Authors
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The University of Sydney -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: As this is a hybrid type II implementation effectiveness trial there are two interventions; 1. Implementation strategies delivered by the research team to the physiotherapists to support them to incorporate physical activity counselling into their routine care; and 2. Evidence‐based intervention (physical activity counselling) delivered by physiotherapists to their patients within their routine care. 1. Implementation strategies: Clinical physiotherapists randomised to the intervention group will have access to all implementation strategies to support and train them to incorporate physical activity counselling into their routine practice. The implementation strategies will include education and training (online and two face‐to‐face workshops three months apart) with tailored strategies to address community referral barriers, creation of a learning collaborative across the district, and facilitation and audit and feedback provided within teams to build clinicians’ Capabilities, Opportunities and Motivations to delivering physical activity counselling within routine care (see below for further information). The implementation strategies were derived from the Expert Recommendations for Implementing Change (ERIC) project(Powell B, 2015, Implement Sci) and the COM‐B behaviour change theoretical model (Michie S, 2011, Implement Sci) and are based around literature describing barriers physiotherapists report stop them from incorporating physical activity counselling into routine practice, as well as literature on existing programs and resources promoting physical activity in clinical or similar populations. In addition, as behaviour is context specific, the findings from pre‐implementation work (BEHAVIOUR part 1 survey conducted in 2020) and interview style consultat CONDITION: physical inactivity; ; physical inactivity Physical Medicine / Rehabilitation ‐ Physiotherapy Public Health ‐ Health promotion/education PRIMARY OUTCOME: Implementation: Reach, operationalized as the proportion of eligible new physiotherapy patients who receive physical activity counselling, measured from screening log completed by physiotherapist.[During 3‐months of patient recruitment.] Patient level: Self‐reported time (hours/week) spent in planned physical activity over the last 7 days, measured using the planned activity subscale of the Incidental and Planned Exercise Questionnaire (IPEQ).[Patient baseline and 6‐months post patient baseline (primary timepoint).] SECONDARY OUTCOME: Implementation determinants: Change in clinician self‐reported Capabilities after receiving the implementation strategies (i.e. education and training (after online education and workshop 1 and 2), embedding PA counselling into practice (i.e. tailored strategies, learning collaborative, facilitation, audit & feedback) will be evaluated to explore determinants of implementation outcomes using a survey adapted from Webb J. et al (Public Health, 2016) and based on COM‐B self‐evaluation questionnaire (Michie S et al. 2014) (within group measure, immediate implementation group).[At the end of online education videos, at the end of workshop 1, just prior to workshop 2, and at the end of workshop 2, ] Implementation determinants: Change in clinician self‐reported Motivations after receiving the implementation strategies (i.e. education and training (after online education and workshop 1 and 2), embedding PA counselling into practice (i.e. tailored strategies, learning collaborative, facilitation, audit & feedback) will be evaluated to explore determinants of implementation outcomes using a survey adapted from Webb J. et al (Public Health, 2016) and based on COM‐B self‐evaluation questionnaire (Michie S et al. 2014) (immediate implementation group, within group measure). [At the end of online education videos, at the end of workshop 1, just prior to workshop 2, and at the end of workshop 2, ] Implementation determinants: Change in clinician self‐reported Opportunities after receiving the implementation strategies (i.e. education and training (after online education and workshop 1 and 2), embedding PA counselling into practice (i.e. tailored strategies, learning collaborative, facilitation, audit & feedback) will be evaluated to explore determinants of implementation outcomes using a survey adapted from Webb J. et al (Public Health, 2016) and based on COM‐B self‐evaluation questionnaire (Michie S et al. 2014) (immediate implementation group, within group measure). [At the end of online education videos, at the end of workshop 1, just prior to workshop 2, and at the end of workshop 2, ] Implementation: Adoption1‐ the number of clinical teams across the district who participated compared to the number who were identified by physiotherapy head of departments and invited to participate within department meetings (presented as a percentage), assessed by an audit of study records maintained by research team.[Recruitment period of 30 physiotherapy teams.] Implementation: Adoption2‐ percentage of eligible physiotherapists within clinical teams who participated in the study (participated in implementation strategies and attempted to deliver physical activity counselling to their patients), measured from attendance/completion sheets of implementation strategies (no between group comparison).[Prior to patient recruitment (immediate implementation group) and 3‐months after 6‐months post patient baseline (waitlist implementation group). ] Implementation: delivery of implementation strategies‐ Adoption: Number of clinicians or managers across the district that contribute content, resources or teaching within the implementation strategies, measured using a study‐specific training and resources log (no between group comparison).[Between randomisation of clinical teams to commencement of patient recruitment. ] Implementation: delivery of implementation strategies‐ Dose delivered: Average dose (hours) per clinical team of implementation strategies delivered (online videos, workshops, audit and feedback, facilitation sessions, learning collaborative, tailored strategies for community referral), measured using a study‐specific training and resources log (immediate implementation group, within group measure).[Between randomisation of clinical teams to commencement of patient recruitment. ] Implementation: delivery of implementation strategies‐ Reach1: Proportion of the different types of clinical physiotherapy teams across the district that participate in the implementation strategies measured from the study recruitment log (no between group comparison).[Prior to patient recruitment (immediate implementation group) and 3‐months after completion of 6‐months post patient baseline (waitlist implementation group).] Implementation: delivery of implementation strategies‐ Reach2: Number of new community physical activity providers identified and added into the study‐specific activity directory measured by research team auditing the study‐specific activity directory (immediate implementation group, within group measure). ; [Measured for each physiotherapy occasion of service from initial physiotherapy assessment to 6‐months post patient baseline.] Implementation: Fidelity1: Current physical activity counselling elements in usual care measured using a study specific checklist. ; [Physiotherapist baseline consent prior to randomisation and at end of implementation phase (prior to patient recruitment).] Implementation: Fidelity2: Physical activity counselling elements used with each recruited patient participant measured by physiotherapist self‐report using a study specific checklist (physical activity assessment, physical activity goal, tailored written action plan, provision of self‐monitoring strategy and resources, review physical activity status and advice, referral to ongoing physical activity). ; [Measured for each physiotherapy occasion of service from initial physiotherapy assessment to 6‐months post patient baseline.] Implementation: Reach2‐ percentage community physical activity providers referred to from number identified assessed by audit of study developed activity directory and study records maintained by physiotherapy teams (within group measure, immediate implementation group).[At the completion of the 6‐months post patient baseline.] Implementation: Reach2‐ percentage of patient participants that are from Culturally And Linguistically Diverse backgrounds that are recruited into the study and complete baseline and 6‐month assessments, assessed by audit of study baseline data records (no between group comparison).[Patient baseline and 6‐month post patient baseline,] Implementation: Sustainability‐ physical activity counselling elements used with a random sample of patients (not recruited into the study) of physiotherapy participants measured by audit of medical records using a study specific checklist (physical activity assessment, physical activity goal, tailored written action plan, provision of self‐monitoring strategy and resources, review physical activity status and advice, referral to ongoing physical activity). (within group measure, immediate implementation group).[Measured for each physiotherapy occasion of service over a 3‐month period starting from the 6‐month post patient baseline. ] Patient level: A study specific questionnaire will collect information on the participant’s impressions of their health care. Specifically, it will ask if they received advice about physical activity from their physiotherapist or other healthcare providers and if they experienced any adverse events (e.g. falls, cardiac events, musculoskeletal injuries) while participating in physical activity over the last 6 months.[6‐months post patient baseline.] Patient level: Average step count per day measured using Actigraph accelerometer model GT3X (Pensacola FL USA) (sub‐sample‐ patient participants will be asked to wear this for 7 days for 5‐10 teams within the trial).[Patient baseline and 6‐months post patient baseline.] Patient level: Barriers to participation in physical activity will be measured using the Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ‐MI). Eight domain and total score are calculated.[Patient baseline and 6‐months post patient baseline.] Patient level: Functioning and wellbeing will be measured using the Patient‐Reported Outcomes Measurement Information System (PROMIS‐29+2 Profile v2.1) [Patient baseline and 6‐months post patient baseline.] Patient level: Healthcare utilisation: within NSW Health will be collected directly from the Activity Based Management (ABM) portal. Frequency of all health encounters (i.e. hospitalisations, emergency department presentations and non‐admitted activities such as specialist consultation and physiotherapy) that participants have in NSW health facilities will be collected and costed using standard costings (such as Independent Hospital Pricing Authority (IHPA) and Medicare) to inform the health economic analysis.[Between patient baseline and 6‐month patient measures.] Patient level: Quality of life will also be measured using the EuroQOL‐5D‐5L five dimensions subscale scores (mobility, self‐care, usual activities, pain or discomfort, anxiety or depression)[Patient baseline and 6‐months post patient baseline.] Patient level: Quality of life will also be measured using the EuroQOL‐5D‐5L visual analogue scale score (0 to 100) [Patient baseline and 6‐months post patient baseline.] Patient level: Quality of life will be measured using the EuroQOL‐5D‐5L composite health utility score.[Patient baseline and 6‐months post patient baseline.] Patient level: Total physical activity (planned and incidental) will be measured using the total time in hours/week measured using the Incidental and Planned Exercise Questionnaire (IPEQ).[Patient baseline and 6‐months post patient baseline.] INCLUSION CRITERIA: Physiotherapy team inclusion: • anticipate they will remain employed within SWSLHD for the next 12 months; • either permanent or at least 6‐month rotation in the identified clinical team; • not working in a split role across two clinical tea ; [At the completion of 6‐month post patient baseline. ] Implementation: delivery of implementation strategies‐ Sustainability1: Percentage of clinical physiotherapists from immediate implementation group involved in delivering implementation strategies or providing resources to waitlist implementation group, measured using a study‐specific training and resources log and completed by research team (within group measure, immediate implementation group). [Measured over a 3‐month period from completion of 6‐months post patient baseline.] Implementation: delivery of implementation strategies‐ Sustainability2: Number of new physical activity opportunities identified between randomisation and 6‐months post patient baseline that were sustained, measured by study‐specific questionnaire of physiotherapists (immediate implementation group, within group measure). [At 3‐months after the 6‐month post patient baseline.] Implementation: delivery of implementation strategies‐Fidelity: The percentage of implementation strategy components that are implemented as prescribed in the study protocol including different implementation strategies, modes of delivery, COM‐B domain, category and intervention functions, proposed content and behaviour change techniques (BCTs), assessed using a study specific checklist of proposed implementation strategies and completed by research staff member not involved in the study (immediate implementation group, within group measure).[Between randomisation of clinical teams to commencement of patient recruitment. ] Implementation: Dose delivered: The dose of physical activity counselling will be measured for immediate and waitlist physiotherapy teams by self‐reported proportion of time spent on physical activity counselling within usual care sessions for recruited patient participants in the trial recorded on study screening log. ; [Measured for each physiotherapy occasion of service from initial physiotherapy assessment to 6‐months post patient baseline.] Implementation: Fidelity3: Physical activity counselling elements used with each recruited patient participant measured by audit of medical records using a study specific checklist (physical activity assessment, physical activity goal, tailored written action plan, provision of self‐monitoring strategy and resources, review physical activity status and advice, referral to ongoing physical activity). This trial will include 30 clusters. A cluster is defined as a hospital clinical team that provides a service for inpatients or outpatients within South Western Sydney Local Health District (SWSLHD), NSW, Australia, that has one or more physiotherapists within the team. For the cluster to be included in the trial there needs to be at least one physiotherapist within the team interested in participating and who meets the following eligibility criteria: • would treat at least 10 new adult patients with a physical disability (a physical disability or physical condition that restricts their mobility in some way and has lasted or is likely to last for > 6 months) within their clinical team over a 3‐month period;
Epistemonikos ID: 8f2ead9e5b785870f2a932cd5158e4558b862030
First added on: Aug 24, 2024