Implementation of Comprehensive High-Dose Aphasia Treatment (CHAT)

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.

Study arms: 1) usual care (control period, years 1, 2 and 3), and 2) CHAT Implementation (intervention period, years 4 -5). There will be a development phase in preparation for Arm 2 - Implementation of CHAT Components (years 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 online modules and an interactive1-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 4-5 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 participants as suitable to the rehabilitation service. 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 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 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 up to 6-7 hours of therapy per week over 8 weeks aiming for a total of 50 hours of therapy during years 4-5of this project. Outcome measurement will occur prior to CHAT therapy commencing. 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 logs for all 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 ; 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 resources and all required therapy programs.