Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000219684
Ethics application status
Approved
Date submitted
25/02/2014
Date registered
28/02/2014
Date last updated
28/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Far North Queensland Hospital Avoidance Trial - chronic disease case management compared with usual care in reducing avoidable hospital and Emergency Department admissions.
Scientific title
Far North Queensland Hospital Avoidance Trial - chronic disease case management compared with usual care in reducing avoidable hospital and Emergency Department admissions.
Secondary ID [1] 284161 0
Nil
Universal Trial Number (UTN)
Trial acronym
FNQHAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Disease 291254 0
Cardiovascular Disease 291255 0
Diabetes 291256 0
Chronic Kidney Disease 291257 0
Chronic Obstructive Pulmonary Disease 291258 0
Condition category
Condition code
Cardiovascular 291597 291597 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 291599 291599 0 0
Diabetes
Renal and Urogenital 291600 291600 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Close case management in the community in addition to usual best practice care.
Consenting eligible participants will have a full baseline assessment performed at Visit 1 and referral to their GP, including a request for a formal care plan. Those randomised to the intervention group (case management) will additionally be allocated to a care co-ordinator who resides in their community.
A key feature of the intervention will be the deployment of an integrated care planning and reporting tool which is attached to the Primary Health Care patient management system, and which can be utilised across the care team, including the Emergency Department, hospital inpatient system, and other community-based care providers e.g. allied health, Indigenous health workers where relevant.
In summary, the intervention group will receive:
(1) A dedicated case manager (Registered Nurse) who will initially map the social and health needs of the client. The case manager will work closely with the participant including face-to-face contact in the clinic, home visits and via telephone. The contact will be provided on an 'as needed' basis over the entire period of the study (approximately 1-2 years).
(2) A “medical home” – referral to a Primary Care service which will provide integrated care and serve as the focus of health care planning and delivery for the client.
(3) The installation, and training by the whole team in the use of, software which will generate an integrated General Physician Management Plan (GPMP) and Team Care Arrangements (TCA), which will be utilised by all providers including allied health and hospital-based services, and which will generate periodic reports for the service providers.
(4) Access to self-management health care coaching for clients who accept this.
(5) For Indigenous clients, a trained health worker will also be assigned to assist with identified issues, and also to mentor the case managers in cultural aspects of care delivery and self-management.
Intervention code [1] 288859 0
Treatment: Other
Comparator / control treatment
Usual best practice care of chronic disease in the community (referral to General Physician).
Control group
Active

Outcomes
Primary outcome [1] 291543 0
Clinical care processes (care plans completed, regular checks according to care plans)
Timepoint [1] 291543 0
12 months
Primary outcome [2] 291544 0
Potentially preventable hospitalisations (PPH) and Emergency Department (ED) visits, and key diagnosis related groups (DRGs), including costing of DRGs avoided.
Data relating to PPHs and Emergency Department visits, and key DRGs is routinely collected by hospitals. We will be accessing this data from Queensland Health at regular intervals throughout the study to quantify these parameters. The data will be also be incorporated into a prospective cost-utility evaluation along-side the clinical trial.
Timepoint [2] 291544 0
12 months
Secondary outcome [1] 307024 0
For diabetes: results including HbA1c, fasting blood glucose, BP, and lipids - achievement of target levels and change from baseline
Timepoint [1] 307024 0
12 months
Secondary outcome [2] 307025 0
For CVD and hypertension: results including BP and lipids - targets and change from baseline
Timepoint [2] 307025 0
12 months
Secondary outcome [3] 307027 0
For renal disease: results including eGFR, urinary ACR and BP control (change from baseline).
Timepoint [3] 307027 0
12 months
Secondary outcome [4] 307028 0
For COPD: target spirometry (change from baseline)
Timepoint [4] 307028 0
12 months
Secondary outcome [5] 307029 0
For all chronic conditions: improved quality of life (measured using AQoL and WHOQOL surveys), depression (measured using PHQ-9), health status (measured by using SF-36) and improvements in self-reported risk behaviours including smoking, physical activity, healthy food intake.
Timepoint [5] 307029 0
12 months

Eligibility
Key inclusion criteria
(1) 8 or more presentations to the ED and/or hospitalisations in the previous 12 months for a Potentially Preventable Hospitalisation (PPH) condition;
(2) aged 18-75;
(3) have at least one chronic condition (diabetes, cardiovascular disease, renal disease or chronic obstructive pulmonary disease); and
(4) reside within the area of a participating site.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) people not permanently residing in the study area;
(2) people on renal dialysis;
(3) people with major mental health problems such as psychosis or with substance misuse problems;
(4) people with a diagnosis of cancer;
(5) people with dementia or other condition which will significantly reduce the ability to consent fully to undertake the program.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
530
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288790 0
Government body
Name [1] 288790 0
Queensland Health,
Health Systems Innovation Branch,
Clinical Access and Redesign Unit
Country [1] 288790 0
Australia
Primary sponsor type
Hospital
Name
Cairns & Hinterland Hospital and Health Service
Address
Cairns & Hinterland Hospital and Health Service
Queensland Health
PO Box 902 Cairns QLD 4870
Country
Australia
Secondary sponsor category [1] 287485 0
University
Name [1] 287485 0
James Cook University
Address [1] 287485 0
Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870
Country [1] 287485 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The FNQHAT is a pragmatic randomised controlled trial which aims to reduce avoidable hospitalisations and Emergency Department visits for ‘frequent flyer’ adults with diabetes, cardiovascular disease, renal disease and chronic obstructive pulmonary disease. The primary objective is to improve primary health care-level chronic care processes (such as benchmarking, care planning and guideline concordance) and also patient outcomes (such as clinical indicator change, avoidable hospitalisations and ED visits and disease progression).
FNQHAT is funded through the Queensland Department of Health’s Health Innovation Fund (HIF) as a joint project between the Cairns and Hinterland Hospital and Health Service (CHHHS) and James Cook University (JCU) Centre for Chronic Disease Prevention in Cairns. The CHHHS Sponsor is Dr Neil Beaton and the JCU lead is Professor Robyn McDermott.
The study aims to recruit up to 530 “frequent flyers” over a 12-24-month period. People with chronic disease who have been identified as visiting one of the three participating hospitals in FNQ (Cairns Hospital, Innisfail Hospital and Mareeba Hospital) will be recruited. At least 25% of participants are expected to be Aboriginal or Torres Strait Islander and therefore the project will be undertaken in collaboration with the relevant Aboriginal Medical Services, WuChopperen in Cairns, Mamu in Innisfail and Mulungu in Mareeba.
The study will compare usual best practice for managing chronic disease in the community (referral to GP) with close case management of clients in addition to usual best practice care. The study will also be trialling software which can connect to both the hospital and primary health care information systems. This will enable the use of a single patient record by the whole care team and will assist in communication between different health services, generating patient management plans and reporting on clinical care processes and measures. A Clinical Governance Group will also be established to oversee provision of care provided to participants and a Data Safety and Monitoring Group will monitor data quality and adverse events and to ensure participant safety throughout the study.
Potential patients for the trial will be identified from EDIS and HBCIS data in participating hospitals according to the following eligibility criteria:
(1) Had 8 or more presentations to the ED and/or hospitalisations in the previous 12 months for a potentially preventable hospitalisation
(2) Aged 18-75 and reside within the area of a participating site.
(3) Have at least one chronic condition identified (diabetes, cardiovascular disease, renal disease or chronic obstructive pulmonary disease).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46530 0
Prof Robyn McDermott
Address 46530 0
Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870
Country 46530 0
Australia
Phone 46530 0
+61 7 4042 1575
Fax 46530 0
Email 46530 0
[email protected]
Contact person for public queries
Name 46531 0
Prof Robyn McDermott
Address 46531 0
Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870
Country 46531 0
Australia
Phone 46531 0
+61 7 4042 1575
Fax 46531 0
Email 46531 0
[email protected]
Contact person for scientific queries
Name 46532 0
Prof Robyn McDermott
Address 46532 0
Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870
Country 46532 0
Australia
Phone 46532 0
+61 7 4042 1575
Fax 46532 0
Email 46532 0
[email protected]

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.