Patient led earlier mobilisation for COnservatively managed displaced Proximal humErus fractures (COPE): Intervention development and feasibility trial

Background Proximal humerus fractures (PHFs) are common and when managed conservatively are treated with a sling for around 6 weeks followed by physiotherapy-led exercises. There is variation in sling type and the accompanying exercise regimens.

Whilst earlier sling removal is believed to be associated with reduced pain, falls, and earlier return to normal activities, optimal configuration of shorter sling duration alongside other components is unknown, and if a minimum time is required.

I propose to develop a new model of care for early sling removal and test its feasibility and acceptability for evaluation within a future definitive trial.

Research question What would a model of care for early sling removal in patients with a conservatively managed PHF consist of (WP1 &2) and is it feasible to test it in a definitive trial (WP3)?

Methods (Timelines) I will establish a stakeholder group comprising of 8 diverse PPI members and 8 health care professionals(HCPs) to advise on all elements of the DCAF. All activities will be designed to follow the NIHR framework for cultural competence.

Appropriate governance and ethical approvals will be obtained WP1 Model of care agreement and development (6 to 12 months) Informed by the evidence from my systematic review, uni-professional and patient focus groups will be convened to obtain views on the different components of the model of care involving early sling removal i.e. which patients to be included, type(s) of sling offered, time to offer early removal and nature and duration of physiotherapy elements.

A consensus panel including PPI members and volunteers from all focus groups will then agree and define the design of the final model of care.

We will additionally work with our PPI group to identify any elements which will require modification to ensure cultural competence in delivery.

WP2 Development of a package to support HCPs to deliver the model care (9 to 18 months) Interviews will be undertaken with doctors to explore barriers and enablers to routinely offering early sling removal.

Thematic analysis of the interviews, underpinned by Normalisation Process Theory, will inform a first workshop with doctors to identify the most appropriate approaches to address barriers and effectively utilise enablers. Materials will be subsequently developed and presented at a second workshop to agree final design and content.

A fidelity framework for process evaluation purposes will be derived from WP1 and 2.

WP3 Feasibility study (19 to 30 months) A single centre study will be performed with 40 patients recruited to receive the intervention. Potential population size and recruitment rate will be assessed. Appropriate outcome measures will be tested for practicability, data quality and completeness. Our fidelity framework will be tested.

The support packages reach and dose will be described. Mechanism of action, acceptability and practicability will be ascertained through stakeholder interviews. Anticipated impact and dissemination As a feasibility study, results will inform future research. Papers will be published on the model of care, delivery support package and feasibility study.

If feasible to conduct a definitive study, I will develop a future grant application.