Condition category
Mental and Behavioural Disorders
Date applied
05/06/2011
Date assigned
13/06/2011
Last edited
24/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Delirium is a state of mental confusion that affects 30-40% of elderly people admitted to hospital. Studies have shown that one in four geriatric patients suffers from an episode of delirium at least once during their stay in the hospital. It is associated with poor outcomes at hospital discharge as the condition of delirium could persist for as long as 6 to 12 months after discharge, resulting in the need for rehabilitation services, nursing home placement or home care services. The Geriatric Monitoring Unit (GMU) is a specialised 5-bed unit for delirious patients, supported by 24-hour intensive nursing care. The GMU provides a controlled environment for the treatment of delirious patients. In this unit, the medical team is able to treat the delirious patients in an optimal environment where aggravating factors of delirium such as the use of physical constraint, medication, changes to surrounding environment and source of noise and distracters can be minimised or removed entirely. The aim of this study is to look at outcomes in patients with delirium who are admitted to the Geriatric Monitoring Unit (GMU), compared to usual clinical care in a general ward setting.

Who can participate?
Patients aged 65 and over with delirium

What does the study involve?
Participants are randomly allocated either to be admitted to GMU or to be put on a waiting list and receive the usual good care in the geriatric medicine department. The duration of delirium, length of hospital stay, rate of falls, types of injuries (if falls occur), reduction in use of physical restraints, medication use, urinary catheter use, pressure ulcers, infections, and family/caregiver satisfaction are all measured when the participants are followed up 6 and 12 months later.

What are the possible benefits and risks of participating?
The results of this study may help the healthcare system by improving patient safety, quality of care, and patient/family/caregiver satisfaction. There are no risks to participants as this is an observational study and no additional specific treatments are carried out.

Where is the study run from?
Tan Tock Seng Hospital (Singapore)

When is the study starting and how long is it expected to run for?
November 2010 to November 2011

Who is funding the study?
Ministry of Health Healthcare Quality Improvement Funding (Singapore)

Who is the main contact?
Dr Mei Sian Chong
Mei_Sian_Chong@ttsh.com.sg

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mei Sian Chong

ORCID ID

Contact details

Department of Geriatric Medicine
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng
Singapore
S308433
Singapore
+65 63577859
Mei_Sian_Chong@ttsh.com.sg

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HQIF 2011/19

Study information

Scientific title

A new model of hospital care for frail elderly persons admitted to hospital with delirium

Acronym

Study hypothesis

The trialists describe a new model of delirium care in the acute care setting, titled Geriatric Monitoring Unit (GMU) where the important concepts of delirium prevention and management are integrated. The primary aim of this study is to compare delirious patients admitted to the Geriatric Monitoring Unit (GMU), compared to usual geriatric care in general ward setting. The trialists postulate better outcomes in patients admitted to GMU versus usual geriatric care. The secondary aims include looking at which specific aspects of the interventions would yield the greatest benefit for future translation on a larger scale. The trialists hypothesize that patients with delirium admitted to the GMU will have better clinical outcomes with less need for physical and psychotropic restraints compared to usual care.

Ethics approval

National Healthcare Group Domain Specific Review Board (DSRB), October 2010, latest approval 03/06/2011, ref: A/10/510

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Delirium care in frail older persons admitted to the geriatric medicine department

Intervention

1. The Geriatric Monitoring Unit (GMU) is a specialised 5 bedded unit which incorporates specific room design for an elder-friendly environment, lower staff-patient ratio, coupled with structured core, supported by 24-hour intensive nursing care
2. Multicomponent intervention and bright light therapy on sleep of these patients as well as the effect in antipsychotic and sedative-hypnotic use
3. The trialists wanted to study if patients with delirium admitted to GMU had better outcomes compared to those managed with usual care in the geriatric medicine department
4. The GMU consist of the interventions as listed above
5. The study consists of a pre/post GMU implementation as well as a concurrent GMU patients versus patients with delirium managed in the geriatric ward as controls

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Duration of delirium and severity of delirium
2. Use of physical and chemical restraints
3. Falls rate
4. Physical injury rate due to agitated behavior
5. Functional outcomes/gains in the elderly geriatric patients
6. Morbidity (such as nosocomial infection rate, urinary catheter use and catheter days, pressure ulcer rate)
7. Patient and family satisfaction score in elderly persons with delirium

Secondary outcome measures

1. Looking at which specific aspects of the interventions would yield the greatest benefit for future translation on a larger scale
2. The effects of the multicomponent intervention and bright light therapy on sleep of these patients as well as their effect on antipsychotic and sedative hypnotic use

Overall trial start date

01/11/2010

Overall trial end date

01/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients above age of 65 years old
2. Admitted to the geriatric medicine department in Tan Tock Seng Hospital who were assessed to have delirium (either on admission or incident delirium during hospital stay)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Medical illnesses which requires special monitoring (e.g. telemetry for arrhythmias or acute myocardial infarction)
2. Deemed to be dangerously ill, in coma or had terminal illness
3. Uncommunicative patients or patients with severe aphasia
4. Severely combative behaviour with high risk of harm
5. Patients with mania or other severe eye disorders and other contraindications to bright light therapy (such as patients on photosensitising medications)
6. Patients with respiratory or contact precautions, or there was verbal refusal of GMU stay by family, patient or physician in charge

Recruitment start date

01/11/2010

Recruitment end date

01/11/2011

Locations

Countries of recruitment

Singapore

Trial participating centre

Tan Tock Seng Hospital
Singapore
S308433
Singapore

Sponsor information

Organisation

Ministry of Health (Singapore)

Sponsor details

College of Medicine Building
16 College Road
169854
Singapore
179854
Singapore

Sponsor type

Government

Website

http://www.moh.gov.sg

Funders

Funder type

Government

Funder name

Ministry of Health Healthcare Quality Improvement Funding (HQIF2) (Singapore)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21838912
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24748778

Publication citations

  1. Protocol

    Chong MS, Chan MP, Kang J, Han HC, Ding YY, Tan TL, A new model of delirium care in the acute geriatric setting: geriatric monitoring unit., BMC Geriatr, 2011, 11, 41, doi: 10.1186/1471-2318-11-41.

  2. Results

    Chong MS, Chan M, Tay L, Ding YY, Outcomes of an innovative model of acute delirium care: the Geriatric Monitoring Unit (GMU), Clin Interv Aging, 2014, 9, 603-612, doi: 10.2147/CIA.S60259.

Additional files

Editorial Notes

24/05/2017: Plain English summary added.