positive CAM: The patient must not be alone in the hospital room. Care staff will be with the patient all the time
Measured: 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
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
Measured: First day at admission on the geriatric ward at 20:00 PM and until discharge. The average length of hospital stay is 7 days.
Length of hospital stay (LOS)
Calculated from admission to discharge from the geriatric ward
Measured: First day at admission on the geriatric ward and until discharge. The average length of hospital stay is 7 days.
Discharge to own home or institutionalization
Recorded if the patients are discharge for home, nursing homes or sheltered housing facilities. Information will be recorded from the medical chart.
Measured: At discharge from geriatric ward. 0-1 hours after discharge.
Re-hospitalization
Recorded if the patients are re-hospitalization
Measured: 0-30 days after discharge
Death
Date of death within 30, 90 and 365 days after admission
Measured: 0-365 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start15 Sep 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Else Marie Damsgaard, Professor, Study chair, Department of Geriatrics , Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199768
- Sponsor's protocol ID
- Delirium in geriatric patients
- Status last verified
- Oct 2017
- First submitted
- 1 Jun 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26967259Inouye 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.
PubMed 23992774Caruso 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.
PubMed 25226117
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03199768
- Acronym / sponsor ID
- Delirium in geriatric patients
- Keywords
- architecture, delirium, environment, hospital design and construction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
9 secondary outcomes
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.
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.
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.
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.
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.
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.
Discharge to own home or institutionalization
Time frame: At discharge from geriatric ward. 0-1 hours after discharge.
Re-hospitalization
Time frame: 0-30 days after discharge
Death
Time frame: 0-365 days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 26967259Siddiqi 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.
- Background: PubMed 23992774Inouye 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.
- Results publication: PubMed 25226117Caruso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Else Marie Damsgaard, Professor study chair
Department of Geriatrics , Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Older Patients, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.