Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000266763
Ethics application status
Approved
Date submitted
5/03/2013
Date registered
6/03/2013
Date last updated
12/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can death from chronic life-limiting illnesses be predicted in Australian general practice? A study exploring the feasibility and acceptability of a case finding approach to care planning of patients nearing the end-of-life.
Scientific title
The study of Australian general practitioners using a systematic death prediction tool versus clinical intuition on the accuracy of prediction of patient death.
Secondary ID [1] 282060 0
Nil known
Universal Trial Number (UTN)
U1111-1140-1414
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 288540 0
Frailty 288541 0
Heart failure 288542 0
Degenerative neurological conditions 288543 0
End stage renal failure 288544 0
End stage liver disease 288545 0
End stage respiratory disease 288546 0
Dementia 288547 0
Condition category
Condition code
Cancer 288874 288874 0 0
Any cancer
Public Health 288901 288901 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Systematic clinical prediction tool, (modified version of the SPICT tool developed in the UK), used to help the GP in identifying patients at risk of dying in the next 12 months. The tool comprises of three elements: (i) 'surprise' question, (ii) general indicators of health, (iii) specific indicators around advanced conditions.
Intervention code [1] 286658 0
Early detection / Screening
Comparator / control treatment
Clinical intuition that the GP normally uses to determine which of their patients are likely to die over the next 12 months.
Control group
Active

Outcomes
Primary outcome [1] 289001 0
% of predicted patients who have actually died. Patient deaths will be identified through interrogation of the practice database.
Timepoint [1] 289001 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [1] 301542 0
Positive predictive value and negative predictive value of prediction of death at 6 months. Patient deaths will be identified through interrogation of the practice database.
Timepoint [1] 301542 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [2] 301543 0
% patients predicted to die who have received or would have benefited from end-of-life care planning during study period. This will be collected through a questionnaire completed by the GP.
Timepoint [2] 301543 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [3] 301544 0
Place of death. This will be collected through a questionnaire completed by the GP.
Timepoint [3] 301544 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [4] 301545 0
Unplanned admissions to Emergency Department or hospital. This will be collected through a questionnaire completed by the GP.
Timepoint [4] 301545 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [5] 301546 0
Use of palliative care specialist services. This will be collected through a questionnaire completed by the GP.
Timepoint [5] 301546 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [6] 301547 0
% non malignant deaths and nursing home deaths correctly identified. The place of death and the cause of death will be collected through a questionnaire completed by the GP. Patient deaths will be collected through an interrogation of the practice database.
Timepoint [6] 301547 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [7] 301548 0
Respondent burden. This will be collected through a questionnaire completed by the GP.
Timepoint [7] 301548 0
Immediately after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying
Secondary outcome [8] 307264 0
Proportion of deaths correctly identified in the practice records when compared to state-based official death registries
Timepoint [8] 307264 0
6 months after the GP has applied the systematic prediction tool or used their clinical intuition to identify patients who are at risk of dying.

Eligibility
Key inclusion criteria
Inclusion criteria for GPs:
1. Working in active clinical general practice.
2. Working in Sydney or Brisbane.

Inclusion criteria for patients:
1. Patients of participating GPs
2. Greater than or equal to 70 years of age or patients under 70 years of age who have been identified as the GP as being at risk of dying in the next 12 months
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for GPs: 1. Not seeing patients >70 years of age. 2. Not having computerised practice database. 3. Having worked <12 months in the practice.

Exclusion criteria for patients: 1. Patients under 70 years of age unless they have been identified by the participating GP as being at risk of dying in the next 12 months.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/12/2012
Actual
5/12/2012
Date of last participant enrolment
Anticipated
15/05/2013
Actual
16/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 286834 0
Charities/Societies/Foundations
Name [1] 286834 0
The Primary Care Collaborative Cancer Clinical Trials Group (PC4) / RACGP research grant.
Country [1] 286834 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 285624 0
University
Name [1] 285624 0
The University of Queensland
Address [1] 285624 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 285624 0
Australia
Other collaborator category [1] 277315 0
Hospital
Name [1] 277315 0
HammondCare Palliative & Supportive Care Services
Address [1] 277315 0
Greenwich Hospital, Pallister House
PO Box 5084
Greenwich NSW 2065
Country [1] 277315 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288900 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 288900 0
Ethics committee country [1] 288900 0
Australia
Date submitted for ethics approval [1] 288900 0
Approval date [1] 288900 0
30/10/2012
Ethics approval number [1] 288900 0
HC12553
Ethics committee name [2] 288901 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 288901 0
Ethics committee country [2] 288901 0
Australia
Date submitted for ethics approval [2] 288901 0
Approval date [2] 288901 0
20/11/2012
Ethics approval number [2] 288901 0
2012001275

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

Contacts
Principal investigator
Name 38270 0
Dr Joel Rhee
Address 38270 0
School of Public Health and Community Medicine
The University of New South Wales
UNSW Sydney, NSW 2052
Country 38270 0
Australia
Phone 38270 0
+61 2 9385 3502
Fax 38270 0
Email 38270 0
[email protected]
Contact person for public queries
Name 38271 0
Joel Rhee
Address 38271 0
School of Public Health and Community Medicine
The University of New South Wales
UNSW Sydney, NSW 2052
Country 38271 0
Australia
Phone 38271 0
+61 2 9385 3502
Fax 38271 0
Email 38271 0
[email protected]
Contact person for scientific queries
Name 38272 0
Joel Rhee
Address 38272 0
School of Public Health and Community Medicine
The University of New South Wales
UNSW Sydney, NSW 2052
Country 38272 0
Australia
Phone 38272 0
+61 2 9385 3502
Fax 38272 0
Email 38272 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.