Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000603516p
Ethics application status
Submitted, not yet approved
Date submitted
26/04/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing doctor and patient attitudes towards advanced care planning in the Emergency Department
Scientific title
Comparing doctor and patient attitudes towards advanced care planning in the Emergency Department
Secondary ID [1] 312038 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced care planning in the elderly 333645 0
Condition category
Condition code
Emergency medicine 330331 330331 0 0
Other emergency care
Public Health 330384 330384 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparison between Emergency patients over 70 and medical doctors in the Emergency Department. Both groups will be assessed by questionnaire. Patient over the age of 70 in the Emergency Department will be surveyed with a questionnaire regarding demographic information (including the elderly risk assessment), previous knowledge and ownership of an advanced care directive, comfort level discussing it and best person to have this discussion. Medical staff will also be surveyed with a questionnaire detailing previous advanced acre planning discussions and their frequency, previous formal training, comfort level and any perceived barriers to its discussion. Survey for both groups will take approximately 5-10 minutes to complete. Both groups will be assessed at a single time point only, there will be no follow up.
Intervention code [1] 328487 0
Not applicable
Comparator / control treatment
The medical doctors will be the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 338091 0
Patients – willingness/comfort to discuss advanced care planning in the Emergency Department.
Timepoint [1] 338091 0
At initial and only contact with survey
Primary outcome [2] 338148 0
Doctors – comfort level in advanced care planning discussions
Timepoint [2] 338148 0
Single time point at initial contact
Secondary outcome [1] 434499 0
Patients - best person/professional to discuss advanced care planning.
Timepoint [1] 434499 0
At initial and only contact with the survey.
Secondary outcome [2] 434500 0
Doctors - best person/professional to discuss advanced care planning.
Timepoint [2] 434500 0
At initial and only contact with survey
Secondary outcome [3] 434700 0
Patients - awareness of advanced care planning
Timepoint [3] 434700 0
At initial and only contact
Secondary outcome [4] 434701 0
Patients - number of pre-existing formal advanced care plans
Timepoint [4] 434701 0
At initial and only contact
Secondary outcome [5] 434702 0
Patients - incidence of previous discussion of advanced care planning.
Timepoint [5] 434702 0
At initial and only contact
Secondary outcome [6] 434703 0
Doctors - frequency of advanced care planning discussion
Timepoint [6] 434703 0
At initial and only contact
Secondary outcome [7] 434704 0
Doctors - incidence of previous formal training
Timepoint [7] 434704 0
At initial and only contact
Secondary outcome [8] 434705 0
Doctors - barriers to discussion in the Emergency Department
Timepoint [8] 434705 0
At initial and only contact

Eligibility
Key inclusion criteria
Patients –
Inclusion - patients over age of 70 presenting to Emergency Department
Doctors –
Inclusion – Doctors working in Royal North Shore Emergency Department
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients - Exclusion – medically unstable (as deemed by treating physician), non-English speaking (unless translated by caregiver present), cognitive impairment (unless primary caregiver present and consents to participate in survey)
Doctors - nil

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis
Mann-Whitney U test for differences in ordinal responses for primary outcomes.
Chi-square test (or Fisher’s exact test) to assess differences in proportions for categorical responses (secondary outcomes).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2024
Actual
Date of last participant enrolment
Anticipated
15/07/2024
Actual
Date of last data collection
Anticipated
15/07/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26484 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 42474 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 316401 0
Hospital
Name [1] 316401 0
Royal North Shore Emergency Department
Country [1] 316401 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 318572 0
None
Name [1] 318572 0
Address [1] 318572 0
Country [1] 318572 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315195 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315195 0
Ethics committee country [1] 315195 0
Australia
Date submitted for ethics approval [1] 315195 0
19/04/2024
Approval date [1] 315195 0
Ethics approval number [1] 315195 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133950 0
Dr Louise Hochholzer
Address 133950 0
Royal North Shore Emergency Department, Reserve Rd, St Leonards, NSW, 2065
Country 133950 0
Australia
Phone 133950 0
+61423479387
Fax 133950 0
Email 133950 0
[email protected]
Contact person for public queries
Name 133951 0
Louise Hochholzer
Address 133951 0
Royal North Shore Emergency Department, Reserve Rd, St Leonards, NSW, 2065
Country 133951 0
Australia
Phone 133951 0
+61423479387
Fax 133951 0
Email 133951 0
[email protected]
Contact person for scientific queries
Name 133952 0
Louise Hochholzer
Address 133952 0
Royal North Shore Emergency Department, Reserve Rd, St Leonards, NSW, 2065
Country 133952 0
Australia
Phone 133952 0
+61423479387
Fax 133952 0
Email 133952 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


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.