Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000795594
Ethics application status
Approved
Date submitted
28/05/2024
Date registered
27/06/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a transitional care intervention for frail older adults returning home from hospital: The TRANSFER-II Study
Scientific title
Feasibility and acceptability of a transitional care intervention for frail older adults returning home from hospital: The TRANSFER-II Study
Secondary ID [1] 312184 0
None
Universal Trial Number (UTN)
Trial acronym
The TRANSFER-II Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
frailty 333939 0
transitional care 333940 0
Condition category
Condition code
Public Health 330610 330610 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TRANSFER-II Study will include the provision of patient centred discharge communication when leaving hospital. Once the participant is recruited, consented and the baseline assessments completed, the intervention commences. The intervention is in addition to standard clinical practice and usual patient care will continue. The Nurse Navigator (intervention nurse) will meet with the patient in hospital before discharge and discuss the plan for home and make any appropriate referrals. At this time the Nurse Navigator will identify 3 patient-centred priorities for home as derived by the discharge summary Plan/Recommendation of care and medical team. These will be determined through discussion with the patient around what is important to them from the list of activities written on the discharge summary plan and then prioritised in a list of 1 to 3 in consultation with the Nurse Navigator. Once discharged, the Nurse Navigator will contact the patient within one week and then again the following week to provide support and answer questions about the discharge summary and follow up plan, and discuss progress of the 3 patient-centred priorities. During this contact the nurse will make any appropriate referrals, facilitate GP review where needed, provide virtual education and resources as necessary.

The intervention is as follows:
• Contact during admission (initial 30 minute consultation) by the Nurse Navigator and discuss with the patient the plan for discharge. Provide the patient the ‘Nurse Navigator Flyer’ (designed by the research team for this study).
• Medical staff complete the discharge summary as usual routine practice.
• Nurse Navigator sets three patient-centred priorities with the patient from the discharge summary plan/recommendations of care, three things to do when the patient returns home, these will be discussed verbally and written down in simple language on the ‘Plan for Home’ sheet (designed by the research team for this study). This may have to be completed over the phone if patient is discharged afterhours or non-working days of the intervention nurse and posted if this is requested by participant (approximately 15-30 minutes).
• The nurse will help to organise and facilitate these patient-centred priorities prior to discharge. At this time, will also help to identify any unmet needs and ensure safety on discharge.
• The nurse will then follow up with a telehealth contact (using a hospital landline) within 1 week of discharge to discuss these 3 patient-centred priorities, then again the following week with a total of 2 points of contact within the intervention. These telehealth contacts will approximately be 30 minutes in duration, and on average 1 week apart.
• Provide support and answer questions about the discharge summary and follow up requirements. Ensuring there is clear communication to the patient about the discharge plan in language that they will understand. During these contacts the intervention nurse will help to facilitate further community support where possible, e.g. organise GP/clinician review or referral to CareFinder.
• These intervention calls may generate additional calls within these points of contact to organise follow up or update the participant with appointment details. For example the participant states they were unable to call their GP for follow up, the intervention nurse calls the GP and books this appointment, then calls the participant back to update appointment time and details. This would be considered one point of contact. Every participant will receive a minimum of 2 contacts approximately 1 week apart,
• These calls and any additional will be tracked and documented within study feasibility data collection through REDCap. Study adherence will also be tracked through REDCap data collection on patients' ability to set and achieve priorities and, through Electronic Medical Records documentation.

All included participants will receive usual care as well as the intervention. Standard practice for discharge is that all patients are assessed during admission for issues returning home and referred to relevant services (e.g. Hospital in the Home) where appropriate. All patients on discharge are given a Discharge Summary as written by the medical team. Currently there is no patient-centred discharge communication or post-discharge follow-up of this nature that exists within the hospital.
Intervention code [1] 328688 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338358 0
Feasibility
Timepoint [1] 338358 0
At conclusion of the study.
Primary outcome [2] 338470 0
Acceptability
Timepoint [2] 338470 0
At conclusion of the study.
Secondary outcome [1] 435624 0
Unplanned readmissions
Timepoint [1] 435624 0
1-, 3-, 6-, and 12-months post-discharge from hospital.
Secondary outcome [2] 435625 0
Mortality
Timepoint [2] 435625 0
1-, 3-, 6-, and 12-months post-discharge from hospital.
Secondary outcome [3] 435626 0
Institutionalisation
Timepoint [3] 435626 0
1-, 3-, 6-, and 12-months post-discharge from hospital.
Secondary outcome [4] 435627 0
Quality of Life
Timepoint [4] 435627 0
Baseline and then 1 month post-discharge from hospital.
Secondary outcome [5] 435628 0
Anxiety and Depression, this will be assessed as a composite outcome as determined by the HADS scale.
Timepoint [5] 435628 0
Baseline and then 1 month post-discharge from hospital.

Eligibility
Key inclusion criteria
• Older adults aged 65 years and above.
• Admitted under the Rehabilitation and Aged Care Services at Blacktown and included in the Western Sydney Clinical Frailty Registry.
• Discharging from hospital and returning home.
• Australian permanent resident.
• Have access to a phone and able to participate in intervention requirements.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Living in Residential Aged Care or permanent institutionalisation.
• Participants admitted under other specialties outside Geriatrics.
• Participants under ongoing legal guardianship.
• Patients with a diagnosis of dementia or those without the capacity to consent.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study uses a feasibility sample size, and the nature of this study is to determine proof of construct related to patient experiences and safety during transition from hospital to home. With a minimum of 100 participants, the 95% CI for any estimated proportion will be no wider than +/- 10%, hence this sample size has been chosen based on a sample size calculation conducted with the primary outcomes.

Statistical analysis will include descriptive statistics (mean, median, number) and estimates of those proportions using a 95% CI. Repeat measures will be reported for continuous and categorical variables. Inferential statistics will be used on remaining outcome measures to compare differences at various timepoints, including Paired t-test and Wilcoxon test.

Qualitative thematic analysis will be conducted on the qualitative question asked to intervention participants at follow up timepoints as per methods established by Braun and Clarke.. Themes will be produced from the responses through the development of codes and relationships of core commonality. There will be consultation within the investigator team to develop key themes that accurately represent the responses of participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
20/08/2024
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
2/02/2026
Actual
Sample size
Target
100
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26607 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 26608 0
Mount Druitt Hospital - Mount Druitt
Recruitment postcode(s) [1] 42649 0
2148 - Blacktown
Recruitment postcode(s) [2] 42650 0
2770 - Mount Druitt

Funding & Sponsors
Funding source category [1] 316554 0
Government body
Name [1] 316554 0
Western Sydney Local Health District
Country [1] 316554 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 318800 0
None
Name [1] 318800 0
Address [1] 318800 0
Country [1] 318800 0
Other collaborator category [1] 283058 0
University
Name [1] 283058 0
University of Wollongong
Address [1] 283058 0
Country [1] 283058 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315346 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315346 0
Ethics committee country [1] 315346 0
Australia
Date submitted for ethics approval [1] 315346 0
16/05/2024
Approval date [1] 315346 0
03/07/2024
Ethics approval number [1] 315346 0
2024/ETH01032

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

Contacts
Principal investigator
Name 134410 0
Prof Caleb Ferguson
Address 134410 0
University of Wollongong, 33 Moore St, Liverpool NSW 2170
Country 134410 0
Australia
Phone 134410 0
+61242214078
Fax 134410 0
Email 134410 0
[email protected]
Contact person for public queries
Name 134411 0
Kirsten Parker
Address 134411 0
University of Wollongong, 33 Moore St, Liverpool NSW 2170
Country 134411 0
Australia
Phone 134411 0
+61403226275
Fax 134411 0
Email 134411 0
[email protected]
Contact person for scientific queries
Name 134412 0
Kirsten Parker
Address 134412 0
University of Wollongong, 33 Moore St, Liverpool NSW 2170
Country 134412 0
Australia
Phone 134412 0
+61403226275
Fax 134412 0
Email 134412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data related to the outcome measures published from this study will be shared only.
When will data be available (start and end dates)?
Start date: Immediately after the outcomes from this study has been published in the peer review journals.
End date: Data will be stored securely for a minimum of 5 years following completion of the research or the last publication as per Section 2.1, Australian Code for the Responsible Conduct of Research.
Available to whom?
Researchers and academics at the discretion of the principal investigator.
Available for what types of analyses?
Systematic review and meta analysis
How or where can data be obtained?
Please contact Kirsten Parker with any requests - [email protected]


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.