ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

FNQHAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Disease

Cardiovascular Disease

Diabetes

Chronic Kidney Disease

Chronic Obstructive Pulmonary Disease

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Metabolic and Endocrine

Diabetes

Renal and Urogenital

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]

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]

Clinical care processes (care plans completed, regular checks according to care plans)

Timepoint [1]

12 months

Primary outcome [2]

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]

12 months

Secondary outcome [1]

For diabetes: results including HbA1c, fasting blood glucose, BP, and lipids - achievement of target levels and change from baseline

Timepoint [1]

12 months

Secondary outcome [2]

For CVD and hypertension: results including BP and lipids - targets and change from baseline

Timepoint [2]

12 months

Secondary outcome [3]

For renal disease: results including eGFR, urinary ACR and BP control (change from baseline).

Timepoint [3]

12 months

Secondary outcome [4]

For COPD: target spirometry (change from baseline)

Timepoint [4]

12 months

Secondary outcome [5]

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]

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?

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]

Government body

Name [1]

Queensland Health,
Health Systems Innovation Branch,
Clinical Access and Redesign Unit

Address [1]

Health Systems Innovation Branch
Clinical Access and Redesign Unit
Department of Health
Level 13, Block 7
Royal Brisbane and Women’s Hospital
Herston QLD 4029

Country [1]

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]

University

Name [1]

James Cook University

Address [1]

Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870

Country [1]

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

Prof Robyn McDermott

Address

Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870

Country

Australia

Phone

+61 7 4042 1575

Fax

robyn.mcdermott@jcu.edu.au

Contact person for public queries

Name

Robyn McDermott

Address

Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870

Country

Australia

Phone

+61 7 4042 1575

Fax

robyn.mcdermott@jcu.edu.au

Contact person for scientific queries

Name

Robyn McDermott

Address

Centre for Chronic Disease Prevention
Faculty of Medicine, Health & Molecular Sciences
James Cook University, PO Box 6811, Cairns QLD 4870

Country

Australia

Phone

+61 7 4042 1575

Fax

robyn.mcdermott@jcu.edu.au

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

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Documents added automatically

No additional documents have been identified.

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