Background: Methodological challenges such as recruitment problems and participant burden
make clinical trials in palliative care difficult. In 2001–2004, two community-based randomized
controlled trials (RCTs) of case conferences in palliative care settings were independently
conducted in Australia—the Queensland Case Conferences trial (QCC) and the Palliative Care
Trial (PCT).
Design: A structured comparative study of the QCC and PCT was conducted, organized by
known practical and organizational barriers to clinical trials in palliative care.
Results: Differences in funding dictated study designs and recruitment success; PCT had 6
times the budget of QCC. Sample size attainment. Only PCT achieved the sample size goal.
QCC focused on reducing attrition through gatekeeping while PCT maximized participation
through detailed recruitment strategies and planned for significant attrition. Testing sustainable
interventions. QCC achieved a higher percentage of planned case conferences; the QCC
strategy required minimal extra work for clinicians while PCT superimposed conferences on
normal work schedules. Minimizing participant burden. Differing strategies of data collection
were implemented to reduce participant burden. QCC had short survey instruments. PCT
incorporated all data collection into normal clinical nursing encounters. Other. Both studies
had acceptable withdrawal rates. Intention-to-treat analyses are planned. Both studies included
substudies to validate new outcome measures.
Conclusions: Health service interventions in palliative care can be studied using RCTs. Detailed
comparative information of strategies, successes and challenges can inform the design
of future trials. Key lessons include adequate funding, recruitment focus, sustainable interventions,
and mechanisms to minimize participant burden.