title: A pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care-methodology of the Palliative Care Trial [ISRCTN 81117481].
abstract: The demand for palliative care is increasing, yet there are few data on the best models of care nor well-validated interventions that translate current evidence into clinical practice. Supporting multidisciplinary patient-centered palliative care while successfully conducting a large clinical trial is a challenge. The Palliative Care Trial (PCT) is a pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial that tests the ability of educational outreach visiting and case conferencing to improve patient-based outcomes such as performance status and pain intensity. Four hundred sixty-one consenting patients and their general practitioners (GPs) were randomized to the following: (1) GP educational outreach visiting versus usual care, (2) Structured patient and caregiver educational outreach visiting versus usual care and (3) A coordinated palliative care model of case conferencing versus the standard model of palliative care in Adelaide, South Australia (3:1 randomization). Main outcome measures included patient functional status over time, pain intensity, and resource utilization. Participants were followed longitudinally until death or November 30, 2004. The interventions are aimed at translating current evidence into clinical practice and there was particular attention in the trial's design to addressing common pitfalls for clinical studies in palliative care. Given the need for evidence about optimal interventions and service delivery models that improve the care of people with life-limiting illness, the results of this rigorous, high quality clinical trial will inform practice. Initial results are expected in mid 2005.
authors.affiliation: Department of Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia. amy.abernethy@duke.edu
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
authors.forename: David C
authors.initials: DC
authors.lastname: Currow
authors.forename: Roger
authors.initials: R
authors.lastname: Hunt
authors.forename: Helena
authors.initials: H
authors.lastname: Williams
authors.forename: Gerda
authors.initials: G
authors.lastname: Roder-Allen
authors.forename: Debra
authors.initials: D
authors.lastname: Rowett
authors.forename: Tania
authors.initials: T
authors.lastname: Shelby-James
authors.forename: Adrian
authors.initials: A
authors.lastname: Esterman
authors.forename: Frank
authors.initials: F
authors.lastname: May
authors.forename: Paddy A
authors.initials: PA
authors.lastname: Phillips
mesh_terms: D000368:Aged; D017028:Caregivers; D016000:Cluster Analysis; D005260:Female; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D059408:Pain Management; D010166:Palliative Care / Q000379:methods* / Q000706:statistics & numerical data*; D010348:Patient Care Team / Q000458:organization & administration*; D010353:Patient Education as Topic / Q000379:methods*; D011786:Quality Control; D012107:Research Design