Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12624000493549
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
22/04/2024
Date last updated
18/08/2024
Date data sharing statement initially provided
22/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising health information exchange during aged care transfers for people living in Residential Aged Care (RAC)
Scientific title
Optimising health information exchange during aged care transfers: Investigating the impact of a national digital health summary for integrated primary care data sharing on hospital presentations in people living in Residential Aged Care (RAC)
Secondary ID [1] 311838 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical emergencies 333370 0
Condition category
Condition code
Public Health 330056 330056 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of the intervention: Digital health summary of information considered critical during the medical transfer of residents living in RAC

Materials used: The project team has developed generic implementation materials (e.g. signs, checklists, manuals, worksheets) and training materials, and then tailored them for each trial site (e.g. training delivery platform and format, physical space and layout, alert systems) in partnership with organisational representatives of each trial site. During the preparatory phase of the trial and at least 1 month before the intervention is due to start, trial sites will be provided with awareness raising materials (e.g. posters, email announcements, newsletter content, videos) to alert staff, residents and families of the trial. The project facilitator will supervise digital training and provide face-to-face training for participating trial sites. Digital training/face-to-face training will be delivered via 2x1 hour workshops conducted one month prior to implementation at each participating RAC site. Attendance to training is not mandatory, however their uptake of participation and involvement will be monitored via audit of website analytics and review of training attendance logs.

Procedures: The NASSS (non-adoption, abandonment, scale-up, spread, sustainability) framework has been adopted to co-design health information considered critical during aged care transfer and guide implementation. The intervention will be delivered as part of usual clinical care, recruitment and analysis for the intervention will be at the RAC site level. Staff from 3 participating RAC sites have helped co-design the digital interface and demonstrated commitment to testing digital health summary in their aged care homes including engagement with Peninsula Health, Ambulance Victoria and GPs using Outcome Health throughout the intervention. Opt-out consent processes for residents has been developed in consultation with participating RAC sites.

Who will deliver the intervention: A digital health summary will be set up for each resident at participating RAC sites, except where a resident has chosen to opt out of the project. Health information presented in the digital health summary includes most recent emergency contact information, presence of Advance Care Directive, allergies, medication precautions, usual level of alertness, mobility requirements, presence of behaviour support plan and post discharge information. Staff from the RAC site, ambulance, Peninsula Health, and GPs using the outcome health system will be able to access the user interface within their own secure clinical systems. Once the resident’s information profile has been set up it will be able to be viewed by RAC staff at any time including prior to a transfer or in other situations where a person requires care. The anticipated time required to review the digital health summary prior to a transfer event is around 5 to 10mins. Participating aged care home residents and their nominated informal carers will have access to review information and have full visibility over the information that is being communicated between healthcare providers. Adherence and usage of digital health summary during the intervention at each participating trial site will be monitored using website analytics.

Mode of delivery: The digital health summary will be hosted on a secure virtual server and accessed via a simple web interface on a PC, laptop, tablet or smart phone. Access will be given to the technology only to authorised end users who are part of the trial (e.g. RAC staff, residents, selected paramedics, relevant hospital staff) and resident profiles will be created so that end users can access the system during the intervention period. The RAC staff involved during a transfer event will be available to answer any additional questions to paramedics/health professionals as required and part of usual clinical care. Digital health summary is designed to compliment not replace existing documentation and processes. Health information presented in digital health summary will be confirmed with the RAC on a fortnightly basis to ensure consistency during the intervention period and/or updated whenever a health change is noted following hospital admission/discharge and/or triggered by events while in RAC.

Number of times: Each trial site will be given access to the digital health summary platform during the 3 month intervention phase. The expectation is that the digital health summary will be used during an ambulance call out or a transfer event to the hospital. The project facilitator will contact the trial site weekly or fortnightly to check on progress and support needs. System improvement activities will be conducted during each intervention phase.

Duration, intensity or dose: At the end of their three-month intervention phase at a trial site there will be a one month evaluation phase prior to commencement of the trial at another trial site,

Location: Three RAC homes located in the Peninsula Health catchment are participating in the study. The digital health summary will be implemented into each of the participating RAC sites, Peninsula Health systems and relevant community care programs, Ambulance Victoria and GPs using Outcome Health systems. The intervention will be embedded in daily clinical practice and only residents from participating RAC will be part of the trial.
Intervention code [1] 328295 0
Prevention
Intervention code [2] 328304 0
Treatment: Other
Comparator / control treatment
Routinely collected data from hospital presentations and ambulance attendances will be used to compare rates in the 3 months prior to the intervention with rates during the intervention. Data will only be accessed for residents within the three participating RAC homes in the trial that are located within Peninsula Health catchment area.
Control group
Historical

Outcomes
Primary outcome [1] 337821 0
Change in proportion of Emergency Department presentations from RAC trial sites
Timepoint [1] 337821 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Primary outcome [2] 337846 0
Change in proportion of hospital admissions from RAC trial sites
Timepoint [2] 337846 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Primary outcome [3] 337847 0
Change in proportion of ambulance attendances that result in a transfer to hospital from RAC trial sites
Timepoint [3] 337847 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Secondary outcome [1] 433402 0
Change in the proportion of combined ED presentations and hospital admissions from RAC trial sites. This will be assessed as a composite outcome.
Timepoint [1] 433402 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Secondary outcome [2] 433453 0
Change in the proportion of residents from RAC trial sites that readmit to hospital within 7 days of hospital discharge
Timepoint [2] 433453 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Secondary outcome [3] 433454 0
Change in the proportion of residents from RAC trial sites that readmit to hospital within 30 days of hospital discharge
Timepoint [3] 433454 0
The 3 month period prior to intervention implementation and during the 3 month intervention period.
Secondary outcome [4] 433455 0
Change in median hospital length of stay of residents from RAC trial sites
Timepoint [4] 433455 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Secondary outcome [5] 433456 0
Change in proportion of emergency ambulance attendances to RAC trial sites
Timepoint [5] 433456 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Secondary outcome [6] 433457 0
Change in proportion of in-hospital adverse events (medication errors, falls, delirium, pressure injuries) in the first 72 hours for residents arriving to hospital from RAC trial sites.
Timepoint [6] 433457 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Secondary outcome [7] 433458 0
Change in proportion of use (e.g. initiation, cessation, frequency, dosage) of psychotropic medications in hospital during the admission event for residents arriving via emergency ambulance transfers from RAC trial sites
Timepoint [7] 433458 0
The 3 month period prior to intervention implementation and during the 3 month intervention period
Secondary outcome [8] 433952 0
Participant reported experience measures: outcomes identified by participants during the design of the intervention as desired outcomes for the study. This will be assessed as a composite outcome.
Timepoint [8] 433952 0
Individual Pre Intervention Survey: Approximately 1 to 4 weeks before the intervention is scheduled to begin at each trial site.

Individual Post Intervention Survey: Within 2 weeks post intervention phase completion at each trial site for all except Ambulance staff who will be approached every 1-2 weeks during the trial to complete the survey.

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [9] 433953 0
Acceptability: To what extent the intervention is judged as suitable, satisfying or attractive to users. This will be assessed as a composite outcome.
Timepoint [9] 433953 0
Individual Pre Intervention Survey: Approximately 1 to 4 weeks before the intervention is scheduled to begin at each trial site.

Individual Post Intervention Survey: Within 2 weeks post intervention phase completion at each trial site for all except Ambulance staff who will be approached every 1-2 weeks during the trial at each site to complete the survey.

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [10] 433954 0
Perceived Appropriateness: whether the intervention is perceived as suitable and a good fit with the organisational culture and individual roles. This will be assessed as a composite outcome.
Timepoint [10] 433954 0
Individual Pre Intervention Survey: Approximately 1 to 4 weeks before the intervention is scheduled to begin at each trial site.

Individual Post Intervention Survey: Within 2 weeks post intervention phase completion at each trial site for all except Ambulance staff who will be approached every 1-2 weeks during the trial at each site to complete the survey.

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [11] 433955 0
Demand: Whether the intervention is seen as a priority and whether it is actually used (e.g. how frequently the system was used during a transfer).
Timepoint [11] 433955 0
Individual Pre Intervention Survey: Approximately 1 to 4 weeks before the intervention is scheduled to begin at each trial site.

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [12] 433956 0
Practicality: To what extent can the intervention be carried out by intended users using existing means, resources, and circumstances and without outside intervention. This will be assessed as a composite outcome.
Timepoint [12] 433956 0
Organisational Pre Intervention Survey: Approximately 1 to 4 weeks before the intervention is scheduled to begin at each trial site.

Organisational Post Intervention Survey: Within 2 weeks post intervention phase completion at each trial site.

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [13] 433957 0
Participant perceptions of the intervention: complexity of the intervention, intervention quality (of implementation and digital health summary system), trustworthiness of source, strength of evidence.
Timepoint [13] 433957 0
Individual Post Intervention Survey: Within 2 weeks post intervention phase completion at each trial site for all except Ambulance staff who will be approached every 1-2 weeks during the trial to complete the survey.

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [14] 433958 0
Implementation: The extent to which the intervention is successfully delivered to intended sites/users and how much it cost and a description of the implementation process that each test site went through. This will be assessed as a composite outcome.
Timepoint [14] 433958 0
Training evaluation survey: At the end of training videos watched in participants own time throughout the trial and at the end of any face-to-face or virtual training sessions conducted by project facilitator (scheduled for Approximately 1 to 4 weeks before the intervention is scheduled to begin at each trial site).

Organisational Post Intervention Survey: Within 2 weeks post intervention phase completion at each trial site.

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [15] 433959 0
Fidelity: Adherence to the intervention protocol with reference to dose/quality
Timepoint [15] 433959 0
Organisational Post Intervention Survey: Within 2 weeks post intervention phase completion at each trial site for all except Ambulance staff who will be approached every 1-2 weeks during the trial to complete the survey.

Structured facilitation notes: continuously throughout the intervention phase for each trial site.
Secondary outcome [16] 433960 0
Effectiveness: which components of the intervention are considered the “active ingredients” necessary for the desired impact
Timepoint [16] 433960 0
Within 2 weeks post intervention phase completion at each trial site for all except Ambulance staff (repeated every 1-2 weeks during the trial, Individual Post Intervention Survey).

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [17] 433961 0
Feasibility: Whether the digital health system works as intended in a given context. This will be assessed as a composite outcome.
Timepoint [17] 433961 0
Approximately 1 to 4 weeks before the intervention is scheduled to begin at each trial site (Individual Pre Intervention Survey) and Within 2 weeks post intervention phase completion at each trial site for all except Ambulance staff (repeated every 1-2 weeks during the trial) (Individual Post Intervention Survey).

Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [18] 433962 0
Integration: To what extent can and was the intervention integrated within existing systems
Timepoint [18] 433962 0
Interviews: For staff excluding Ambulance staff, within 4 weeks post intervention phase completion at each trial site. For residents and family carers, within a month after discharge from hospital. For ambulance staff, within a month of their attendance at a trial site.
Secondary outcome [19] 433963 0
Intervention programme analytics: To measure the participants’ direct interaction with the digital health summary system.
Timepoint [19] 433963 0
At the end of 3 month intervention phase at each trial site.
Secondary outcome [20] 433964 0
System set up and failures. This will be assessed as a composite outcome.
Timepoint [20] 433964 0
At the end of 3 month intervention phase at each trial site.

Eligibility
Key inclusion criteria
Intervention will be delivered at RAC site level.
This means all residents are included from the participating site, except those residents who decide to opt out of the study.

RAC homes will be eligible for the feasibility study if they:
• Are located in the Frankston Mornington Peninsula catchment area
• Provide residential care for adults aged 65 years of age and over
• Are not involved in another research study requiring significant practice changes at the same time as the site’s scheduled feasibility trial (i.e. to avoid over burdening the staff and residents)

For process evaluation, only a subset of patients/staff will be included based on the following criteria:
Residents living in RAC homes
• Live in the participating residential aged care home during the testing phase
• Are able to provide informed consent
• Are able to communicate in English

Ambulance, hospital, primary care and IT staff
• Working in relevant sectors of these organisations during the trial

Clinical staff from Peninsula Health, Ambulance Victoria, Primary Care and IT staff from RAC
• Provided care for RAC residents during the testing period OR
• Are involved in the recording or management of data or information at the relevant organisation during the testing period OR
• Are involved in managing relevant organisational workflows during the testing period, OR
• Are employed to deliver IT services within one of the target organisations (e.g. hospital, primary care)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents living in RAC homes and staff involved in the study who do not meet the inclusion criteria (for intervention and/or process evaluation)

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)
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
This is a pre post study design where outcomes (e.g. hospital presentation) in 3months prior to the intervention will be compared with outcomes during the intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the characteristics of the study sample and quantitative study outcomes.

Quantitative outcome data will be analysed by comparing data from the baseline (control) periods (3 months prior to implementation) to the intervention periods (i.e. the three months during which the intervention is being tested) using a before-and-after comparison analysis. In addition, regression modelling appropriate to the nature and distribution of the dependent variable will be used to compare control and intervention periods e.g. negative binomial or poison regression will be used for count data, logistic regression for binary outcomes and linear regression for continuous outcome data. For readmissions Cox Proportional Hazards regression will be used and adjusted for the competing risk of death. Models will be adjusted for patient factors available in the routinely collected data known to be associated with health outcomes such as age, sex, comorbidities, time in aged care, polypharmacy etc to adjust for differences in patient case mix between the control and intervention periods. A 2-sided p-value of < 0.05 will be considered statistically significant. However, as this is a feasibility study and not fully powered for significance the effect size will also be considered when interpreting the results.

Survey Data will be analysed using descriptive statistics, appropriate to the distribution of the data will be used to determine frequencies, means/ medians as appropriate. Non-parametric inferential statistics may be used if a sufficient sample size is achieved.

For the qualitative data, interview transcripts, field notes and project documentation will be manually checked to ensure deidentification before importing into NVivo for analysis. Transcripts will not be returned to participants for comment or correction due to time constraints of the research study. Several members of the research team with experience in qualitative data analysis will code the transcripts and discuss issues of salience raised by participants. Data will be analysed iteratively to help identify theoretical saturation and to identify further areas for probing during data collection. For data on end user attitudes towards adoption of our proposed approach, we will likely use an inductive reflexive thematic analysis approach, informed by Braun and Clarke. The codes will be used to elicit themes based on participant narratives which will be presented to the research team/CIs throughout the analysis stages for formative feedback.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2024
Actual
1/07/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
350
Accrual to date
92
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26340 0
Regis Aged Care Rosebud - Capel Sound
Recruitment hospital [2] 26341 0
Regis Aged Care Frankston - Frankston
Recruitment hospital [3] 26393 0
Arcare Aged Care Balnarring - Balnarring
Recruitment postcode(s) [1] 42313 0
3940 - Capel Sound
Recruitment postcode(s) [2] 42314 0
3199 - Frankston
Recruitment postcode(s) [3] 42370 0
3926 - Balnarring

Funding & Sponsors
Funding source category [1] 316139 0
Government body
Name [1] 316139 0
Australian Department of Health, Department of Industry, Science, Energy & Resources, Medical Research Future Fund (MRFF)
Country [1] 316139 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318314 0
Hospital
Name [1] 318314 0
Peninsula Health
Address [1] 318314 0
Country [1] 318314 0
Australia
Other collaborator category [1] 282996 0
Commercial sector/Industry
Name [1] 282996 0
Outcome Health (Melbourne East GP Network)
Address [1] 282996 0
Country [1] 282996 0
Australia
Other collaborator category [2] 282997 0
Government body
Name [2] 282997 0
Ambulance Victoria
Address [2] 282997 0
Country [2] 282997 0
Australia
Other collaborator category [3] 282998 0
Commercial sector/Industry
Name [3] 282998 0
Regis Aged Care
Address [3] 282998 0
Country [3] 282998 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314964 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 314964 0
Ethics committee country [1] 314964 0
Australia
Date submitted for ethics approval [1] 314964 0
17/02/2023
Approval date [1] 314964 0
07/06/2023
Ethics approval number [1] 314964 0
LNR/88532/PH-2023

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

Contacts
Principal investigator
Name 133274 0
A/Prof Nadine ANDREW
Address 133274 0
The Ngarnga Centre, The Frankston Hospital, 2 Hastings Road, Frankston VIC 3199
Country 133274 0
Australia
Phone 133274 0
+61 432538603
Fax 133274 0
Email 133274 0
Nadine.Andrew@monash.edu
Contact person for public queries
Name 133275 0
Dr. Sumit PARIKH
Address 133275 0
The Ngarnga Centre, The Frankston Hospital, 2 Hastings Road, Frankston VIC 3199
Country 133275 0
Australia
Phone 133275 0
+61 449194040
Fax 133275 0
Email 133275 0
Sumit.Parikh@monash.edu
Contact person for scientific queries
Name 133276 0
A/Prof. Nadine ANDREW
Address 133276 0
The Ngarnga Centre, The Frankston Hospital, 2 Hastings Road, Frankston VIC 3199
Country 133276 0
Australia
Phone 133276 0
+61 432538603
Fax 133276 0
Email 133276 0
Nadine.Andrew@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to ethical and legal restrictions associated with access to routinely collected data used for the main efficacy outcomes, person-level data from this study cannot be shared.
Aggregated data can be made available upon request and will be presented in published articles, posters and presentations.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22034Ethical approval    387554-(Uploaded-01-04-2024-21-41-06)-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.