ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000512921

Ethics application status

Approved

Date submitted

20/04/2011

Date registered

17/05/2011

Date last updated

17/05/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

The OASIS study: Observational Australian Study Investigating the epidemiology, outcomes and management of non-traumatic Subarachnoid haemorrhage.

Scientific title

Observational Australian Study Investigating the epidemiology, outcomes and management of non-traumatic Subarachnoid haemorrhage using linked health administrative data.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

OASIS

Linked study record

Health condition

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

Subarachnoid Haemorrhage (non-traumatic)

Condition category

Condition code

Stroke

Haemorrhagic

Public Health

Epidemiology

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Non-traumatic subarachnoid haemorrhage (SAH) accounts for 1 to 7% of all strokes and around 30% with SAH die within one month. SAH is characterised by bleeding in the subarachnoid space between the thin arachnoid and pia mater coverings of the brain. Ruptured cerebral aneurysms account for 85% of non-traumatic SAH.

Using linked administrative data-sets, it is now feasible to examine SAH care. We aim to use routinely collected data to carry out a large-scale analysis of outcomes for SAH. We aim to determine short and longer-term quality of care and the safety and efficacy of procedures undertaken to treat SAH in a contemporary acute care setting. Our proposed project is a cost effective, timely alternative to existing labour-intensive efforts to observe SAH care and outcomes. Our methods minimise selection and referral biases, utilising state-wide data from the largest cohort of SAH patients ever studied in Australia (~5,000). Our proposed project aims to analyse linked administrative data-bases to identify patients with SAH and characterise short and long-term outcomes, such as fact and cause of death and re-admission to hospital.

Outcomes will be assessed from time of hospital admission to up to 10 years post-hospitalisation.

Intervention code [1]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Epidemiological description of outcomes for non-traumatic SAH will be undertaken. Specifically, the following analyses will be conducted
-Age- and sex-standardised incidence;
-Mortality rates;
-Relative survival amongst 90-day survivors;
-Recurrent SAH
-Uptake of rehabilitation and "exposure" to hospital rehabilitation.

Variation in these outcomes according to patient, hospital and disease characteristics, and year of hospital admission will be explored.

These outcomes will be determined by linkage of hospitalisation data to subsequent hospitalisations and mortality indices (cause and fact of death).

Timepoint [1]

-Yearly incidence rates will be calculated for the years 2000-2007.
-Data to estimate mortality at 24-hours, 48-hours, 7-days, 30-days, 90-days, 180-days, 1-year, and up to ten years will be available (ie from 2000 to 2010).
-1-year to up to 10-years relative survival will be calculated.
-Risk of recurrent non-traumatic SAH at up to nine years after hospital admission for acute SAH (ie from 2000 to 2009).

Primary outcome [2]

A proxy measure of disability, "time spent in hospital", will be determined from hospital admissions data, adapting a validated measure in which time spent at home was correlated with standardised measures of disability in stroke patients (Quinn, Dawson, Lees et al 2008). The number of days spent in hospital will be calculated and this measure will be applied to those patients who survive the follow-up period.

Variation in these outcomes according to patient, hospital and disease characteristics, and year of hospital admission will be explored.

References: Quinn TJ, Dawson J, Lees JS, Chang TP, Walters MR, Lees KR. Time Spent at Home Poststroke
"Home-Time" a Meaningful and Robust Outcome Measure for Stroke Trials. Stroke 2008; 39: 231.

Timepoint [2]

90-days, 12-months and up to 9-years following hospitalisation for non-traumatic SAH.

Primary outcome [3]

Management and patterns of care of non-traumatic SAH. Examples of outcomes investigated are as follows:
-Uptake of neurosurgical interventions (eg clipping, coiling, CSF shunting, intraventricular drainage);
-Arrival and transfer to a hospital offering a neurosurgical unit (ie Category A stroke unit hospital);
-ED triage prior to admission to hospital for SAH or prior to death from SAH;
-Time from hospital admission to administration of neurosurgical interventions;
-Hospital caseload;
-ICU and mechanical ventilation;
-modifiable patient complications of care;
-Uptake of diagnostic procedures

Variation in these outcomes according to patient, hospital and disease characteristics, and year of hospital admission will be explored.

Timepoint [3]

These outcomes are "in-hospital" outcomes from July 1, 2000 to June 30, 2009.

Secondary outcome [1]

Methodological sub-studies are planned, including:
-Validation of administrative recording of SAH and other comorbidities, procedures and patient characteristics;
-Development of a "severity index" against gold standard specialist assessment using Glasgow Coma Score, Hunt and Hess Scale and World Federation of Neurological Sciences scales;
-effect of "look-back" period for comorbidity, herald symptoms and other antecedents;
-Fact of death as a proxy for "SAH cause-specific death" at 30-days, 90-days and 12-months.

Timepoint [1]

These outcomes will utilise hospitalisation data from July 1, 2000 to June 30, 2009 and death data from July 1, 2000 to June 30 2010.

Eligibility

Key inclusion criteria

NSW residents aged 18 years or over with a hospital separation for SAH or who died outside hospital with SAH noted as a cause of death.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with the following criteria will be excluded:
-a concomitant code for head trauma or traumatic injury;
-residents of other Australian states;
-patients with diagnostic codes (as selected by clinical experts) for brain malignancy or benign brain tumour.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2000

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

4000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council of Australia

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Government body

Name

National Health and Medical Research Council of Australia

Address

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NSW Population & Health Services Research Ethics Committee

Ethics committee address [1]

Cancer Institute NSW, Australian Technology Park, Level 9, 8 Central Avenue, Eveleigh, NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/03/2007

Ethics approval number [1]

2007/03/023

Summary

Brief summary

Subarachnoid haemorrhage (SAH) accounts for 5% of all strokes, yet 30% of people affected with SAH will die within 90 days and survivors are often disabled. Unlike ischaemic stroke, there is a relatively higher risk of SAH in younger age groups, yet risk factors are ill-defined. Therefore, determining health service variables impacting on outcomes will inform policy and practice. It is now feasible to examine SAH care and its outcomes on a large scale at a relatively modest cost. We will analyse linked routinely collected morbidity and mortality data to explore outcomes and patterns of care in SAH on a large scale. The study will describe discharge destinations and readmissions and be able to quantify the effect of hospital services according to different models of care, resources and settings (eg principal and non-principal referral, neurosurgical vs non-neurosurgical) and neurovascular interventions. Such a large-scale analysis of services and care patterns will be of international significance informing bed-side care and health service planning to improve individual, health service and societal outcomes. We hypothesise that the risk of 30-day, 90-day and 12 month all-cause mortality will be correlated with health service delivery for patients with SAH. Specifically, patients with SAH admitted to a hospital offering a neurosurgical unit will have a reduced risk of all-cause and disease-specific mortality and spend less time in hospital in the year after a SAH. There will be significant variation in all-cause and disease-specific mortality and hospital re-admission according to: hospital type (eg principal referral versus other, rural versus urban location), caseload, and patient and disease characteristics. We will identify emergency presentations and hospital separations for SAH in New South Wales from July 2000 until June 2010. Data from these sources will be linked to the NSW Registry of Birth, Deaths and Marriages (fact of death) and ABS Causes of Death data.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

A/Professor John M Worthington

Address

Department of Neurophysiology
Liverpool Hospital,
Elizabeth Street
Level 1,
Clinical Services Building
Liverpool Health Service
Liverpool NSW 2170

Country

Australia

Phone

61 2 9828 3643

Fax

John.Worthington@sswahs.nsw.gov.au

Contact person for scientific queries

Name

A/Professor John M Worthington

Address

Department of Neurophysiology
Liverpool Hospital,
Elizabeth Street
Level 1,
Clinical Services Building
Liverpool Health Service
Liverpool NSW 2170

Country

Australia

Phone

61 2 9828 3643

Fax

John.Worthington@sswahs.nsw.gov.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

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