Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12608000539336
Ethics application status
Approved
Date submitted
18/09/2008
Date registered
27/10/2008
Date last updated
27/10/2008
Type of registration
Retrospectively registered
Titles & IDs
Public title
Randomised control trial of advance care planning using the Respecting Patient Choices program in elderly medical patients.
Query!
Scientific title
Randomised control trial of advance care planning using the Respecting Patient Choices program in elderly medical patients, looking at whether end of life wishes were known and respected.
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Medical conditions of any type requiring patients to be admitted to medical, cardiology or respiratory uinits at a large acute teaching hospital in melbourne
3716
0
Query!
Condition category
Condition code
Respiratory
3884
3884
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Cardiovascular
3885
3885
0
0
Query!
Coronary heart disease
Query!
Infection
3886
3886
0
0
Query!
Other infectious diseases
Query!
Cancer
3887
3887
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Advance care planning. This involves a nurse or other health professional to come and discuss an individuals future health wishes. Generally this is done with family members also present. This usually takes between 1 and 2 hours over 1-3 visits during the hospital stay. The patients will then be followed for 6 months.
Query!
Intervention code [1]
3428
0
Other interventions
Query!
Comparator / control treatment
Usual treatment is the normal treatments someone receives when they are admitted to hospital with any type of medical problem. There is no universal usual treatment as it varies with the medical condition, but would include tests, medication and other treatments as required. The control treatment will occur for 6 months.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
4785
0
Wishes known and respected. This will be measured via telephone questionnaires, involving the deceased patients nominated relative, and via review of the patients hospital file
Query!
Assessment method [1]
4785
0
Query!
Timepoint [1]
4785
0
6 months
Query!
Secondary outcome [1]
8082
0
outcome of advance care planning. This is measured by a telephone questionnaire to a relative (the appropriate relative is decided at the time the person is enrolled, and the relative consents to be interviewed if the patient subsequently dies. Some of these are novel questionnaires, and the IES (Impact of events scale, and the HADS - hospital anxiety and depression scale) will also be used
Query!
Assessment method [1]
8082
0
Query!
Timepoint [1]
8082
0
6 months
Query!
Eligibility
Key inclusion criteria
medical inpatients, english speaking, aged > 80
Query!
Minimum age
80
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
not competent, non english speaking
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation concealment via sealed opaque envelops of consecutive admissions to hospital, randomised via non investigator in trial
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomistation
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
16/08/2007
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
300
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
3895
0
Hospital
Query!
Name [1]
3895
0
Austin Health
Query!
Address [1]
3895
0
145 Studley road, Heidelberg Victoria 3084
Query!
Country [1]
3895
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Austin health
Query!
Address
145 Studley Road Heidelberg Victoria 3084
Query!
Country
Australia
Query!
Secondary sponsor category [1]
3497
0
None
Query!
Name [1]
3497
0
Query!
Address [1]
3497
0
Query!
Country [1]
3497
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
5948
0
Austin health Research Ethics committee
Query!
Ethics committee address [1]
5948
0
Austin health, 145 studley road heidelberg Victoria 3084
Query!
Ethics committee country [1]
5948
0
Australia
Query!
Date submitted for ethics approval [1]
5948
0
Query!
Approval date [1]
5948
0
31/07/2007
Query!
Ethics approval number [1]
5948
0
Query!
Summary
Brief summary
Many patients would like to have a say in their future health care treatment choices. Currently for many people they don't get this opportunity, as they are not routinely asked, or they may become unconscious, confused or very sick, and may not be able to participate in their medical decision making. We propose that a formal program aimed at making advance care planning available will allow people to express their wishes, and have their end of life wishe=s respected. We also think that advance care planning may lessen the stress placed on relatives around the time of the persons death.
Query!
Trial website
Nil
Query!
Trial related presentations / publications
Nil
Query!
Public notes
Query!
Contacts
Principal investigator
Name
28951
0
Query!
Address
28951
0
Query!
Country
28951
0
Query!
Phone
28951
0
Query!
Fax
28951
0
Query!
Email
28951
0
Query!
Contact person for public queries
Name
12108
0
Karen detering
Query!
Address
12108
0
Austin health, 145 Studley Road heidelberg Victoria3084
Query!
Country
12108
0
Australia
Query!
Phone
12108
0
03 9496 5660
Query!
Fax
12108
0
03 9496 5124
Query!
Email
12108
0
[email protected]
Query!
Contact person for scientific queries
Name
3036
0
Karen detering
Query!
Address
3036
0
Austin health, 145 Studley Road heidelberg Victoria 3084
Query!
Country
3036
0
Australia
Query!
Phone
3036
0
03 9496 5660
Query!
Fax
3036
0
9496 5124
Query!
Email
3036
0
[email protected]
Query!
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.
Download to PDF