Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000588493
Ethics application status
Approved
Date submitted
3/05/2016
Date registered
6/05/2016
Date last updated
14/10/2021
Date data sharing statement initially provided
14/10/2021
Date results provided
14/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A nurse led model of care for older people in the Emergency Department (ED). An evaluation of the Aged Care Emergency (ACE) Program
Scientific title
A nurse led model of care for older people in the ED. An evaluation of the Aged Care Emergency (ACE) Program
Secondary ID [1] 289108 0
None
Universal Trial Number (UTN)
U1111-1182-4431
Trial acronym
ACE (Aged Care Emergency)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older person care 298568 0
Nursing home care 298569 0
Emergency Care 298570 0
Transitions of care 298607 0
Condition category
Condition code
Public Health 298650 298650 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
The ACE service model of care comprised
1. An ED advanced practice nurse with aged care skills, (ACE Clinical Nurse Consultant) who led and coordinated the ACE service.
2. More than twenty evidence based algorithms, developed in consultation with clinical experts, and RACF staff in the region, were standardized for the management of common problems for RACF residents: for example, falls, shortness of breath and indwelling urinary catheter issues. These are available at http://www.ecinsw.com.au/ace
3. The ACE Clinical Nurse Consultant (CNC) who commenced in October 2010, 5 months prior to the intervention, worked with RACF and ED staff to develop, test and the refine the algorithms and provide education and training. The manual of algorithms guides and supports RACF staff to manage acutely unwell residents in situ and is used as a reference source by RNs, AINs, PCAs, GPs and ED staff.
4. An education program for clinical staff in RACFs, prior to the introduction of the model supported using the manual of algorithms. The education service provided onsite by the ACE CNC, for the study RACF staff. The program constituted two hours of presentation with ongoing education provide as required or requested provided in groups.
5. An ED RN led telephone consultation service for RACF staff, 12 hours during the day, 7 days a week to provide clinical support, assist decision making in the RACF as well as receive clinical handover when the resident required transfer. The four ED RNs were all advanced care nurses with skills and experience in aged care nursing. Their role included identification of care needs, care planning and advocacy for the older person.
5. Establishment of the purpose of the ED transfer based on the older person’s goals of care by the RACF staff, with support from the ED Registered Nurse (RN).
6. Proactive case management, aligned to the goals of care in the ED by the ED RNs.
7. A collaborative respectful relationship with RACFs, ambulance, EDs, GPs and the primary care organisation, working together to achieve optimal patient outcomes.
8. video-telehealth consultation was added to this study between July 2016 and August 2017 as an additional component to the ACE program for acutely unwell residents in RACs.

The intervention occurred for 9 months. The program, including written material, presentations and phone support, was only available to the 4 intervention RACFs, maintaining fidelity of the study. It has since been rolled out to other sites. Staff worked only within the intervention RACFs.
Intervention code [1] 294611 0
Treatment: Other
Comparator / control treatment
Usual Care for control RACFs:
For acutely unwell residents in the control RACFs, residents are assessed by AINs and PCAs with support from RNs who may not be in the facility. Primary medical care is provided by General Medical Practitioners who visit the RACF as required and have competing demands of a busy practice. There is generally limited handover of clinical information or contact between the RACF and the ED prior to ED arrival. When residents require an ED visit, they are transported by ambulance to and from hospital. Usual Care for control RACFs:
For acutely unwell residents in the control RACFs, residents are assessed by AINs and PCAs with support from RNs who may not be in the facility. Primary medical care is provided by General Medical Practitioners who visit the RACF as required and have competing demands of a busy practice. There is generally limited handover of clinical information or contact between the RACF and the ED prior to ED arrival. When residents require an ED visit, they are transported by ambulance to and from hospital. Video-telehealth supported clinical assessment and management was available to acutely unwell patients between July 2016 and Aug 2017.
Control group
Active

Outcomes
Primary outcome [1] 298146 0
Hospital admission following Emergency Department presentation using the hospital information system.
Timepoint [1] 298146 0
At time of ED presentation
Secondary outcome [1] 323268 0
Number of ED presentation per aged care facility using the hospital information system.
Timepoint [1] 323268 0
Throughout the 9 month period, numbers of ED presentations were monitored from both the intervention and control Residential Aged Care Facilities. This was also compared with the same time periods for the 2 years prior.
Secondary outcome [2] 323269 0
ED length of stay (LOS) in minutes from time of presentation to discharge from ED using the hospital information system.
Timepoint [2] 323269 0
From ED arrival to ED discharge in minutes.
Secondary outcome [3] 323270 0
Hospital length of stay using the hospital information system
Timepoint [3] 323270 0
Days from ED presentation to hospital discharge in days.
Secondary outcome [4] 323271 0
28 day readmission using the hospital information system
Timepoint [4] 323271 0
28 days post discharge from a hospital admission.

Eligibility
Key inclusion criteria
The intervention groups were four residential aged care facilities (RACFs) who frequently referred patients to the Emergency Department. All resident transfers were reviewed in the hospital information system.

The 4 intervention RACFs were purposefully chosen as they frequently transferred patients to the ED, more commonly than other RACFs. They had previously participated in focus groups that identified barriers and facilitators to quality management of acutely unwell residents as RACFs that frequently transferred patients to the ED.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Only residents from the 4 residential aged care facilities were included. All other Residential aged Care Facilities were excluded.

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



Intervention assignment
Other
Other design features
Residential Aged Care Facilities were purposely selected as frequent referrers of patients to the ED.

The 4 intervention and 8 control RACFs were monitored for 24 months prior to the intervention with standard care. During the 9 months intervention period,all 12 RACFs continued to be monitored, the 4 intervention RACFs participating in the intervention and the 8 controls with standard care.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The study was a controlled pre-post design involving 12 RACFs. Four RACFs with a history of high ED presentations elected to be intervention sites, following their previous participation in a study that identified barriers and facilitators to quality management of acutely unwell residents. For each of the four intervention RACFs, two control RACFs were selected, matched for size (bed number) and RACF type (ratio of high care beds to low care beds and presence of dementia-specific beds). These identifiers were used as they are publically reported in the DPS Guide to Aged Care and represent features that are impacted by RACF policy and staffing, such as provision of Registered Nurses. None of the beds included respite short stay beds or specific specialist beds.

Intervention RACFs and control RACFs were reviewed over the same monthly periods from 2009 to 2011 to eliminate any seasonal variation. Data were analysed by comparing the control and intervention RACFs before and after the intervention, thereby allowing for changes related to time and not the intervention.

Generalized estimating equations (GEE) were used to estimate differential changes between intervention and control RACFs in pre- and post-intervention means (for continuous outcomes) or log-odds (binary outcomes). Differential changes were assessed using a term reflecting the interaction between intervention group (intervention/control) and time (pre/post). This allowed assessment of whether the intervention specifically affected pre-post differences, after accounting for other, unrelated factors that may have also influenced pre-post differences (reflected in control group pre-post differences). Efficacy of the intervention was assessed by testing the two-sided null hypothesis that the interaction term coefficient = 0. The GEE was structured to account for potential correlation between repeated measures (ED presentations) by a single patient, and between patients from the individual RACFs. An exchangeable correlation structure was assumed. Models for outcomes were adjusted for the following covariates to account for the matched nature of the design:
1. RACF pair (as a fixed effect)
2. RACF bed number
3. RACF high care: low care bed ratio
For ED presentation, bed number was incorporated into the outcome variable, so was not indicated as a covariate. Further, RACF pair and high: low care ratio had non-significant (p>0.1) parameter estimates and their removal produced a negligible change in the model. Thus, for parsimony (given fewer observations for this summary outcome measure), no covariates were included in the final model.

Results show estimated parameters, 95% confidence intervals and p-values for the main effects of group (intervention/control) and time (pre/post), and their interaction. Parameters for RACF matching factors are not shown. For continuous outcomes (outcomes 2 and 4), parameters represent the predicted change in the mean outcome for the specified level of group, time, or group×time, compared to the reference group mean. For binary outcomes (outcomes 1, 3, and 5) the parameters are expressed as odds ratios, reflecting the predicted ratio in mean odds of the outcome for specified level of group, time, or group×time, compared to the reference group odds. Associations reaching p<0.05 were considered significant. All statistical analyses were programmed using SAS v9.4 (SAS Institute, Cary, North Carolina, USA)

Study Size:
Four RACFs were selected for intervention as a practical and feasible number on which to intervene in the time available. Based on the number of ED transfers in the baseline period, 1257, we estimated we had 80% power to detect a 30% reduction in transfers at a p-value of 0.05.




Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
31/12/2011
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
1257
Accrual to date
Final
1257
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5703 0
John Hunter Hospital Royal Newcastle Centre - New Lambton

Funding & Sponsors
Funding source category [1] 293478 0
Government body
Name [1] 293478 0
NSW Health
Country [1] 293478 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Local Health District
Address
Locked Bag 1, New Lambton, NSW, 2305
Country
Australia
Secondary sponsor category [1] 292302 0
None
Name [1] 292302 0
Address [1] 292302 0
Country [1] 292302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294920 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 294920 0
Ethics committee country [1] 294920 0
Australia
Date submitted for ethics approval [1] 294920 0
21/12/2010
Approval date [1] 294920 0
16/02/2011
Ethics approval number [1] 294920 0
Approval for the study was obtained from Hunter New England Health Human Research Ethics Committee reference no. 11/02/16.5.01; HREC/10/HNE/402; SSA/10/HNE/402)

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

Contacts
Principal investigator
Name 65494 0
Dr Carolyn Hullick
Address 65494 0
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Country 65494 0
Australia
Phone 65494 0
+61249214913
Fax 65494 0
Email 65494 0
[email protected]
Contact person for public queries
Name 65495 0
Carolyn Hullick
Address 65495 0
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Country 65495 0
Australia
Phone 65495 0
+61249214913
Fax 65495 0
Email 65495 0
[email protected]
Contact person for scientific queries
Name 65496 0
Carolyn Hullick
Address 65496 0
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Country 65496 0
Australia
Phone 65496 0
+61214913
Fax 65496 0
Email 65496 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.