ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Medical emergencies

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

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]

Change in proportion of Emergency Department presentations from RAC trial sites

Timepoint [1]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Primary outcome [2]

Change in proportion of hospital admissions from RAC trial sites

Timepoint [2]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Primary outcome [3]

Change in proportion of ambulance attendances that result in a transfer to hospital from RAC trial sites

Timepoint [3]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Secondary outcome [1]

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]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Secondary outcome [2]

Change in the proportion of residents from RAC trial sites that readmit to hospital within 7 days of hospital discharge

Timepoint [2]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Secondary outcome [3]

Change in the proportion of residents from RAC trial sites that readmit to hospital within 30 days of hospital discharge

Timepoint [3]

The 3 month period prior to intervention implementation and during the 3 month intervention period.

Secondary outcome [4]

Change in median hospital length of stay of residents from RAC trial sites

Timepoint [4]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Secondary outcome [5]

Change in proportion of emergency ambulance attendances to RAC trial sites

Timepoint [5]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Secondary outcome [6]

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]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Secondary outcome [7]

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]

The 3 month period prior to intervention implementation and during the 3 month intervention period

Secondary outcome [8]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Fidelity: Adherence to the intervention protocol with reference to dose/quality

Timepoint [15]

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]

Effectiveness: which components of the intervention are considered the “active ingredients” necessary for the desired impact

Timepoint [16]

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]

Feasibility: Whether the digital health system works as intended in a given context. This will be assessed as a composite outcome.

Timepoint [17]

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]

Integration: To what extent can and was the intervention integrated within existing systems

Timepoint [18]

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]

Intervention programme analytics: To measure the participants’ direct interaction with the digital health summary system.

Timepoint [19]

At the end of 3 month intervention phase at each trial site.

Secondary outcome [20]

System set up and failures. This will be assessed as a composite outcome.

Timepoint [20]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Regis Aged Care Rosebud - Capel Sound

Recruitment hospital [2]

Regis Aged Care Frankston - Frankston

Recruitment hospital [3]

Arcare Aged Care Balnarring - Balnarring

Recruitment postcode(s) [1]

3940 - Capel Sound

Recruitment postcode(s) [2]

3199 - Frankston

Recruitment postcode(s) [3]

3926 - Balnarring

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Department of Health, Department of Industry, Science, Energy & Resources, Medical Research Future Fund (MRFF)

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Peninsula Health

Address [1]

Country [1]

Australia

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Outcome Health (Melbourne East GP Network)

Address [1]

Country [1]

Australia

Other collaborator category [2]

Government body

Name [2]

Ambulance Victoria

Address [2]

Country [2]

Australia

Other collaborator category [3]

Commercial sector/Industry

Name [3]

Regis Aged Care

Address [3]

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health Human Research Ethics Committee

Ethics committee address [1]

https://www.peninsulahealth-research.org.au/ethics/human-research-ethics-committee/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/02/2023

Approval date [1]

07/06/2023

Ethics approval number [1]

LNR/88532/PH-2023

Summary

Brief summary

When residents are transferred across settings their health information is often not shared optimally, impacting the care they receive. Accurate communication of health and medical information at point-of-care during and after a transfer has been shown to reduce avoidable hospitalizations, shorten length of hospital stays and reduce ambulance call outs and transfers. We have co-designed, in partnership with staff representatives from the aged care, IT and the clinical sector, as well as aged care residents and their informal carers, a prototype digital health summary system for sharing agreed upon point of care information considered critical during the transfer of people living in residential aged care. Therefore, the aim of this study is to test the feasibility of the digital health summary and its effectiveness in reducing ambulance transfers and hospital presentations to generate preliminary data on intervention effectiveness. To achieve this aim, we will recruit 3 RAC homes for prototype testing using sequential pre-post study designs (one for each site). This will allow us to evaluate, learn and refine our implementation over 3 iterations, learning from the failings/barriers encountered in each previous attempt. We will use routinely collected hospital and Ambulance Victoria data to determine the impact on our primary, secondary and adverse event outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Nadine ANDREW

Address

The Ngarnga Centre, The Frankston Hospital, 2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61 432538603

Fax

[email protected]

Contact person for public queries

Name

Dr. Sumit PARIKH

Address

The Ngarnga Centre, The Frankston Hospital, 2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61 449194040

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof. Nadine ANDREW

Address

The Ngarnga Centre, The Frankston Hospital, 2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61 432538603

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
22034	Ethical 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.

Trial Review

Documents added manually

Documents added automatically