None listed
Conditions
Brief summary
Physical inactivity is a global health problem causing 5.3 million deaths per year and costing healthcare systems $53.8 billion worldwide in 2013. Those who are most profoundly inactive account for a disproportionately high percentage of the deaths and healthcare costs that are attributable to physical inactivity, thus strategies which target those with low activity are required. People with moderate to severe traumatic brain injury (msTBI) are particularly inactive in the long-term, increasing the risk of preventable disease and compounding the primary effects of TBI in this typically young adult population. Our team was funded by the Medical Research Future Fund TBI Mission to develop the first Physical Activity Clinical Practice Guideline for people living with msTBI (Stage One). Our guideline was developed for the Australian context in collaboration with key stakeholders, including people living with msTBI, their families, carers and health professionals. It includes 10 recommendations for children, adolescents, adults, and older adults living with moderate to severe TBI for the delivery and promotion of physical activity across the continuum of care. The next phase of this work is to conduct implementation research to support national adoption of clinical guidelines for people with msTBI. We plan to conduct a hybrid type III implementation-effectiveness cluster RCT in 20 rehabilitation services across Australia. The trial aims to evaluate the effectiveness of implementation support to teams of health professionals working in rehabilitation services to increase concordance with the Australian Physical Activity Clinical Practice Guideline recommendations for people with msTBI (immediate-implementation sites) compared to services who do not receive implementation support (waitlist sites). Qualitative and economic sub-studies are embedded within the trial. We will initially collect service-level data and work with sites to identify implementation support strategies for each participating site during a service mapping process for all teams. Sites will then be randomised into either immediate implementation support or delayed implementation support (waitlist control). Teams in the immediate implementation support will receive a tailored implementation strategies for 3-months to support the prescription and promotion of physical activity interventions consistent with the guideline recommendations. Teams in the delayed group will receive the implementation strategies after collection of the primary outcome (6-months). We hypothesise that health professionals in the immediate implementation support group will demonstrate higher levels of concordance with the guideline recommendations compared with health professionals in the delayed group.
Interventions
Description of intervention(s) / exposure: This is a hybrid type III implementation-effectiveness cluster randomised controlled trial (RCT) in 20 rehabilitation services across Australia. A hybrid type III trial is one in which the primary focus is evaluating the success of implementation strategies to help people or organisations put evidence-based interventions or policies into practice, while the secondary focus is on evaluating patient-level outcomes. This clinical trial aims to evaluate the
Description of intervention(s) / exposure: This is a hybrid type III implementation-effectiveness cluster randomised controlled trial (RCT) in 20 rehabilitation services across Australia. A hybrid type III trial is one in which the primary focus is evaluating the success of implementation strategies to help people or organisations put evidence-based interventions or policies into practice, while the secondary focus is on evaluating patient-level outcomes. This clinical trial aims to evaluate the effectiveness of implementation support to teams of health professionals working in rehabilitation services to increase concordance with the Australian Physical Activity Clinical Practice Guideline recommendations for people with moderate to severe traumatic brain injury (msTBI) (immediate-implementation sites) compared to services who do not receive implementation support (waitlist sites). The trial involves i) Implementation strategies delivered by the research team to health professionals to support them to prescribe and promote physical activity interventions in concordance with guideline recommendations within their routine care; and ii) Evidence-based physical activity interventions delivered by health professionals to msTBI patients within their routine care. Qualitative and economic sub-studies are embedded within the trial. IMPLEMENTATION STRATEGIES The implementation strategies selected will be described using terminology from the Expert Recommendations for Implementing Change (ERIC) taxonomy (Powell et al., 2015) and will address barriers to guideline implementation identified from our Stage one audit of health services and interest-holder focus groups. The strategies will be delivered to the sites by a central implementation support team over a 3-month period and will predominantly be delivered to teams of health professionals working in rehabilitation services with teams randomised to receive the strategies either immediately (intervention) or delayed (waitlist control). The Capabilities, Opportunities, Motivation-Behaviour (COM-B) behaviour change theoretical model (Michie, van Stralen, & West, 2011) has been used to identify and categorise facilitators and barriers to guide our selection of implementation strategies. Additional strategies may be added if new barriers to implementation of the guideline recommendations are identified. The current planned implementation strategies can be categorised under four main activities: 1) service mapping and implementation planning; 2) online resource hub; 3) site capacity building; and 4) advocacy for policy change. The chosen strategies are considered effective at improving professional practices of health professionals (e.g., physiotherapists, exercise physiologists), and will be considered practical, feasible, and acceptable to our interest-holders. Implementation activity 1: Service mapping and implementation planning Implementation strategies: Conduct local needs assessment; assess for readiness and identify barriers and facilitators; develop a formal implementation blueprint. Target audience/ mode of delivery/ who delivered: Eligible health professionals at recruited sites/ in-person (or online if needed)/ research team (central implementation support). Time-frame: Pre-implementation, prior to randomisation Barriers targeted: Heterogeneous clinical sites requiring tailoring of implementation support. Detailed description of intervention: All sites will take part in the service mapping and implementation planning which will occur prior to the implementation period (immediate implementation group) or baseline (delayed implementation group). A member (or members) of the research team will attend a face-to-face session with recruited health professionals at each site for approximately two-hours and conduct the service mapping and implementation planning. Implementation activity 2: Online resource hub Implementation strategies: Create a learning collaborative; develop and distribute educational materials; use advisory boards; promote network weaving; capture and share local knowledge; conduct ongoing training; involve patients/consumers and family members. Target audience/ mode of delivery/ who delivered: Health professionals in the trial, their patients, and other relevant interest-holders/ closed website with password protected learning management system for health professional training created by research team and co-designed with interest-holders. Time-frame: Open to study sites from the commencement of their 3-month implementation support period (immediate or delayed). Access maintained after this period. Barriers targeted: Capability, opportunity and motivation of health professionals; barriers across socioecological model (i.e., individual patient-level, interpersonal, community and organisation, and policy). Detailed description of intervention: The resource hub will include: i) A range of educational and motivational resources will be available targeting different interest-holders. For example, motivational and informational videos of people with msTBI being active, templates for funding requests, educational brochures on brain injury and physical activity, procedures for delivery of physical activity interventions; ii) Guideline recommendations presented in different formats (e.g., infographics); iii) Online training courses for health professionals supporting the prescription and promotion of physical activity interventions; and iv) Links to other relevant sites. Resources will continue to be developed with sites throughout the trial. Implementation activity 3: Site capacity building Implementation strategies: Prepare site champions; conduct educational outreach visits; conduct ongoing training; capture and share local knowledge; facilitation; organise clinician implementation team meetings. Target audience/ mode of delivery/ who delivered: Health professionals in the trial/ in-person and online/ research team. Time-frame: 3-month implementation period. Barriers targeted: Motivation (beliefs about interventions); Capability (knowledge and skills); and Opportunity (social and physical). Detailed description of intervention: Tailored to site education and training needs, provided onsite by research team with content expertise (e.g., Investigators Hassett [aerobic exercise], Williams [mobility and strength training]). Where possible, the delivery of the training and education will be aligned with the sites continuing professional development requirements and schedule. Online training resources will be developed with sites and shared via online resource hub to support ongoing training needs. Implementation activity 4: Advocacy for policy change Implementation strategies: Tailor strategies to address barriers. Target audience/ mode of delivery/ who delivered: Government; community physical activity organisations/ mixed/ research team and project investigators. Time-frame: Throughout the trial targeting policies in the community setting of implementation sites. Barriers targeted: Community factors (e.g., accessibility, community physical activity options, belonging) and policy factors (e.g., funding complexities; legislation limiting choice). Detailed description of intervention: We will leverage this national project to seek opportunities to advocate for accessible community-based physical activity and contribute to policy discussions that support funding for evidence-based physical activity. Examples through our online hub may include accessibility checklists for community settings. EVIDENCE-BASED INTERVENTION The intervention to be implemented is physical activity in concordance with the 10 recommendations from the Australian Physical Activity Clinical Practice Guideline for people with msTBI (Hassett, Johnson et al., 2025). The guideline recommends the delivery of aerobic exercise, strength training, mobility training, sport and physical recreation, and the promotion of overall physical activity by health professionals to children and adolescents, and adults and older adults with msTBI. The physical activity interventions are recommended to be delivered across the continuum of care (i.e., inpatient, outpatient, and community); and each recommendation has actionable good practice points (GPPs) for health professionals to put the recommendation into practice. The physical activity interventions will be delivered by health professionals for whom the prescription and promotion of physical activity is within their scope of practice. This will primarily be physiotherapists and exercise physiologists, but may include other health professionals (e.g., leisure therapists). Participating health professionals will use physical and/or informational materials used in their routine prescription and promotion of physical activity, as well as any further resources and materials provided or accessed via the implementation support strategies described above. The specific prescription (i.e., mode, frequency, intensity, and duration of physical activity) will be variable across patients depending on their impairments and level of disability and where they are along the continuum of rehabilitation care. Delivery of the intervention will be monitored by a research assistant blinded to site randomisation who will review the health professional’s prescription and promotion of physical activity via their msTBI patients electronic medical records.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Sites will be eligible if: - They are a rehabilitation service that provides rehabilitation treatment for adults and/or children with msTBI (defined as posttraumatic amnesia greater than or equal to 24 hours; or Glasgow Coma Scale on hospital admission less than or equal to 12; or loss of consciousness at time of injury >30mins) (Bradshaw, 2008). - They have patients with msTBI that the team of health professionals would prescribe and/or promote physical activity to over a six-month period. Health professional participants - A health professional providing inpatient, outpatient, transitional and/or community-based clinical services within a participating rehabilitation service that admits adults and/or children with msTBI. - Health professionals who have the scope of practice to include physical activity prescription and promotion, primarily physiotherapists and exercise physiologists. - Willingness to provide informed consent and willingness to participate and comply with the study requirements. Patient participants - children and adolescents, adults and older adults with msTBI (defined as posttraumatic amnesia greater than or equal to 24 hours; or Glasgow Coma Scale on hospital admission less than or equal to 12; or loss of consciousness at time of injury >30mins) (Bradshaw, 2008) who are current clients of participating health professionals and eligible to receive delivery and/or promotion of physical activity during the 6-month patient-recruitment period for that site, and who are willing to answer a short telephone-based survey (or written/online survey if preferred) on quality of life and physical activity participation at baseline, and at 3-, 6- and 12-months post study recruitment. - Sufficient cognitive, behavioural and language capabilities to respond to verbal questionnaires independently or with the help of informal/formal supports (e.g., parent, guardian, support worker) if needed. - Able to provide written or verbal response in English or a preferred language using translated study documents and/or in the presence of a NAATI ((National Accreditation Authority for Translators and Interpreters) ) Health Language Interpreter or bilingual health worker.
Exclusion criteria
Health professional participants .- Health professionals who are not working in relevant clinical areas outlined above will be excluded from participation in this study. Patient participants - Participants who have a medical condition precluding physical activity/exercise, have insufficient capabilities or support of another person to respond to written or verbal questionnaires, or have a progressive neurological disease or condition (e.g., delirium, severe psychiatric disorders) will be excluded from participation in this study.
Outcome results
None listed