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Trial registered on ANZCTR


Registration number
ACTRN12613001377729
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
16/12/2013
Date last updated
16/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Case conferences between general practitioners and specialist teams to plan end of life care of people with end stage heart failure and lung disease: Pilot study
Scientific title
Do case conferences between general practitioners and specialist teams improve outcomes and service utilisation in people with life limiting heart and lung disease compared to usual care?
Secondary ID [1] 283742 0
nil
Universal Trial Number (UTN)
Trial acronym
BASIC-PC (Better Assessment, Support and Interdisciplinary Collaboration - Palliative Care)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 290706 0
end stage lung disease 290707 0
end of life care 290708 0
Condition category
Condition code
Cardiovascular 291076 291076 0 0
Other cardiovascular diseases
Respiratory 291077 291077 0 0
Chronic obstructive pulmonary disease
Public Health 291107 291107 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single case conference of 30-40 minutes between General practitioner, palliative care physician and specialist nurse to develop a care plan for persons with life limiting heart or lung disease. Case conference provides a comprehensive review of the case from a palliative care perspective, including symptom control, psychosocial issues for patient and carer, advance care planning and service delivery, with an emphasis on care coordination between specialist and community based care.
Intervention code [1] 288429 0
Treatment: Other
Comparator / control treatment
Normal care- specialist medical services focusing on maximising function, general practitioner providing day to day care but not in close liaison with specialists, and nurses providing case management at home, and palliative care not involved at all

Control data: Hospital and GP Records search for service utilisation. Time period is up to 12 months prior to the case conference, compared with up to twelve months, or to death, post case conference. Post case conference records searched for evidence of compliance with recommendations from case conference.
Control group
Historical

Outcomes
Primary outcome [1] 291065 0
Annual rate of hospitalisations - a hospitalisation is any stay in hospital for one night or more, as assessed by the public health medical record
Timepoint [1] 291065 0
12 months post case conference (or death).
Secondary outcome [1] 305931 0
Australia Modified Karnofsky Performance Scale
Timepoint [1] 305931 0
one and three months
Secondary outcome [2] 305932 0
Palliative Outcomes Scale
Timepoint [2] 305932 0
one and three months
Secondary outcome [3] 305933 0
Hospital Anxiety and Depression Scale ( ill person and primary carer)
Timepoint [3] 305933 0
one and three months
Secondary outcome [4] 305937 0
Health related Quality of Life (SF12) ( ill person and primary carer)
Timepoint [4] 305937 0
one and three months
Secondary outcome [5] 305938 0
Personal Costs of care - questionaire completed by patient and carer for personal costs incurred- eg visits to medical services, medications, medical supplies, work time lost. Cost estimate for the health services of providing care (eg cost per day of an admission, an ED visit, a home visit by the nurse), cost estimates for health service providers in preparing for and conducting the case conference and subsequent report.
Timepoint [5] 305938 0
three months
Secondary outcome [6] 305939 0
Other service utilisation data - number ED visits, number of ED visits without admission, number of hospital admissions and average length of stay. Data derived from public health records. Calculated annual rates of these parameters.
Timepoint [6] 305939 0
12 months or at death
Secondary outcome [7] 305940 0
Carer Support Needs Assessment Tool
Timepoint [7] 305940 0
one and three months
Secondary outcome [8] 305942 0
Carer Strain Index
Timepoint [8] 305942 0
one and three months

Eligibility
Key inclusion criteria
persons identified by heart failure or lung health as being at risk of dying within 12 months
Minimum age
18 Years
Maximum age
105 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
high risk of death with three months
severe cognitive impairment
resident of a Residential Aged Care Facility

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible persons identified by the heart failure or lung health team nurses using the surprise question ( Would I be surprised if this person died within 12 months?"

The nurse approaches the patient to gauge interest in conducting a case conference. If yes, they are given patient information sheet and consent form. The nurse completes consent process at their next visit. Details are then passed to the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not relevant for pilot -
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a pilot to refine the case conference process and gather data to calculate sample size. A full RCT will be planned based on pilot data.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
for non-normally distributed data:
Wilcoxon Rank sum test comparing health service utilisation data.

for normally distributed data
paired t tests for continuous data
Chi Square ( or Student) test for categorical data

Recruitment
Recruitment status
Recruiting
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)
QLD
Recruitment hospital [1] 1849 0
Ipswich Hospital - Ipswich

Funding & Sponsors
Funding source category [1] 288413 0
Government body
Name [1] 288413 0
National Health and Medical Research Council
Address [1] 288413 0
16 Marcus Clarke Street,
Canberra, ACT, 2601
Country [1] 288413 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia
Queensland, 4072
Country
Australia
Secondary sponsor category [1] 287121 0
None
Name [1] 287121 0
Address [1] 287121 0
Country [1] 287121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290292 0
West Moreton Human Ethics Review Committee
Ethics committee address [1] 290292 0
East St
Ipswich, Queensland, 4305
Ethics committee country [1] 290292 0
Australia
Date submitted for ethics approval [1] 290292 0
Approval date [1] 290292 0
11/11/2011
Ethics approval number [1] 290292 0
HREC/11/QWMS/36

Summary
Brief summary
With the ageing of the population, the number of people entering the last stages of life will increase rapidly in the coming few years. Most people will die of progressive, non-malignant disease and most will never be reviewed by a specialist palliative care team, in spite of the intensity of many peoples' needs being equivalent to those dying of cancer.
This study aims to improve the care of people dying of non-malignant disease, by conducting a case conference between the patient's GP, their specialist heart failure or lung health nurse, and a palliative care specialist. The purpose is to conduct a comprehensive case review, and develop a clear care plan with clear allocation of tasks. We will compare service utilisation after the conference with that of the previous 12 months, patient outcomes, carer outcomes, and a health economic analysis. This project is a pilot and will lead to a formal randomised controlled trial.
Trial website
http://primarysecondarycre.com/
Trial related presentations / publications
none to date
Public notes

Contacts
Principal investigator
Name 44890 0
Prof Geoffrey Mitcehll
Address 44890 0
School of Medicine
University of Queensland Ipswich Campus
Salisbury Rd
Ipswich, 4305
Country 44890 0
Australia
Phone 44890 0
+61 7 3381 1363
Fax 44890 0
+61 7 3381 1356
Email 44890 0
g.mitchell@uq.edu.au
Contact person for public queries
Name 44891 0
Prof Geoffrey Mitchell
Address 44891 0
School of Medicine
University of Queensland Ipswich Campus
Salisbury Rd
Ipswich, 4305
Country 44891 0
Australia
Phone 44891 0
+617 3381 1363
Fax 44891 0
+61 7 3381 1356
Email 44891 0
g.mitchell@q.edu.au
Contact person for scientific queries
Name 44892 0
Prof Geoffrey Mitchell
Address 44892 0
School of Medicine
University of Queensland Ipswich Campus
Salisbury Rd
Ipswich, 4305
Country 44892 0
Australia
Phone 44892 0
+61 7 3381 1363
Fax 44892 0
+61 7 3381 1356
Email 44892 0
g.mitchell@uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results