Driving quality in delirium care through a patient-centered monitoring system in palliative care: Protocol for the two-staged exploratory sequential mixed methods MODEL-PC study

Introduction
Delirium is a serious acute neurocognitive condition that is common in palliative care units and yet under-addressed. To improve delirium care in this setting, we will develop and pilot a monitoring system that integrates the Delirium Clinical Care Standard, Palliative Care Outcomes Collaboration (PCOC) methods, and perspectives of patients, carers and staff.

Methods
This paper reports the protocol for a two-stage, exploratory, sequential mixed-methods implementation study. Stage 1 data collection includes Delirium Standard-aligned process mapping and clinical audits, and Critical Incident Technique interviews with patients, carers and staff with a recent experience of delirium. We will present integrated stage 1 findings to stakeholders then collaboratively develop a delirium monitoring system that aligns with the Delirium Standard and PCOC methods. In stage 2, we will pilot the new system and repeat stage 1 data collection and analyses, adding PCOC and adverse event measures. Implementation principles and strategies such as audit and feedback and education will be applied. We developed simplified participants information sheets and consent forms for interview and process mapping participants, who will provide written informed consent; and waiver of consent to collect clinical audit, PCOC and adverse event data from patients’ medical records is approved. At study end, we will report implementation, effectiveness and safety outcomes, including systemic utility of the delirium monitoring system for wider testing and use to meet the Delirium Standard in palliative care units. Quantitative data analyses will include descriptive and inferential statistics and qualitative analyses will incorporate thematic content analysis aligned to the Critical Incident Technique. Mixed methods data integration will be at the end of each stage.

Discussion
This protocol paper describes the mixed methods, systems integration, and innovative measures and study processes of the MODEL-PC study. We also share data collection tools and a simplified information sheet and consent form for patients.