Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001015730
Ethics application status
Approved
Date submitted
10/06/2022
Date registered
20/07/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
20/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Stroke Clinical Registry - LIfe after Stroke Tailored Support (A-LISTS) study
Scientific title
Australian Stroke Clinical Registry - LIfe after Stroke Tailored Support (A-LISTS) study:
mixed methods study with a pilot randomised controlled trial for people living with stroke
Secondary ID [1] 306717 0
None
Universal Trial Number (UTN)
U1111-1276-1898
Trial acronym
A-LISTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 325695 0
Condition category
Condition code
Stroke 323044 323044 0 0
Ischaemic
Stroke 323045 323045 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-hospital component (all participants before randomisation): Baseline assessments are completed by trained data collectors for the Australian Stroke Clinical Registry (AuSCR) by phone. For the baseline assessment, consented participants are asked questions about their current health conditions and residence, quality of life (EuroQoL-5-3L dimension, EQ-5D), disability (modified Rankin Scale, mRS) and complete the longer-term unmet needs (LUNS) questionnaire. This interview will take approximately 30 minutes to complete. All participants are informed that a stroke service coordinator from the hospital that they were discharged from that participates in AuSCR may contact them via phone.

Randomisation: For those allocated to the intervention group, an electronic report about the participants health and unmet needs status is generated (A-LISTS patient report), and then securely forwarded electronically to the participating hospital's nominated service coordinator. The report includes a summary of the baseline measurements ascertained by the AuSCR team member for the participant.

Hospital component (post randomisation): The nominated stroke service coordinator will receive an ~4 hour training program via videoconference with relevant project team members and with online modules with self-assessments prior to commencement of the trial. The stroke service coordinator will contact the participant via telephone to ask them questions about their health status and unmet needs, clarifying with them about current management and also their past medical history related to their baseline responses. They will seek to understand the potential contributing factors for the responses. The stroke service coordinator will determine which healthcare providers are currently managing their care and if they need further support from the hospital or a broader range of healthcare providers. They will determine if the participant's General Practitioner (GP) should be contacted/involved and ask permission to forward the A-LISTS patient report. The stroke service coordinator will then outline what additional support or case management might be offered and seeks approval to set up consultations, as required. This consultation may take up to 60-90 minutes. The outcomes of this assessment are documented in the participant's medical file and the relevant data entered into the electronic case report form (eCRF).

One of three options then occurs. Option 1 is if no further action is required by the hospital, the service coordinator will send the A-LISTS patient report to the nominated GP, if the participant consents to this, with a cover letter outlining the initial review and its outcomes and any further steps discussed with the patient. Option 2 is if further action is required by the hospital, the service coordinator can then arrange telehealth or in person consultations with relevant members of the interdisciplinary team and/ GP or other health care providers in the community as advised by the patient. Additionally, referrals and any additional appointments with the stroke team can be scheduled, as required. Option 3 is if the participant is uncontactable or refuses to engage with the hospital. A cover letter and a copy of the A-LISTS patient report will be sent to the GP with the patient's permission. If uncontactable, or permission is not granted then details will be documented in the medical record. All relevant data will be entered into the eCRF.
The criteria for determining whether the participant falls into option 1 or 2 is dependent on the stroke service coordinators judgement. If the coordinator identifies suitable follow-up services and the participant agrees, then a referral will be made. If the participant reports that they feel they do not need a follow-up service then no referral will be made.

During the 12 week intervention period, participants are asked to complete a paper diary by writing down any time they have contact with a healthcare or community services provider, including medical specialist visits or attend an allied health therapy session (such as a physiotherapist, etc). The stroke service coordinator has a maximum of 4 hours per week for 12 weeks to make follow-up calls. Subsequent calls to participants may be via telephone, face-to-face or video-conference depending on the participants preference.

End week 12: A follow-up survey repeating the baseline assessments is conducted over the phone around week 12-14 post randomisation whereby a blinded research assistant from the AuSCR office collects the follow-up data. This will take approximately 30 minutes to complete. Participants will be asked questions about their current residence, quality of life (EQ-5D), disability (mRS), longer-term unmet needs (LUNS), the number of unplanned hospital visits since discharge and the number of current health or community services used, new medication use and any costs incurred since randomisation.
Intervention code [1] 323163 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive their usual care in the community. Usual care may involve the participant contacting their GP or other health care providers of their own accord if they have concerns regarding an unmet need. To avoid unblinding to group allocation, the control group will not be informed about the type of intervention being tested but will be told that the method by which we communicate with them, and the amount of communication will differ based on the group they have been allocated. To support engagement (and to mask the true nature of the intervention), following randomisation, and consistent with the intervention group, they will be provided a paper diary to record healthcare and community services contacts and referrals including the date and reason for the visit, and asked to complete the follow-up survey to be conducted within 12-14 weeks following randomisation. The follow-up survey repeating the baseline assessments is conducted over the phone around week 12-14 post randomisation whereby a blinded research assistant from the AuSCR office collects the follow-up data. This interview will take approximately 30 minutes to complete.
The clinicians from the hospitals will not be directly informed of these participants that have met inclusion criteria for the follow-up service until after the trial is completed. This is to avoid cross-overs. At the end of the trial, should control participants have ongoing high levels of unmet needs, this information will be passed onto the hospital team and they can choose to offer the Stroke Follow-up Service within their own resources to these participants or, if the patient consents, a copy of their A-LISTS patient report that can be generated from their follow-up survey will be posted or emailed to their local GP.
Control group
Active

Outcomes
Primary outcome [1] 330801 0
The proportion of participants that completed the feasibility trial assessed by auditing the study database
Timepoint [1] 330801 0
12-14 weeks post randomisation
Primary outcome [2] 330802 0
The proportion of intervention participants that attended the follow-up service assessed by auditing the study database
Timepoint [2] 330802 0
12-14 weeks post randomisation
Primary outcome [3] 330854 0
The proportion of participants (patients) satisfied with the follow-up service assessed through a survey and/or interview/focus group with questions designed specifically for this study
Timepoint [3] 330854 0
12-14 weeks post randomisation
Secondary outcome [1] 407839 0
Proportion of unplanned presentations to emergency departments or admission (composite) to hospital assessed by a survey with questions designed specifically for this study
Timepoint [1] 407839 0
12-14 weeks post randomisation
Secondary outcome [2] 407840 0
Proportion of participants with extreme health problems (as defined by the criteria for reaching the threshold for referral to the follow-up service (composite outcome): defined as i) an extreme problem in any EQ-5D dimension; or ii) an overall HR-QoL score on the Visual Analogue Scale (VAS) below 60.
Timepoint [2] 407840 0
12-14 weeks post randomisation
Secondary outcome [3] 407842 0
Proportion of participants reporting extreme problems in any domain of the 5 domains of the EQ5D-3L
Timepoint [3] 407842 0
12-14 weeks post randomisation
Secondary outcome [4] 407843 0
Proportion of participants reporting an overall HR QoL Visual Analogue Scale score (Eq5D) of 60 or less.
Timepoint [4] 407843 0
12-14 weeks post randomisation
Secondary outcome [5] 410178 0
Proportion of participants with a change in their global disability assessed using the modified Rankin scale
Timepoint [5] 410178 0
12-14 weeks post randomisation
Secondary outcome [6] 410179 0
Costs assessed using a cost consequences analysis
Unit prices for resources used and productivity will be obtained from the most contemporary Australian sources.
Timepoint [6] 410179 0
12-14 weeks post randomisation
Secondary outcome [7] 411406 0
The proportion of participants (clinicians) satisfied with the follow-up service assessed through a survey and/or interview/focus group
Timepoint [7] 411406 0
12-14 weeks post randomisation
Secondary outcome [8] 411413 0
Proportion of health services used* assessed by a survey with questions designed specifically for this study

*Participants health diary used as a memory aid to respond to this outcome
Timepoint [8] 411413 0
12-14 weeks post randomisation
Secondary outcome [9] 411414 0
Proportion of medications used assessed by a survey with questions designed specifically for this study
Timepoint [9] 411414 0
12-14 weeks post randomisation
Secondary outcome [10] 433547 0
Median/mean number of unmet needs (measured using Long-Term Unmet Needs (LUNS) survey - 22 items).
Timepoint [10] 433547 0
Secondary outcome [11] 433548 0
Median/mean number of unmet needs (measured using Long-Term Unmet Needs (LUNS) survey - 22 items).
Timepoint [11] 433548 0
12-14 weeks post randomisation

Eligibility
Key inclusion criteria
Must meet the agreed criteria for ‘high levels of unmet health needs’ provisionally defined as an extreme problem in any EQ5D domain, or have an overall quality of life score of below 60 (Visual Analogue Scale, EQ5D) self-report on the Australian Stroke Clinical Registry follow-up survey conducted between 90-180 days after stroke and will:
i) have indicated a willingness to be contacted for further research on the Australian Stroke Clinical Registry follow-up survey conducted between 90-180 days after stroke;
ii) be aged 18 years and above;
iii) have a confirmed acute stroke;
iv) be living in the community in a private residence, (i.e., not hospital or high care residential aged care facility or other institution);
v) able to participate in English and provide informed consent via a self-report or appropriate proxy to assist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Australian Stroke Clinical Registry registrants with a transient ischemic stroke (TIA) will be excluded as they are often managed in outpatient stroke services and should not have any residual impairments as the condition is not permanent
ii) Have a life threating illnesses and are unlikely to survive to the study endpoint (i.e. 12-14 weeks post randomisation).

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation occurs using the online system through REDCap (1:1 ratio), stratified by age (<65 or 65+ years) and sex (male, female).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The A-LISTS study has two stages: i) an intervention co-design stage with clinicians, academics and people with lived experience of stroke (not registered separately); and ii) a randomised controlled pilot trial to test the feasibility of providing the follow-up service intervention.
The two stages have not been registered separately.
Other design features:
Qualitative (interviews/focus group) and a process evaluation that includes acceptability and feasibility feedback and assessment of intervention fidelity assessed throughout the trial at the research-team level and the practitioner-patient level.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the trial population at baseline. Within group changes will be examined using McNemar’s test and between group differences will be examined using parametric or non-parametric methods appropriate to the distribution of the data. Where feasible, multivariable statistical models will also be used to adjust for baseline differences between the intervention and control groups for baseline variables with a p-value of <0.2.
Primary analyses will be based on intention-to-treat principles. Statistical significance determined at p < 0.05. Per program analyses and sensitivity analyses will also be performed.

Due to the skewed distribution of continuous outcomes, between-group differences will be reported as median difference (95% CI). Reporting of patient (e.g., type of unmet need) and hospital (e.g., metro/rural location) will be described as part of the analysis and presentation of results. We will describe the difference in the proportion of patients in each group that remain in the ‘high levels of unmet needs’ group at 90-days post randomisation. We will also explore differences in HRQoL and Unmet needs (LUNS questionnaire) in terms of change scores.
The modified Rankin (mRS) change will be assessed as a shift analysis. The Cochran-Mantel-Haenszel shift test will be used to analyse the distribution of the 90-day mRS outcomes in the intervention and control groups. The results will also be compared using a dichotomized mRS outcome by logistic regression (0 to 2 vs 3, or 0 to 1 vs 3)
For the cost consequences analysis, resource use items will be valued using the most appropriate price to convert these into costs. HRQoL data from the EQ5D-3L will be converted to a utility score. The reported clinically meaningful difference in the EQ-5D utility scores ranges from 8 and 12 points in considering whether an intervention is worthwhile for stroke.

Between group differences in EQ-5D utility scores and the Visual Analogue Scale responses, and the differences in the proportion of participants with a clinically meaningful change in these scores will be assessed. We will also describe changes to problems reported in each of the EQ-5D dimensions (mobility, self-care usual activities, pain, anxiety and depression) by group.

Where appropriate, multivariable statistical models will also be used to adjust for baseline differences between comparator groups where outcome data are being assessed. Treatment of missing data will be based on the satisfiability of missingness at random assumptions. Statistical significance will be determined at p<0.05. Sensitivity analyses may also be performed, if appropriate.

Treatment of missing data will be based on the satisfiability of ‘missingness at random’ assumptions.

Feasibility data will be analysed descriptively including participants attending consultations for which there was a referral, and missing data on surveys.
Intervention fidelity data including completion of the follow-up service training, or intervention forms and the project issues register will also be summarised.
Cost consequence analysis to explore costs from a societal and health sector perspective.
Focus group and open text responses from the satisfaction surveys will be analysed using inductive and deductive thematic analyses as appropriate with coding of a proportion of records checked by two researchers.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2023
Actual
4/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 22003 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 22004 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 22005 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 22006 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 22007 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [6] 22008 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 22009 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [8] 22536 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [9] 22537 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [10] 22538 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 37124 0
3050 - Parkville
Recruitment postcode(s) [2] 37121 0
3084 - Heidelberg
Recruitment postcode(s) [3] 37125 0
3168 - Clayton
Recruitment postcode(s) [4] 37127 0
3220 - Geelong
Recruitment postcode(s) [5] 37775 0
4020 - Redcliffe
Recruitment postcode(s) [6] 37777 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 37122 0
4575 - Birtinya
Recruitment postcode(s) [8] 37776 0
4700 - Rockhampton
Recruitment postcode(s) [9] 37123 0
5000 - Adelaide
Recruitment postcode(s) [10] 37126 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 311043 0
Government body
Name [1] 311043 0
National Health and Medical Research Council (2020 Cardiovascular Health Mission, #2008668)
Country [1] 311043 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Florey Institute of Neuroscience and Mental Health
Address
245 Burgundy Street, Heidelberg, VIC, 3084
Country
Australia
Secondary sponsor category [1] 313199 0
None
Name [1] 313199 0
Address [1] 313199 0
Country [1] 313199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310592 0
Austin Health Research Ethics Department
Ethics committee address [1] 310592 0
L8 Harold Stokes Building,
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
Ethics committee country [1] 310592 0
Australia
Date submitted for ethics approval [1] 310592 0
16/03/2022
Approval date [1] 310592 0
29/11/2022
Ethics approval number [1] 310592 0
HREC/89487/Austin-2022
Ethics committee name [2] 311075 0
Monash University
Ethics committee address [2] 311075 0
Wellington Road
Clayton
Victoria
3800
Ethics committee country [2] 311075 0
Australia
Date submitted for ethics approval [2] 311075 0
14/06/2022
Approval date [2] 311075 0
07/02/2023
Ethics approval number [2] 311075 0
Project Number: 36820

Summary
Brief summary
After a new stroke, the presence of physical disability, loss of employment, inability to participate in pre-stroke activities, social isolation, anxiety and depression make returning to the community difficult. Many people living with stroke have ongoing disability and report extreme problems in their quality of life. The purpose of this project is to develop and evaluate the feasibility of providing a co-designed, hospital-initiated follow-up service to support people living with stroke. This service is designed to prioritise support to people who are registered in the Australian Stroke Clinical Registry and report unmet needs and extreme health problems on a patient-reported outcomes survey collected between 90-180 days of discharge from hospital after a new stroke.

Following the design and an initial non-randomised piloting of the intervention components (not registered separately) in up to 5 patients at one hospital to enable refinements to the clinical tools and protocol, we seek to complete a multicentre, randomised controlled pilot trial. In up to 6 hospitals and with approximately 100 eligible patients randomised to either usual care or the intervention we will test the feasibility and acceptability of this proposed follow-up service. Our study includes a process evaluation and cost consequences analysis to inform future scaling of the intervention including providing an understanding of the costs to provide the service in terms of the type of patient benefits may be achieved. The outcomes of this study may also be used to inform undertaking a fully powered effectiveness study.

We seek to proactively use registry data to provide more tailored support for survivors of stroke who have reported extreme unmet needs and direct them to relevant services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118194 0
Prof Dominique Cadilhac
Address 118194 0
Public Health and Health Services Research Group — Stroke

The Florey Institute of Neuroscience and Mental Health

245 Burgundy Street, Heidelberg, VIC, 3084
Country 118194 0
Australia
Phone 118194 0
+61 3 9035 7032
Fax 118194 0
Email 118194 0
dominique.cadilhac@florey.edu.au
Contact person for public queries
Name 118195 0
Mr Andrew Ross
Address 118195 0
The Florey Institute of Neuroscience and Mental Health

245 Burgundy Street, Heidelberg, VIC, 3084
Country 118195 0
Australia
Phone 118195 0
+61 3 9035 7067
Fax 118195 0
Email 118195 0
andrew.ross@florey.edu.au
Contact person for scientific queries
Name 118196 0
Prof Dominique Cadilhac
Address 118196 0
Public Health and Health Services Research Group — Stroke

The Florey Institute of Neuroscience and Mental Health

245 Burgundy Street, Heidelberg, VIC, 3084
Country 118196 0
Australia
Phone 118196 0
+61 3 9035 7032
Fax 118196 0
Email 118196 0
dominique.cadilhac@florey.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
On completion of publications by the investigators and A-LISTS collaborators, anonymised data will be available for secondary research purposes such as pooling data for meta analysis of similar studies, or complimentary research questions.
Data from the Australian Stroke Clinical Registry used in this study cannot be shared. Qualified investigators may apply to access those data separately.
When will data be available (start and end dates)?
Anticipated from 2024, no end date determined.
Available to whom?
Academics and students
Available for what types of analyses?
Research questions that do not replicate our primary and secondary outcome analyses
How or where can data be obtained?
Direct contact with the Coordinating Principal Investigator, Professor Dominique Cadilhac by email dominique.cadilhac@florey.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15458Study protocol  dominique.cadilhac@florey.edu.au
15460Informed consent form  dominique.cadilhac@florey.edu.au
15522Clinical study report  dominique.cadilhac@florey.edu.au
15523Ethical approval  dominique.cadilhac@florey.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIResearch Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry2024https://doi.org/10.1016/j.jphys.2024.02.015
N.B. These documents automatically identified may not have been verified by the study sponsor.