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
Trial registered on ANZCTR


Registration number
ACTRN12619000094178
Ethics application status
Approved
Date submitted
10/01/2019
Date registered
22/01/2019
Date last updated
17/09/2023
Date data sharing statement initially provided
22/01/2019
Date results information initially provided
23/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Epidemiology of adult patients with headache presenting to emergency departments (The HEAD study)
Scientific title
Observational study of headache among adult patients presenting to emergency departments
Secondary ID [1] 297032 0
Nil
Universal Trial Number (UTN)
U1111-1226-5061
Trial acronym
HEAD study
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Headache in adults 311013 0
Migraine 311014 0
Condition category
Condition code
Neurological 309660 309660 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All adult patients presenting to participating emergency departments (ED) will have epidemiological data collected. There is no intervention.
Intervention code [1] 313310 0
Not applicable
Comparator / control treatment
No control group - descriptive only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318631 0
Distribution of diagnoses (from a coded list). Determined by the treating doctor's coding of final emergency department diagnosis as per the ED data management system and the clinical record.
Timepoint [1] 318631 0
In ED
Primary outcome [2] 318632 0
Distribution of medications administered to participants (from a coded list). Determined by drugs administered as per participant's medication chart..
Timepoint [2] 318632 0
in ED
Primary outcome [3] 318633 0
Disposition from the emergency department. Determined by discharge destination field on emergency department data management system
Timepoint [3] 318633 0
in ED
Secondary outcome [1] 365546 0
The proportion of patients having a CT scan as part of their investigations. Determined by CT scan recorded in participants medical record
Timepoint [1] 365546 0
in ED
Secondary outcome [2] 365809 0
In hospital mortality, determined by discharge destination in hospital data management system
Timepoint [2] 365809 0
During hospital stay

Eligibility
Key inclusion criteria
Adult patients (18 or older) with a primary ED presenting problem of headache
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of trauma within 48 hours of presentation
• Missing medical records
• Inter-hospital transfers
• Representation with same headache as previous visit
• Headache as an associated symptom rather than main complaint

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2019
Actual
1/03/2019
Date of last participant enrolment
Anticipated
31/03/2019
Actual
31/10/2019
Date of last data collection
Anticipated
31/08/2019
Actual
1/12/2019
Sample size
Target
1500
Accrual to date
Final
4536
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21180 0
Belgium
State/province [1] 21180 0
Country [2] 21181 0
France
State/province [2] 21181 0
Country [3] 21182 0
Turkey
State/province [3] 21182 0
Country [4] 21183 0
Israel
State/province [4] 21183 0
Country [5] 21184 0
United Kingdom
State/province [5] 21184 0

Funding & Sponsors
Funding source category [1] 301601 0
Self funded/Unfunded
Name [1] 301601 0
Country [1] 301601 0
Primary sponsor type
Individual
Name
Anne-Maree Kelly
Address
Joseph Epstein Centre for Emergency Medicine Research, WHCRE, Sunshine Hospital St Albans, Victoria 3021
Country
Australia
Secondary sponsor category [1] 301304 0
None
Name [1] 301304 0
Address [1] 301304 0
Country [1] 301304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302328 0
Melbourne Health HREC
Ethics committee address [1] 302328 0
Office for Research, Level 2, South West, 300 Grattan Street, Parkville Victoria 3052
Ethics committee country [1] 302328 0
Australia
Date submitted for ethics approval [1] 302328 0
Approval date [1] 302328 0
24/09/2018
Ethics approval number [1] 302328 0

Summary
Brief summary
Headache is a common reason for presentation to emergency departments (ED). Headache presentations have been shown to comprise 1.35% (95%CI 1.34-1.36%) of total public hospital ED presentations across Queensland. There are a wide range of possible causes including primary headache (benign headache), migraine, trigeminal neuralgia, tumours, ntracranial haemorrhage, meningitis/ encephalitis/ cerebral abscess, toxicities and cerebrovascular events. This study will provide aninter-regional and international perspective on the epidemiology of non-trauma-related headache, its investigation, treatment and outcome.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 89838 0
Prof Anne-Maree Kelly
Address 89838 0
Joseph Epstein Centre for Emergency Medicine Research,WHCRE, Sunshine Hospital, St Albans VIC 3021
Country 89838 0
Australia
Phone 89838 0
+61 03 8345 6666
Fax 89838 0
Email 89838 0
[email protected]
Contact person for public queries
Name 89839 0
Ms Sharon Klim
Address 89839 0
Joseph Epstein Centre for Emergency Medicine Research, WHCRE, Sunshine Hospital, St Albans VIC 3021
Country 89839 0
Australia
Phone 89839 0
+61 3 83456666
Fax 89839 0
Email 89839 0
[email protected]
Contact person for scientific queries
Name 89840 0
Prof Anne-Maree Kelly
Address 89840 0
Joseph Epstein Centre for Emergency Medicine Research, WHCRE, Sunshine Hospital, St Albans VIC 3021
Country 89840 0
Australia
Phone 89840 0
+61 03 8345 6666
Fax 89840 0
Email 89840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval requirements across countries preclude


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1019Study protocol    376695-(Uploaded-10-01-2019-12-48-42)-Study-related document.pdf
1020Ethical approval    376695-(Uploaded-10-01-2019-12-49-16)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Kelly AM, Kuan WS, Chu KH, Kinnear FB, Keijzers G,... [More Details]
Study results articleYes Pellatt RAF, Kamona S, Chu K, Sweeny A, Kuan WS, K... [More Details]
Study results articleYes Roberts T, Horner DE, Chu K, Than M, Kelly AM, Kli... [More Details]
Study results articleYes Beck S, Kinnear FB, Maree Kelly A, Chu KH, Sen Kua... [More Details]
Study results articleYes Kelly AM, Chu KH, Kuan WS, Keijzers G, Kinnear FB,... [More Details]
Study results articleYes Chu K, Kelly AM, Kinnear F, Keijzers G, Kamona S. ... [More Details]
Study results articleYes Wijeratne T, Kuan WS, Kelly AM, Chu KH, Kinnear FB... [More Details]
Study results articleYes Chu K, Kelly AM, Keijzers G, Kinnear F, Kuan WS, G... [More Details]
Plain language summaryNo We enrolled 4536 patients (67 hospitals, 10 countr... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Headache in Emergency Departments study: Opioid prescribing in patients presenting with headache. A multicenter, cross-sectional, observational study.2021https://dx.doi.org/10.1111/head.14217
EmbasePrimary headache drug treatment in emergency departments in Australia and New Zealand.2022https://dx.doi.org/10.5694/mja2.51670
N.B. These documents automatically identified may not have been verified by the study sponsor.