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Trial registered on ANZCTR


Registration number
ACTRN12619001692123
Ethics application status
Approved
Date submitted
12/11/2019
Date registered
2/12/2019
Date last updated
28/01/2022
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Partnerships in Aged-Care Emergency services using Interactive Telehealth (PACE-IT) incorporating telehealth visual assessment, information sharing and decision making for people living in residential aged-care facilities (RACF)
Scientific title
Partnerships in Aged-Care Emergency services using Interactive Telehealth (PACE-IT) incorporating telehealth visual assessment, information sharing and decision making for people living in residential aged-care facilities (RACF)
Secondary ID [1] 299855 0
Nil Known
Universal Trial Number (UTN)
N/A
Trial acronym
PACE-IT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Emergency care intervention
 314986 0
Older patients 315253 0
Dementia 315254 0
Frail elderly 315255 0
Vulnerable population 315256 0
Chronic illness 315257 0
Condition category
Condition code
Emergency medicine 313320 313320 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
This implementation study uses a stepped-wedge cluster randomised controlled design.
Sixteen RACFs (8 clusters) partnered with four hospital EDs are included. At regular time periods (steps) of 4 weeks, one RACF cluster (2 RACFs) will implement the intervention.
During the one month baseline study period 1, all clusters are in a control period. Data collection commences in period 1 through to period 10, ie one month post implementation of the intervention in all clusters. ED data are aggregated monthly to indicate the number and outcomes of ACE/ASET calls and those assisted through the telehealth intervention. We will test for differences in ED presentations and hospital admissions between intervention and control periods.

Existing Aged Care Emergency (ACE)/ Agedcare Services in Emergency Team (ASET) models will be strengthened and augmented with a novel Telehealth video linked interactive visual assessment and follow up phone call. This approach adds visual assessment capability and increases engagement and information exchange with residents, Residential Aged Care Facility (RACF) staff and families, if present.

A video assessment and information sharing protocol will be initiated if a medical situation presents using the following steps:
1. Initial phone call or text from RACF to ACE/ASET nurse to log a request for consultation
2. Log requires provision of demographic and other relevant clinical data
3. ACE/ASET nurse responds with appointment for telehealth consultation
4. Telehealth video call from ACE/ASET nurse to RACF staff involving interactive visual assessment of the resident and shared decision making, with involvement of resident, staff and family members if present
5. If the resident is not transferred to ED or admitted to hospital a follow up phone call from the ACE/ASET nurse to RACF 24 hours post consultation will be attended to identify what alternative non hospital services were accessed and what treatment was delivered, and any adverse events
6. An electronic GP communication will be generated to summarise the reason for and outcome of the consultation.

The visual link will be supported through Pexip in Hunter New England Local Health District (HNELHD) and Western NSW Local Health District (WNSWLHD).
Telehealth is widely used in both LHDs, with HNELHD conducting 50% of State-wide telehealth consults annually (9453 telehealth appointments for 2018).

Usual care (occurring prior to the stepped implementation of the intervention in each RACF) involves existing aged-care emergency service delivery models at each site with no telehealth consultation option.



Intervention code [1] 315910 0
Prevention
Comparator / control treatment
During the one month baseline study period 1, all clusters are in a control period.
Control group
Active

Outcomes
Primary outcome [1] 321796 0
ED presentations by RACF residents as assessed by audit of Emergency
Department presentation records
Timepoint [1] 321796 0
Data collection commences in period 1 through to period 10, ie one month post implementation of the intervention in all clusters. The ED presentation data will be aggregated for each RACF per month, and the rate of ED presentations (per RACF beds) will be compared between intervention and control periods using a generalised linear mixed effects regression model (Poisson or negative binomial with a log link).
Secondary outcome [1] 376236 0
Acceptability and uptake of the intervention by RACF staff survey based on Likert Scale and Focus group meetings
Timepoint [1] 376236 0
1. Survey attended immediately post telehealth consultation for 3 months post implementation
2. Focus groups 3 months post commencement of implementation
Secondary outcome [2] 377218 0
Monitoring adverse events and safety of resident via a follow up phone call for every telehealth consultation.
Timepoint [2] 377218 0
Follow up phone call within 24 hours of telehealth consultation. Data collection commences in period 1 through to period 10, ie one month post implementation of the intervention in all clusters.
Secondary outcome [3] 377313 0
Acceptability and uptake of the intervention by ACE-ASET staff via focus group meetings pre and post implementation.
Timepoint [3] 377313 0
3 month post implementation.
Secondary outcome [4] 377314 0
Acceptability and uptake of the intervention by RACF residents and family interviews
Timepoint [4] 377314 0
3 months post implementation.
Secondary outcome [5] 377447 0
Health care associated costs related to hospital admissions post telehealth call data collected via Emergency Department presentation records.
Timepoint [5] 377447 0
Commences in period 1 through to period 10, ie one month post implementation of the intervention in all clusters.

Eligibility
Key inclusion criteria
Recruitment of residents only from the 16 participating RACFs.

Involvement in the Visual Telehealth ACE call intervention
Formal signed consent will not be sought from individual residents. This intervention will be embedded into normal practice. The already existing ACE model of care is augmented through the addition of Visual Telehealth ACE call, 24 hour follow-up phone call and consultation documentation summary to the RACF and GP.

Residents and Carer Interviews
Inclusion criteria
1. RACF residents in participating RACFs greater than 65 years old and who have participated in a Visual Telehealth ACE call.
2. Aboriginal residents in participating RACFs greater than 50 years old and who have participated in a Visual Telehealth ACE call.
3. A family member(s) involved in a Visual Telehealth ACE call.






Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents with a cognitive impairment who are unable to provide an informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a cluster controlled randomised stepped wedge design. However, those doing data analysis will be blinded as to whether implementation of the intervention has taken place in any individual site.
Given the practice change nature of the intervention, staff of RACFs will be aware of the period of intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 16 RACFs in the study will be selected for order of implementation via the use of a simple randomisation using a randomisation table created by computer software (Stata/IC 14.1). It was a 2 step process randomising the hospital ED then randomising the RACFs (within each hospital) for the start date of implementation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Implementation is via a cluster controlled randomised stepped wedge design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample

The pilot identified 82 RACF ED presentations/100 beds annually. With the 16 RACFs contributing 1435 beds (average equals to 87) in this study, adopting the intervention in the sequence, we will have 80% power to detect a 35% relative reduction in ED presentations /100 beds annually (at 5% significance) assuming an intra-class correlation of 0.01.

The sample size is 1435 participants. This implementation study uses a Stepped Wedge cluster randomised controlled design. The stepped wedge design reconciles the need for rigorous evaluation with organisational logistical and resource constraints. Sixteen RACFs (8 clusters) partnered with four hospital EDs are included. At regular time periods (steps) of 4 weeks, one RACF cluster (2 RACFs) will implement the intervention. Pilot work in four RACFs indicates that sequenced implementation across 8 clusters (16) intervention RACFs is achievable and effective within the 4 week time period with eight steps involving implementation at two sites per step.

During the one month baseline study period 1, all clusters are in a control period. Data collection commences in period 1 through to period 10, ie one month post implementation of the intervention in all clusters. ED data are aggregated monthly to indicate the number and outcomes of ACE/ASET calls and those assisted through the Visual Telehealth ACE call intervention. We will test for differences in ED presentations and hospital admissions between intervention and control periods.

For the primary outcome, Emergency Department presentation data will be analysed to identify presentations involving transfer from the participating RACFs. The ED presentation data will be aggregated for each RACF per month, and the rate of ED presentations (per RACF beds) will be compared between intervention and control periods using a generalised linear mixed effects regression model (Poisson or negative binomial with a log link). The model will include: number of ED presentations in that period as the outcome variable; fixed effects for step and period; random effect for site; and the log number of RACF beds per facility as an offset term. Secondary outcomes will be analysed using similar models. The study is designed so that the onset of winter will be approximately the mid-point of the study, such that the aggregated control and intervention time periods across steps will involve equal amounts of winter/non winter time, thus accounting for seasonal variations during the “flu” season. The fixed effect for step will control for a common underlying secular trend across all clusters.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2020
Actual
1/03/2020
Date of last participant enrolment
Anticipated
31/07/2021
Actual
30/04/2021
Date of last data collection
Anticipated
31/07/2021
Actual
30/04/2021
Sample size
Target
1435
Accrual to date
Final
1792
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15045 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 15046 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [3] 15047 0
Belmont Hospital - Belmont
Recruitment hospital [4] 15055 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 28334 0
2305 - New Lambton
Recruitment postcode(s) [2] 28335 0
2340 - Tamworth
Recruitment postcode(s) [3] 28336 0
2280 - Belmont
Recruitment postcode(s) [4] 28345 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 304123 0
Government body
Name [1] 304123 0
Ministry of Health
Country [1] 304123 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Michelle Giles
Address
Nursing and Midwifery Research Centre
72 Watt Street, Gate Cottage, James Fletcher Campus
Newcastle, NSW 2300
Australia
Country
Australia
Secondary sponsor category [1] 304363 0
Individual
Name [1] 304363 0
Ms Carla Sunner
Address [1] 304363 0
Nursing and Midwifery Research Centre
72 Watt Street, Gate Cottage, James Fletcher Campus
Newcastle, NSW 2300
Australia
Country [1] 304363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304610 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304610 0
Ethics committee country [1] 304610 0
Australia
Date submitted for ethics approval [1] 304610 0
27/09/2019
Approval date [1] 304610 0
07/11/2019
Ethics approval number [1] 304610 0
2019/ETH12853

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

Contacts
Principal investigator
Name 97574 0
Ms Carla Sunner
Address 97574 0
Nursing and Midwifery Research Centre
72 Watt Street, Gate Cottage, James Fletcher Campus, NSW 2300
Country 97574 0
Australia
Phone 97574 0
+61 477 329 996
Fax 97574 0
Email 97574 0
Carla.sunner@health.nsw.gov.au
Contact person for public queries
Name 97575 0
Carla Sunner
Address 97575 0
Nursing and Midwifery Research Centre
72 Watt Street, Gate Cottage, James Fletcher Campus, NSW 2300
Country 97575 0
Australia
Phone 97575 0
+61 477 329 996
Fax 97575 0
Email 97575 0
Carla.sunner@health.nsw.gov.au
Contact person for scientific queries
Name 97576 0
Carla Sunner
Address 97576 0
Nursing and Midwifery Research Centre
72 Watt Street, Gate Cottage, James Fletcher Campus, NSW 2300
Country 97576 0
Australia
Phone 97576 0
+61 477 329 996
Fax 97576 0
Email 97576 0
Carla.sunner@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The information is health record information that cannot be publicly shared. Any information will be aggregated and de-identified before reporting findings.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5633Ethical approval    378629-(Uploaded-12-11-2019-11-48-26)-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.