• David C Currow, Amy P Abernethy, Tania M Shelby-James, and Paddy A Phillips.
• Department of Palliative and Supportive Services, Flinders University, Bedford Park. david.currow@rgh.sa.gov.au
• Palliat Med. 2006 Dec 1; 20 (8): 735-43.

AbstractEnd-of-life care must be informed by methodologically rigorous, high-quality research, but well-documented barriers make the conduct of palliative care clinical trials difficult. With careful consideration to study design and procedures, these barriers are surmountable. This paper discusses the approach used in a large scale, randomised, controlled trial of service-based interventions in a regional palliative care service in South Australia, and the impact of this trial on palliative care research more broadly, the changes to the service in which it was conducted, and on health policy beyond palliative care. The Palliative Care Trial evaluated three interventions in a 2 x 2 x 2 factorial cluster randomised design: case conferences, general practitioner education, and patient education. Main outcomes were performance status, pain intensity, and resource utilisation. A total of 461 patients were enrolled in the study. Pre-study planning and piloting is crucial, and accurately estimated withdrawal and death rates in the study. Other study design elements that facilitated this research included assessment of three interventions at one time, a dedicated recruitment role, a single clinical triage point, embedding data collection into routine clinical assessments, and meaningful outcome measures. Recruitment and retention of participants is possible if barriers are systematically identified and addressed. This study challenged and developed the research culture within our clinical team and subsequently translated into further research.

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