Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial.

Area of Science:

• Critical care medicine
• Rehabilitation research
• Project management in clinical trials

Background:

• Clinical trials management can be informed by project management theory.
• The CYCLE pilot randomized controlled trial (RCT) assessed the feasibility of early in-bed cycling in the intensive care unit (ICU).
• In-bed cycling is a novel intervention requiring specialized personnel and equipment in ICUs.

Purpose of the Study:

• To describe the implementation and conduct of the pilot RCT using a project management approach.
• To identify challenges and lessons learned in managing a multicenter ICU rehabilitation trial.

Main Methods:

• Retrospective review of trial activities, timelines, and personnel.
• Activities organized into four project management phases: initiation, planning, execution, and monitoring/controlling.
• Descriptive statistics and qualitative summary of lessons learned.

Main Results:

• Seven Canadian ICUs participated; time to first enrollment varied (median 185 days for REB, 162 days for contracts).
• 128 personnel trained, 80 completed activities; 4 sites needed additional training.
• Over 15 months, 864 patients screened, 256 eligible, 66 enrolled; 74% of eligible patients not randomized, primarily due to physiotherapist availability (80%).
• 13% of recruitment weeks lost due to physiotherapist staffing shortages.

Conclusions:

• Multicenter ICU rehabilitation trials require extensive planning, rigorous training, and dedicated personnel.
• Lessons learned include anticipating site needs, regular communication, data analysis, contingency planning, and acknowledging site contributions.
• Findings can guide future complex intervention trials in rehabilitation settings.