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
ACTRN12619001620112
Ethics application status
Approved
Date submitted
14/10/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Date results information initially provided
22/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Aged Care Emergency (ACE) Program
Scientific title
A program to improve care for acutely unwell residents of Aged Care Facilities reduces hospital transfers and admissions: a large-scale, stepped wedge cluster trial evaluation of the Aged Care Emergency (ACE) program
Secondary ID [1] 299543 0
None
Universal Trial Number (UTN)
Trial acronym
ACE
Linked study record
This is a follow-up of ACTRN12616000588493.

Health condition
Health condition(s) or problem(s) studied:
Geriatrics 314801 0
Acutely unwell residents of residential aged care facilities 314802 0
Condition category
Condition code
Emergency medicine 313142 313142 0 0
Other emergency care
Public Health 313455 313455 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Aged Care Emergency (ACE) program is a complex intervention with seven elements designed to improve the capability of Residential Aged Care Facilities (RACFs) to avoid transferring acutely unwell residents to the Emergency Department (ED). When transfer is necessary, the ED is informed about the residents and their care needs, including advanced care planning, allowing residents to have their care coordinated in ED. This supports avoiding hospital admission where only ED care is required.

The ACE advanced practice nurse from the local health district and the primary care organisation together coordinated the implementation with assistance of a nurse educator and administrative support. A governance committee representing the health service, primary care organisation, RACFs and ambulance oversaw the implementation.

Essential elements of ACE
1. A 24-hour nurse-led telephone consultation service for staff in RACFs provided by registered nurses (RNs) in the ED during the day and after hours by RNs from the local general practice organisation.
2. Evidenced based algorithms for common acute symptoms and problems experienced by residents from RACFs, developed in consultation with multi-disciplinary hospital and community based clinicians along with RACF clinical leaders and the ambulance service.
3. If transfer is required, the telephone call also clarifies the reason for transfer to hospital through establishing the resident’s goals of ED care.
4. Once in the ED, the resident receives proactive case management, under the guidance of specialist aged care nurses. When the resident is transferred to the ED, the aged care nurse prioritises assessing the patients and managing them in accordance with the clinical handover from the RACF including care in line with their goals of care. They do not require referral from an ED doctor in order to see the patient.
5. Empowerment of RACF staff occurs through education in communication techniques including effective clinical handover, recognition of the deteriorating patient, and the evidence based ACE algorithms.
6. The community of practice supports relationships and collaboration across RACFs, GPs, ambulance, local hospitals and EDs with a shared understanding of the capability of each service. Quarterly meetings are held to identify barriers and facilitators of care. Regular governance and operational meetings are also held with clinicians and managers. Every RACF is assigned a home ED.
7. Ongoing change management and coordination for the ACE program key stakeholders.

Prior to the intervention, participants receive usual care with staff in the RACF determining when patients are transferred to the ED, sometimes with the support of their families and General Practitioners when residents are acutely unwell. In the ED, they received usual care.

The study design was a non-randomised stepped wedge design with 10 steps. Each step contained between 4 and16 RACFs, with an average of 7 RACFs in each sequence. RACFs allocated to each sequence had an average of 84.7 beds with a minimum of 31 beds and maximum of 188 beds. The duration between steps varied, ranging from one month to 21 months. There was a 12 months baseline period prior to the intervention as well as a 12 month follow up period. Each step had a 3 month transition period for the intervention to be implemented. All 10 steps were implemented over 48 months.

Random allocation of RACFs to steps was not undertaken for logistical reasons, to ensure that the intervention could be adequately delivered and supported within constrained resources and to reduce the chances of contamination by keeping clusters from similar regions together. As each region received the intervention, the local hospital EDs were partnered with all RACFs and recruited into the program. For pragmatic reasons, early steps focussed on metropolitan RACFs while later sequences included regional RACFs.
Intervention code [1] 315796 0
Treatment: Other
Comparator / control treatment
When residents of RACFs become acutely unwell, they are assessed by staff in RACFs. These staff may or may not be registered nurses. Attempts are made to call the patients families and their general practitioner. Generally the staff make the decision whether or not to send the resident to hospital. in at least 90% of cases this is via ambulance with a paramedic.
Control group
Active

Outcomes
Primary outcome [1] 321668 0
Admission to hospital. Hospital administrative data was used to identify ED transfer and hospital admission.
Timepoint [1] 321668 0
There was a 3 month transition period after the intervention was introduced to each RACF. Comparisons were made comparing admissions to hospital for each RACF before and after the intervention per one thousand RACF bed days per month.
Secondary outcome [1] 375824 0
Transfer to the Emergency Department. Hospital administrative data was used to identify ED transfer and hospital admission.
Timepoint [1] 375824 0
There was a 3 month transition period after the intervention was introduced to each RACF. Comparisons were made comparing transfer to ED for each RACF before and after the intervention per one thousand RACF bed days per month.

Eligibility
Key inclusion criteria
All residents living in RACFs enrolled in ACE program
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not living in Residential Aged Care Facilities

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



Intervention assignment
Other
Other design features
A non-randomised stepped wedge design, with a control arm, was employed to evaluate the ACE program. A 12-month baseline period where none of the clusters received the intervention was conducted; as well as a final 12-month follow-up period where all intervention clusters received the intervention. A three-month transition period was also employed to allow clusters adequate time to implement the intervention and embed the new processes and knowledge within their service. Intervention clusters were allocated to one of the 10 sequences with clusters within the same region allocated to the same sequence. As each region received the intervention, the local hospital EDs were partnered with each RACF and recruited into the program. Early sequences focussed on metropolitan RACFs while later sequences included regional RACFs. Four clusters were allocated to the control arm and did not receive the intervention at any point throughout the study period. All four control RACFs were from a single geographic location and thus associated with one ED that was also not involved in the intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Generalized linear mixed models (GLMM) assuming a negative binomial distribution and applying a log link function were used to estimate differences between the control and the intervention condition in the log value of the following outcomes: (1) number of inpatient admissions per month and (2) number of ED presentations per month. Negative binomial models were used as the outcomes were all count variables that illustrated overdispersion. Robust standard errors and the Gauss-Hermite Quadrature as the likelihood approximation were employed in all models. All adjusted models included a random level intercept for RACF to account for the clustered design of the study; as well as fixed effect for: time (represented as a categorical variable with a level for each month of data collected) to control for possible secular trends; and experimental condition (control vs. intervention) to allow for evaluation of the ACE program. A model adjusting for RACF characteristics was also conducted to control for potential confounding due to the non-randomized design of the trial. In the full adjusted models, the following RACF characteristics were included as fixed effects: remoteness, dementia care, respite, self-care and 24/7 registered nurse (RN). Furthermore, an offset of the log number of beds per RACF was also included in all models to account for variation in the number of beds between RACFs. The incidence rate ratios (i.e. exponentiated parameter estimates), 95% CIs and p-values from the full adjusted models are presented for the main effect of intervention period (control condition vs. intervention condition). A significant difference in the study period estimate at the 0.05 p-value was used to evaluate the effectiveness of the ACE program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
31/08/2017
Date of last data collection
Anticipated
Actual
31/08/2017
Sample size
Target
4004
Accrual to date
Final
7253
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14951 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 14952 0
Belmont Hospital - Belmont
Recruitment hospital [3] 14953 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 14954 0
Singleton District Hospital - Singleton
Recruitment hospital [5] 14955 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [6] 14956 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [7] 14957 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment postcode(s) [1] 28237 0
2305 - New Lambton
Recruitment postcode(s) [2] 28238 0
2280 - Belmont
Recruitment postcode(s) [3] 28239 0
2298 - Waratah
Recruitment postcode(s) [4] 28240 0
2330 - Singleton
Recruitment postcode(s) [5] 28241 0
2340 - Tamworth
Recruitment postcode(s) [6] 28242 0
2350 - Armidale
Recruitment postcode(s) [7] 28243 0
2430 - Taree

Funding & Sponsors
Funding source category [1] 304032 0
Government body
Name [1] 304032 0
Hunter New England Local Health District
Country [1] 304032 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lockout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 304552 0
Commercial sector/Industry
Name [1] 304552 0
Hunter Primary Care
Address [1] 304552 0
7 Warabrook Blvd, Warabrook NSW 2304
Country [1] 304552 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304523 0
Hunter New England Human Research Ethics Comittee
Ethics committee address [1] 304523 0
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 304523 0
Australia
Date submitted for ethics approval [1] 304523 0
Approval date [1] 304523 0
14/07/2014
Ethics approval number [1] 304523 0
14/06/18/5.10

Summary
Brief summary
Older people living in residential care facilities (RACFs) are some of the most vulnerable in society with increasingly complex health and personal care needs. Transfers to Emergency Departments and hospitalization are common. The Aged Care Emergency Program was developed to better support acutely unwell residents in RACFs. It is a multi-component service level intervention designed to support RACF staff in identifying and addressing medical needs with an aim to reduce unnecessary hospital admissions.

Using a stepped wedge non-randomised cluster design, a large scale evaluation was made of the roll out of the program across a broad geographic area of Hunter New England local health district.

Trial website
https://ace.healthpathways.org.au (Username: aged, Password: care)
Trial related presentations / publications
Public notes
Regarding ethics evaluation. This followed on from Hunter New England Research Ethics Committee. 11/02/16.5.01; HREC/10/HNE/402; SSA/10/HNE/402. The evaluation used hospital administrative data. The intervention was being rolled out anyway, based on the success of the pilot ACTRN12616000588493. Stepped-wedge cluster trial is a suitable analysis for a complex health services research evaluation. It is suitable for real world settings with limited exclusion criteria. Given there was a decision to make this a regional intervention, a decision was made to apply for ethics in order to be able evaluate this complex pragmatic intervention. The intervention had been described, the calendar for roll out was known and already underway. This allowed retrospective analysis of the data

Contacts
Principal investigator
Name 97254 0
Dr Carolyn Hullick
Address 97254 0
Belmont Hospital
PO Box 2365 Gateshead NSW 2290
Country 97254 0
Australia
Phone 97254 0
+61 419984835
Fax 97254 0
+61 2 49232189
Email 97254 0
[email protected]
Contact person for public queries
Name 97255 0
Dr Carolyn Hullick
Address 97255 0
Belmont Hospital
PO Box 2365 Gateshead NSW 2290
Country 97255 0
Australia
Phone 97255 0
+61 419984835
Fax 97255 0
+61 2 49232189
Email 97255 0
[email protected]
Contact person for scientific queries
Name 97256 0
Dr Carolyn Hullick
Address 97256 0
Belmont Hospital
PO Box 2365 Gateshead NSW 2290
Country 97256 0
Australia
Phone 97256 0
+61 419984835
Fax 97256 0
+61 2 49232189
Email 97256 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
Hospital administrative data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5290Ethical approval    378549-(Uploaded-13-11-2019-17-04-00)-Study-related document.pdf



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.