Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach

Area of Science:

• Palliative Care Research
• Health Services Research
• Methodology

Background:

• Evaluating complex interventions in palliative care requires a clear understanding of usual care.
• Lack of standardized methods for describing usual care hinders interpretation of intervention effectiveness.
• This study addresses the need for feasible approaches to characterize usual care in palliative care settings.

Purpose of the Study:

• To demonstrate the feasibility of a multi-method approach for describing usual care in palliative care randomized controlled trials (RCTs).
• To provide a practical framework for researchers to define and assess usual care within complex intervention studies.
• To enhance the reliability and interpretability of findings from palliative care intervention research.

Main Methods:

• A feasibility cluster randomized controlled trial (RCT) employing a multi-method approach.
• Data collection included usual care questionnaires, baseline case note review, and focus groups with ward staff.
• Analysis involved thematic analysis of qualitative data, descriptive statistics, and methodological triangulation.

Main Results:

• The multi-method approach proved feasible for describing usual care in the selected palliative care wards.
• Findings revealed similarities, heterogeneity, and subtle changes in usual care practices during the trial.
• The approach provided a comprehensive understanding of usual care in terms of context, structures, processes, and outcomes.

Conclusions:

• A feasible and practical multi-method approach for defining usual care in palliative care research is presented.
• Accurate description of usual care enhances the reliability of complex intervention evaluations.
• This methodology can inform future research and policy development in palliative care.