Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000936921
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
31/08/2011
Date last updated
31/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reliability of an 'online' geriatirc assessment procedure.
Scientific title
'Online' Geriatric assessment procedure for older adults referred for geriatric assessment during acute care episode for consideration of reliability of triage decisions
Secondary ID [1] 262966 0
None
Universal Trial Number (UTN)
U1111-1124-0793
Trial acronym
CGA Reliability study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
'Online' Geriatric assessment procedure for older adults. 270669 0
Condition category
Condition code
Other 270841 270841 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients receive usual care (a face to face consult by a specialist geriatrician). In addition, the patients medical details are accessed using an 'online' system by a second geriatrician. Each specialist records their predicted triage decisions.

Primary outcome relates to triage decisions made by the consultating team. The triage decision is either: discharge to home; discharge to residenitial care (high or low care); or likely to be deceased. this is compared with actual discharge decisions and three month outcomes.

Patients receive the usual Nurse Assessment which is a comprehensive geriatric assessmnent using the interRAI Acute Care instrument. The data is entered into the CeGA online system which is a web based system which refines the data entered and presents a report. the report is read 'online' by a geriatrician and an online consult is completed and a comment with recommendations is written by the geriatrician onto the web based system, which is added to the report. the final report is referred back to the ward where the patient is. It is printed out and added to the patients file. for this study, the patient is assessed once, on referral for a geriatric consult. Assessments occur across the duration of the project.

Patient recruitment will continue from July 1 2009 to December 31, 2011 (2.5 years). Analysis and paper writing will continue through 2012.
Intervention code [1] 269287 0
Other interventions
Comparator / control treatment
All patients receive usual care (a face to face consult by a specialist geriatrician). In addition, patients receive a second face to face consult by a different geriatrician. Each specialist records their predicted triage decisions.
Both consultations need to occur within the usual assessment/consult timeframe in order for the hospital to achieve their geriatric consult KPIs. For example, if a patient is assessed by the nurse on Monday afternoon, and the usual consult round is Tuesday morning. Then both consults have to occur prior to the conclusion of the Tuesday consult round. In this way the patient is not waiting any longer than they would normally wait within the usual care process. each hospital has a different timetable for clinical rounds, but the process is the same. Complete the research project element within the same timetable for usual care.
Control group
Active

Outcomes
Primary outcome [1] 279523 0
Agreement between the triage decisions from live-live assessments and between the triage decisions from live-online assessments, calculated using kappa statistics, reported with 95% confidence intervals.
Timepoint [1] 279523 0
Time of consult; time of discharge; three months post discharge.
Secondary outcome [1] 287814 0
Agreement between the recognition of common geriatric syndromes from live-live assessments and between the recognition of common geriatric syndromes from live-online assessments, calculated using kappa statistics, reported with 95% confidence intervals.
Timepoint [1] 287814 0
Time of consult.

Eligibility
Key inclusion criteria
Inpatient in hospital (acute care) general medical ward or geriatric ward.
Referral for a geriatric consultation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously seen by either of the specialist geratricians.
Previously enrolled in the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consent for participation in the study will be secured by the nurse assessor prior to the commencement of the consultation. Non-consenting patients will receive the “normal” geriatric consultation for the hospital site.
Each consenting patient will undergo sequential assessment by two independent geriatricians, designated “geriatrician 1” (G1) and “geriatrician 2” (G2), in one of the following randomly allocated configurations: live-live (G1-G2), live-live (G2-G1), online-live (G1-G2) or online-live (G2-G1).
After consent, Research Assistant randamises patients using sealed opaque envelopes.
The paired geriatricians will be blinded to the results of their colleague’s assessment. In the case of live-live assessments the order in which the geriatricians consult the patient will be randomly allocated in order to minimise any systematic influence that the interaction of the first geriatrician with the patient may have on the second assessment. For online-live pairings, the order in which assessments is conducted need not be randomly allocated since only one of the two geriatricians will interact with the patient directly.
In all cases, a structured assessment will be performed by a nurse assessor, using the process described above. Once these findings have been entered by the nurse into the software system, geriatrician consultation follows. The paired geriatrician assessments will be conducted within the timeframe of usual geriatric consults at the site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 'ralloc' command was used to generate 2 separate randomisations in Stata version 10.1 for the CGA Reliability Study.
For step 1 of the study, 404 patients are equally randomised to the 4 treatment arms in blocks of 4 and 8.
For step 2, 200 patients are equally randomised to the 2 treatment arms (doctors 1 and 2) in blocks of 2 and 4. Due to the constraint that a maximum of two patients are to be randomised on any one day and the same doctor must not be used for both, the second of the two patients is deterministically allocated to the doctor who does not attend to the first of the two patients.
Allocations are approximately balanced across 3 studies centres.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All participants receive standard care (face-to-face consult).
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4404 0
3128
Recruitment postcode(s) [2] 4405 0
3076
Recruitment postcode(s) [3] 4433 0
4102

Funding & Sponsors
Funding source category [1] 269747 0
Government body
Name [1] 269747 0
National Health and Medical Research Council
Country [1] 269747 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 268787 0
University
Name [1] 268787 0
Centre for Research in Geriatric Medicine
Address [1] 268787 0
Level 2, Bld 33
CRGM
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [1] 268787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271710 0
Princess Alexandra Human Research Ethics Committee
Ethics committee address [1] 271710 0
Ethics committee country [1] 271710 0
Australia
Date submitted for ethics approval [1] 271710 0
Approval date [1] 271710 0
27/08/2008
Ethics approval number [1] 271710 0
2008/156
Ethics committee name [2] 271711 0
Eastern Health Research and Ethics Committee
Ethics committee address [2] 271711 0
Ethics committee country [2] 271711 0
Australia
Date submitted for ethics approval [2] 271711 0
Approval date [2] 271711 0
16/03/2011
Ethics approval number [2] 271711 0
E92/0910
Ethics committee name [3] 271712 0
The Northern Health HREC Acute Division
Ethics committee address [3] 271712 0
Ethics committee country [3] 271712 0
Australia
Date submitted for ethics approval [3] 271712 0
Approval date [3] 271712 0
07/09/2011
Ethics approval number [3] 271712 0
A38/10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33085 0
Address 33085 0
Country 33085 0
Phone 33085 0
Fax 33085 0
Email 33085 0
Contact person for public queries
Name 16332 0
Dr Melinda Martin-Khan
Address 16332 0
Level 2 Building 33
Centre for Research in Geriatric Medicine
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 16332 0
Australia
Phone 16332 0
61731765530
Fax 16332 0
61731766945
Email 16332 0
[email protected]
Contact person for scientific queries
Name 7260 0
Dr Melinda Martin-Khan
Address 7260 0
Level 2 Building 33
Centre for Research in Geriatric Medicine
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 7260 0
Australia
Phone 7260 0
61731765530
Fax 7260 0
61731766945
Email 7260 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.