Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000194864
Ethics application status
Approved
Date submitted
24/12/2020
Date registered
23/02/2021
Date last updated
17/02/2022
Date data sharing statement initially provided
23/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The implementation and effectiveness of Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR) on levels of patient physical activity.
Scientific title
The effect of Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR)
within routine care versus routine physiotherapy care alone on patient physical activity
levels: hybrid type II effectiveness-implementation cluster randomised controlled trial.
Secondary ID [1] 303078 0
APP1201086
Universal Trial Number (UTN)
U1111-1262-9223
Trial acronym
BEHAVIOUR (Brief Physical Activity Counselling by Physiotherapists)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 320149 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318095 318095 0 0
Physiotherapy
Public Health 318096 318096 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 consultation with local clinicians and physiotherapy managers have informed the implementation strategies to ensure the correct local influences are addressed as part of the implementation strategies.

Implementation strategy 1: Education
Mode of delivery/ where/ length: Series of short education videos /online/~ 1hr total
Time- frame: Prior to attending workshop 1
Intervention content: 3-10 min videos on different topics identified as knowledge gaps in BEHAVIOUR part 1 survey (conducted as part of pre-implementation work in 2020).

Implementation strategy 2: Education and training (Conduct educational meetings and ongoing training, change record systems, make training dynamic, promote adaptability)
Mode of delivery/ where/ length: Workshops 1 & 2: face-to-face workshop /at team’s hospital/ maximum 4 hours
Time- frame: workshop 1: 2-3 weeks after hospital rotation, workshop 2: 3-mths later.
Intervention content: Made up of presentations (e.g. how to do PA counselling- 1st encounter, follow up encounters, PA counselling with patients from Culturally And Linguistically Diverse (CALD) communities), tasks (e.g. role playing, using scripts, reviewing resources), discussions (e.g. group sharing reflections & experiences of content presented and practised) and audio clips (e.g. experienced PT delivering PA counselling). Paper-based and PDF manuals designed specifically for this study with slides and resources will be given to each participant. Resources will include links to available resources e.g. Moving Medicine https://movingmedicine.ac.uk/; WHO: https://www.who.int/health-topics/physical-activity; and copies of study developed resources.

Implementation strategy 3: Create a learning collaborative
Mode of delivery/ where/ length: Communication platform/online-Microsoft Teams/ length project
Time- frame: Added at workshop 1
Intervention content: Access to online videos, sharing resources developed across teams, place to communicate, ask questions, share feedback on audit

Implementation strategy 4: Tailored strategies to address community referral barriers
Mode of delivery/ where/ length: This will be tailored and determined with each team to address their specific context and the barriers they have with community referrals for their patients.
Time- frame: Start at workshop 1
Intervention content: Provide training in finding PA opportunities, help to develop links with physical activity services, referral resources, evaluation tools of community PA opportunities

Implementation strategy 5: Facilitation and Audit & Feedback within teams
Mode of delivery/ where/ length: Mix of face-to-face & remote delivery to included physiotherapists in immediate cluster teams/ in their clinical settings/ ~ monthly (1-2hrs)
Time- frame: Between workshop 1 & workshop 2
Intervention content: Working with team to identify/ modify/ develop resources for their team (including local Activity Directory or similar resource), identify & connect with appropriate PA opportunities, modify physiotherapy assessment forms to include PA information to collect, Audit and feedback with colleague between workshops.

2. Physical activity counselling within routine care
Patients who are recruited into the trial will receive their routine physiotherapy assessment and intervention to address the therapeutic reason that they have been referred to physiotherapy. This may include some aspects of physical activity counselling as we know from preliminary work done in the local health district that some physiotherapists incorporate some aspects of physical activity counselling in routine care. It is anticipated that patients who are treated by physiotherapists who have received the implementation strategies will be more likely to receive more elements of physical activity counselling as part of their usual practice (with no additional time added onto the consultation). The frequency and length of physiotherapy consultations will vary and will be based on the therapeutic reason the person has been referred for physiotherapy and the appointment schedules for the different teams. Therefore, the overall duration of the intervention will vary between teams and patients (depending on their therapeutic needs), however it will range between being seen for one day up to being seen over a period of 6 months in total.
Physical activity counselling refers to a component of patient consultation aimed at changing health behaviour as a means of primary or secondary prevention of life-style related chronic health conditions. The physical activity counselling intervention is underpinned by theoretical models of behaviour change (COM-B, Self Determination Theory, Social Cognitive Theory), Motivational Interviewing and incorporates behaviour change techniques shown to increase physical activity in the general population as well as people with physical disabilities. The physical activity counselling elements include: 1. Asking, raising the topic of physical activity; 2. Assessing physical activity levels (questionnaire or device-based) and influences on physical activity behaviour; 3. Provide tailored advice about physical activity (e.g. benefits, options- delivered verbally, or using handouts or website links); 4. Collaborative goal setting and action planning; 5. Arrange referral or signpost to community physical activity services/opportunities; 6. Provide self-monitoring strategies (e.g. activity diary, pedometer, phone App); 7. Review physical activity status, discuss barriers and facilitators in follow up treatment sessions; 8. Use motivational interviewing techniques (person-centred approach) throughout.
The fidelity of the delivery of physical activity counselling will be measured by audit of medical records and physiotherapist self-report checklist (see outcome measure section).
Intervention code [1] 319370 0
Prevention
Intervention code [2] 319371 0
Behaviour
Intervention code [3] 319372 0
Lifestyle
Comparator / control treatment
Waitlist control study. Teams of physiotherapists assigned to the waitlist control group will receive an updated version of the Implementation strategies at the completion of the patient 6 month measures.
Control group
Active

Outcomes
Primary outcome [1] 326081 0
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).
Timepoint [1] 326081 0
Patient baseline and 6-months post patient baseline (primary timepoint).
Primary outcome [2] 326082 0
Implementation: Reach, operationalized as the proportion of eligible new physiotherapy patients who receive physical activity counselling, measured from screening log completed by physiotherapist.
Timepoint [2] 326082 0
During 3-months of patient recruitment.
Secondary outcome [1] 390061 0
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).
Timepoint [1] 390061 0
Patient baseline and 6-months post patient baseline.
Secondary outcome [2] 390062 0
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).
Timepoint [2] 390062 0
Patient baseline and 6-months post patient baseline.
Secondary outcome [3] 390063 0
Patient level: Functioning and wellbeing will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29+2 Profile v2.1)
Timepoint [3] 390063 0
Patient baseline and 6-months post patient baseline.
Secondary outcome [4] 390064 0
Patient level: Quality of life will be measured using the EuroQOL-5D-5L composite health utility score.
Timepoint [4] 390064 0
Patient baseline and 6-months post patient baseline.
Secondary outcome [5] 390065 0
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.
Timepoint [5] 390065 0
Patient baseline and 6-months post patient baseline.
Secondary outcome [6] 390066 0
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.
Timepoint [6] 390066 0
Between patient baseline and 6-month patient measures.
Secondary outcome [7] 390067 0
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.
Timepoint [7] 390067 0
6-months post patient baseline.
Secondary outcome [8] 390068 0
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.
Timepoint [8] 390068 0
Measured for each physiotherapy occasion of service from initial physiotherapy assessment to 6-months post patient baseline.
Secondary outcome [9] 390069 0
Implementation: Fidelity1: Current physical activity counselling elements in usual care measured using a study specific checklist.
Timepoint [9] 390069 0
Physiotherapist baseline consent prior to randomisation and at end of implementation phase (prior to patient recruitment).
Secondary outcome [10] 390070 0
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).
Timepoint [10] 390070 0
Measured for each physiotherapy occasion of service from initial physiotherapy assessment to 6-months post patient baseline.
Secondary outcome [11] 390071 0
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).
Timepoint [11] 390071 0
Measured for each physiotherapy occasion of service from initial physiotherapy assessment to 6-months post patient baseline.
Secondary outcome [12] 390072 0
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).
Timepoint [12] 390072 0
Patient baseline and 6-month post patient baseline,
Secondary outcome [13] 390073 0
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.
Timepoint [13] 390073 0
Recruitment period of 30 physiotherapy teams.
Secondary outcome [14] 390074 0
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).
Timepoint [14] 390074 0
Measured for each physiotherapy occasion of service over a 3-month period starting from the 6-month post patient baseline.
Secondary outcome [15] 390075 0
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).
Timepoint [15] 390075 0
Prior to patient recruitment (immediate implementation group) and 3-months after completion of 6-months post patient baseline (waitlist implementation group).
Secondary outcome [16] 390076 0
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).
Timepoint [16] 390076 0
Between randomisation of clinical teams to commencement of patient recruitment.
Secondary outcome [17] 390077 0
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).
Timepoint [17] 390077 0
Between randomisation of clinical teams to commencement of patient recruitment.
Secondary outcome [18] 390078 0
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).
Timepoint [18] 390078 0
Between randomisation of clinical teams to commencement of patient recruitment.
Secondary outcome [19] 390079 0
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).
Timepoint [19] 390079 0
Measured over a 3-month period from completion of 6-months post patient baseline.
Secondary outcome [20] 390080 0
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).
Timepoint [20] 390080 0
At the end of workshop 1 (to include education videos) and at the end of workshop 2 (to include between workshop 1 & 2 timeframe).
Secondary outcome [21] 390981 0
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)
Timepoint [21] 390981 0
Patient baseline and 6-months post patient baseline.
Secondary outcome [22] 390982 0
Patient level: Quality of life will also be measured using the EuroQOL-5D-5L visual analogue scale score (0 to 100)
Timepoint [22] 390982 0
Patient baseline and 6-months post patient baseline.
Secondary outcome [23] 390983 0
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).
Timepoint [23] 390983 0
At the completion of the 6-months post patient baseline.
Secondary outcome [24] 390984 0
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).
Timepoint [24] 390984 0
Prior to patient recruitment (immediate implementation group) and 3-months after 6-months post patient baseline (waitlist implementation group).
Secondary outcome [25] 390985 0
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).
Timepoint [25] 390985 0
At the completion of 6-month post patient baseline.
Secondary outcome [26] 390995 0
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).
Timepoint [26] 390995 0
At 3-months after the 6-month post patient baseline.
Secondary outcome [27] 390997 0
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).
Timepoint [27] 390997 0
At the end of workshop 1 (to include education videos) and at the end of workshop 2 (to include between workshop 1 & 2 timeframe).
Secondary outcome [28] 390998 0
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).
Timepoint [28] 390998 0
At the end of workshop 1 (to include education videos) and at the end of workshop 2 (to include between workshop 1 & 2 timeframe).

Eligibility
Key inclusion criteria
Physiotherapy team inclusion:
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:
• 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;
• would treat at least 10 new eligible adult patients within their clinical team over a 3-month period;
• not working in a split role across two clinical teams that have both been identified as potential clusters for the trial.

Patient inclusion:
Patient-participants are likely to be affected by common and/or burdensome conditions such as, but not limited to, osteoarthritis, lower limb amputations, chronic pain, stroke, brain injury, cardiac and pulmonary disease.
The trial will include any consenting adults (18 + years) who:
• are a new patient of one of the participating physiotherapists during the recruitment period;
• live in the community (as opposed to residential care);
• are able to leave their home without physical assistance from another person but may use a walking aid or wheelchair (anticipated within 6-months of recruitment);
• are without major cognitive impairment (e.g. diagnosis of dementia);
• have sufficient language capabilities to respond to written questionnaires in English, Arabic or Vietnamese.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physiotherapy team exclusion:
Nil

Patient exclusion criteria:
The trial will exclude adults who:
• are residents of residential aged care facilities;
• have the following medical conditions: delirium, acute medical illnesses, severe psychiatric disorders, rapidly progressive neurological diseases;
• have any medical reason for which strategies to increase physical activity would be contra-indicated, determined by the treating physiotherapist.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation. The randomisation schedule will be generated and managed by the NHMRC Clinical Trials Centre (CTC) who are not involved at the clinical site or in the recruitment of clusters to ensure concealed allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic. The randomisation schedule will include minimisation based on average number of occasions of service delivered by each clinical team (high dose vs. low dose i.e. equal to or above the median number of occasions of service vs. below the median number of occasions of service).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This is a cluster randomised controlled trial using a type II effectiveness-implementation hybrid design in that it enables the simultaneous testing of a clinical intervention and implementation strategies. Thirty physiotherapy clinical teams (made up of at least 1 physiotherapist) treating patients in SWSLHD will make up the 30 clusters and will be randomised to an immediate or delayed intervention group to receive the implementation strategies described in step 3: Intervention/exposure. Between months 3 to 6, each physiotherapy team will recruit an average of 10 patients with a maximum of 20 patients per cluster (n=300). Patients being treated by intervention physiotherapists will receive physical activity counselling incorporating evidence-based behaviour change components as part of their physiotherapy management. Patients being treated by delayed physiotherapists will receive their routine care.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
Sample size calculation was undertaken in STATA 14.2 using “clustersampsi” command. Recruitment of 300 patients undergoing physiotherapy is sufficient to detect a 1.5 hour between-group difference in the self-reported time spent in planned physical activity per week, estimated at 3 hours/week (SD 4.4 hours/week) (delayed group) to 4.5 hours/week (intervention group) (a between group difference found to be achievable in our previous studies, Hassett L, PlosMed 2020). All calculations used 80% power, alpha = 0.025 (to account for co-primary outcomes), 15 clusters per arm, average cluster sizes of 10, baseline-covariance 0.6 and intra cluster correlation 0.05. This sample size will also be sufficient to detect an absolute 25% difference in the proportion of eligible patients receiving physical activity counselling (primary implementation outcome (reach) 35% in the delayed group and 60% in the intervention group).

Statistical analysis
Quantitative analysis
Primary analyses will be pre-planned and conducted while masked to group allocation. To account for correlation among individuals within clusters, all statistical models will use a generalised estimating equations (GEE) approach with an exchangeable correlation structure.

Patient-level outcomes:
The primary analysis will evaluate the effect of implementation strategies to train and support physiotherapists to deliver physical activity counselling as part of their routine care [targeted at the cluster level] on patient level outcomes of planned physical activity (co-primary aim), overall physical activity (self-reported and device-measured (sub-sample only)), quality of life, barriers to physical activity and impressions of physiotherapy (secondary aims). The main (intention-to-treat (ITT)) dataset analysed will be constituted of all patients recruited into the study irrespective of what amount of physical activity counselling they received from their treating physiotherapist. For the continuous outcomes (planned physical activity, hours/week; total physical activity, (self-reported: hours/week, device-measured: average stepcount per day (sub-sample only)); PROMIS-29 domain scores, pain intensity score, physical and mental health summary scores and utility score; EQ-5D5L VAS score, domain scores and health utility score; BPAQ-MI domain and total scores), multiple linear regression will be used with group (implementation group vs. waitlist control) as primary independent variable and baseline scores as a covariate. Binary logistic regression will be used to compare groups on dichotomous outcome measures (impressions of physiotherapy questions) with group (implementation group vs. waitlist control) as primary independent variable. To account for correlation among individuals within clusters, all statistical models will be analysed within the framework of generalised estimating equations (GEE) with an exchangeable correlation structure. For the continuous outcomes the difference between groups, 95% CI and p-value will be the output. For the binary outcomes the odds ratio of the groups, 95%CI and p-value will be the output.

Implementation-level outcomes:
Implementation outcomes are measured both in respect to the delivery of physical activity counselling within routine physiotherapy care and delivery of the implementation strategies to support and train physiotherapists. Some of these are measured for both groups (implementation group and waitlist control group) with between group statistical comparisons conducted, and others are measured only for the implementation group and the statistics will be presented descriptively.
For the continuous outcomes measured for both groups evaluating the delivery of physical activity counselling (reach [co-primary aim], dose delivered and fidelity), multiple linear regression will be used with group (implementation group vs. waitlist control) as primary independent variable. For the continuous outcomes the difference between groups, 95% CI and p-value will be the output.
All other implementation outcomes (delivery of physical activity counselling: adoption, sustainability; delivery of implementation strategies: reach, adoption, dose delivered, fidelity, sustainability) will be descriptively presented.

Exploratory sub-group analysis:
The study is not powered to detect between group differences for subgroup analysis. However, exploratory and pre-specified subgroup analyses will be undertaken on the co-primary outcomes (i.e., self-reported planned physical activity and reach of delivery of physical activity counselling) to help understand if these variables are likely to impact on the outcomes and should be included in future trial designs and implementation and scale-up efforts. All subgroups will be defined by data collected prior to randomisation. Subgroup analysis will be conducted on each of the primary outcomes for:
• Sex (male versus female)
• Age (age entered as continuous covariate and as categorical (above and below median age); both analyses will be considered)
• Language spoken at home (English versus non-English)
• Inpatient vs. outpatient
• High dose vs. low dose physiotherapy contact (above and below the median number of occasions of service)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/02/2021
Actual
26/02/2021
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
30/01/2023
Actual
Sample size
Target
330
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18257 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 18258 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 18259 0
Fairfield Hospital - Prairiewood
Recruitment hospital [4] 18260 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 18261 0
Camden Hospital - Camden
Recruitment hospital [6] 18262 0
Bowral Hospital - Bowral
Recruitment postcode(s) [1] 32320 0
2170 - Liverpool
Recruitment postcode(s) [2] 32321 0
2200 - Bankstown
Recruitment postcode(s) [3] 32322 0
2176 - Prairiewood
Recruitment postcode(s) [4] 32323 0
2560 - Campbelltown
Recruitment postcode(s) [5] 32324 0
2570 - Camden
Recruitment postcode(s) [6] 32325 0
2576 - Bowral

Funding & Sponsors
Funding source category [1] 307482 0
Government body
Name [1] 307482 0
Department of Health, Medical Research Future Fund
Country [1] 307482 0
Australia
Funding source category [2] 307483 0
Government body
Name [2] 307483 0
NHMRC
Country [2] 307483 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 308158 0
None
Name [1] 308158 0
Address [1] 308158 0
Country [1] 308158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307557 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307557 0
Ethics committee country [1] 307557 0
Australia
Date submitted for ethics approval [1] 307557 0
Approval date [1] 307557 0
04/03/2020
Ethics approval number [1] 307557 0
2019/ETH13622

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

Contacts
Principal investigator
Name 107666 0
Dr Leanne Hassett
Address 107666 0
Institute for Musculoskeletal Health, Faculty of Medicine & Health, University of Sydney
PO Box M179,
Missenden Road,
Camperdown, NSW 2050
Country 107666 0
Australia
Phone 107666 0
+61408241708
Fax 107666 0
Email 107666 0
[email protected]
Contact person for public queries
Name 107667 0
Leanne Hassett
Address 107667 0
Institute for Musculoskeletal Health, Faculty of Medicine & Health, University of Sydney
PO Box M179,
Missenden Road,
Camperdown, NSW 2050
Country 107667 0
Australia
Phone 107667 0
+61408241708
Fax 107667 0
Email 107667 0
[email protected]
Contact person for scientific queries
Name 107668 0
Leanne Hassett
Address 107668 0
Institute for Musculoskeletal Health, Faculty of Medicine & Health, University of Sydney
PO Box M179,
Missenden Road,
Camperdown, NSW 2050
Country 107668 0
Australia
Phone 107668 0
+61408241708
Fax 107668 0
Email 107668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient-level data for primary and secondary outcomes.
When will data be available (start and end dates)?
Data will be available when the main study results paper is published. There is no end date for data availability.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
The data will be made available on the University of Sydney’s open access institutional repository, Sydney eScholarship repository (https://ses.library.usyd.edu.au/)


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.