Real-time monitoring and feedback to improve shared decision-making for surgery (the ALPACA Study): protocol for a mixed-methods study to inform co-development of an inclusive intervention

Introduction: High-quality shared decision making (SDM) is a priority of health services, but only achieved in a minority of surgical consultations. Improving SDM for surgical patients may lead to more effective care and moderate the impact of treatment consequences. There is a need to establish effective ways to achieve sustained and large-scale improvements in SDM for all patients whatever their background. The ALPACA study aims to develop, pilot, and evaluate a decision support intervention that uses real-time feedback of patients’ experience of SDM to change patients’ and healthcare professionals’ decision-making processes before adult elective surgery and to improve patient and health service outcomes.
Methods and analysis: This protocol outlines a mixed-method study, involving diverse stakeholders (adult patients, healthcare professionals, members of the community) and three NHS trusts in England. Detailed methods for the assessment of the feasibility, usability, and stakeholder views of implementing a novel system to monitor the SDM process for surgery automatically and in real-time are described. The study will measure the SDM process using validated instruments (CollaboRATE, SDM-Q-9, SHARED-Q10) and will conduct semi-structured interviews and focus groups to examine 1) the feasibility of automated data collection, 2) the usability of the novel system, and 3) the views of diverse stakeholders to inform the use of the system to improve SDM. Future phases of this work will complete the development and evaluation of the intervention.
Ethics and dissemination: Ethical approval was granted by the NHS HRA North West - Liverpool Central Research Ethics Committee (reference: 21/PR/0345). Approval was also granted by North Bristol NHS Trust to undertake quality improvement work (reference: Q80008) overseen by the consent & SDM programme board and reporting to an Executive Assurance Committee.

 
Strengths and limitations of this study
• A mixed-methods study design will use a diverse representative sample of surgical patients from a range of NHS trusts to determine the feasibility of data collection, the usability of the novel system and understand views of diverse stakeholders to inform use of the system.
• Recruitment will focus on recognised under-served groups (economically disadvantaged, older age, ethnic minority) from Bristol and Bradford to maximise reach to an ethnically and socio-economically diverse population.
• The study uses three validated questionnaires to monitor SDM (CollaboRATE, SDM-Q-9, SHARED-Q10), including first use of the SHARED-Q10 measure in a surgical setting.
• This study excluded patients without decisional capacity due to distinct requirements and guidance for consent and shared decision making processes in this population.