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Trial registered on ANZCTR


Registration number
ACTRN12605000301662
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
5/09/2005
Date last updated
5/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a question prompt list for palliative care patients and their caregivers
Scientific title
A randomised controlled trial of a question prompt list (QPL) for palliative care consultations, to evaluate the effect of the QPL on the total number of patient/caregiver questions during the consultation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients, and their cargeivers, with advanced progressive life limiting illnesses being referred for palliative care 389 0
Condition category
Condition code
Other 461 461 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a question prompt list (QPL) 20 minutes before palliative care consultation with physician endorsement of the QPL during consultation.
Intervention code [1] 355 0
Other interventions
Comparator / control treatment
Controls received standard PC consultation
Control group
Placebo

Outcomes
Primary outcome [1] 522 0
Total number of patient questions during the palliative care consultation (following provision of the question prompt list)
Timepoint [1] 522 0
Secondary outcome [1] 1117 0
Total numbers of items discussed, patient concerns and caregiver questions/concerns during the consultation
Timepoint [1] 1117 0
Secondary outcome [2] 1118 0
Number of items discussed, patient/caregiver questions/concerns about 9 individual topics during the consultation
Timepoint [2] 1118 0
Secondary outcome [3] 1119 0
Achievement of patient information preferences
Timepoint [3] 1119 0
24-hour/3-week follow up
Secondary outcome [4] 1120 0
Patient satisfaction with the consultation
Timepoint [4] 1120 0
24-hour follow up
Secondary outcome [5] 1121 0
Patient anxiety
Timepoint [5] 1121 0
24-hour/3-week follow up
Secondary outcome [6] 1122 0
Physician satisfaction with communication during the consultation
Timepoint [6] 1122 0
24-hour follow up
Secondary outcome [7] 1123 0
Consultation duration.
Timepoint [7] 1123 0

Eligibility
Key inclusion criteria
1) Diagnosis of advanced progressive life-limiting illness; 2) English-speaking; 3) able and well enough to read QPL and complete questionnaires; 4) seeing PC physician for either 1st, 2nd or 3rd consultation.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using sequentially numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomised in blocks using random number generator in Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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] 513 0
Government body
Name [1] 513 0
NHMRC postgraduate research scholarship
Address [1] 513 0
Country [1] 513 0
Australia
Primary sponsor type
University
Name
Medical Psychology Research Unit, University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 420 0
None
Name [1] 420 0
Nil
Address [1] 420 0
Country [1] 420 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1491 0
Sydney University
Ethics committee address [1] 1491 0
Ethics committee country [1] 1491 0
Australia
Date submitted for ethics approval [1] 1491 0
Approval date [1] 1491 0
Ethics approval number [1] 1491 0
Ethics committee name [2] 1492 0
Royal Prince Alfred Hospital
Ethics committee address [2] 1492 0
Ethics committee country [2] 1492 0
Australia
Date submitted for ethics approval [2] 1492 0
Approval date [2] 1492 0
Ethics approval number [2] 1492 0
Ethics committee name [3] 1493 0
Concord Hospital
Ethics committee address [3] 1493 0
Ethics committee country [3] 1493 0
Australia
Date submitted for ethics approval [3] 1493 0
Approval date [3] 1493 0
Ethics approval number [3] 1493 0
Ethics committee name [4] 1494 0
St Vincent's Hospital
Ethics committee address [4] 1494 0
Ethics committee country [4] 1494 0
Australia
Date submitted for ethics approval [4] 1494 0
Approval date [4] 1494 0
Ethics approval number [4] 1494 0
Ethics committee name [5] 1495 0
Prince of Wales Hospital
Ethics committee address [5] 1495 0
Ethics committee country [5] 1495 0
Australia
Date submitted for ethics approval [5] 1495 0
Approval date [5] 1495 0
Ethics approval number [5] 1495 0
Ethics committee name [6] 1496 0
St George Hospital
Ethics committee address [6] 1496 0
Ethics committee country [6] 1496 0
Australia
Date submitted for ethics approval [6] 1496 0
Approval date [6] 1496 0
Ethics approval number [6] 1496 0
Ethics committee name [7] 1497 0
Calvary Hospital
Ethics committee address [7] 1497 0
Ethics committee country [7] 1497 0
Australia
Date submitted for ethics approval [7] 1497 0
Approval date [7] 1497 0
Ethics approval number [7] 1497 0
Ethics committee name [8] 1498 0
Nepean Hospital
Ethics committee address [8] 1498 0
Ethics committee country [8] 1498 0
Australia
Date submitted for ethics approval [8] 1498 0
Approval date [8] 1498 0
Ethics approval number [8] 1498 0
Ethics committee name [9] 1499 0
Liverpool Hospital
Ethics committee address [9] 1499 0
Ethics committee country [9] 1499 0
Australia
Date submitted for ethics approval [9] 1499 0
Approval date [9] 1499 0
Ethics approval number [9] 1499 0
Ethics committee name [10] 1500 0
Westmead Hospital
Ethics committee address [10] 1500 0
Ethics committee country [10] 1500 0
Australia
Date submitted for ethics approval [10] 1500 0
Approval date [10] 1500 0
Ethics approval number [10] 1500 0
Ethics committee name [11] 1501 0
Flinders Medical Centre
Ethics committee address [11] 1501 0
Ethics committee country [11] 1501 0
Australia
Date submitted for ethics approval [11] 1501 0
Approval date [11] 1501 0
Ethics approval number [11] 1501 0

Summary
Brief summary
Patients being referred for palliative care have high levels of anxiety and significant informational and emotional needs. Previous research suggests these needs are not always met. Provision of a question prompt list (QPL) to cancer patients before initial oncology consultations has been found to promote patient question asking, reduce anxiety, improve recall and shorten the consultation. We have developed a QPL specifically for palliative care patients. We will study the effects of providing patients with this QPL before their consultation with a palliative care doctor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35630 0
Address 35630 0
Country 35630 0
Phone 35630 0
Fax 35630 0
Email 35630 0
Contact person for public queries
Name 9544 0
Ms Rhonda Devine
Address 9544 0
Medical Psychology Research Unit
University of Sydney
Blackburn Building D06
Camperdown NSW 2006
Country 9544 0
Australia
Phone 9544 0
+61 2 90365380
Fax 9544 0
+61 2 90365420
Email 9544 0
rhonade@med.usyd.edu.au
Contact person for scientific queries
Name 472 0
Dr Josephine Clayton
Address 472 0
Medical Psychology Research Unit
University of Sydney
Blackburn Building D06
Camperdown NSW 2006
Country 472 0
Australia
Phone 472 0
+61 2 90365289
Fax 472 0
+61 2 9036 5292
Email 472 0
jclayton@usyd.edu.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