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.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
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
ACTRN12625000844448p
Ethics application status
Submitted, not yet approved
Date submitted
1/07/2025
Date registered
6/08/2025
Date last updated
6/08/2025
Date data sharing statement initially provided
6/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Supportive Care for Chronic Disease: An audit to evaluate the existing Supportive Care for Chronic Disease services program in the Hunter New England Health District.
Query!
Scientific title
Supportive Care for Chronic Disease: An audit to evaluate the existing Supportive Care for Chronic Disease services program in the Hunter New England Health District.
Query!
Secondary ID [1]
314592
0
Nil known.
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Liver Disease
337707
0
Query!
Heart Failure
337708
0
Query!
Motor Neurone Disease
337710
0
Query!
Movement Disorders
337711
0
Query!
Voluntary Assisted Dying
337712
0
Query!
Other chronic diseases
337829
0
Query!
Chronic Obstructive Pulmonary Disease
337835
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
334043
334043
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Cardiovascular
334086
334086
0
0
Query!
Coronary heart disease
Query!
Neurological
334087
334087
0
0
Query!
Neurodegenerative diseases
Query!
Neurological
334088
334088
0
0
Query!
Parkinson's disease
Query!
Public Health
334089
334089
0
0
Query!
Health service research
Query!
Respiratory
334168
334168
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
An audit to evaluate the existing Supportive Care for Chronic Disease (SCCD) service program will be undertaken by clinicians or medical students or allied health students with access to Hunter New England Health District (HNELHD) medical records. The SCCD program delivers holistic and person-centred care for patients and their carers alongside existing health care (standard care). SCCD involves chronic disease care plus implementation of palliative care principles for adults living with advanced liver disease, heart failure, motor neurone disease, Parkinson’s disease, chronic obstructive pulmonary disease and Aboriginal people with advanced non-malignant comorbidities (ICCAPP), with estimated life expectancy two years or less.
The SCCD service offers a 12-week program to patients and their nominated carers provided by social work, dietitian, speech pathology and occupational therapy via in-person, telehealth or virtual care. Additional psychosocial and emotional support is provided on a need’s basis by a psychiatrist for individuals assessed by the SCCD team to have elevated levels of disease related burden or distress, carer burden or psychiatric illness. Patients receive a minimum of four occasions of service and carers three occasions across the 12-week program. Patient/Carer-Reported Measures are completed electronically within 48 hours of each scheduled contact. The outcomes of these measures guide the focus of the planned consultations as well as the expressed concerns of patients and carers during consultations. Clinical care and advice are provided during consultations with additional care co-ordination and support undertaken between planned consultations according to patient and carer need.
This study will be an audit of existing service data with no patient participation. Patients and carers will complete the SCCD program regardless of their involvement in this study. The audit will involve data collected from 25th August 2025 to 30 June 2032, from patient medical records (HNELHD clinical systems and databases); SCCD service data (Excel spreadsheet and progress notes populated with patient/carer demographics, scheduled appointments, attendance, referrals, interventions and planned/unplanned health service utilisations); patient/carer reported measures [Integrated Palliative Outcomes Scale (IPOS), Euroqol (EQ)-5D-5L, Malnutrition Screening Tool (MST), EAT-10 Swallowing Screening tool (EAT-10), Carer Experience Scale (CES), Carer Support Needs Assessment Tool (CSNAT) ]; and questionnaires (post service completion feedback survey). Data collection will be completed at a at a single timepoint, 6 months after completion of the SCCD program. Data will be analysed retrospectively with a focus on three timeframes, 6 months pre-referral to SCCD, during the SCCD program and 6 months after SCCD program completion. Direct identifiers will not be collected. The database will be held on HNELHD servers.
Query!
Intervention code [1]
331217
0
Not applicable
Query!
Comparator / control treatment
Standard care for all SCCD participants is conducted in multidisciplinary outpatient settings. Depending on diagnosis, patient participants receive care from a specialist physician (e.g. cardiologist) with additional support from allied health clinicians according to resourcing of each disease specific multidisciplinary team. This support may be planned or on an ad hoc basis. Participants are referred to the SCCD program by a member of their treating specialist team according to disease specific referral criteria. Participants will act as their own controls with data compared at 3 timeframes at 6 months pre-referral to SCCD, during the SCCD program and 6 months after SCCD program completion. The reference comparator will be the 6 months pre-referral to SCCD program.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
341707
0
Change in unplanned health service utilisation across the 3 timeframes.
Query!
Assessment method [1]
341707
0
Composite primary outcome. Service Activity Data - unplanned health service utilisation i. Emergency Department presentations ii. Unplanned hospital admissions iii. Bed days (unplanned) Assessed by data linkage to medical records and clinical applications portal.
Query!
Timepoint [1]
341707
0
Reported monthly and compared at 3 timeframes: during the 6 months pre referral to SCCD, at completion of the SCCD program and during 6 months following completion of SCCD program.
Query!
Secondary outcome [1]
448445
0
Disease Related Burden
Query!
Assessment method [1]
448445
0
Patient Reported Measures: i. Integrated Palliative Outcomes Scale (IPOS) ii. Euroqol (EQ)-5D-5L iii. Malnutrition Screening Tool (MST) iv. EAT-10 Swallowing Screening tool (EAT-10) Client reported and stored in REDCap database. This is a composite outcome.
Query!
Timepoint [1]
448445
0
Existing data collected at each patient contact, baseline and weeks 4, 8 and 12.
Query!
Secondary outcome [2]
448446
0
Change in Advanced Care Planning practices
Query!
Assessment method [2]
448446
0
Composite outcome. Rates of documentation of Advanced Care Directives, Not for Resuscitation orders, and ambulance care plans during the SCCD program stage sourced in medical records and HNELHD clinical systems (iPM, CAP, DMR) or as reported by patient or carer.
Query!
Timepoint [2]
448446
0
Reported at completion of the SCCD program.
Query!
Secondary outcome [3]
448447
0
The impact of SCCD mode of care delivery upon HSU.
Query!
Assessment method [3]
448447
0
Service activity. I. In-person II. Telehealth III. Virtual care Mode of care collated in service database.
Query!
Timepoint [3]
448447
0
Reported monthly. Surveys sent via mail with replied paid envelope or emailed electronically to participants within 2 weeks of discharge from SCCD program.
Query!
Secondary outcome [4]
448791
0
Financial impact related to any benefit in HSU with consideration of costs associated to deliver the intervention.
Query!
Assessment method [4]
448791
0
Cost utility analysis and health service utilisation data. Taking a health service perspective, the costing analysis will include direct healthcare costs associated with the study’s primary outcomes of change in unplanned health service utilisation with ED presentations, inpatient hospitalisations, and outpatient appointments across the 3 timeframes. Quality-adjusted life years (QALYs) will be calculated using EQ-5D-5L utility scores collected at weeks 0, 4, 8, and 12.
Query!
Timepoint [4]
448791
0
At completion of the SCCD program.
Query!
Secondary outcome [5]
450147
0
Carer burden
Query!
Assessment method [5]
450147
0
Carer reported measures: i. Carer Experience Scale (CES) ii. Carer Support Needs Assessment Tool (CSNAT) Carer reported and stored in REDCap database. This is a composite measure.
Query!
Timepoint [5]
450147
0
Existing data collected at each carer contact, baseline and weeks 6 and 12.
Query!
Secondary outcome [6]
450148
0
The impact of mode of SCCD care delivery upon carer experience of health care.
Query!
Assessment method [6]
450148
0
Post program feedback surveys specifically designed for this study. I. In-person II. Telehealth III. Virtual care Mode of care collated in service database.
Query!
Timepoint [6]
450148
0
Reported monthly. Surveys sent via mail with replied paid envelope or emailed electronically to participants within 2 weeks of discharge from SCCD program.
Query!
Secondary outcome [7]
450338
0
The impact of SCCD mode of care delivery upon patient experience of health care.
Query!
Assessment method [7]
450338
0
Post program feedback surveys specifically designed for this study. I. In-person II. Telehealth III. Virtual care Mode of care collated in service database.
Query!
Timepoint [7]
450338
0
Reported monthly. Surveys sent via mail with replied paid envelope or emailed electronically to participants within 2 weeks of discharge from SCCD program.
Query!
Eligibility
Key inclusion criteria
Adults living with advanced liver disease, heart failure, motor neurone disease, Parkinson’s disease, chronic obstructive pulmonary disease, and Aboriginal people with advanced comorbidities (ICCAPP), with estimated life expectancy 2 years or less, who have attended the SSCD program in Hunter New England Health District.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Malignant conditions without a concurrent diagnosis of chronic disease.
Anyone under 18 years of age.
Query!
Study design
Purpose
Natural history
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Both
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
25/08/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
30/06/2032
Query!
Actual
Query!
Date of last data collection
Anticipated
30/06/2032
Query!
Actual
Query!
Sample size
Target
400
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
28006
0
John Hunter Hospital - New Lambton
Query!
Recruitment postcode(s) [1]
44209
0
2305 - New Lambton
Query!
Funding & Sponsors
Funding source category [1]
319139
0
Charities/Societies/Foundations
Query!
Name [1]
319139
0
John Hunter Hospital Charitable Trust
Query!
Address [1]
319139
0
Query!
Country [1]
319139
0
Australia
Query!
Funding source category [2]
319142
0
Other Collaborative groups
Query!
Name [2]
319142
0
Hunter Medical Research Institute
Query!
Address [2]
319142
0
Query!
Country [2]
319142
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Professor Katie Wynne, John Hunter Hospital, New Lambton Heights.
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
321608
0
None
Query!
Name [1]
321608
0
Query!
Address [1]
321608
0
Query!
Country [1]
321608
0
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
317732
0
Hunter New England Human Research Ethics Committee
Query!
Ethics committee address [1]
317732
0
https://www.hnehealth.nsw.gov.au/research-office/research_ethics
Query!
Ethics committee country [1]
317732
0
Australia
Query!
Date submitted for ethics approval [1]
317732
0
27/06/2025
Query!
Approval date [1]
317732
0
Query!
Ethics approval number [1]
317732
0
Query!
Summary
Brief summary
Primary aim of this research is to evaluate the impact of the Supportive Care in Chronic Disease (SCCD) model on health service utilisation and consumer experience among patients with liver disease, heart failure, Parkinson’s disease, motor neurone disease, chronic obstructive pulmonary disease, and for patients within the Integrated Chronic Care for Aboriginal People Programs (ICCAPP), with a prognosis of 2 years or less, and their carers.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
141966
0
Prof Katie Wynne
Query!
Address
141966
0
John Hunter Hospital, Locked Bag 1, New Lambton Heights, NSW 2305.
Query!
Country
141966
0
Australia
Query!
Phone
141966
0
+61429995896
Query!
Fax
141966
0
Query!
Email
141966
0
[email protected]
Query!
Contact person for public queries
Name
141967
0
Shaye Ludlow
Query!
Address
141967
0
John Hunter Hospital, Locked Bag 1, New Lambton Heights, NSW 2305.
Query!
Country
141967
0
Australia
Query!
Phone
141967
0
+61249213686
Query!
Fax
141967
0
Query!
Email
141967
0
[email protected]
Query!
Contact person for scientific queries
Name
141968
0
Prof Katie Wynne
Query!
Address
141968
0
John Hunter Hospital, Locked Bag 1, New Lambton Heights, NSW 2305.
Query!
Country
141968
0
Australia
Query!
Phone
141968
0
+61429995896
Query!
Fax
141968
0
Query!
Email
141968
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
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