A comparison of methodologies from two longitudinal community-based randomized controlled trials of similar interventions in palliative care: what worked and what did not?

Abstract

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 gate-keeping 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 sub-studies 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.