Implementing a shared decision-making intervention to support treatment decisions for patients following an anterior cruciate ligament rupture - a protocol for the POP-ACLR feasibility study

Hayley M Carter; David J Beard; Charlotte Dodsley; Paul Leighton; Joshua McCallion; Fiona Moffatt; Benjamin E Smith; Kate E Webster; Pip Logan

doi:10.1186/s40814-024-01503-6

Implementing a shared decision-making intervention to support treatment decisions for patients following an anterior cruciate ligament rupture - a protocol for the POP-ACLR feasibility study

Pilot Feasibility Stud. 2024 May 7;10(1):72. doi: 10.1186/s40814-024-01503-6.

Authors

Hayley M Carter^{1

2}, David J Beard³, Charlotte Dodsley⁴, Paul Leighton⁵, Joshua McCallion⁴, Fiona Moffatt⁶, Benjamin E Smith^{7

5}, Kate E Webster⁸, Pip Logan⁵

Affiliations

¹ Physiotherapy Outpatients, Florence Nightingale Community Hospital, Level 3, Derby, DE1 2QY, UK. hayley.carter1@nhs.net.
² School of Medicine, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK. hayley.carter1@nhs.net.
³ Surgical Intervention Trials Unit, NDORMS, Botnar Research Centre, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK.
⁴ Patient representative, The POP-ACLR Study, Nottingham, UK.
⁵ School of Medicine, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK.
⁶ School of Health Sciences, Queen's Medical Centre, University of Nottingham, Nottingham, NG7 2HA, UK.
⁷ Physiotherapy Outpatients, Florence Nightingale Community Hospital, Level 3, Derby, DE1 2QY, UK.
⁸ School of Allied Health, Human Services and Sport, La Trobe University, Kingsbury Drive, Bundoora, VIC, 3086, Australia.

Abstract

Background: Treatment for anterior cruciate ligament (ACL) rupture may follow a surgical or nonsurgical pathway. At present, there is uncertainty around treatment choice. Two shared decision-making tools have been codesigned to support patients to make a decision about treatment following an ACL rupture. The shared decision-making tools include a patient information leaflet and an option grid. We report the protocol for a mixed-methods feasibility study, with nested qualitative interviews, to understand feasibility, acceptability, indicators of effectiveness and implementation factors of these shared decision-making tools (combined to form one shared decision-making intervention).

Methods: A single-centre non-randomised feasibility study will be conducted with 20 patients. Patients diagnosed with an ACL rupture following magnetic resonance imaging will be identified from an orthopaedic clinic. The shared decision-making intervention will be delivered during a clinical consultation with a physiotherapist. The primary feasibility outcomes include the following: recruitment rate, fidelity, acceptability and follow-up questionnaire completion. The secondary outcome is the satisfaction with decision scale. The nested qualitative interview will explore experience of using the shared decision-making intervention to understand acceptability, implementation factors and areas for further refinement.

Discussion: This study will determine the feasibility of using a newly developed shared decision-making intervention designed to support patients to make a decision about treatment of their ACL rupture. The acceptability and indicators of effectiveness will also be explored. In the long term, the shared decision-making intervention may improve service and patient outcomes and ensure cost-effectiveness for the NHS; ensuring those most likely to benefit from surgical treatment proceed along this pathway.

Trial registration: Pending registration on ISRCTN.

Keywords: Anterior cruciate ligament; Extended normalisation process theory; Intervention development; Nominal group technique; Shared decision-making.

Grants and funding

NIHR302104/National Institute for Health and Care Research