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Trial registered on ANZCTR


Registration number
ACTRN12621000335897
Ethics application status
Approved
Date submitted
27/01/2021
Date registered
24/03/2021
Date last updated
8/11/2022
Date data sharing statement initially provided
24/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting DEmentia Friendly EmergeNcy DepartmentS: The effect of a hospital audit-directed action plan on adverse events in older people with cognitive impairment presenting to ED
Scientific title
Promoting DEmentia Friendly EmergeNcy DepartmentS: The effect of a hospital audit-directed action plan on adverse events in older people with cognitive impairment presenting to ED
Secondary ID [1] 303161 0
None
Universal Trial Number (UTN)
Trial acronym
DEFENDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment 320883 0
dementia 320884 0
delirium 320885 0
Condition category
Condition code
Neurological 318224 318224 0 0
Dementias
Neurological 318697 318697 0 0
Alzheimer's disease
Neurological 318698 318698 0 0
Other neurological disorders
Injuries and Accidents 318699 318699 0 0
Fractures
Injuries and Accidents 318700 318700 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline audits will be undertaken within three participating hospital Emergency Departments (EDs) to inform the development of interventions at each site. This audit will occur over a 4-week period. An ED staff member will complete the Hospital Environment Audit Tool (HEAT), an evidence-based tool that provides practical strategies to optimise the environment in order to best meet the needs of older people and increase their participation in their care. All ED staff will be invited to complete a 10-15minute survey seeking their understanding of evidence-based strategies for the care of older people living with cognitive impairment and their carer/companion in ED. Questions will explore the perceived extent to which of evidence-based strategies are being applied in their ED setting and to prioritise areas for improvement. Fifty consecutive records for ED patients aged 60 and older who present to each ED site will be audited if their primary discharge diagnoses are coded as: confusion, hip fracture, delirium, or dementia. Records will be examined for adverse events in ED and processes related to discharge planning.

ED staff will be invited to take part in a co-design process to improve the care environment for ED patients with cognitive impairment. The invitation will be extended to all ED staff and up to 8 staff who first express interest will be invited to attend three by one-hour meetings conducted over a 6-8 week period. At the first meeting, findings from the baseline audit will be summarised by the research team and presented to ED staff and ED staff will identify a priority area of concern to address. The second meeting will involve discussing possible solutions to the priority concern and drafting an intervention and action plan for implementation. The third meeting will review the action plan and reflect on any initial activities that have been undertaken and try to resolve barriers raised. ED staff, with support from the external research team, will identify a feasible action plan to implement within the three month intervention period and with the available funds to purchase equipment/environmental modifications. Funds from the research study have been allocated to each ED site to support data collection and small modifications. Therefore, the intervention will vary at each site to be responsive to local needs and priorities. The research team includes researchers with expertise in clinical care, dementia care and physical environments. It is envisaged that the intervention will focus on either environmental modification, support/information for carer/supporters of patients with cognitive impairment, and/or care processes to help support patients during their visit to the ED or to support their discharge (eg discharge information, follow-up care). Directly following the co-design phase of 6-8 weeks, each ED will implement the intervention for 3 months. After this three months we will survey ED staff to assess whether the intervention was implemented as planned as well as barriers and enablers to implementing the intervention. The survey will take approximately five minutes to complete. We will also conduct interviews with four patients and/or their supporter/family carers from each ED who attended the ED during the intervention period.
Intervention code [1] 319483 0
Treatment: Other
Comparator / control treatment
We will use the baseline audit of patient records (50 consecutive records for ED patients aged 60 and older who present to each ED site if their primary discharge diagnoses are coded as: confusion, hip fracture, delirium, or dementia prior to the intervention period commencing) to provide a comparison and will repeat this audit in each ED with 50 patients meeting the same criteria and attending the ED after the 3-month intervention period.
Control group
Historical

Outcomes
Primary outcome [1] 326231 0
Evidence of adverse events in the Emergency Department in patients with cognitive impairment assessed by audit of 50 patient files at each of the three participating sites. Total number of adverse events from the following: Delirium / acute confusion, Code grey, Restraint, Stat dose – anti-psychotics, Stat dose – benzodiazepine, Nursing special or Other
Timepoint [1] 326231 0
Timepoint:
1. patients attending the ED prior to the Intervention period.
2. patients attending the ED after the 3-month intervention period has completed.
Primary outcome [2] 326232 0
Evidence of adverse events in the Emergency Department in patients with cognitive impairment assessed by audit of 50 patient files at each of the three participating sites. Binary measure of whether or not a patient had any adverse event during their ED visit. An adverse event will be identified from a checklist including: Fall, Delirium/acute confusion, Code grey, Restraint, Stat dose – anti-psychotics, Stat dose – benzodiazepine, Nursing special, or other.
Timepoint [2] 326232 0
Timepoint:
1. patients attending the ED prior to the Intervention period.
2. patients attending the ED after the 3-month intervention period has completed.
Secondary outcome [1] 390621 0
Evidence of being discharged home from the Emergency Department with support as assessed by audit of 50 patient files at each of the three participating sites. Binary measure of whether or not support on discharge was provided.
Timepoint [1] 390621 0
Timepoint:
1. patients attending the ED prior to the Intervention period.
2. patients attending the ED after the 3-month intervention period has completed.
Secondary outcome [2] 390623 0
Staff perceptions of changes. Barriers and enablers of implementing the intervention. Assessed through an online study-specific anonymous survey.
Timepoint [2] 390623 0
1 timepoint: within one month after the 3 month intervention period has finished.
Secondary outcome [3] 390629 0
Composite measure of patient and/or their family carer/supporter's perceptions of care during an ED presentation assessed through a joint qualitative interview with patients with cognitive impairment who attended the ED and/or their family carer/supporter - depending on capacity and availability. Interview questions have been designed specifically for this study.
Timepoint [3] 390629 0
1 timepoint: Interviews will be conducted with patients who attended the ED during or within one month after the 3 month intervention period has finished. Interviews will be conducted in the one month following the 3 month intervention period.

Eligibility
Key inclusion criteria
All staff in the three participating Emergency Departments (EDs) at Austin Hospital. St Vincent's Hospital Melbourne and Footscray Hospital.
The file audit and post-intervention patient interviews will include patients aged 60 and older who present to one of the participating EDs with a discharge diagnosis as confusion, hip fracture, delirium or dementia and their family carer/supporter who attended the ED with the patient (if applicable).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients and carers with limited English proficiency will be excluded due to the need for interpreters.

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



Intervention assignment
Other
Other design features
Each site will implement a tailored intervention that is based on the priorities and needs of each site. File audits will compare care provided to patients before and after the intervention is implemented at each site (historical comparison group).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Thematic analysis will identify key themes from qualitative interviews with patients and carers.

Descriptive statistics and thematic analysis will be used to assess outcomes from the post-intervention staff survey.

Chi square tests and t-test will compare characteristics of patients in the baseline audit with those in the post-intervention audit.
Multiple logistic regressions will assess the impact of the intervention (pre intervention audit compared with post intervention audit) controlling for site (3 sites) on binary outcomes from the audit (adverse events, and evidence of discharge planning). Multiple linear regression will assess the impact of the intervention controlling for sites on number of adverse events.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
20/04/2021
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
350
Accrual to date
213
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18453 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 32563 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 307570 0
Other Collaborative groups
Name [1] 307570 0
Melbourne Ageing Research Collaboration (MARC)
Country [1] 307570 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Ageing Research Institute
Address
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country
Australia
Secondary sponsor category [1] 308298 0
None
Name [1] 308298 0
Address [1] 308298 0
Country [1] 308298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307629 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 307629 0
Ethics committee country [1] 307629 0
Australia
Date submitted for ethics approval [1] 307629 0
27/02/2020
Approval date [1] 307629 0
03/07/2020
Ethics approval number [1] 307629 0
HREC/61237/Austin-2020

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

Contacts
Principal investigator
Name 107922 0
A/Prof Frances Batchelor
Address 107922 0
National Ageing Research Institute
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 107922 0
Australia
Phone 107922 0
+61 3 83872383
Fax 107922 0
Email 107922 0
f.batchelor@nari.unimelb.edu.au
Contact person for public queries
Name 107923 0
Frances Batchelor
Address 107923 0
National Ageing Research Institute
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 107923 0
Australia
Phone 107923 0
+61 383872305
Fax 107923 0
Email 107923 0
f.batchelor@nari.edu.au
Contact person for scientific queries
Name 107924 0
Frances Batchelor
Address 107924 0
National Ageing Research Institute
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 107924 0
Australia
Phone 107924 0
+61 383872305
Fax 107924 0
Email 107924 0
f.batchelor@nari.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
Our ethically approved protocol states information collected will only be used for the purpose of the research project and it will only be disclosed with participant’s permission, except as required by law.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10270Study protocol  f.batchelor@nari.edu.au
10273Informed consent form  f.batchelor@nari.edu.au
10274Ethical approval  f.batchelor@nari.edu.au



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.