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Trial registered on ANZCTR


Registration number
ACTRN12616000821493
Ethics application status
Approved
Date submitted
26/05/2016
Date registered
22/06/2016
Date last updated
22/11/2019
Date data sharing statement initially provided
28/11/2018
Date results provided
28/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Gold Coast Integrated Care for patients with chronic disease through a non-randomised controlled clinical trial
Scientific title
Evaluation of cost-effectiveness of the Gold Coast Integrated Care Pilot Program for patients with chronic disease: a pragmatic non-randomised controlled clinical trial
Secondary ID [1] 289291 0
None
Universal Trial Number (UTN)
Trial acronym
GCIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 298896 0
chronic heart disease 298897 0
chronic obstructive pulmonary disease 298898 0
chronic kidney disease 298899 0
Condition category
Condition code
Metabolic and Endocrine 294211 294211 0 0
Diabetes
Cardiovascular 297860 297860 0 0
Coronary heart disease
Respiratory 298974 298974 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intervention group of patients with complex and chronic conditions at high risk of hospitalisation will be recruited to have their care managed within the integrated care program. The program was developed in collaboration with general practitioners to reduce presentations to the health service emergency department, improve the capacity of specialist outpatients, and decrease planned and unplanned admission rates. The program is delivered by a multidisciplinary team facilitated by sharing information between primary and secondary health services through a highly advanced information and communication systems platform.

Patients who are identified as high risk with complex co-morbid conditions will undertake a Holistic Assessment process. The Holistic Assessment is a comprehensive review of existing client information, their relevant clinical results, and identification of their current service providers in order to generate a detailed summary of the patient’s medical and social needs to build a jointly agreed individualised and flexible Shared Care Plan. The patient-centred shared care plan considers all physical, mental, emotional, social and environmental factors that may be influencing a client’s health status and their service utilisation. The assessment and development of the care plan is conducted over a two week period from the time the patient is consented. Service Navigators contact patients by phone to begin the process of Holistic Assessment. Once consent is obtained, the Service Navigators have patients complete an evaluation questionnaire (including quality of life, social support, satisfaction with care, and capabilities) by phone which includes a health profile of approximately one hour. Appointments are then made for the patient to have a one hour personal core risk assessment conducted by a Nurse Navigator/GCIC clinician, and a medical and pharmacy review all of which are conducted either at the Coordination Centre, the general practice or the patient’s home. The risk assessment includes validated tools to gather patient data on cognition, medication misadventure, falls, pressure injury/care, malnutrition, function, emotional health and wellbeing, continence, pain, wound, dysphagia, lower limb care, advanced care planning and frailty. The risk of hospitalisation is then estimated through purposely designed instruments. Information from the core risk assessment is then shared between the GP and the GCIC medical staff as the basis for a collaborative care plan which is then signed off by the patient, the GP and the GCIC medical team.

The Shared Care Plan is generated by the Nurse Navigator/GCIC Clinician who performs the risk assessment, which is then shared with the patient’s general practitioner. Once the patient, the GP and the GCIC medical team agrees on the plan, the Nurse Navigator/GCIC Clinician delegates tasks to the Service Navigators and other clinicians who will organise services.

The Shared Care Plan includes an Exacerbation Plan. The GCIC Coordination Centre monitors all hospital admissions/discharges for patients of network practices through the state-wide electronic Management Information System. Irrespective of whether a patient has had a hospital admission they are advised during the initial enrolment with GCIC that if they experience exacerbation of symptoms they should contact Gold Coast Integrated care on a 1300 number. Alternatively they have the choice of contacting their General Practice. General practice staff (GP/practice nurse/GCIC Nurse Navigator) in turn are requested to contact GCIC for any patient exacerbations so that their shared care record can be updated. The Coordination Centre can also be notified of a patients exacerbation event by other care providers i.e. other hospital and health services or non-government organisations. The patients shared care record will provide notifications of all exacerbation events that have occurred. In case of an emergency Queensland Ambulance Service will attend calls as usual. Where patients are identified as not requiring the Emergency Department, but are on the GCIC program the need for hospitalisation will be determined by the paramedics (who may seek support from GCIC or the GP to confirm actions required) based on the Exacerbation Plan included in the patient's copy of the Management Plan.

The Shared Care Plan, event history and monitoring information is kept in the Shared Care Record, which is a custom-built computer database with internet access, designed to assist with creating, gathering, storing and presenting of longitudinal healthcare history and patient information, as contributed by the patient’s care team. This information will be used to manage the patient's ongoing care. The Shared Care Record will be linked with other information systems including GP Practice Management systems to ensure that a patient’s healthcare information is available from one location, and will be central to facilitating timely communication of care needs between multiple health care providers. The service will be accessible to all members of a patient’s care team, including the patient.

Participants of the intervention group will be exposed to the intervention for at least 24 months. If the program is not funded to continue at the end of the trial than patients and practices will be notified and a transition process (lasting approximately 6 months) will be initiated in which patients' care coordination will revert to their general practice. As the GCIC model is founded on the general practice remaining at the centre of patient care this transition is expected to be a relatively straightforward process for all stakeholders involved.
Intervention code [1] 290946 0
Treatment: Other
Comparator / control treatment
Participants in the control group will continue to receive the health care available to the wider population of the Gold Coast area, i.e. the method of care management, monitoring, services, interventions and decision making will remain unchanged.
Control group
Active

Outcomes
Primary outcome [1] 294000 0
Overall cost of delivering health care services for patients with complex needs, including Medicare and Pharmaceutical Benefits Scheme costs, hospital emergency, inpatient, outpatient and investigation costs reported by the Gold Coast Hospital and Health Service, staff cost reported by GCIC management.
Timepoint [1] 294000 0
observed for 12 to 36 months
Secondary outcome [1] 312331 0
Quality of life (AQoL-4D) survey
Timepoint [1] 312331 0
baseline and 12 monthly follow-ups for 12 to 36 months
Secondary outcome [2] 312332 0
Cost-effectiveness.
These costs calculated for the primary outcome will be adjusted using demographic, practice and baseline factors identified from regression analyses, and will be standardised into a common year to account for spurious effects of inflation.
Quality-adjusted life years will be estimated by scoring the standard Australian preference-based algorithm AQoL-4D, and multiplying survival by the time in each health state (i.e. between survey time points).
The Incremental Cost Effectiveness Ratio will be estimated as difference in costs divided by the difference in quality-adjusted life-years. This analysis will indicate if the service provides value for money at an acceptable level.
Timepoint [2] 312332 0
observed for 12 to 36 months, and projected for 5 years

Eligibility
Key inclusion criteria
Patients of participating general practices in the Gold Coast region, categorised as high risk with diagnosed chronic diseases including diabetes, chronic heart disease, chronic obstructive pulmonary disease or chronic kidney disease and with high utilisation of hospital services (one or more inpatient admissions in the past 3 years, one or more emergency department presentations in the past 3 years, at least 5 currently prescribed medications, or at least 20 general practice visits in the last year.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Maternity patients, those undergoing treatment for cancer, or residents of aged care facilities

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)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be utilised to describe the sample population and to compare to the general (demographically similar) population. Data will be set up as required for simple, longitudinal or time-to-event analysis. Missing data will be imputed where necessary using multiple imputation techniques (sensitivity analyses will be performed without imputations). Data will be analysed with a range of methods (from simple hypothesis tests to advanced model analyses) depending on the research question, size and nature of dataset, and the complexity of relationships between variables. The incremental cost-effectiveness ratio will be calculated, and economic models will be created to generate forward estimates.

The detectable difference in healthcare cost per patient was calculated based on: the average number of intervention arm participants enrolled at each network general practices (clusters), the mean cost per participant (in the control group) over two years of $10,000 (Australian Dollars in 2015; standard deviation: 4,000), coefficient of variance within each cluster of 0.47, an intra-cluster correlation of 0.01, resulting in a difference of $644 at the 5% significance level which can be detected with 80% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/11/2015
Date of last participant enrolment
Anticipated
31/08/2016
Actual
1/08/2017
Date of last data collection
Anticipated
31/12/2018
Actual
31/12/2018
Sample size
Target
4500
Accrual to date
Final
4647
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5857 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 13295 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 290556 0
Government body
Name [1] 290556 0
Queensland Health
Country [1] 290556 0
Australia
Funding source category [2] 293686 0
Government body
Name [2] 293686 0
Gold Coast Hospital and Health Service
Country [2] 293686 0
Australia
Funding source category [3] 293687 0
Government body
Name [3] 293687 0
Gold Coast Primary Health Network
Country [3] 293687 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard, Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 292521 0
Government body
Name [1] 292521 0
Department of Health
Address [1] 292521 0
23 Furzer Street, Phillip, ACT 2606
Country [1] 292521 0
Australia
Other collaborator category [1] 279006 0
University
Name [1] 279006 0
Griffith University
Address [1] 279006 0
Parklands Drive, Southport, QLD 4215
Country [1] 279006 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292200 0
Human Research Ethics Committee, Gold Coast Hospital and Health Service, Queensland Health
Ethics committee address [1] 292200 0
Ethics committee country [1] 292200 0
Australia
Date submitted for ethics approval [1] 292200 0
15/01/2015
Approval date [1] 292200 0
16/03/2015
Ethics approval number [1] 292200 0
HREC/15/QGC/22
Ethics committee name [2] 292741 0
Human Research Ethics Committee, Office for Research, Griffith University
Ethics committee address [2] 292741 0
Ethics committee country [2] 292741 0
Australia
Date submitted for ethics approval [2] 292741 0
08/04/2015
Approval date [2] 292741 0
12/04/2015
Ethics approval number [2] 292741 0
MED/22/15/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 424 424 0 0
/AnzctrAttachments/367745-15 QGC 22 Approval Letter.pdf
Attachments [2] 425 425 0 0
/AnzctrAttachments/367745-Letter of approval MED 22 15 HREC-1.pdf

Contacts
Principal investigator
Name 54038 0
Prof Paul Scuffham
Address 54038 0
N78 2.34, The Circuit, School of Medicine, Nathan Campus, Griffith University, Nathan, QLD 4111
Country 54038 0
Australia
Phone 54038 0
+61 7 3382 1367
Fax 54038 0
Email 54038 0
p.scuffham@griffith.edu.au
Contact person for public queries
Name 54039 0
Lauren Ward
Address 54039 0
Gold Coast Health and Hospital Service, 8 High Street, Southport, QLD 4215
Country 54039 0
Australia
Phone 54039 0
+61 7 5626 0421
Fax 54039 0
Email 54039 0
l.ward@griffith.edu.au
Contact person for scientific queries
Name 54040 0
Paul Scuffham
Address 54040 0
N78 2.34, The Circuit, School of Medicine, Nathan Campus, Griffith University, Nathan, QLD 4111
Country 54040 0
Australia
Phone 54040 0
+61 7 3382 1367
Fax 54040 0
Email 54040 0
p.scuffham@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive, potentially re-identifiable data.


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
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the Gold Coast Integrated Care for patients with chronic disease or high risk of hospitalisation through a non-randomised controlled clinical trial: A pilot study protocol.2017https://dx.doi.org/10.1136/bmjopen-2017-016776
N.B. These documents automatically identified may not have been verified by the study sponsor.