CLINICAL AND COST-EFFECTIVENESS OF A PERSONALISED GUIDED CONSULTATION VERSUS USUAL PHYSIOTHERAPY CARE IN PEOPLE PRESENTING WITH SHOULDER PAIN: A PROTOCOL FOR THE PANDA-S CLUSTER RANDOMISED CONTROLLED TRIAL AND PROCESS EVALUATION

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ABSTRACT Introduction Musculoskeletal shoulder pain is a common reason for people to be treated in physiotherapy services, but diagnosis can be difficult and often does not guide treatment or predict outcome. People with shoulder pain cite a need for clear information, and timely, tailored consultations for their pain. This trial will evaluate the introduction of a personalised guided consultation to help physiotherapists manage care for individuals with shoulder pain. Methods and analysis This is a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of introducing a personalised guided consultation compared to usual UK NHS physiotherapy care. Physiotherapy services (n=16) will be randomised in a 1:1 ratio to either intervention (physiotherapy training package and personalised guided consultation incorporating a new prognostic tool) or control (usual care). 832 participants (416 in each arm) identified from participating physiotherapy service waiting lists aged 18 years or over with shoulder pain will be enrolled. Follow-up will occur at 3-time points: 6 weeks, 6 months and 12 months. The primary outcome will be the Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes include global perceived change of the shoulder condition, sleep, work absence and the impact of shoulder pain on work performance, healthcare utilisation and health-related quality of life (using the EQ-5D-5L). A multi-method process evaluation will investigate views and experiences of participants and physiotherapists, assess uptake, facilitators and barriers to delivery, and changes in factors assumed to explain intervention outcomes. Primary analysis of effectiveness will be by intention-to-treat, and a health economic evaluation will assess cost-utility of introducing the personalised consultation. Ethics and dissemination The trial received ethics approval from the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070). Findings will be shared through journal publications, media outlets, and conference presentations. Supported by patient contributors and clinical advisors, we will communicate findings through a designated website, networks, newsletters, leaflets, and in the participating physiotherapy services. Trial registration ISRCTN: 45377604 STRENGTHS AND LIMITATIONS OF THIS STUDY This large cluster randomised controlled trial will evaluate the effects and costs of a new intervention, comprising a scalable physiotherapy training package and a personalised guided consultation that incorporates a new prognostic tool, to improve care for patients with shoulder pain in physiotherapy services. A multi-method process evaluation, informed by predefined logic model, will assess the uptake, acceptability and delivery the intervention. This approach will allow for a comprehensive understanding of the perspectives and experiences of both participants and physiotherapists. The first phase will be an internal pilot designed to strengthen the trial by assessing recruitment, retention, and intervention uptake, increasing the likelihood of successfully delivering the full trial. A potential limitation of the cluster trial design is the increased risk of participation bias related to differential recruitment between trial arms.

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