Effectiveness-implementation hybrid type 2 study evaluating an intervention to support 'information work' in dementia care: an implementation study protocol.

INTRODUCTION: Patients with long-term conditions consistently report a lack of information around services and support available to them. This unmet need for information is significant among people with dementia and family carers. A quality improvement intervention is being carried out to tackle this issue as part of a co-creation initiative in the North East of England (UK). The intervention consists of the dissemination (via the local Community Mental Health Services for Older People) of a leaflet about services available to people with dementia and their family carers in the study site. This protocol is reported in accordance with the Standards for Reporting Implementation Studies. METHODS AND ANALYSIS: This effectiveness-implementation hybrid type 2 study aims at understanding (1) the unfolding and outcomes of the implementation strategy, (2) the outcomes of the intervention (for people with dementia and family carers, staff implementing the intervention and local service providers) and (3) the contribution of co-creation to the design and implementation of the intervention and its outcomes. The prospective theory of change of the intervention articulated by local stakeholders is used as a reference framework against which to assess the implementation and outcomes of the intervention. Evaluation data will be collected through in-depth interviews with people with dementia and family carers receiving the intervention, staff implementing the intervention and managers from local service providers. Referral data from local service providers will be collected to triangulate the interview data. A focus group with key stakeholders will support the sense-making of findings. The realist configuration of mechanism-context-outcome, operationalised using an information behaviour model, will inform data analysis and interpretation. ETHICS AND DISSEMINATION: Ethical and research governance approvals have been obtained from the West Midlands-South Birmingham Research Ethics Committee. The results of the study will be submitted for publication in peer-reviewed journals and disseminated through conferences.

Development of a sensitive and fast UHPLC-MS/MS method for determination of clopidogrel, clopidogrel acid and clopidogrel active metabolite H4 in human plasma.

BACKGROUND: Quantitation of CAM H4 in biological matrix has been a challenge due to low concentrations, instability and the existence of four CAM diastereomers. Historically, either inactive clopidogrel acid or CAM diastereomers without separation were measured for exposure and PK parameters. RESULTS: This study presents a sensitive and fast UHPLC-MS/MS method for simultaneous quantitation of clopidogrel, clopidogrel acid and active metabolite H4 in human plasma. The method demonstrated the separation of H4 from other isomers and yet retained clopidogrel acid. Matrix stabilities, accuracy and precision, recovery and matrix effect were evaluated during development. CONCLUSION: With LLOQ of 0.05 ng/ml for clopidogrel and H4, and 5.5 min LC gradient, it is the most sensitive and fastest method to our knowledge.