ICU research coordinator activities: a time-in-motion multicenter study

Background

ICU Research Coordinators (ICURCs) represent a growing membership in the Canadian Critical Care Trials Group (CCCTG). The professional contribution of ICURCs to clinical critical care research is profound, but has not been well characterized.

Objective

To describe the settings, studies, resources, tools, and activities of Canadian ICURCs.

Methods

We conducted a prospective observational time-in-motion study of CCCTG ICURCs from 20 September to 15 October 2004. We generated items and domains in focus groups. The instrument was formatted using both open and closed ended responses. We piloted for comprehensiveness and clarity. We obtained data on the setting, studies, tools and resources available in each center, then used a weekly management log to document activities under seven domains. Completed forms were faxed to the Methods Center at St Joseph's Healthcare and entered into an Excel Spreadsheet for descriptive analyses.

Results

Twenty ICURCs participated from 13 mixed ICUs (100% university-affiliated hospitals with 440 ± 225 hospital beds and 23 ± 11 ICU beds). Over 4 weeks in 13 ICUs, 104 ± 64 patients were admitted, 74 ± 60 were screened and 9 ± 9 were enrolled in studies. On average, there were 4.6 ± 2.1 peer reviewed, and 3.8 ± 3.5 industry studies; 5.8 ± 3.4 were RCTs, 2.8 ± 2.3 were observational and 0.8 ± 1.2 were other designs. On average, 7.1 ± 5.8 studies enrolled adults and 1.5 ± 2.4 enrolled children. These resources were accessed electronically: laboratory data (100%), diagnostic images (53.8%), radiology reports (69.2%), ECGs (15.4%) and clinical information systems (15.4%). Data collection tools include: paper (100%), NCR paper (38.5%), datafax (38.5%), laptop (7.7%), PDAs (0%), and Web-based approaches (84.6%). Time spent in each of seven activities was: study preparation (literature review, inhouse protocol development, REB submissions and amendments, budget preparation, CRF development and piloting, regulatory document assembly, in-services), 16.5%; research conduct (screening, consent and family meetings, pharmacy and other study supplies, data collection and queries, conducting and preparing tests, AE and SAE reporting, bedside protocol compliance), 44.1%; communication (email/ telephone calls/mail, staff education), 14.3%; management (team meetings, multicentered management, screening and finance logs, initiation audit and close-out visits), 13.5%; data management (database creation and data entry, analysis), 3.9%; dissemination (interim and final reports, conference preparation and presentation), 3.0%; and miscellaneous, 4.7%.

Conclusions

CCCTG ICURCs work primarily in mixed university-affiliated ICUs, conducting randomized trials in adults. The availability of electronic resources is modest, and variable data collection methods are employed. ICURCs engage in many activities to prepare, implement, and manage investigations for critically ill patients.