Implementing an integrated psychological and physical intervention in routine physiotherapy practice for patients with musculoskeletal road traffic injury: protocol for a hybrid implementation-effectiveness type III cluster randomised controlled trial

在针对肌肉骨骼交通事故损伤患者的常规物理治疗实践中实施心理和生理综合干预:一项混合实施效果III型整群随机对照试验方案

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Abstract

BACKGROUND: Up to 50% of individuals with musculoskeletal road traffic injury (RTI) develop chronic pain, resulting in substantial individual and societal burden. Integrated psychological and physical care, such as StressModex, improves patient outcomes compared to physical treatment alone. However, StressModex is not routinely implemented in physiotherapy practice, due to limited training access and physiotherapists' lack of confidence in delivering psychological care. To address this gap, we developed a blended learning implementation strategy-Physiotherapist bIopsyChosocial On-line Training (PICOT)-guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. The aims of this trial are to compare: (1) the effectiveness of PICOT versus in-person training on the reach of StressModex in routine community private physiotherapy practice; (2) the effectiveness of PICOT versus in-person training on adoption, implementation fidelity, sustainability, and maintenance of StressModex; (3) the effectiveness of PICOT versus in-person training on patient health outcomes; and (4) the cost-effectiveness of PICOT versus in-person training. Trial outcomes are informed by the RE-AIM framework. METHODS: This is a hybrid type III implementation-effectiveness, cluster randomised, superiority trial with embedded economic and qualitative process evaluations. Thirty primary care physiotherapy clinics across Australia will be randomly assigned to either the PICOT or traditional 2-day in-person training. PICOT includes a 6-week online program, 6 weeks (once/week) of real-time online group training with individualised feedback, then 3 clinical supervision on-line sessions (once per fortnight). All on-line sessions are co-facilitated by a clinical psychologist and expert physiotherapist. Following training, physiotherapists will deliver StressModex to eligible patients (≥ 18 years, ≤ 12 weeks of musculoskeletal spinal pain post RTI, and at risk of poor recovery). The primary implementation outcome is reach, defined as the proportion of eligible patients treated with StressModex over 8 months. Secondary outcomes include adoption (training participation and initial uptake), implementation (dose, fidelity, and sustainability of delivery), patient health outcomes (collected at Time1, 8 weeks, 6-, and 12 months), and cost-effectiveness. DISCUSSION: This trial will provide critical evidence on scalable training models for embedding integrated psychological and physical care into physiotherapy practice. Findings will inform strategies to improve the implementation and sustainment of evidence-based interventions for musculoskeletal RTIs. TRIAL REGISTRATION: ACTRN12624001268538. Registered on 18 October 2024. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspxid=388006&showOriginal=true&isReview=true.

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