Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000507987
Ethics application status
Approved
Date submitted
23/03/2020
Date registered
23/04/2020
Date last updated
3/04/2024
Date data sharing statement initially provided
23/04/2020
Date results provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Researching Early Detection of Deterioration In Elderly residents
Scientific title
A stepped-wedge randomised-controlled trial assessing the implementation, effectiveness and cost-consequences of a tailored Early Detection of Deterioration In Elderly residents (EDDIE+) program to prevent unnecessary hospital admission in twelve residential aged care homes.
Secondary ID [1] 299704 0
GNT1177501
Universal Trial Number (UTN)
U1111-1242-9442
Trial acronym
EDDIE+
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly deterioration 315054 0
Condition category
Condition code
Public Health 313386 313386 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EDDIE+

Intervention exposure
The intervention consists of four components.
1. Education and training of all nursing and care staff
A nurse educator will deliver face-to-face training sessions for all Residential Aged Care (RAC) home nursing and care staff on early identification of deterioration and response. Teaching and learning strategies will be tailored to meet individual RAC home needs and may also include online content delivery. Core delivery will consist of two, one hour session delivered during the four week Intervention introduction phase. Duration and frequency of sessions will be tailored to suit RAC home backfill arrangements.
Training will be developed to align with relevant existing Bolton Clarke policies and procedures, Department of Health guidelines, Queensland Ambulance guidelines and existing hospital avoidance initiatives.
2. Decision support tools
A core decision support tools covering clinical decision-making guidelines for managing deterioration for a number of conditions will be available to nursing and care staff. The tools will reflect best practice clinical guidelines and align with Bolton Clarke policies and procedures. Their use and function will be covered in the face to face training sessions. The decision support tools will be made available to all RAC home staff throughout the intervention period with the aim of embedding use into business as usual practices.
3. Diagnostic medical equipment
Each participating RAC home will provided with medical equipment as identified in the environmental scan and mapping exercise at each site:
o Bladder scanner
o ECG machine
o Pulse oximeters
o Vital signs monitor
4. Implementation facilitation and clinical systems support
Each site will have one internal facilitator who will assist with implementation and facilitation of the project at their site. This facilitator will also work closely with the nurse educator and an experienced implementation scientist to enable and support the implementation process and to embed the program into standard business practices. This may include regular stakeholder engagement, working with management to develop new business policies and practices and close collaboration with nursing and care staff including ‘on the job’ support and training.

The study will use a stepped-wedge design with the intervention exposure phase running for 4 to 48 weeks.

Intervention adherence and fidelity will be monitored by the project team. The project team will have fortnightly contact Bolton Clarke facilitator at each site where fidelity will be monitored. Strategies to maintain and improve fidelity will be tailored to suit site requirements. Strategies include reminder posters will be displayed in staff common areas and reminder messages distributed through usual staff communication channels, such as team meetings, shift change over meetings, email.
Intervention code [1] 317219 0
Early detection / Screening
Comparator / control treatment
Each RAC home will act as its own control. The control phase (Baseline) will last 4 to 48 weeks depending on site allocation. During the baseline phase, usual care of residents currently undertaken by the RAC home will continue.
RAC home characteristics and resident demographic and health service utilisation historical data will be requested during the baseline phase. RAC home characteristic and resident demographic data will be requested from existing Bolton Clarke datasets. Resident demographic and health service utilisation data will be requested from existing datasets held by Queensland Health. Historical data will be requested for the twelve months prior to Baseline phase (week 3).
Control group
Active

Outcomes
Primary outcome [1] 321871 0
Change in total number of hospital bed days as assessed by data extraction from hospital admission records.
Timepoint [1] 321871 0
These data will be collected at the conclusion of the intervention (week 59). Data will be collected for the baseline and intervention phases.
Historical data for the twelve months prior to baseline (week 3) will be collected at baseline to allow for potential seasonality and other time trends will be extracted at baseline.
Secondary outcome [1] 376535 0
Change in Emergency Department transfers as assessed by data linkage hospital medical records.
Timepoint [1] 376535 0
These data will be collected at the conclusion of the intervention (week 59). Data will be collected for the baseline and intervention phases.
Historical data for the twelve months prior to baseline will be collected at baseline to allow for potential seasonality and other time trends will be extracted at baseline.
Secondary outcome [2] 376536 0
Change in hospital admission rates as assessed by data linkage of hospital medical records.
Timepoint [2] 376536 0
These data will be collected at the conclusion of the intervention (week 59). Data will be collected for the baseline and intervention phases.
Historical data for the twelve months prior to baseline (week 3) will be collected at baseline to allow for potential seasonality and other time trends will be extracted at baseline.
Secondary outcome [3] 376537 0
Change in length of hospital stay as assessed by data linkage of hospital medical records.
Timepoint [3] 376537 0
These data will be collected at the conclusion of the intervention (week 59). Data will be collected for the baseline and intervention phases.
Historical data for the twelve months prior to baseline (week 3) will be collected at baseline to allow for potential seasonality and other time trends will be extracted at baseline.
Secondary outcome [4] 376538 0
Family awareness and experience as assessed by a questionnaire and/or interview of residents' family member or nominated advocate. The questionnaire and interview guide have been designed specifically for this study.
Timepoint [4] 376538 0
Questionnaire data will be collected once from a family member or nominated advocate of each resident on a single occasion only between weeks 56-62.
Interview data will be collected from one family member or nominated advocate per resident of a sample of residents (maximum 30) on a single occasion between weeks 56-62.

Secondary outcome [5] 376539 0
Change in staff job-related self-efficacy as assessed through the Job-related self-efficacy questionnaire completed by nursing and care staff pre- and post-intervention.
Timepoint [5] 376539 0
These data will be collected via questionnaire once at the beginning of the Intervention introduction phase (week 8-52) and once at the end of the intervention phase (week 58).
Secondary outcome [6] 376540 0
Cost of implementing EDDIE+ as assessed by project records of costs incurred.
Timepoint [6] 376540 0
These data will be collected week 1 to 58.
Secondary outcome [7] 376541 0
Change in cost of health service use as assessed by data linkage of medical records.
Timepoint [7] 376541 0
These data will be collected at the conclusion of the intervention (week 59). Data will be collected for the baseline and intervention phases.

Eligibility
Key inclusion criteria
1. RAC homes
Bolton Clarke Residential Aged Care Facility located within Queensland.

2. Nursing and care staff at enrolled RAC homes
Nursing and care staff employed by Bolton Clarke at each enrolled RAC home.

3. Residents
All residents at each enrolled facility.

4. Residents' family members or nominated advocates
Family members or nominated advocates of residents at an enrolled RAC home.

5. RAC Stakeholders
Key internal and external stakeholders of enrolled RAC homes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed. As this is a stepped-wedge study design, all sites will act as their own control and receive the intervention. The timing of switch over from baseline to intervention introduction will be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer randomisation will be used. Enrolled sites will be randomly allocated to intervention timings through the allocation of site identifiers 1 to 12 prior to the commencement of the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The intervention consists of four components of which each enrolled RAC home will receive. Within these four components, tailoring can occur to adapt to the local context and needs. As per the stepped-wedge design each RAC home will receive the intervention for between 4 and 48 weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Simulation-based statistical power calculation was performed for the primary outcome of total hospital bed days. The design of 12 sites of 100 residents per site with 1 month observation period before the start and after the last site commencing introduction, and 1 site switched from baseline to intervention introduction each month, is estimated to have a 91% power to detect a 41% reduction in total bed days from a control period total hospital bed days of 346 bed days per 100 residents per year. The power calculation was based on a 5% statistical significance level.

The time unit used in the analyses of Outcomes 1 to 4 is months. Data from the introduction phase will not be in included in the statistical analyses here, but will instead be incorporated into the process evaluation. Subgroup analyses of the primary outcome and outcomes 2 to 6 will be performed for each individual RAC home separately.

We will review historical data on the primary outcome and secondary outcomes where historical data is able to be extracted from administrative databases. Historical data will be used to investigate potential seasonality and other time trends that should be incorporated into the statistical analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2020
Actual
11/01/2021
Date of last participant enrolment
Anticipated
6/06/2022
Actual
6/07/2022
Date of last data collection
Anticipated
6/06/2022
Actual
13/07/2022
Sample size
Target
1200
Accrual to date
Final
789
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304180 0
Government body
Name [1] 304180 0
National Health and Medical Research Council
Country [1] 304180 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434
Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 305723 0
None
Name [1] 305723 0
Address [1] 305723 0
Country [1] 305723 0
Other collaborator category [1] 281018 0
Commercial sector/Industry
Name [1] 281018 0
Bolton Clarke
Address [1] 281018 0
3/44 Musk Ave
Kelvin Grove QLD 4059
Country [1] 281018 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304653 0
Bolton Clarke Human Research Ethics Committee
Ethics committee address [1] 304653 0
Ethics committee country [1] 304653 0
Australia
Date submitted for ethics approval [1] 304653 0
24/03/2020
Approval date [1] 304653 0
22/07/2020
Ethics approval number [1] 304653 0
170031
Ethics committee name [2] 308506 0
Queensland University of Technology HREC
Ethics committee address [2] 308506 0
Ethics committee country [2] 308506 0
Australia
Date submitted for ethics approval [2] 308506 0
05/08/2020
Approval date [2] 308506 0
12/08/2020
Ethics approval number [2] 308506 0
2000000618

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

Contacts
Principal investigator
Name 55850 0
Prof Gillian Harvey
Address 55850 0
School of Nursing and Health Science, Flinders University, Sturt Rd, Bedford Park SA 5042
Country 55850 0
Australia
Phone 55850 0
+61 87421 9422
Fax 55850 0
Email 55850 0
[email protected]
Contact person for public queries
Name 55851 0
Alison Farrington
Address 55851 0
Australian Centre for Health Services Innovation
Centre for Healthcare Transformation
School of Public Health and Social Work
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country 55851 0
Australia
Phone 55851 0
+61 7 3138 6132
Fax 55851 0
Email 55851 0
[email protected]
Contact person for scientific queries
Name 55852 0
Gillian Harvey
Address 55852 0
School of Nursing and Health Science, Flinders University, Sturt Rd, Bedford Park SA 5042
Country 55852 0
Australia
Phone 55852 0
+61 87421 9422
Fax 55852 0
Email 55852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable data sets for outcomes 1-8
When will data be available (start and end dates)?
Data will be available once results have been published. No end date will be in place.
Available to whom?
Data will be available to people who have ethical or other applicable approvals to use the data sets, as approved by the data custodian.
Available for what types of analyses?
Data will be available for analyses that reflect the original intent of the data collection and have appropriate ethical or other approvals in place.
How or where can data be obtained?
Data will be available via the data custodian, CI Xing Lee ([email protected]). Information about the data set, including DOI will be publicly available once data sets are available.


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.