This feasibility trial protocol followed the SPIRIT statement on defining standard protocol items for clinical trials and its checklist (8) and the CONSORT statement extension to randomised pilot and feasibility trials and its checklist (9).
Trial design
This will be a two-arm feasibility randomised controlled trial with an experimental and control group. The 6-week on-line intervention which will be delivered as part of the trial is a stand-alone, post-graduate level educational course called Virtual gait analysis course for paediatric physiotherapists (VGAPP). Eligible physiotherapists who will consent to take part in the study will be randomly allocated into experimental and control groups. A repeated measures design will be adopted, whereby participants will complete outcome measures at baseline, immediately after the intervention and at 4 months. This includes collection of feedback as part of a full process evaluation.
Figure 1. shows the study flow diagram, and Table 1. indicates the schedule of enrolment, intervention and outcome measures (8).
[Figure 1 Study flow diagram]
Table 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram illustrating the study design and timescales.
Design | Study period |
Enrolment | Allocation | Baseline | Pre-intervention | Intervention (experimental) | End of intervention | Follow up 4 months | Intervention (control) | End of study |
ENROLMENT | | | | | | | | | |
Participant recruitment | x | | | | | | | | |
Eligibility screen | x | | | | | | | | |
Informed consent | x | | | | | | | | |
Allocation | | x | | | | | | | |
INTERVENTION | | | | | | | | | |
Pre-intervention resources | | | | x | | | | | |
6-week intervention | | | | | x | | | | |
Live sessions | | | | | x | | | | |
ASSESSMENTS | | | | | | | | | |
Feasibility outcomes (recruitment) | x | | x | | | | | | |
Feasibility outcomes (retention) | | | | | | | | | x |
Feasibility outcomes (VLE data) | | | | | | x | | | |
Acceptability | | | x | | | x | x | | |
Process evaluation | x | | x | | x | x | x | | x |
Demographics | | | x | | | | | | |
Attitudes | | | x | | | x | x | | |
Satisfaction | | | | | | x | | | |
Self-rated knowledge | | | x | | | x | x | | |
Self-rated confidence | | | x | | | x | x | | |
Knowledge test | | | x | | | x | x | | |
Practice change | | | | | | x | x | | |
Intention to change practice | | | | | | x | x | | |
Economic | | | | | | | | | x |
VLE - Virtual Learning Environment
Participants
Study setting
This study will be conducted virtually using Queen Mary University of London (QMUL) virtual learning environment (VLE), online questionnaires (Survey Monkey) and Microsoft Teams, eradicating the need for participants to travel, reducing both cost and participants’ time. This is also in line with the findings of the national survey of paediatric physiotherapists indicating that on-line training is a sought-after method of learning. Participating clinicians will be working in variety of settings within the UK, where the data will be collected.
Eligibility criteria
The aim of the inclusion and exclusion criteria is to ensure that participants are actively involved in assessment and treatment of ambulant CYPwCP and have currently available opportunities to apply the taught knowledge and skills in their workplace. The eligibility criteria were reviewed during the stakeholder focus groups including both clinicians and educators. Focus groups found inclusion and exclusion criteria appropriate for the feasibility trial.
Inclusion Criteria
Exclusion Criteria
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Outside of UK
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Not currently employed as physiotherapist or on a career break
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In rotational posts, where they could rotate to specialty not managing ambulant CYPwCP
Intervention
Design and refinement
This educational intervention uses a multicomponent approach grounded in behavioural change techniques (BCTs). The overall aim of the intervention is to improve gait-related clinical practice.
The intervention will be delivered via Queen Mary University of London (QMUL) virtual learning environment (VLE). Intervention (VGAPP) comprises of pre-course resources and 6 weeks of virtual gait analysis course. Content of the VGAPP course has been developed based on evidence from the scientific literature, current best practice and informed by the scoping review, qualitative study and national survey of paediatric physiotherapists in the UK. The stakeholder engagement has been integral to the research and intervention design, delivery and evaluation process, and included Patient and Families (PPI-A) interviews and Clinicians and Educators Focus Groups (PPI-B). PPI-A included children, young people and their families who have a lived experience of cerebral palsy and received IGA as part of management of their condition. PPI-A was involved in the design of intervention prior to involving clinicians in order to ensure that the project is centred around the needs of patients, and to ensure that the practice behaviour change and transfer of knowledge will directly benefit patients and their families. PPI-B were representatives from all UK nations, with a variety of paediatric physiotherapy specialisms, experience levels and from different work settings. Thus providing invaluable insight and the opportunity for further refinement of the intervention design, content, delivery and evaluation methods (Fig. 2). A detailed PPI involvement report, including the educational intervention refinement process is available from the corresponding author on reasonable request.
[Figure 2 Stakeholder engagement during the refinement process of the intervention and evaluation design]
Pre-intervention resources
Pre-intervention resources will include the pre-course manual, meet and greet’ forum. and reading list. Participants will be able to complete a self-diagnostic tool to identify and reflect on their current IGA engagement and barriers to confident gait-related practice.
Intervention components
The intervention is a stand-alone, post-graduate level educational event delivered fully on-line. It will employ the delivery of weekly on-line plenary sessions incorporating active learning - synchronous on-line problem-based learning sessions and seminars integrating elements of experimental learning within learning community; weekly tasks (asynchronous) to facilitate revision and application in practice and formative assessment/feedback opportunities (short knowledge quizzes, open questions within the discussion forum) to support learning autonomy and facilitate participant’s recall and self-regulation. Table 2 provides an indicative number of hours for each activity to give an overall picture of the workload a participant would be expected to undertake.
Table 2
Intervention learning format and an indicative number of hours for each activity.
Learning Format | Module specific breakdown | Hours |
Content | Seminars/PBL sessions Lectures/plenary On-line live forum interaction | 5 13 2 |
Student/peer learning | Discussion/group work | 4 |
Student independent learning time | Pre-session preparations (total): Completing assessments (incl. formative) | 4 3 |
Total study hours (6 weeks total). | 31 |
Pre-course preparation | 2–4 |
The Intended Learning Outcomes (ILOs) have been designed and benchmarked against the 'QAA Statements Physiotherapy (2001) Academic Content.
Academic content:
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[Demonstrates an understanding of] the interdisciplinary knowledge that underpins gait analysis practice including elements of human anatomy, biomechanics, gross motor development; C1
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[Demonstrates an understanding of] the principles of typical gait pattern and how movement patterns are likely to be affected by some of the childhood diseases; C1
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[Demonstrates an understanding of] the available measurement technologies and the principles on which they are based; C1
Disciplinary skills:
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Applies variety of gait assessment methods in context of own practice and service delivery; B1 C2
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Uses the gait analysis outputs in clinical practice to aid treatment decision-making and measurement – in line with clinical reasoning paradigms and evidence-based practice; A1 B1 C2
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Communicates assessment findings and gait related decision-making effectively with multidisciplinary team, patients and families; A2 A3 B2 C2
Attributes:
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Cultivates an individualised, patient-centred approach to assessment and treatment planning; B2
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Reflects on own practice to identify the needs within own role and wider aspects of service delivery; A3 A4 B2 (Health and Social Care equivalent B4)
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[Demonstrates a] creative drive to implement the knowledge and skills, improve own practice and support development of others; A3 A4 B2 (Health and Social Care equivalent B3)
Behaviour change techniques (BCT)
Techniques used in the intervention content within the BCT taxonomy: Goals and planning: goal setting, problem solving, action planning; Social support; Shaping knowledge: instruction on how to perform the behaviours, behavioural experiments; Comparison of the behaviours: demonstration of the behaviour; Associations: prompts and cues; Reward and threat: Self-incentive, social incentive (professional setting); Antecedents: encouragement to restructure the physical environment, adding objects to environment; Identity: identification of self as a role model, identity associated with changed behaviour; Fig. 3. outlines the logic model of the study.
[Figure 3 Feasibility RCT study logic model]
Control group intervention
To compare the effects of the intervention against usual practice, participants allocated into the control group will be asked to continue with their usual practice. At the point of enrolment, the control group to study will gain access to the virtual learning environment, receive basic orientation resources but no training or guidance will be offered during this time. Participants in the control group will be asked to complete the same measurements as those in the intervention group and at the same timepoints (Table 1). The control group will be offered the full intervention after the completion of the third round of assessments. Provision of educational content and its timing in the control group has been reviewed during the stakeholder focus groups including of clinicians and educators.
Outcome measures
Outcome measures have been grouped as primary outcome measures (trial feasibility related outcomes) and secondary outcome measures (trial research-related outcomes) collated in Table 3.
Recruitment will be determined as feasible if we are able to recruit 24 participants within 4 months. Retention rates will be considered at two stages: 1) from expression of interest to consent – it will be deemed feasible if greater than 50%; 2) from consent to curse completion - it will be deemed feasible if greater than 75%. Additionally, engagement (participants’ interactions with an online system) data will be collected during intervention via the analytics tools in the QMUL Virtual Learning Environment which log the detail of activity access, time and completion for each component. It will be deemed feasible if the average proportion of completed learning sessions and tasks will be ≥ 66%
Secondary outcomes: knowledge, skills, attitudes and satisfaction will be collected via online questionnaires (Survey Monkey platform) and during skill tests (OSCE). Knowledge, skills, attitudes will be collected at three timepoints (Table 1).
Baseline (pre-intervention)
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Questionnaire including background (demographics, current gait analysis practice, access to IGA equipment, barrier to gait analysis practice), attitudes (reasons for joining the study, anticipated changes in practice after the intervention, beliefs), confidence (self-rated) and knowledge (self-rated and multiple-choice question test).
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Objective structured clinical examination (OSCE) of a patient case. Assessment will be delivered on-line, recorded and scored against a standardised scoring sheet including gait related clinical reasoning and treatment planning based on evidence and findings, problem solving, systematicity of approach, ability to link various types of gait-related information, confidence in engagement with gait data, analysis of gait graphs, communication (including use of gait related terminology, providing lay explanations to parent) implementation of biopsychosocial model or ICF to decision-making;
Post intervention (immediately after 6-week intervention)
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Questionnaire including attitudes (planning practice change, implemented practice change, beliefs), confidence (self-rated), knowledge (self-rated and multiple choice question test) and satisfaction (experimental group only).
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OSCE of a different patient case (scored against the same criteria as at baseline)
Re-test (4 months post-intervention).
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Questionnaire attitudes (planning practice change, implemented practice change, beliefs), confidence (self-rated), knowledge (self-rated and multiple-choice question test)
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OSCE of a different patient case (scored against the same criteria as at baseline)
Knowledge and skills retention as well as attitudes will be measured between timepoints, with a focus on changes between baseline and immediately post intervention and at long-term follow-up. Satisfaction questionnaire will contain 28 items, each assessed on a five-point Likert-scale, related to the relevance and scientific quality of the content, the educational structure and delivery. Satisfaction feedback will be collected immediately after intervention delivery (experimental group).
Sample size
In light of the study objectives and recommendations the target sample size will be of a minimum 12 participants per trial arm, therefore a minimum of 24 in total is anticipated. Guidance from the National Institute for Health Research (NIHR) indicates that a sample size of 30 is appropriate to answer the questions posed by a feasibility trial (10). A lower number of participants will be better suited for an educational intervention for clinicians – it will ensure delivery of a high-quality learning experience and allow for active engagement with tutors during problem-based learning within the experimental group. Furthermore, the stakeholder focus groups including of clinicians and educators reviewed the proposed sample size and reported it as appropriate for the feasibility trial.
Recruitment
Participants will be recruited via the largest national paediatric physiotherapy network (Association of Chartered Paediatric Physiotherapists) using bulletins, social media and targeted emails to team leads across the UK. The advertisement will provide general information about the intervention and the research study together with inclusion and exclusion criteria. Upon expression of interest participants will be screened against eligibility criteria and the Participant’s Information Sheet and Consent Form will be sent to prospective participants via email. Participants will return signed consent forms electronically to the Research Lead. In line with the advice from the clinician and educator focus group, the recruitment of study participants will commence early to ensure that participants are able to make suitable arrangements in the workplace.
Participant timeline
Time schedule of enrolment, intervention and assessments has been presented in Table 1. After the eligibility criteria screen and receipt of their written informed consent 24 participants will be enrolled to the study. After random allocation to the trial arms, participants will receive access to the password protected online platform hosted by Queen Mary University of London. All participants will be asked to complete the baseline assessment including the questionnaire (background, attitudes, knowledge and skills) and objective structured clinical examination (OSCE) of a patient case (assessment will be delivered on-line, recorded and scored against standardised scoring sheet). After completing the baseline assessment participants assigned to the experimental arm will gain access to the pre-course learning resources (6 weeks prior to start of the course). The experimental group will commence the six weekly blocks of intervention including pre-recorded resources, problem-based learning tasks, discussion forums and live sessions. At 6-weeks participants from both arms will be asked to complete the second assessment including the questionnaire (attitudes, knowledge and skills, and satisfaction scores in experimental group only) and the second OSCE of a patient case. Four months after the intervention participants in both trial arms will be asked to complete the third assessment including the questionnaire (attitudes, knowledge and skills) and the OSCE of a patient case. Once all the data is collected participants in the control group will gain access to the pre-reading resources and start the 6-weekly intervention sessions.
Assignment of intervention
Allocation, concealment mechanism and Implementation
Participants who met inclusion criteria and returned the consent form will be assigned an ID number in the Microsoft Excel spreadsheet. Participants will be assigned to groups randomly. In case there is more eligible physiotherapists than spaces, participants will be chosen by the number generation software which will be used in the allocation process. This will be conducted by an external person not related to the study or the research team. To avoid contamination, participants from the same healthcare trusts will be randomised to the same group.
Information about group randomisation will be provided in Participant’s Information Sheet. Participants in this study will not be blinded to the group allocation or deceived. This has been discussed in the stakeholder focus groups who agreed that; in the context of clinical practice deceiving participants could mean a loss of their study/annual leave if pre-booked specifically to attend the intervention as well as potential cancelations of clinics in the control group. Participants will be informed about their allocation at the time of receiving instructions with the QMUL VLE platform access, together with the information that the control group will gain access to the full intervention and all resources provided to the experimental group after final assessments are completed. Participants will be informed that they are free to withdraw at any time without needing to provide a reason, and with no penalties or detrimental effects.
Data collection, management and analysis
In line with accepted practice for feasibility studies no power analysis will be conducted, and all analyses will be exploratory only. Data analysis will be performed after the last trial participant has completed final assessments (outcomes at 4 months post intervention). Data will be managed initially in Microsoft Excel software and analysed using IBM SPSS statistics software. Table 3 provides a summary of outcome measures, hypotheses and analysis planned in the study.
Data management and research governance
A baseline table (descriptive statistics and frequencies) will compare the demographic and clinical characteristics including gender, age, experience, education, practice setting, contract type, study leave availability to participate in intervention, access to equipment and gait analysis training. The primary outcomes will be reported using descriptive statistics. The quantitative variables will be presented as means and standard deviations.
A preliminary analysis of between-group differences will be conducted to determine the range of potential effect sizes from repeated measures ANOVA. Feasibility outcomes will be presented as number of participants meeting the a priori definitions. Kendall's tau-b (τb) correlation coefficient will be used to measure of the strength and direction of association that exists between two variables measured on at least an ordinal scale. To explore the extent and patterns of missing outcome data, we will report the proportion of missing values per item, proportion of participants who will complete all items on the questionnaires. The proportion of missing data will also be reported for the other key outcomes and compared between the participants from intervention and control groups.
Table 3
Summary of primary and secondary outcome measures, hypotheses and analysis methods planned in the study.
Variable/Task | Hypothesis/Target | Outcome measure | Method of analysis |
Primary |
Recruitment | Study will recruit 24 participants | Number of participants | Descriptive statistics |
Retention | Study will retain 75% of sample | Number of participants | Descriptive statistics |
Engagement | The average proportion of completed VLE items will be ≥ 66% | Average proportion of completed VLE items | Descriptive Statistics |
Secondary |
Knowledge | EG will have improved knowledge scores relative to CG. EG will increase knowledge scores. EG will maintain knowledge scores. | MCQ test | Effect sizes and 95% CIs from repeated measures ANOVA test and Kruskal-Wallis H test |
Skills | EG will have improved practical skills scores relative to CG. EG will increase practical skills scores. EG will maintain practical skills scores. | OSCE | Effect sizes and 95% CIs from repeated measures ANOVA test and Kruskal-Wallis H test |
Attitudes | EG will have improved gait-related practice behaviours. | Questionnaires: Self-reported knowledge and confidence, practice change, practice change planning, beliefs Semi structured interviews | Effect sizes and 95% CIs from repeated measures ANOVA test Framework method for qualitative data (Ritchie 2014) |
Satisfaction | EG will demonstrate a high satisfaction rate. | Satisfaction questionnaire | Descriptive statistics |
EG experimental group, CG control group, VLE – virtual learning environment, MCQ – multiple choice question, OSCE – observed standardised clinical examination.
Qualitative data will be analysed according to the Framework approach (11), a realist approach located within an interpretivist frame. The opinions and experiences of participants will be explored to understand any barriers, facilitators and issues related to running of the educational intervention as part of a trial and its contextual reality in clinical practice with special consideration of any unintended or unforeseen effects of trial intervention. During active familiarisation, the textual data will be coded, codes will be organised into themes and subthemes to construct a thematic framework to aid indexing. To ensure rigour and consistency the analysis process will undergo investigator triangulation. This data will be presented as quotes and descriptive summaries.
Process evaluation
The process evaluation has been informed by Medical Research Council guidance on process evaluation of complex interventions (12, 13) and the Implementation Outcome Framework (IOF) (14). Proctor et al. described eight implementation outcomes in the IOF: acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration (or coverage), and sustainability. Each of these implementation outcomes aligns with important considerations for trial design and implementation however the ‘adoption’ outcome does not directly align with process evaluation of our current feasibility trial design and delivery, as it is not offered by other educational providers. Therefore, seven out of eight implementation outcomes will be included in this process evaluation. In addition, the COM-B model and the behaviour change techniques taxonomy (BCTT) (15), widely used frameworks in behaviour change and implementation research, will support the process evaluation analysis and an in-depth exploration of the barriers and facilitators of implementing the feasibility trial.
Implementation outcomes
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Acceptability of the intervention and of the assessments will include data on the duration, content and delivery methods. Synthesis of anticipated and possible benefit to participants over existing options and reports on participants’ logistics related to taking part in the trial (protected study time, ensuring opportunities in practice) including logistics of multiple assessments. The findings will be supplemented with observations made by the researchers, educators, administrative staff and examiners throughout the implementation of the intervention. Collectively, these will provide important information on the acceptability of the trial measurements and the intervention.
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Appropriateness of the trial design for the trial aim including outcome measures and intervention components.
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Feasibility assessment of the participant enrolment rate, retention, and compliance with intervention, timelines of enrolment and completion thresholds are reasonable (see primary outcome measures section). Baseline comparisons will be carried out to detect any substantial differences between participants recruited from the control and intervention arms. During the process the inclusion and exclusion criteria for participants will be assessed, sample size and anticipated effect size defined for the definitive trial. Participant withdrawals and number of participants lost to follow up (and where possible, reasons and participants’ key baseline characteristics) will be analysed.
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Fidelity to the trial protocol including follow up and an amount of intervention group crossover will be assessed in the evaluation process.
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The implementation cost analysis will be exploratory with the aim to inform the design of a full cost-utility analysis alongside a future definitive trial. Implementation cost will include the cost of administration involved in running the trial and cost related to production and delivery of the intervention and assessment components – such as speaker fees, and OSCE examiners and moderators will be reviewed.
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Coverage – process evaluation will include analysis of proportion of eligible participants being offered trial and if possible, proportion of participants in the population represented by eligibility criteria.
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Sustainability – sustained participant interest throughout the trial period and sustained staffing levels to deliver and facilitate participants’ learning journey during intervention will be explored during the process evaluation to inform the sustainability criteria for the definitive trial.