Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000123741
Ethics application status
Approved
Date submitted
29/08/2021
Date registered
25/01/2022
Date last updated
25/01/2022
Date data sharing statement initially provided
25/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does online professional development for physiotherapists enhance clinical practice and patient outcomes? A mixed methods evaluation.
Scientific title
Does online professional development for physiotherapists enhance clinical practice and patient outcomes? A mixed methods evaluation.
Secondary ID [1] 305158 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
back pain 323422 0
neck pain 323423 0
Condition category
Condition code
Musculoskeletal 320976 320976 0 0
Other muscular and skeletal disorders
Public Health 322403 322403 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be online clinical mentoring, where physiotherapist learner participants will undertake six sessions of online clinical mentoring over six weeks. Four of the sessions will be group mentoring sessions, with three physiotherapist learners and clinical mentor. Two of the sessions will be individualised with one physiotherapist learner and one clinical mentor. Each session will be of one hour duration. The intervention group will also complete four hours of self-directed activities, which will consist of preparation of a case study, recording of a patient-physiotherapist encounter and completion of a study-specific, clinical reflection form.

The clinical mentoring sessions will be provided by APA titled Musculoskeletal Physiotherapists with at least two years of experience in the education of physiotherapists which includes providing clinical mentoring to entry level or post-graduate physiotherapists and/or physiotherapy students. The mentors will have training on the use of online technologies, and evidence informed clinical mentoring which is based on recently published systematic reviews relevant to the professional development of physiotherapists.
Intervention code [1] 321564 0
Behaviour
Comparator / control treatment
The comparator intervention will be asynchronous online lectures.
Physiotherapist learner participants will watch six pre-recorded lectures over six weeks. Each lecture will be of one hour duration. The lectures intended learning outcomes will be to improve the physiotherapist learners’ knowledge of evidence based-practice principles and published clinical guidelines pertaining to back and neck pain. The comparison group will also complete four hours of self-directed activities, which consists of reading publications relating to evidence-based practice, clinical guidelines and spinal pain physiotherapy care.
Control group
Active

Outcomes
Primary outcome [1] 328753 0
Efficacy of patient treatment under the physiotherapist learners will be evaluated using the "Patient-Specific Functional Scale.'
Timepoint [1] 328753 0
The outcomes of patients under the care of the physiotherapist learners will be evaluated after the professional development interventions. Consecutive eligible patients with spinal pain under the care of the learner physiotherapist will be evaluated with the outcome measure at initial appointment and four weeks after the initial appointment.
Secondary outcome [1] 400245 0
Efficacy of patient treatment under the physiotherapist learners will be evaluated with the 'Functional rating index.'
Timepoint [1] 400245 0
The outcomes of patients under the care of the physiotherapist learners will be evaluated after the professional development interventions. Consecutive eligible patients with spinal pain under the care of the learner physiotherapist will be evaluated with the outcome measure at initial appointment and four weeks after the initial appointment.
Secondary outcome [2] 400246 0
Efficacy of patient treatment under the physiotherapist learners will be evaluated using the 'Global Rating of Change.''
Timepoint [2] 400246 0
The outcomes of patients under the care of the physiotherapist learners will be evaluated after the professional development interventions. Consecutive eligible patients with spinal pain under the care of the learner physiotherapist will be evaluated with the outcome measure at initial appointment and four weeks after the initial appointment.
Secondary outcome [3] 400247 0
Patients of the physiotherapist learners will be evaluated for the number of appointments attended over a four week period.
Timepoint [3] 400247 0
The outcomes of patients under the care of the physiotherapist learners will be evaluated after the professional development interventions. Consecutive eligible patients with spinal pain under the care of the learner physiotherapist will be evaluated four weeks after the initial appointment.
Secondary outcome [4] 400248 0
Physiotherapist learners confidence will be measured with the ‘Clinician Confidence Questionnaire for Patients with Spine Pain.’
Timepoint [4] 400248 0
Will be evaluated before randomisation and immediately following the professional development intervention.
Secondary outcome [5] 400249 0
Physiotherapist learners will be evaluated using the 'Self-Reflection Insight Scale.'
Timepoint [5] 400249 0
Will be evaluated before randomisation and immediately following the professional development intervention.
Secondary outcome [6] 400250 0
Physiotherapist learners satisfaction with the education intervention will be evaluated using a single question of “Were you satisfied with the professional development experience you participated in as part of this research project?” A 5-point scale Likert scale will be used,
Timepoint [6] 400250 0
Will be evaluated immediately following the professional development intervention.

Eligibility
Key inclusion criteria
Physiotherapist learner participants:

To be eligible for this project, physiotherapist learner participants will be physiotherapists with full Australian Health Practitioner Regulation Agency registration and working in the private practice. They will have no more than 5 years of experience working as a physiotherapist. They will have a caseload of at least 3 new patients with spinal pain per week. Participants will be planning to continue to practice as a physiotherapist with this caseload for at least 6 months following participation in the online professional development intervention of the study.

Patient participants
Patients of the participating physiotherapists will be recruited to evaluate outcomes. To be eligible, patients will have spine pain (+/- limb pain) in any area of the spine, which is of any duration. They will attend the physiotherapy practice to receive care from the participating physiotherapist. They will be seeing the physiotherapist learner for the first time due to this episode of spinal pain.

Additional patients of the participating physiotherapists will be recruited for a patient-physiotherapist leaner encounter video recording. This is to ensure that these participants willingly provide consent to the use of the recording and collection of their demographic information. These patients will have the same inclusion criteria as those recruited for outcomes, except they will not need to be seeing the physiotherapist learner for the first time. Written consent will be obtained for participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Physiotherapist learner participants:
Physiotherapists learners will excluded if they have previously completed or are currently enrolled in a post-graduate musculoskeletal or sports physiotherapy program which includes mentored clinical practice hours. Physiotherapist learners will also be excluded if they have been working as physiotherapists for more than 5 years,

Patient participants
Patients will be excluded if they have a suspected or confirmed diagnosis which would contra-indicate physiotherapy management and require onward medical referral, as per usual physiotherapy practice. Such diagnoses are unable to be exhaustive, but include serious pathology such as spinal fractures, aortic aneurysm or cancer. Patients will also be excluded where English language proficiency or cognitive function limits ability to consent and/or complete the patient questionnaires.

Patients will be excluded from evaluating outcomes if they have been seen by the physiotherapist learner for the same episode of spinal pain in the previous month.

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)
Group allocation will be concealed, by having an offsite researcher contact the physiotherapists with regards to their group allocation. They will be allocated to group A and group B. Which group is the online clinical mentored group and which is the online lecture group will not be divulged to the allocating researcher until after recruitment completion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random numbers generator software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation
Sample size calculations are based on the planned linear mixed models analysis using GLIMMPSE software (https://glimmpse.samplesizeshop.org/), with statistical significance set at 0.05, power at 0.80 and the expected between group differences of 1.0 (SD 2.0) for the primary patient outcome of the patient specific functional scale. For adequate power, the estimated sample size required is 22 physiotherapists and 198 patients. To account for drop outs, the sample size will be 24 physiotherapists who will recruit 9 patients each (216 patients).

If during the trial, it appears to be unrealistic for the physiotherapists to recruit 9 patients each within the reasonable timeframe of one month, then an alternative physiotherapist/patient number will be utilized which is adequately powered. This alternative is 26 physiotherapists (13 in each group) with each recruiting 7 patients (182 patients). To account for drop outs 30 physiotherapists (15 in each group) would be recruited, each asked to recruit 7 patients each (210 patients).

The above sample size calculations only apply for the patients seen after the physiotherapy professional development intervention. The same number of patients will be recruited before randomisation to allow for baseline comparisons between the groups. The total number of patients will therefore be between 420 and 432 patients.

Statistical analysis
For the patient reported outcome data a linear mixed model regression analysis will be used, with the treatment effect estimated from the group (intervention versus comparison) and time interaction. The mixed model will be used to allow for within physiotherapist variation and the between physiotherapist variation separately in the model. The mixed model also allows modelling of the variation between patents within a physiotherapist and the variation between physiotherapist groups. Data will be analysed according to intention-to-treat principles, with means and confidence intervals reported.

The patient outcomes will also be dichotomized, and risk ratio, risk difference and numbers needed to treat will be determined using a logistic mixed models analysis. The physiotherapist learner outcomes of confidence, self-reflection and satisfaction will be considered as ordinal outcomes and analysed using a Mann-Whitney U test, adjusting for baseline differences as required.

The clinical mentoring group participants will also complete semi-structured interviews which will be thematically analysed using a phenomenological approach.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
4/04/2022
Actual
Sample size
Target
458
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309547 0
University
Name [1] 309547 0
Western Sydney University
Country [1] 309547 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Campbelltown Campus
Locked Bag 1797
Penrith, NSW 2751
Country
Australia
Secondary sponsor category [1] 310543 0
University
Name [1] 310543 0
La Trobe University
Address [1] 310543 0
La Trobe University
Bundoora, Victoria, 3083
Country [1] 310543 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309327 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 309327 0
Ethics committee country [1] 309327 0
Australia
Date submitted for ethics approval [1] 309327 0
16/09/2021
Approval date [1] 309327 0
08/12/2021
Ethics approval number [1] 309327 0
H14629
Ethics committee name [2] 309329 0
La Trobe University Human Research Ethics Committee
Ethics committee address [2] 309329 0
Ethics committee country [2] 309329 0
Australia
Date submitted for ethics approval [2] 309329 0
17/12/2021
Approval date [2] 309329 0
20/12/2021
Ethics approval number [2] 309329 0
H14629

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

Contacts
Principal investigator
Name 113778 0
Mr Edmund Leahy
Address 113778 0
Health Sciences 3
La Trobe University
Bundoora VIC 3086
Country 113778 0
Australia
Phone 113778 0
+61 3 9479 5857
Fax 113778 0
Email 113778 0
18772874@student.westernsydney.edu.au
Contact person for public queries
Name 113779 0
Edmund Leahy
Address 113779 0
Health Sciences 3
La Trobe University
Bundoora VIC 3086
Country 113779 0
Australia
Phone 113779 0
+61 3 9479 5857
Fax 113779 0
Email 113779 0
18772874@student.westernsydney.edu.au
Contact person for scientific queries
Name 113780 0
Edmund Leahy
Address 113780 0
Health Sciences 3
La Trobe University
Bundoora VIC 3086
Country 113780 0
Australia
Phone 113780 0
+61 3 9479 5857
Fax 113780 0
Email 113780 0
18772874@student.westernsydney.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13016Ethical approval  18772874@student.westernsydney.edu.au



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.