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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.
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

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
Condition category
Condition code
Respiratory 3884 3884 0 0
Chronic obstructive pulmonary disease
Cardiovascular 3885 3885 0 0
Coronary heart disease
Infection 3886 3886 0 0
Other infectious diseases
Cancer 3887 3887 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3428 0
Other interventions
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.
Control group
Active

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
Timepoint [1] 4785 0
6 months
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
Timepoint [1] 8082 0
6 months

Eligibility
Key inclusion criteria
medical inpatients, english speaking, aged > 80
Minimum age
80 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not competent, non english speaking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomistation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3895 0
Hospital
Name [1] 3895 0
Austin Health
Address [1] 3895 0
145 Studley road, Heidelberg Victoria 3084
Country [1] 3895 0
Australia
Primary sponsor type
Hospital
Name
Austin health
Address
145 Studley Road Heidelberg Victoria 3084
Country
Australia
Secondary sponsor category [1] 3497 0
None
Name [1] 3497 0
Address [1] 3497 0
Country [1] 3497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5948 0
Austin health Research Ethics committee
Ethics committee address [1] 5948 0
Austin health, 145 studley road heidelberg Victoria 3084
Ethics committee country [1] 5948 0
Australia
Date submitted for ethics approval [1] 5948 0
Approval date [1] 5948 0
31/07/2007
Ethics approval number [1] 5948 0

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.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 28951 0
Address 28951 0
Country 28951 0
Phone 28951 0
Fax 28951 0
Email 28951 0
Contact person for public queries
Name 12108 0
Karen detering
Address 12108 0
Austin health, 145 Studley Road heidelberg Victoria3084
Country 12108 0
Australia
Phone 12108 0
03 9496 5660
Fax 12108 0
03 9496 5124
Email 12108 0
karen.detering@austin.org.au
Contact person for scientific queries
Name 3036 0
Karen detering
Address 3036 0
Austin health, 145 Studley Road heidelberg Victoria 3084
Country 3036 0
Australia
Phone 3036 0
03 9496 5660
Fax 3036 0
9496 5124
Email 3036 0
karen.detering@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary