Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001765819
Ethics application status
Approved
Date submitted
25/11/2021
Date registered
23/12/2021
Date last updated
10/01/2023
Date data sharing statement initially provided
23/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of Comprehensive High-Dose Aphasia Treatment (CHAT)
Scientific title
Implementation of Comprehensive High-Dose Aphasia Treatment (CHAT) in People with Post-Stroke Aphasia
Secondary ID [1] 303359 0
None
Universal Trial Number (UTN)
Trial acronym
CHAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia 320620 0
Stroke 320621 0
Condition category
Condition code
Neurological 318476 318476 0 0
Other neurological disorders
Stroke 321913 321913 0 0
Ischaemic
Stroke 321914 321914 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study arms: 1) usual care (control period, years 1-2), and 2) CHAT Implementation (intervention period, years 3-4). There will be a development phase in preparation for Arm 2 - Implementation of CHAT Components (years 1-2). There will be a transition period between Usual Care (arm 1) and CHAT Implementation (arm 2) to enable training and up-skilling for CHAT Implementation.

Treating speech pathologists and relevant stakeholders will receive tailored training prior to commencing each study phase. Prior to the control arm, treating speech pathologists and relevant stakeholders will participate in training in trial-related aspects of Usual Care data collection, including how to administer and score the assessment battery, and how to enter trial-related data to the database (via REDCap). Prior to CHAT, they will receive specialised training relating to the CHAT intervention through a 2-day training program prior to commencement of arm 2, in addition to training in trial-related procedures and, if not already completed, data collection and entry procedures as above.

Training as part of the preparatory phase will provide treating speech pathologists and relevant stakeholders with knowledge and skills in trial-related matters, assessment and data entry, and components of the CHAT program to be trialled, with a focus on the goal setting and clinical planning components. This will include specialist online educational training and an interactive workshop.

Development Phase: Implementation of a structured, group-led clinical planning model alongside individual CHAT Components
WHY- To explore the feasibility, acceptability, and potential effectiveness of implementing the structured, group-led model for goal setting and treatment planning for the CHAT program in arm 2.
WHO- Speech pathologists +/- allied health assistants +/- speech pathology students working in public rehabilitation services with people with post-stroke aphasia and their carers/significant others.
Participants with aphasia and family members will be recruited to trial the goal setting and clinical planning model and evaluate its effects on treatment through delivery of individual CHAT therapy components. Participants recruited to the development phase will not be included in the intervention arm.
WHAT- For recruited people with aphasia, speech pathologists will complete a core assessment battery, individualised and collaborative goal-setting, group-led treatment planning, and subsequently will implement evidence-based treatment through individual components of the CHAT program as informed by this planning. Participants will receive one of the CHAT therapy components listed below:
- Individual impairment-based therapy: evidence-based treatments based within a cognitive-neurological framework delivered 1:1 with the patient.
- Individual computer-based therapy: evidence-based treatments targeting both impairment level and functional language delivered 1:1 with the patient via computer programs and/or tablet applications.
or
- Individual functional therapy focusing on successful communication within activities of daily living through use of interventions including communication partner training, capacity building of people with aphasia and script training.
Therapy will be delivered at a dose of approximately 2 hours per week for 8 weeks (total 14-16 hours)
Family members will be asked to participate where available.
Speech pathologists will be provided with support, protocols, and resources from the research team and local site champions to implement the goal setting and clinical planning model as guided by implementation theory and a tailored implementation plan. Speech pathologists will also be provided with the required hardware (e.g. iPads) and software (e.g. apps) to complete computer therapy, protocols and resources for evidence-based treatment approaches which may be used in therapy.
HOW- therapy may be delivered face to face or via telerehabilitation depending on the needs of each site. Goal setting will be conducted collaboratively with the person with aphasia and their family member (where available). Clinical planning will include a dedicated clinical planning session which will occur with the group of treating speech pathologists and/or relevant stakeholders at each site, with the support of the research team.
WHEN and HOW MUCH- A component of CHAT therapy will be delivered over an 8 week period for each patient. Outcome measurement will occur at baseline, post-treatment and at 3mth follow-up.
TAILORING- all aspects of CHAT goal setting and therapy are individually-tailored based on the patient’s personal communication goals. Therapy approaches, education and/or communication strategies are selected based on the patient’s goals and outcomes of language assessments in collaboration with the person with aphasia and their significant other/carer. Intervention may be tailored throughout therapy as the person with aphasia’s communication improves and/or their goals evolve.
MODIFICATION- the CHAT program is being modified in this phase to deliver only selected component/s. This will be determined by the sites in collaboration with researchers.
HOW WELL- Fidelity will be evaluated in several ways: 1) clinicians complete a session log for all assessment, goal setting/planning, and therapy sessions which will be triangulated by treatment progress notes where available; 2) video/audio recordings of sessions will be reviewed by a member of the research team at least once per week; 3) Feedback provided to staff through meetings; 4) all staff members will be provided with specialised training in CHAT components, goal setting, and treatment planning; and 5) treating clinicians will be provided with the manualised protocols and all required goal setting, treatment planning, and therapy resources.

Arm 2: Implementation of the whole CHAT program - years 3-4
WHY- to evaluate the implementation of the whole CHAT program within public rehabilitation settings
WHO- Speech pathologists +/- allied health assistants +/- students working in public rehabilitation services with people with post-stroke aphasia and their carers/significant others. All treating speech pathologists will receive specialised training in the CHAT program.
Therapy will be delivered to cohorts of up to 8 participants at a time.
WHAT- Speech pathologists will implement the whole CHAT program with people with aphasia. The CHAT program is comprised of evidence-based therapy within:
- A 1-2 hour individualised and patient-led goal-setting session with people with aphasia and their carer/significant other prior to therapy.
- Individual impairment-based therapy: evidence-based treatments based within a cognitive-neurological framework delivered 1:1 with the patient.
- Individual computer-based therapy: evidence-based treatments targeting both impairment level and functional language delivered 1:1 with the patient via computer programs and/or tablet applications.
- Individual functional therapy focusing on successful communication within activities of daily living through use of interventions including communication partner training, capacity building of people with aphasia and script training.
- Group therapy focusing on providing education and support for living successfully with aphasia delivered to the participating cohort collectively. The number of patient attendees will vary depending on recruitment to each CHAT cohort (could include up to 16). The number and professional background of facilitators will vary depending on the topic of the session.
- Family involvement in therapy and a high level of communication partner training and education throughout the components of CHAT
- Therapy delivered at a high dose in cohorts of up to 8 people with aphasia at a time
Speech pathologists will be provided with the required hardware (e.g. iPads) and software (e.g. apps) to complete computer therapy. The research team will also provide speech pathologists with therapy protocols and resources for evidence-based treatment approaches which will be used in therapy.
Speech pathologists will receive the support of the research team and local site champions throughout implementation of CHAT. This will include a community of practice involving all participating sites.
HOW- Therapy may be delivered face to face or via telerehabilitation. The CHAT program contains both individual and group therapy components as described above.
WHEN and HOW MUCH- Patients will receive 6-7 hours of therapy per week over 8 weeks for a total of 50 hours of therapy during years 3-4 of this project. Outcome measurement will occur prior to goal-setting, post-treatment and at 3mth follow-up.
TAILORING- all aspects of CHAT therapy are individually-tailored based on the patient’s personal communication goals. Therapy approaches, education and communication strategies are selected based on the patient’s goals and outcomes of language assessments in collaboration with the person with aphasia and their significant other/carer. Intervention may be tailored throughout therapy as the person with aphasia’s communication improves and/or their goals evolve.
MODIFICATION- There are not planned modifications to the CHAT program for this study arm, however clinicians may experience a requirement to modify aspects of CHAT to suit local context. This will be recorded via the completion of adaptation logs.
HOW WELL- Fidelity will be evaluated in several ways: 1) clinicians complete a session log for all assessment, goal-setting/planning, and therapy sessions which will be triangulated by treatment progress notes where available; 2) video/audio recordings of sessions will be reviewed by a member of the research team at least once per week; 3) Feedback provided to staff through meetings; 4) all staff members will be provided with CHAT training; and 5) treating clinicians will be provided with the CHAT manual and all required therapy programs.
Intervention code [1] 319669 0
Rehabilitation
Comparator / control treatment
Arm 1 (usual care) will act as a control group for study arm 2 (CHAT Implementation) and will be administered in years 1-2 of the study. Demographically similar sites from arm 1 will also act as a control group for the preparatory phase in order to investigate the potential effectiveness of the goal setting and clinical planning model in influencing the nature of therapy provided (e.g. goal directed, appropriate selection of evidence-based treatments, individualised to the person with aphasia).
WHY- CHAT effectiveness and potential effectiveness of the clinical planning model will be determined by comparing its outcomes to outcomes achieved via usual care.
WHO- Speech pathologists working in public rehabilitation services with people with post-stroke aphasia and their carers/significant others
WHAT- speech pathologists will deliver usual care for people with post-stroke aphasia at their site in line with their organisation's policies/guidelines. No additional therapy approaches, therapy materials or therapy support will be provided within this arm.
HOW- The use of individual, group, face to face or telerehabilitation therapy modalities will be subject to organisational policies/guidelines.
WHEN and HOW MUCH- usual care will occur in years 1-2 of this project. Usual care therapy will be examined over an 8 week period per patient. The number, duration and frequency of sessions delivered will depend on local clinical procedures and organisational guidelines. Outcome measurement will occur prior to goal-setting, post-treatment and at 3mth follow-up.
TAILORING- N/A
MODIFICATIONS- N/A
HOW WELL- the research team will monitor fidelity in administration and scoring of the research assessment battery. All assessors will have their first assessment reviewed by the research team for fidelity, and a subsequent assessment in the first three months of usual care data collection (or their next assessment if no additional are completed in the first three months). Researchers will provide individualised written and/or verbal feedback to assessors regarding assessment fidelity. Assessors will receive specialised training in the conduct of the assessment battery for research purposes via online modules and an interactive workshop prior to data collection. 6-monthly refresher training as well as access to training resources (including a protocolised manual) will be made available to all assessors to support assessment fidelity.
Control group
Active

Outcomes
Primary outcome [1] 326434 0
A purpose-built composite score will be used to measure the proportion of comprehensive, high-dose aphasia treatment received. This score summarises the proportion of all recommended care received in a single score, and will be derived from individual participant receipt of clinical indicators of high-quality aphasia treatment from evidence-based recommendations, the CHAT program, and expert consensus. This tool will be developed and validated during the development phase of this study. Subject to change based on the outcomes of validation procedures, clinical indicators for the composite score include:
1. Information about aphasia is provided to the person with aphasia.
2. Information is provided to the person with aphasia’s primary carer(s) about…
a. Aphasia
b. Support
3. The primary communication partner and/or primary carer(s) of the person with aphasia are provided with communication partner training.
4. Goal setting is undertaken in partnership with the person with aphasia and their primary carer(s) and/or communication partner(s) (if possible).
5. The person with aphasia receives comprehensive aphasia therapy.
6. The person with aphasia receives high-dose aphasia therapy.
Data for input into the composite score will be derived from video/audio recordings of treatment sessions, treatment logs, a review of patients' chart notes, and will be triangulated via a patient and family member-reported outcome measure regarding care received.
Timepoint [1] 326434 0
The composite score will be calculated after the completion of 8 weeks of therapy for each patient in study arms 1 and 2 (i.e. usual care and CHAT implementation).
Secondary outcome [1] 402409 0
Service-level reach and participation
Obtained through:
1. Description of service provision at each site obtained through a series of questionnaires specifically-designed for this study;
2. Number of enquiries about the CHAT program obtained from medical record data.
Timepoint [1] 402409 0
Prior to baseline assessment of the participant during Usual Care, CHAT Components and CHAT Implementation and ongoing as service-level situation changes, CHAT enquiries change, and/or new clinicians are recruited (years 1-4).
Secondary outcome [2] 402420 0
Treatment fidelity:
Evaluated through structured observation and documentation of CHAT components (including rationale), a CHAT adjustment/adaptation log, video/audio recording CHAT therapy sessions, session logs, participant engagement (ie dose received), dose delivered (ie days of therapy, duration, number of days/sessions per day, session length, session density, repetition, task difficulty, task complexity), time spent on other areas of SP practice (as documented in treatment logs), and discharge and follow-up procedures. This is completed as an audit of the proportion of comprehensive aphasia treatment received (via the composite score).
Timepoint [2] 402420 0
CHAT fidelity data will be obtained throughout arm 2 of this study (CHAT implementation, years 3-4) and during the development phase (CHAT components, years 1-2). Composite scores will be calculated on completion of each treatment block for CHAT Implementation only.
Secondary outcome [3] 402476 0
Stakeholder perspectives
Obtained via semi-structured interviews and/or focus groups at a service level, including discussion of barriers and facilitators to implementation.
Timepoint [3] 402476 0
For arm 2 (CHAT Implementation arm): Prior to CHAT Implementation training and data collection phase (i.e. post-usual care), and after CHAT Implementation data collection phase (end year 4); prior to and post-data collection phase for CHAT components (years 1-2).
For the preparatory arm: post-implementation of each CHAT component.
Secondary outcome [4] 402477 0
Service-level economic evaluation
Service-level economic data (e.g. number of speech pathologists employed, designated FTE, appointment level, allied health assistants, student involvement) obtained via economic data for the organisation from managerial records.
Timepoint [4] 402477 0
Obtained for control arm 1 (Usual Care) and intervention arm 2 (CHAT Implementation), years 1-4; data collection ongoing throughout each study arm.
Secondary outcome [5] 402478 0
Patient satisfaction Questionnaire in aphasia-friendly format, relating to satisfaction with goal-setting, treatment planning, impairment-based therapy, computer therapy, functional therapy, and/or group therapy. Questionnaires developed specifically for this study.
Timepoint [5] 402478 0
Immediately post-8 weeks of therapy for participants in arm 2 (CHAT Implementation) and the development phase (CHAT Components).
Secondary outcome [6] 402479 0
Patient perspectives
Semi-structured interviews and/or focus groups investigating experiences of receiving CHAT components or the whole CHAT program.
Timepoint [6] 402479 0
Immediately post-8 weeks of therapy for participants in arm 2 (CHAT Implementation).
Secondary outcome [7] 402480 0
Clinical effectiveness: language outcomes
Obtained via completion of a language assessment battery, the Comprehensive Aphasia Test (CAT).
Timepoint [7] 402480 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment.
Data collected in both arms 1 (usual care) and 2 (CHAT Implementation) and the development phase (CHAT Components).
Secondary outcome [8] 402481 0
Clinical effectiveness: health-related quality of life
Obtained via the Stroke and Aphasia Quality of Life-39 (SAQOL-39) measure for people with aphasia.
Timepoint [8] 402481 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation)
Secondary outcome [9] 402482 0
Patient minimal important change in communication abilities: a 6-point Likert scale completed by the person with aphasia. Asks how much communication has changed as a result of therapy.
Timepoint [9] 402482 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation)
Secondary outcome [10] 402483 0
Fatigue: Chalder Fatigue Scale (CFS): questionnaire to assess mental and physical fatigue of person with aphasia.
Timepoint [10] 402483 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation)
Secondary outcome [11] 402484 0
Motivation: the Stroke Rehabilitation Motivation Scale - 7 item (SRMS-7) in aphasia-friendly version.
Timepoint [11] 402484 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation)
Secondary outcome [12] 402485 0
Clinician satisfaction: satisfaction questionnaire to assess satisfaction with the CHAT program and its components, designed specifically for this study.
Timepoint [12] 402485 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in arm 2 (CHAT Implementation).
Secondary outcome [13] 402486 0
Clinician perspectives
Semi-structured interviews/focus groups from a sample of speech pathologists to explore satisfaction with and perspectives on patient outcomes, feasibility and acceptibility of intervention in context, as well as barriers/facilitators to implementation.
Timepoint [13] 402486 0
Prior to CHAT Implementation training and data collection phase (i.e. post-usual care), and after CHAT Implementation data collection phase (end year 4); post-data trial of CHAT components during the preparatory phase (years 1-2).
Secondary outcome [14] 404119 0
Clinician-Level Reach and Participation
Clinician information (e.g. qualification and level of experience) obtained from a series of questionnaires specifically-designed for this study, and via semi-structured interviews and/or focus groups.
Timepoint [14] 404119 0
Prior to patient baseline assessment for Usual Care, CHAT Components and CHAT Implementation however may be ongoing throughout the project e.g. for CHAT enquiries and where changes occur (years 1-4)
Secondary outcome [15] 404123 0
Patient-level reach and participation
Obtained through goal-attainment scaling engagement scales entered into REDCap.
Timepoint [15] 404123 0
Collected post-treatment in arm 1 (usual care), the preparatory phase, and arm 2 (CHAT Implementation).
Secondary outcome [16] 404127 0
Stakeholder self-report barriers change
Obtained via self-report barriers change score questionnaire based on the Theoretical Domains Framework (attitudes, knowledge, skills and barriers) developed specifically for this study.
Timepoint [16] 404127 0
prior to Usual Care arm (start year 1), midway through Usual Care data collection, prior to CHAT Implementation arm (i.e. post-usual care), halfway through CHAT Implementation data collection, and post-CHAT Implementation arm (end year 4); prior to, midway through and post-development phase (implementation of CHAT Components (years 1-2))
Secondary outcome [17] 404128 0
Stakeholder perspectives organisational readiness for change
Obtained through the Organisational Readiness for Implementing Change (ORIC) questionnaire.
Timepoint [17] 404128 0
prior to Usual Care (start year 1), midway through Usual Care, prior to CHAT Implementation (i.e. post-usual care), halfway through CHAT Implementation, and post-CHAT Implementation (end year 4); prior to, midway through and post-implementation of CHAT Components (years 1-2)
Secondary outcome [18] 404129 0
Patient-level economic evaluation
Obtained through:
Resource use diary completed by the patient and their carer/significant other.
Resource use questionnaire completed y patients and their carer/significant other.
Both the resource use diary and resource use questionnaire were designed specifically for this study.
Timepoint [18] 404129 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment.
Data collected in both arms 1 (usual care) and 2 (CHAT Implementation).
Secondary outcome [19] 404130 0
Carer satisfaction
Questionnaire relating to satisfaction with goal-setting, impairment-based therapy, computer therapy, functional therapy, and/or group therapy.
Questionnaire developed specifically for this study.
Timepoint [19] 404130 0
Immediately post-8 weeks of therapy for participants in arm 2 (CHAT Implementation).
Secondary outcome [20] 404131 0
Carer perspectives
Obtained via semi-structured interviews and/or focus groups, investigating experiences of receiving either CHAT Components or the whole CHAT program.
Timepoint [20] 404131 0
Immediately post-8 weeks of therapy for participants in arm 2 (CHAT Implementation)
Secondary outcome [21] 404132 0
Clinical effectiveness: functional communication abilities
Obtained using the Communication Effectiveness Index (CETI), a proxy-rated measure of functional communication. Data collected from communication partner.
Timepoint [21] 404132 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment.
Data collected in both arms 1 (usual care) and 2 (CHAT Implementation) and the development phase (CHAT Components).
Secondary outcome [22] 404133 0
Clinical effectiveness: communication in everyday life
Obtained via the Scenario Test UK, a performance-based measure of communication of the participant with aphasia in everyday life.
Timepoint [22] 404133 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation).
Secondary outcome [23] 404134 0
Clinical effectiveness: Communication confidence
Obtained via the Communication Confidence Rating Scale for Aphasia (CCRSA),a self-report measure of confidence in communication within everyday life.
Timepoint [23] 404134 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation).
Secondary outcome [24] 404135 0
Clinical effectiveness: global quality of life
Obtained via the EQ-5D-5L health questionnaire: measures mobility, personal care, usual activities, pain/discomfort, and anxiety/depression. Self-complete (by person with aphasia) and proxy measures (completed by carer) available.
Timepoint [24] 404135 0
Baseline, immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation).
Secondary outcome [25] 404136 0
Clinician self-reported barriers change
Obtained via self-reported barriers change score questionnaire developed for this study based on the Theoretical Domains Framework (attitudes, skills, knowledge, and other barriers).
Timepoint [25] 404136 0
Prior to, halfway through and post- Usual Care and CHAT Implementation arms; pre- and post-development phase (implementation of CHAT Components)
Secondary outcome [26] 404137 0
Clinician perspectives organisational readiness for change
Obtained via the Organisational Readiness to Implement Change (ORIC) questionnaire.
Timepoint [26] 404137 0
Prior to, halfway through and post- Usual Care and CHAT Implementation arms; pre- and post-development phase (implementation of CHAT Components)
Secondary outcome [27] 404138 0
Speech Pathologist minimal important change in communication abilities: a 6-point Likert scale completed by the treating speech pathologist/s. Asks how much communication has changed as a result of therapy.
Timepoint [27] 404138 0
Immediately after 8 weeks of treatment, and 3 months after treatment. Data collected in both arms 1 (usual care) and 2 (CHAT Implementation).
Secondary outcome [28] 417326 0
The General Health Questionnaire will be administered with people with aphasia as a measure of participant distress, as a screener for anxiety and depression.
Timepoint [28] 417326 0
Baseline, immediately post the 8-week therapy period, and at the 3 month follow up timepoints during arm 1 (usual care) and 2 (CHAT Implementation).
Secondary outcome [29] 417327 0
People with aphasias' perspectives on the degree to which treatment delivered was individualised to their needs will be measured via a therapeutic alliance survey based on Duncan & Miller (2003). Treating speech pathologists may also use this measure to better tailor their therapy to the needs of the person with aphasia throughout treatment, and will inform the acceptability of treatment during the development phase.
Timepoint [29] 417327 0
This measure will be administered at the end of each therapy session during the preparatory arm and arm 2 (CHAT Implementation).
Secondary outcome [30] 417328 0
Feasibility of implementing the goal-setting and clinical planning model, measured through analysis of proportion of patients from whom a treatment plan was completed, and time and frequency spent engaged in clinical planning activities. This information will be obtained via a program-specific therapy planning document and the treatment log.
Timepoint [30] 417328 0
Following delivery of 8 weeks therapy during the preparatory arm.
Secondary outcome [31] 417329 0
Potential effectiveness of the goal setting and clinical planning model will be determined by examining whether treatment was goal-directed, individualised to the person with aphasia, and whether appropriate evidence-based treatments were provided to target the patient's goals relative to their language impairment. This will be determined via review of treatment notes, therapy logs, and therapy videos, subjectively graded by members of the research team, to determine whether these parameters are/are not evident in treatment delivery using a checklist specifically designed for this study.
Timepoint [31] 417329 0
Following the 8 week treatment period during the development arm and arm 1 (usual care) in the first 1-2 years of this trial.
Secondary outcome [32] 417330 0
Patient-reported outcome measure during arm 1 and 2.
The PROM will measure patient perspectives on whether key aphasia care elements (as specified within the composite score) were received, and their degree of satisfaction with these care elements. PWA will firstly indicate whether each care element was/wasn't received, and will then rate their satisfaction (if received) on a 5-point rating scale from no - definitely not, to yes- definitely.
Timepoint [32] 417330 0
Post 8 weeks of therapy.
Secondary outcome [33] 417331 0
Family-reported outcome measure.
The PROM will measure family member perspectives on whether key aphasia care elements (as specified within the composite score) were received, and their degree of satisfaction with these care elements. Family members will firstly indicate whether each care element was/wasn't received, and will then rate their satisfaction (if received) on a 5-point rating scale from no - definitely not, to yes- definitely.
Timepoint [33] 417331 0
Post 8 weeks of treatment.

Eligibility
Key inclusion criteria
Group 1: Patients admitted to one of the sites with post-stroke aphasia who meet the following eligibility criteria will be eligible to participate in the study:
Inclusion criteria:
(1) Aged 18 years or older at time of consent.
(2) Documented stroke.
(3) > 1-month post onset of stroke.
(4) Presence of aphasia as identified by a speech pathologist using either:
a. The Language Screening Test (LAST) - (Flamand-Roze et al., 2011)
b. The Comprehensive Aphasia Test (CAT) - (Swinburn, Porter, & Howard, 2004)
Group 2: Treating staff and students
Qualified clinical speech pathologists and allied health assistants employed by the health service with experience working in aphasia rehabilitation and who are considered as treating clinicians for the usual care and/or CHAT arm of this trial will be eligible to participate in this study. All relevant staff involved in the delivery of the program within their clinical setting (allied health professionals, e.g., occupational therapists, physiotherapists, neuropsychologists, social workers playing a role in the delivery of therapy sessions) will be eligible to participate in this study. Students on placement at participating sites may also be involved and considered eligible.
Group 3: Non-treating stakeholders
Stakeholders supporting the implementation of the program within their clinical setting but not involved in the delivery of usual care and/or the CHAT program will be eligible to participate.
This includes speech pathologists not involved in delivery of usual care and/or the CHAT program, allied health assistants not involved in the delivery of usual care and/or the CHAT program, allied health professionals, nursing staff, administrative and support staff (including food services and transport staff), medical staff and service/clinical managers working at the participating sites.
Group 4: Family members, significant others and/or carers of patients with post-stroke aphasia will be eligible to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group 1: Patients admitted to one of the sites with post-stroke aphasia
Exclusion criteria:
1) Absence of functional English skills in those of non-English speaking background
2) Significant co-morbidities that would prevent participation in aphasia rehabilitation as determined by the treating speech pathologist in consultation with the multi-disciplinary team
3) People with aphasia who have previously been enrolled in the study in Usual Care (arm 1, control period) will not be included in CHAT Implementation (arm 2, intervention period)

People with aphasia who do not have capacity to provide consent to this research will not be eligible to participate until a time when they are deemed to have capacity to consent to research. Consent may be obtained via signed written consent, verbal consent, or non-verbal consent depending on the usual communication preferences and abilities of the person with aphasia.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This will be a multi-centre, pragmatic, prospective non-randomized before-and-after trial. This study has two consecutive study arms: 1) usual care (control period) and 2) CHAT Implementation (intervention period). No patient participants will be recruited to both of these study arms.
NB: the development phase, CHAT Components, will occur at the same time as Usual Care (i.e. years 1-2), however will not involve sites that are participating in the Usual Care arm.

Blinding will be used for the assessment of the primary outcome measure.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Service level data: median regression adjusted for patient clustering by service (to project against residual confounding) will be used to compare differences between pre- and post-usual care and intervention periods. Multilevel logistic regression analysis will be used for dichotomised outcomes such as those relating to individual indicators.

Patient level data: linear mixed models will be used to evaluate effectiveness of CHAT implementation vs usual care and to determine if outcomes vary over time and/or across groups. All outcomes are measured on an interval scale. Adjustment for potential confounders (including linear trends) will be performed. Baseline characteristics of the Usual Care and CHAT Implementation groups (arms 1 and 2) will be examined prior to modelling to account for any differences between groups and to adjust the model to account for confounding effects. Collinearity of the covariates will be assessed before including them into the modelling. Linear mixed model results will be presented in the form of odds ratios and their 95% confidence intervals.

Clinician level data: descriptive statistics (m, SD, IQR); mean within-group differences using paired t-tests and 95% CIs for continuous data.

All qualitative data: content analysis guided by a theoretically grounded approach (e.g the Theoretical Domains Framework) to analyse barriers and facilitators to implementation. Comparative analysis will occur between sources (e.g. between speech pathologists, patients with aphasia, significant others etc.) to identify common and distinctive themes.

Process evaluation: qualitative patient, clinician and researcher perspectives will be explored via the RE-AIM framework and considered in conjunction with process and fidelity data to evaluate reach, implementation and maintenance/sustainability. This will be triangulated and completed prior to knowledge of the trial effectiveness outcomes to minimise bias.

Economic evaluation: costs of Usual Care and CHAT Implementation (arms 1 and 2) will be calculated through comparison to a standard reference year (2023) and appropriate unit prices will be applied as appropriate to determine the net difference in $/unit improvement on relevant outcome measures. Cost-utility analysis will include the use of quality-adjusted life years as an outcome metric. Multivariable probabilistic and sensitivity analyses will be performed to assess robustness of incremental cost-effectiveness ratios and account for variability. Methods for statistical analysis will be refined throughout this project as these are new methods for this field.

Data analysis for the preparatory phase: descriptive statistical methods (such as pre-post comparisons of average scores and ranges) will be used to analyse quanitative data obtained during the development arm to compare outcomes pre-post implementation of CHAT components. The anticipated small sample size of 16-20 participants will likely prevent statistical analysis of these outcomes and is not recommended for the conduct of pilot/feasibility research of this nature (Eldridge et al., 2016).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
188
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 307773 0
Government body
Name [1] 307773 0
National Health and Medical Research Council
Country [1] 307773 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Queensland, 4072
Australia
Country
Australia
Secondary sponsor category [1] 308478 0
University
Name [1] 308478 0
The University of Technology Sydney
Address [1] 308478 0
15 Broadway
Ultimo, NSW
2007
Australia
Country [1] 308478 0
Australia
Secondary sponsor category [2] 311099 0
University
Name [2] 311099 0
Monash University
Address [2] 311099 0
Wellington Road
Clayton, VIC
3800
Australia
Country [2] 311099 0
Australia
Secondary sponsor category [3] 311100 0
University
Name [3] 311100 0
Southern Cross University
Address [3] 311100 0
Gold Coast Airport
Terminal Drive
Bilinga, QLD
4225
Country [3] 311100 0
Australia
Other collaborator category [1] 282042 0
Government body
Name [1] 282042 0
Central Adelaide Local Health Network (Hampstead Rehabilitation Centre, the Queen Elizabeth Hospital)
Address [1] 282042 0
Hampstead Rehabilitation Centre: 207-235 Hampstead Rd, Northfield SA 5085
The Queen Elizabeth Hospital: 28 Woodville Rd, Woodville South SA 5011
Country [1] 282042 0
Australia
Other collaborator category [2] 282044 0
Other Collaborative groups
Name [2] 282044 0
Australian Aphasia Association
Address [2] 282044 0
PO Box 6104, St Lucia QLD 4067
Country [2] 282044 0
Australia
Other collaborator category [3] 282045 0
Government body
Name [3] 282045 0
Cairns Hinterland Hospital and Health Service (Cairns Hospital, Innisfail Hospital and Adult Community Health Services)
Address [3] 282045 0
Cairns hospital: 165 The Esplanade, Cairns QLD 4870
Innisfail hospital: 87 Rankin St, Innisfail QLD 4860
Adult Community Health Services: 381 Sheridan St, Cairns North QLD 4870
Country [3] 282045 0
Australia
Other collaborator category [4] 282046 0
Government body
Name [4] 282046 0
Metro North Hospital and Health Service (Surgical Treatment and Rehabilitation Service (STARS), The Prince Charles Hospital, and Community and Oral Health)
Address [4] 282046 0
STARS: 296 Herston Rd, Herston QLD 4029
TPCH: 627 Rode Rd, Chermside QLD 4032
Community and Oral Health: 490 Hamilton Road, Chermside QLD 4032
Country [4] 282046 0
Australia
Other collaborator category [5] 282047 0
Government body
Name [5] 282047 0
Illawarra Shoalhaven Local Health District (Port Kembla Hospital, Shoalhaven District Memorial Hospital, Wollongong Hospital, Shellharbour Hospital, Coledale Hospital, Bulli Hospital and Aged Care Centre, David Berry Hospital)
Address [5] 282047 0
Port Kembla Hospital: 89-91 Cowper Street, Warrawong NSW 2502
Shoalhaven District Memorial Hospital: Scenic Dr, Nowra NSW 2541
Wollongong Hospital: Loftus St, Wollongong NSW 2500
Shellharbour Hospital: 15-17 Madigan Blvd, Mount Warrigal NSW 2528
Coledale Hospital: 638-646 Lawrence Hargrave Dr, Thirroul NSW 2515
Bulli Hospital: Hospital Rd, Bulli NSW 2516
David Berry Hospital: 85 Tannery Rd, Berry NSW 2535
Country [5] 282047 0
Australia
Other collaborator category [6] 282048 0
Hospital
Name [6] 282048 0
Metro South Health (Princess Alexandra Hospital)
Address [6] 282048 0
199 Ipswich Rd, Woolloongabba QLD 4102
Country [6] 282048 0
Australia
Other collaborator category [7] 282049 0
Government body
Name [7] 282049 0
Sunshine Coast Hospital and Health Service (Sunshine Coast University Hospital, Gympie Hospital)
Address [7] 282049 0
SCUH: 6 Doherty St, Birtinya QLD 4575
Gympie Hospital: 12 Henry St, Gympie QLD 4570
Country [7] 282049 0
Australia
Other collaborator category [8] 282050 0
Other Collaborative groups
Name [8] 282050 0
Speech Pathology Australia
Address [8] 282050 0
Level 1 / 114 William Street
Melbourne Victoria 3000
Australia
Country [8] 282050 0
Australia
Other collaborator category [9] 282051 0
Government body
Name [9] 282051 0
Queensland Government Statewide Rehabilitation Clinical Network
Address [9] 282051 0
GPO Box 48, Brisbane 4001
Country [9] 282051 0
Australia
Other collaborator category [10] 282052 0
Charities/Societies/Foundations
Name [10] 282052 0
Stroke Foundation
Address [10] 282052 0
Level 7, 461 Bourke Street Melbourne VIC 3000
Country [10] 282052 0
Australia
Other collaborator category [11] 282053 0
Government body
Name [11] 282053 0
West Moreton Health (Ipswich Hospital, Community-Based Rehabilitation Team)
Address [11] 282053 0
Ipswich Hospital: Chelmsford Ave, Ipswich QLD 4305
CBRT: 2 Bell Street, Ipswich QLD 4305
Country [11] 282053 0
Australia
Other collaborator category [12] 282059 0
Other Collaborative groups
Name [12] 282059 0
Queensland Health Allied Health Translating Research Into Practice (AH-TRIP)
Address [12] 282059 0
37 Kent Street,
Woolloongabba QLD 4102
Australia
Country [12] 282059 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307794 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 307794 0
Ethics committee country [1] 307794 0
Australia
Date submitted for ethics approval [1] 307794 0
22/10/2021
Approval date [1] 307794 0
25/11/2021
Ethics approval number [1] 307794 0
HREC/2021/QRBW/72154

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

Contacts
Principal investigator
Name 108518 0
Prof David Copland
Address 108518 0
The University of Queensland
St Lucia, QLD 4072

The University of Queensland, Queensland Aphasia Research Centre
Situated within the Surgical Treatment and Rehabilitation Service (STARS)
296 Herston Rd, Herston QLD 4029
Country 108518 0
Australia
Phone 108518 0
+61 733465539
Fax 108518 0
Email 108518 0
d.copland@uq.edu.au
Contact person for public queries
Name 108519 0
David Copland
Address 108519 0
The University of Queensland
St Lucia, QLD 4072

The University of Queensland, Queensland Aphasia Research Centre
Situated within the Surgical Treatment and Rehabilitation Service (STARS)
296 Herston Rd, Herston QLD 4029
Country 108519 0
Australia
Phone 108519 0
+61 733465539
Fax 108519 0
Email 108519 0
d.copland@uq.edu.au
Contact person for scientific queries
Name 108520 0
David Copland
Address 108520 0
The University of Queensland
St Lucia, QLD 4072

The University of Queensland, Queensland Aphasia Research Centre
Situated within the Surgical Treatment and Rehabilitation Service (STARS)
296 Herston Rd, Herston QLD 4029
Country 108520 0
Australia
Phone 108520 0
+61 733466110
Fax 108520 0
Email 108520 0
d.copland@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethical approval to share individual participant data.


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.