Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001045202p
Ethics application status
Submitted, not yet approved
Date submitted
1/06/2018
Date registered
22/06/2018
Date last updated
22/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Collaborative Supportive Care for Patients with Complex Chronic Disease
Scientific title
Collaborative supportive care for life-limiting chronic conditions: A prospective randomised controlled study comparing supportive care with standard care.
Secondary ID [1] 295000 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Chronic Disease 308263 0
Condition category
Condition code
Cardiovascular 306949 306949 0 0
Coronary heart disease
Renal and Urogenital 306950 306950 0 0
Kidney disease
Respiratory 306951 306951 0 0
Chronic obstructive pulmonary disease
Neurological 306953 306953 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multidisciplinary supportive care clinic management and ongoing followup as clinically required: this clinic consists of palliative care, renal medicine, general medicine, cardiac failure medicine, social work, advance care planning and complex care nurse practitioners working in a combined clinic using a multidisciplinary clinic paradigm to manage chronic disease and care plan.
Face to face consultations with patients and their carers with a palliative care physician and/or general medicine physician, nurse practitioner, and social work. Medical issues will be reviewed, symptoms managed, and care planning issues reviewed,
The clinic review will be on an as required basis after the initial review. These may be up to weekly if needed. All participants are reviewed until death.
Patients family physicians will be provided with a summary of the consultation and a care plan to each patient. Each clinic will also have a multidisciplinary meeting to discuss each patients needs.

Intervention code [1] 301255 0
Other interventions
Comparator / control treatment
Standard care : this is all usual health care other than the interventional clinic. Standard care includes that provided by usual outpatient speciality clinics within Monash Health, usual inpatient care and emergency department care, and community care including general practice.
Control group
Active

Outcomes
Primary outcome [1] 305939 0
Symptom Assessment :utilising the palliative care "symptom assessment scale": 11 point numeric scale from 0 to 10 for appetite, sleep, nausea, pain, fatigue, breathing problems, bowel problems.
Timepoint [1] 305939 0
1 year post randomisation
Primary outcome [2] 306129 0
quality of life measures: McGills Quality of Life Questionnaire
Timepoint [2] 306129 0
1 year post randomisation
Primary outcome [3] 306130 0
Health professional rated score for symptom severity: 4 point scale for pain, other symptom, psycho-spiritual distress and carer distress resulting in a composite score with a sub-score for each component.
Timepoint [3] 306130 0
1 year post randomisation
Secondary outcome [1] 347079 0
hospital admissions: medical record review and where possible data linkages.
Timepoint [1] 347079 0
1 year post randomisation
Secondary outcome [2] 347640 0
emergency room attendances:medical record review and where possible data linkages.
Timepoint [2] 347640 0
1 year post randomisation
Secondary outcome [3] 347642 0
General practitioner episodes of contact:medical record review and where possible data linkages.
Timepoint [3] 347642 0
1 year post randomisation
Secondary outcome [4] 347643 0
Number of patient/carer episodes of contact (composite score) - this will be determined by medical record review of documented contacts.
Timepoint [4] 347643 0
1 year post randomisation
Secondary outcome [5] 347644 0
advance care plans completed: bymedical record review
Timepoint [5] 347644 0
1 year post randomisation
Secondary outcome [6] 347645 0
Number of episodes of contact with other health care professionals: by medical record review and where possible data linkages.
Timepoint [6] 347645 0
1 year post randomisation
Secondary outcome [7] 347650 0
number of community service referrals: medical record review and where possible data linkages.
Timepoint [7] 347650 0
1 year post randomisation

Eligibility
Key inclusion criteria
Adult 18 years of age
Being "Supportive and Palliative Care Indicators Tool positive in accordance to the tools criteria. ( https://www.spict.org.uk/) i.e. positive for section 1 ( General indicators of poor or deteriorating health ) and positive for an indicator in section 2(Clinical indicators of life- limiting conditions) of the tool.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient already having been referred to the intervention supportive care clinic

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)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 randomisation using simple randomisation table created by STATA software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be conducted by using STATA software. All statistical tests will be done two-tailed with 95% confidence intervals. For patients ‘lost to final follow-up’, data collected from consent to the time of the last contact will be included in analyses.
Descriptive statistics. Normally distributed quantitative data will be analyzed by mean and standard deviation. Data that are not normally distributed will be reported by median and inter-quartile range. Qualitative data will be reported by frequency distributions and percentages. Multivariate analysis. ANCOVA model. and Linear Mixed Models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
5/10/2020
Actual
Date of last data collection
Anticipated
4/10/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10928 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 22702 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 299521 0
Hospital
Name [1] 299521 0
Monash Health
Country [1] 299521 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Health
246 Clayton Road,
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 298821 0
None
Name [1] 298821 0
Address [1] 298821 0
Country [1] 298821 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300418 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 300418 0
Ethics committee country [1] 300418 0
Australia
Date submitted for ethics approval [1] 300418 0
21/06/2018
Approval date [1] 300418 0
Ethics approval number [1] 300418 0

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

Contacts
Principal investigator
Name 83598 0
A/Prof Peter Poon
Address 83598 0
Supportive and Palliative Care
Monash Health
246 Clayton Road
Clayton VICTORIA 3168
Country 83598 0
Australia
Phone 83598 0
+613 9594 5347
Fax 83598 0
+613 9594 6344
Email 83598 0
peter.poon@monashhealth.org
Contact person for public queries
Name 83599 0
Peter Poon
Address 83599 0
Supportive and Palliative Care
Monash Health
246 Clayton Road
Clayton VICTORIA 3168
Country 83599 0
Australia
Phone 83599 0
+613 9594 5347
Fax 83599 0
+613 9594 6344
Email 83599 0
peter.poon@monashhealth.org
Contact person for scientific queries
Name 83600 0
Peter Poon
Address 83600 0
Supportive and Palliative Care
Monash Health
246 Clayton Road
Clayton VICTORIA 3168
Country 83600 0
Australia
Phone 83600 0
+613 9594 5347
Fax 83600 0
+613 9594 6344
Email 83600 0
peter.poon@monashhealth.org

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.