None listed
Conditions
Brief summary
Primary purpose: To compare the effectiveness of the two implementation strategies (PICOT versus in-person training) on the implementation of StressModex in routine physiotherapy practice. Secondary purpose: To evaluate the effectiveness of the two implementation strategies on patient health outcomes. Third purpose: To assess the cost-effectiveness of the two implementation strategies We hypothesise that (1) physiotherapists who receive the PICOT implementation strategy will be more likely to deliver StressModex to their patients with musculoskeletal spinal (neck and/or back) pain following non-catastrophic road traffic crash (measured by reach, adoption, dose, fidelity and sustainability of StressModex) compared to physiotherapists who receive usual in-person training; (2) patients of physiotherapy clinics participating in PICOT will have better health outcomes; and (3) the PICOT implementation strategy will be cost-effective compared to usual in-person training.
Interventions
As this is a hybrid implementation-effectiveness type III cluster RCT, the intervention is an implementation strategy designed to upskill physiotherapists in the delivery of integrated psychological and physical care (StressModex) for patients with musculoskeletal spinal pain following road traffic injury: PICOT (Physiotherapists bIopsyChosocial On-line Training). PICOT comprises a blended learning approach over 6 weeks, including 1) online self-paced modules, 2) real-time zoom sessions co-facilitated by a clinical psychologist and expert physiotherapist, and 3) practice feedback. Online self-paced modules: The physiotherapists will complete 6 online self-paced modules weekly over 6 weeks, with each module taking 20-30 minutes to complete. The modules reflect the content of the StressModex treatment manual and include: (1) pain education and the influence of stress on pain, (2) stress-management strategies, e.g., relaxed breathing, muscle relaxation, (3) problem solving skills, (4) use of positive coping statements, (5) real-world practice of skills, and (6) relapse prevention. These online modules will be presented via an engaging format that includes quizzes, short videos of experts delivering StressModex, Q&A video session, and downloadable written resources. All modules are integrated with guideline recommended exercise. Real time zoom sessions: The weekly group online sessions (each 1 hour), co-facilitated by a clinical psychologist and expert physiotherapist, will include skills role play in small break-out groups, case studies and general discussion/questions. Following the 6-week program, online facilitated discussion sessions (each 1 hour) will be held fortnightly for a further 6 weeks, to support physiotherapist training through discussion of issues that may arise as they implement StressModex into practice. Practice feedback: After each training session delivered through online platforms, the physiotherapist will be asked to videotape the relevant practice session with a patient or colleague. The clinical psychologist will provide feedback on each of the 6 sessions to the physiotherapists. Adherence to the online training platform modules will be monitored using analytics from the training platform. Attendance at the zoom sessions will be monitored by the research assistant recording attendance at each session. After the physiotherapists have completed the training, the physiotherapists will recruit eligible patients from their respective clinics and deliver 6 individual sessions of StressModex over 8 weeks (StressModex is a 6-week intervention, but we will allow an additional 2 weeks for delivery to account for interruptions such as patient/physiotherapist illness, holidays, rescheduling of appointments etc.). Duration of each session will be as per standard physiotherapy consultation session with both being up to 50 minutes duration. Please see an overall outline of the week-to-week delivery of StressModex below: Week 1: Patient education about stress and pain, relaxation techniques of abdominal breathing and exercise; Week 2: Relaxation techniques of progressive muscle relaxation (body scans) and Exercise Week 3: Problem Solving techniques (the physiotherapist will teach the patient problem solving techniques of identifying a problem, brainstorming solutions and weighing up options) and Exercise Week 4: Positive coping statements (the physiotherapist will teach the patient about the effect of unhelpful thoughts on pain and stress and how these can be replaced with more helpful thoughts) and Exercise Week 5: Developing a coping plan (the physiotherapist will teach the patient how to develop a plan to deal with individual like stressors using the skills they have learnt in the first 4 sessions) and Exercise Week 6: Maintenance/relapse prevention (the physiotherapist will teach the patient about how to prevent relapses in their stress and pain) and Exercise. The exercise component will include low load exercises to encourage movement, progressing to strengthening exercise as tolerated, exercises to improve eye head co-ordination, balance exercises and will advise the patient on returning to aerobic exercise (e.g. walking) and relevant daily activities. The exercises will be tailored and then progressed in individual patients as deemed appropriate by the physiotherapist. They are guideline recommended exercises of which physiotherapists are very familiar with. Some examples of the exercises include: range of movement exercises for the neck, lifting the head off the treatment bed commencing with pillows under the head progressing to lying flat, overhead press exercise with light weights progressing weight as tolerated, following a laser pointer on the wall with head and eyes, standing on one leg progressing from eyes open to eyes closed. Focus groups will be held with physiotherapists from both training groups and champion physiotherapists at each site at the end of the patient recruitment phase (one focus group for each trial arm). Each focus group will last ~1.5 hours. To ensure a range of experiences in the focus groups, up to 10 physiotherapists from each trial arm will be purposively selected from those who opt in for the additional focus group. Selection will be based on factors such as gender, years of practice, seniority level, clinic roles (e.g., manager), geographic location, and patient volumes. A qualitative researcher in the team will conduct the focus group to gather information about the clinical setting (e.g., organisation and interpersonal dynamics, care practice) and explore physiotherapists’ experiences and barriers/facilitators to delivering StressModex within the trial. For example, questions will include physiotherapists’ experience participating in this trial, and receiving training either online or in person, recruiting and identifying eligible patient-participants, experience in delivering StressModex, considering what factors made it easy or difficult to deliver StressModex in their clinical practice, and what contextual factors or resources helped or hindered such delivery.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria for the primary care physiotherapy clinics (clusters): • Employ at least three physiotherapists. • See approx. 30 patients with spinal musculoskeletal road traffic injury annually. Inclusion criteria for patient participants: • Musculoskeletal spinal (neck and/or back) pain following road traffic injury. • Spinal pain is < /= 12 weeks in duration. • Screened at medium to high risk of poor recovery on a validated tool appropriate for the clinical presentation (e.g., WhipPredict, Orebro, or StarTBack). • Aged >/= 18 years. • Proficient in written and spoken English.
Exclusion criteria
Exclusion criteria for patient participants: • Serious spinal pathology (e.g., metastatic disease, spinal fracture or dislocation). • Diagnosed inflammatory or neurological conditions.